Advisory of May 11, 2005, announcing the hearing

WITNESSES

SUBMISSIONS FOR THE RECORD

Ablechild.org, New Canaan, CT, Sheila Matthews and Gloria M. Wright, statement and attachment

Alliance for Human Research Protection, New York, NY, Vera Hassner Sharav and John H. Noble, Jr., Ph.D., statement

American Family Rights Association, Morongo Valley, CA, Cheri Carlene Campbell, statement

Asplund, Linn, Waterbury, CT, statement

Child Welfare League of America, Alexandra Yoffie, statement

Jacobi Medical Center, Bronx, NY, Andrew Wiznia, letter

Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Alfred Sommer, M.D., letter

National Institute of Allergy and Infectious Diseases, Division of Aids, Office for Policy in Clinical Research Operations, Potomac, MD, Jonathan M. Fishbein, M.D., letter

New York City Administration for Children's Services, New York, NY, John Mattingly, statement

Pediatric Aids Clinical Trials Group, University of California, San Diego, La Jolla, CA, Stephen A. Spector, M.D., statement

Sabato, Patricia, Sandy Hook, CT, statement

Schuldt, Sharon, Rockford, IL, letter

William Glasser, Inc., Chatsworth, CA, William Glasser, M.D., letter

Wednesday, May 18, 2005

U.S. House of Representatives,
Committee on Ways and Means,
Subcommittee on Human Resources,
Washington, DC.

The Subcommittee met, pursuant to notice, at 2:09 p.m., in room B-318, Rayburn House Office Building, Hon. Wally Herger (Chairman of the Subcommittee) presiding.

[The advisory announcing the hearing follows:]

Chairman HERGER.  Good afternoon, and welcome to today's hearing.  To begin the hearing today, I would like to make note that we have a new Member on the Subcommittee, Mr. Devin Nunes of California.  Welcome, Devin.  We look forward to working with you on the many important issues within the Subcommittee's jurisdiction. 

At today's hearing, the Subcommittee will examine an extraordinarily sensitive topic, the enrollment of children in foster care in clinical drug trials involving experimental but potentially lifesaving drugs.  Children in foster care have been separated from their biological parents and placed in a temporary setting which can last for years or, in some cases, their entire childhood.  Many of these children have special medical needs, including life-threatening illnesses like Acquired Immunodeficiency Syndrome (AIDS).  Thousands of foster children in the late 1980s and early 1990s were afflicted by AIDS. Treatments for children had not yet been found or tested.  For some of these children, clinical trials were seen as a promising and possibly only way to save, lengthen or improve these young lives.  When biological parents could not be found or were incapacitated due to addiction or illness, social workers, court personnel and others involved in the children's care had to make life-and-death decisions about whether foster children should be placed in clinical trials.  Those trials involved both hope and risk.  Concerns have been raised about the right balance between hope and risk, and who gets to make that critical decision. 

Recent news stories report that States have a variety of policies for when children in foster care may or may not participate in clinical trials.  Even though there are Federal guidelines, there is no consistent policy across States.  These reports also suggest that, in some cases, protections were either not enforced or were inadequate.  These are serious allegations.  That is why it is important that we closely examine the facts.  It seems to me there are three main questions involved in today's hearings.  First, should children in foster care be involved in clinical trials?  Second, if foster children are permitted to participate in clinical trials, what are the protections now in place to ensure their safety?  Third, are those protections adequate?  Some States have adopted the policy that children in foster care simply cannot participate in clinical trials, as we will hear described shortly.  Other States permit participation, but only based on the decision of a judge or following the naming of an independent advocate to monitor the foster child's best interest.  Still other States rely on the foster care system and its case workers, medical experts and foster parents to make these decisions.  In some cases, these decisions are made after trying to consult the child's biological parents. 

As I mentioned earlier, our purpose today is to understand these various measures, all of which are designed to protect children in foster care to determine whether those protections are adequate and appropriate.  In other words, how do we balance risk and hope?  Given the lack of available information on this topic, I have asked the U.S. Department of Health and Human Services (HHS) to survey the 50 States about the specific policies and protections they have in place regarding the enrollment of foster children in clinical trials.  I look forward to the results of that survey. 

We welcome all our witnesses today to explore these issues.  I note there are no Democrat or Republican witnesses here today.  I appreciate the cooperation of Mr. McDermott and his staff in selecting the witnesses appearing before us.  Joining us are experts on topics ranging from Federal protections for children enrolled in clinical studies to individuals familiar with State policies regarding foster child enrollment.  I would also note that we have written background information and written testimony from a variety of sources who could not join us today, including the child protection agencies of New York City and the State of Illinois.  The official record of this hearing will remain open for 2 weeks should others wish to offer their input for this Subcommittee's consideration. 

We look forward to today's testimony and our witnesses' help in answering our many questions and helping us decide how best to proceed.  Without objection, each Member will have the opportunity to submit a written statement and have it included in the record at this point.  Mr. McDermott, would you care to make a statement?

[The opening statement of Chairman Herger follows:]

Mr. MCDERMOTT.  Surely.  Thank you, Mr. Chairman.  First of all, I want to thank the Chairman for having this hearing.  I think it is an important issue and one that requires us to be thoughtful.  Sometimes issues like this can be sort of explosive, but I think this is an issue to be thoughtful about because I am sure many were shocked when they read the recent press accounts of foster kids being involved in clinical trials without adequate protection.  As a physician, I know the role medicine plays in saving and improving lives every day.  I have been involved in the AIDS epidemic beginning when I was with the State Department in 1987, so I have seen the evolution of the Department.  Many of these cases we are talking about here were late 1980s cases, early 1990s cases.  I think we have to put things in perspective of the real crash feeling there was in those days about getting some treatment and figuring out what we could do for a variety of people in this situation. 

However, we learned through top-notch investigative reporting by the AP that children in the child welfare system had participated in scientific experiments used to determine the effectiveness of AIDS medication, and that participating, in my view, is not necessarily bad.  I want to say that right up front, because trials are scientific paths to new and more effective treatments.   I think what is true, however, is we must be assured that the system defends the best interests of the children involved in these studies.  They are alone.  They have been taken away from their parents.  They are without an advocate.  They are vulnerable, and they could be taken advantage of by the system if it fails them. 

Over the last 18 months, this Subcommittee has heard hearings about a number of issues affecting kids in the Federal, State child welfare programs, and this issue is like many of them:  It is has the potential for being explosive.  The child welfare program in the richest, most powerful country in the world is and has been often an abysmal failure.  Now, we don't need proof of more of that.  We can give you all kinds of examples of it.  We know about kids losing their lives in the child welfare system.  Practically every State legislature every year deals with one case or another, and everybody wrings their hands, and the problems go on.  The kids are sometimes locked up.  Sometimes starved under the supervision of the agencies.  We know the children have been used without proper supervision for drug testing. 

Now, the question the public has to ask us and I think we have to ask ourselves on this Subcommittee is, how do we give that proper supervision?  When are we going to reform the child welfare system so that we protect these vulnerable kids and provide them with the opportunity to succeed?  They have enough strikes against them going in because they are in the foster system, and the question really is, what can we do not to make it worse for them but to make it better? 

We have a group of distinguished witnesses here today, and I for one expect them to give us ideas about how we can improve the system for children.  The Subcommittee put out a press release announcing today's hearing.  Now, press releases are one part of the political process, but our challenge and really what the public should demand of us is a bipartisan Subcommittee action.  I really think, Mr. Chairman, we need to act to improve the welfare of children that do not have a stable and safe family.  We really need reform on a variety of things, but it takes courage and leadership and new resources, but it needs to be done.  It is not an easy job.  I dealt with these issues when I was in the State legislature, and they are no less contentious now up here than they were down there.  Our Nation's children need us.  They need what we put together in a child welfare program that lifts them up rather than puts them down or lets them down.  I for one am grateful for you for having this hearing, and I hope that we can come out of it with some things that we can then put into law and actually do something.  We have talked a lot and listened a lot, but it is time for us to do something.  Thank you, Mr. Chairman. 

Chairman HERGER.  Thank you, Mr. McDermott.  Before we move on to our testimony, I want to remind our witnesses to limit their oral statement to 5 minutes.  However, without objection, all the written testimony will be made a part of the permanent record.  To start our hearing this afternoon, we will hear from the Honorable Donald Young, M.D., who is the acting principal deputy assistant secretary for planning and evaluation at HHS.  Dr. Young, please proceed with your testimony.

STATEMENT OF DONALD YOUNG, M.D., ACTING PRINCIPAL DEPUTY ASSISTANT SECRETARY FOR PLANNING AND EVALUATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES  

Dr. YOUNG.  Mr. Chairman, distinguished Members of the Subcommittee, thank you for inviting me here today to discuss Federal protections for foster children enrolled in clinical trials.  I am Dr. Donald Young, deputy assistant secretary for planning and evaluation in HHS.  The President and Secretary Leavitt have as a first principle the protection of the most vulnerable in our population.  Foster children are certainly vulnerable, and failing to protect them will not be tolerated. 

Dramatic advances in prevention and treatment of disease have been achieved through research.  A crucial part of these medical advances involves participation of human subjects, including children, in clinical trials.  The Department of Health and Human Services is deeply committed to ensuring the protection of the rights and welfare of every individual who participates in clinical research.  This afternoon, I will discuss the evolution of the Human Immunodeficiency Virus (HIV)/ AIDS, the management of the disease, pediatric AIDS and foster care, and the Federal protections in place to ensure the safety of human subjects, including children, and children who are wards. 

In 1990, as many as 2,000 babies were born infected with HIV.  Now that number has been reduced to a bit more than 200 a year in the United States..  HIV has evolved from a disease that kills to a disease that is chronic and manageable.  Clinical research including research in children is necessary to make advances in medicine.  Clinical research involves risks, however, and it is the responsibility of the medical research community to ensure that all trial participants fully understand both the potential benefits and the potential risks of their participation. 

It is estimated that, through 1989, between 16 and 22 percent of pediatric AIDS patients were children in foster care.  Many of these children were placed in foster care because the caretaker parent had died or become incapacitated by AIDS, or because of neglect, abuse, or abandonment associated with parental drug abuse.  The fact that fewer than 2 percent of foster children diagnosed as HIV-positive in 1989 were participating in clinical trials was viewed as evidence that the foster care system had failed to completely and effectively cope with the influx of HIV-infected children. 

At the time, most State laws allowed only for standard medical treatment for children in foster care; because there were no standard treatments for HIV-infected children, this limitation represented a critical barrier to medical care for children with HIV.  Federal regulations are in place to provide protections for human subjects, including children and foster children, involved in HHS conducted, supported or regulated research.  Ultimately, however, it is the State and in some cases county foster care agencies that decide who provides permission for these children to be enrolled in clinical trials.  Institutional review boards (IRB)--working with researchers establish within Federal guidelines what procedures should be followed to acquire consent in specific study protocols.  The HHS and Food and Drug Administration (FDA) regulations also contain a number of other requirements relating to IRB membership and procedures, criteria for IRB approval of research, suspension or termination of IRB approval research and general requirements for informed consent. 

The regulations permit IRBs to approve three categories of research or clinical investigation involving children as research subjects.  A fourth category requires an additional level of review.  First, research or clinical investigations not involving greater than minimal risk to the children:  There, the IRB must determine that the research or clinical investigation presents no greater than minimal risk to the children.  Second, research or clinical investigation involving greater than minimal risk but preserving the prospect of direct benefit to the individual child subjects:  Here, the IRB must determine the risk is justified by the anticipated benefits to the subjects, the relation of the anticipated benefit to the risk presented by the study is at least as favorable to the subjects as that provided by alternative available approaches. 

In each of the next two categories, HHS and FDA regulations include a provision that provides additional protections for children who are wards of the State or any other agency, institution, or entity.  First, research or clinical investigations involving greater than minimal risk and no prospect for direct benefit to the individual child subjects but likely to yield generalizeable knowledge about the subject's disorder or condition:  The IRB must determine the risk of the research or clinical investigation represents a minor increase over minimal risk; the intervention or procedure presents experiences to the child subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social or educational situations; the intervention or procedure is likely to yield generalizeable knowledge about the subject's disorder or condition which is of vital importance for the understanding or amelioration of the disorder or condition.  Second, research or clinical investigation that the IRB believes does not meet the above categories of the HHS or FDA regulations but finds that the research presents a reasonable opportunity to further the understanding, prevention or alleviation of a serious problem affecting the health or welfare of children requires a specific level of HHS review beyond that provided by the IRB. 

In all cases, the IRB must ensure that adequate provisions have been made for soliciting permission of parents or legal guardians and the assent of the children to the extent required by HHS and FDA regulations.  Before children who are wards of the State or any other agency, institution or entity can be included in either of the last two categories of research or clinical investigations, the research must meet the following conditions:  The research must either be related to the children's status as wards or conducted in schools, camps, hospitals, institutions or similar settings in which the majority of children involved as subjects are not wards.  The IRB must require appointment of an advocate for each child who is a ward in addition to any other individual acting on behalf of the child as guardian. 

The Office of Human Research Protections (OHRP) and FDA have implemented oversight activities both to respond to complaints and to monitor compliance with Federal regulations.  OHRP's compliance oversight activities can be divided into three major categories.  First, for-cause oversight investigations; second, not-for-cause compliance oversight surveillance evaluations; and, third, review and analysis of institutional reports of noncompliance, unanticipated problems involving risks to subjects, or suspensions or terminations of IRB approval of research. 

FDA regulation and oversight for clinical research extend not only to IRBs and institutions but to clinical investigators, research sponsors, contract research organizations, laboratory facilities conducting preclinical research and bioequivalence firms.  As you know, Mr. Chairman, of recent press reports there is an ongoing investigation, and I will not be able to answer any questions related to the investigation. 

In conclusion, we continue to address challenges posed by the threat of HIV/AIDS and are committed to basic and clinical research to strengthen the Nation's ability to cope with this infectious disease.  The protection of human subjects, including children, in clinical trials has been and will remain a top priority for HHS.  HHS is firmly committed to the protection of the rights and welfare of every individual who participates in human research, consistent with sound ethical standards and regulatory requirements.  I will be happy to answer any questions.

[The prepared statement of Dr. Young follows:]

Chairman HERGER.  Thank you, Dr. Young.  The gentleman from California, Mr. Nunes, to inquire. 

Mr. NUNES.  Thank you, Mr. Chairman, and thank you for welcoming me to the Subcommittee.  Welcome, Dr. Young.  In relation to some of the news reports that have been out there recently, do we know whether any children in foster care today are participating in clinical trials?  If so, do you know how many?

Dr. YOUNG.  I do not have that information.  We know that across the National Institutes of Health (NIH) there are a number of clinical trials ongoing and children participating, but I do not have numbers of children in foster care that might be in that group. 

Mr. NUNES.  Okay.  Could that be something that you could find out?  Could you submit that to the Subcommittee if you do?

Dr. YOUNG.  If we can find it through our survey information, I will. 

Mr. NUNES.  Okay.  Another question.  Your testimony says that the State child welfare agencies were strongly urged to reduce barriers to foster children's participation in such trials.  In the early days of the AIDS crisis, what were those barriers, and who strongly urged State officials to reduce those barriers?

Dr. YOUNG.  I think that the desire to reduce those came from across the community.  In those years, as I said in my testimony, there was no treatment unless you were involved in a clinical trial.  This was an emerging disease, and treatments were just emerging at that time, so there was wide support.  The barriers included the State laws and requirements that I mentioned in my testimony that said only standard care could be given to individuals in foster care.  That prevented them from being enrolled, and the feeling was that the children in foster care should have the same opportunity to make a decision, an election or to have their wards do it for them, to participate if they wanted to participate and get the value and advantage of that trial. 

Mr. NUNES.  Thank you, Doctor.  Thank you, Mr. Chairman. 

Chairman HERGER.  Thank you.  The gentleman from Washington, Mr. McDermott, to inquire. 

Mr. MCDERMOTT.  Thank you, Dr. Young.  Good testimony and I would like to ask you a couple questions about the structuring of the clinical trials.  Is there anything in the NIH requirements that require a State to have in place an advocacy requirement?  Or can any physician who wants to do a trial in whatever State send in an application and operate within the laws of that State and be considered acceptable to NIH?  In other words, does NIH have a set of standards that require that the State must fit?

Dr. YOUNG.  The Office of Human Protection is the Federal agency, has a baseline set of requirements that must be adhered to and that the IRB must follow.  That deals with, as I said in my testimony, the last two categories, those clinical trials where there is more than a minimal risk involved.  Under those circumstances, then, an advocate needs to be appointed for children in foster care to make the decision and ensure that the child is protected and fully informed. 

Mr. MCDERMOTT.  The question then comes down to these--it is always words.  In your testimony, you said you may say that protection is not required if the research has minimal risk--minimal being the operative word--or if it has the prospect of direct benefit.  Those again being the operative words.  Who makes those decisions as to what is minimal, what is direct benefit to the child?  How is that determined?

Dr. YOUNG.  The Institutional Review Board has the responsibility to approve all research protocols that are put forward by investigators.  Most of those institutional review boards are under a hospital, academic medical center or other place that also has the responsibility to ensure that there is IRB compliance to that.  There is a set of Federal rules.  There are then the requirements that the IRB must consider in making a decision whether to approve the research as well as any additional requirements that come from the institution.  Beyond that, there are a number of States that have also passed laws that may--putting stronger requirements in place. 

Mr. MCDERMOTT.  Could it be possible today to have a child brought into a clinical trial in a State where there was no requirement for advocacy for something--these AIDS drugs when we were looking back at them in 1987 and 1988 and 1989, there was no children's research being done.  What this was about is really the first children's research.  How did anybody decide it was minimal risk or that it was a direct benefit to the kids?  How did they come up--without an advocate--it would seem to me like you would want to automatically have an advocate in something as new as that.

Dr. YOUNG.  Yes.  There are two parts to your question.  One is the advocate and the situations more than minimal risk that there must be an advocate.  That is not to say, however, in all situations there isn't the State agency or a ward that is making decisions.  Somebody has to consent to it, and it has to be an informed consent.  It is only when the risk is more than minimal and the conditions that I described in my testimony that, in addition to that, you need a special advocate for the patient.  Now, the second part of that are the rules and requirements for research to make sure that it is conducted properly.  You need an advocate, but you need a research protocol that is laid out that protects the individuals in that trial, whether they are foster children, adults or children not in foster care. 

Mr. MCDERMOTT.  The reason I ask those questions, I can envision a situation in which a child care worker who is dealing with AIDS cases coming out of a city hospital or whatever may have 30, 40 kids or 60 kids, and to expect the child care worker to be on top of the case, it seems to me, sets the ground for kids slipping through the cracks as they do in a variety of different ways in the system.  I wonder if you--, if you don't have minimum requirements for how many--or maximum requirements for how many kids a worker is responsible for, to expect he or she to cover 60 kids, all of whom are in AIDS treatment programs all over the city or whatever, it seems like you would want to have somebody for each kid to look after or at least--you can see my problem.

Dr. YOUNG.  I do, and let me try to explain it one more time.  There is an advocate appointed for the children in foster care.  That advocate is different under the requirements.  That advocate is different than the State agency.  That advocate could be part of the PRB.  It could be somebody who is particularly interested in kids.  Each advocate might have one, two or three kids.  This is not the case worker who is the advocate under those situations.  The advocate is somebody in addition to the State foster care agency. 

Mr. MCDERMOTT.  So, this is a volunteer who comes in and gets involved in the advocacy program in the local State agency and has three kids with maybe no background whatsoever in the specific issues.

Dr. YOUNG.  No.  There are requirements also regarding the advocacy that are part of the PRB requirements, that the advocate have the knowledge and be familiar with the condition.  It is not anyone off the street can come in and be an advocate. 

Mr. MCDERMOTT.  I wasn't implying that they were just off the street.  This is a specific, very difficult decision to put a kid into a treatment case.  , the reason I am sensitive about this is, we have a cancer center in Seattle. I have seen what happens when you are using advanced treatments in cancer and then people later say, well, I didn't know the risks.  There is a whole lot of responding backwards and forwards about what people knew.  In this case, you have a kid who doesn't have a clue what is going on.  He is being brought or she is being brought, put into the system, and I am wondering how you know, how you can guarantee that that kid has somebody who really understands what is going on? 

Dr. YOUNG.  I understand your question.  That is the issue of what is informed consent, and how much knowledge must you have to achieve informed consent?  That question is directly relevant to all research, and particularly to research on kids, and then foster kids add an additional level and layer.  So, there is a responsibility to attempt to communicate as clearly as one can, but as you know, in lay terms, it is sometimes difficult to communicate fully and yet keep a message simple that people can understand.  That is a challenge for this kind of research.  It is a challenge for cancer research in children, any kind of research that has substantial risks but substantial rewards. 

Chairman HERGER.  The gentleman's time has expired.  The gentleman from Colorado, Mr. Beauprez, to inquire. 

Mr. BEAUPREZ.  I thank the Chairman, and I thank Dr. Young as well for his testimony and for being here with us today. I think the gentleman from Washington has probably already begun going down a path that is of most concern to the Subcommittee.  Let me stay in that track for a minute.  Doctor, as I first heard about this issue, I guess one of the knee-jerk reactions would be, well, let us just not submit foster children to clinical trials.  That is not really where we want to go.  Is it?  I am guessing that the numbers--they are staggering numbers, frankly, that you shared with us of 16 to 22 percent of children now with HIV back in 1990 were foster care children.  We would actually want them to have access to some of the state-of-the-art treatment.  I am assuming that that is correct? 

Dr. YOUNG.  Yes, sir, I agree with you.  They should have the opportunity to make their--their guardians should have the opportunity to make the decision if they wish to participate.  If they choose not to, that is fine.  To exclude them from even having the opportunity to make that decision I don't believe is correct. 

Mr. BEAUPREZ.  Unfortunately, sometimes, it is that very population that disproportionately is burdened with some of the diseases we would like to get a handle on.

Dr. YOUNG.  That was particularly true back in the late 1980s for HIV/AIDS when clinical research, clinical trials was the only opportunity, the only hope for treatment. 

Mr. BEAUPREZ.  The question becomes who then best make this decision or assist the child in making this decision and that is what I want to probe a little bit more with you.  I contacted some of our folks back in Colorado who wrestle with this, and the idea of the child advocate seemed to make perfect sense to me:  Let us get someone out there who has maybe even met some standard across some threshold on the per chance that we have got a foster parent--because we hear about these tragic cases where the foster parent was not the best choice for the child's well-being, and we all are traumatized by that, as the child who at least is traumatized.  What I found out is that, in the opinion at least of the medical professionals back in my State, many, many, many times it is the foster parent on their way to becoming the adoptive parent because, apparently, we have a very high percentage of exactly that that happens, that may well be the person with the child's best interest at heart.  It crosses my mind that we would not want to categorically preclude foster parents from the process, either.  Would that be a fair assessment? 

Dr. YOUNG.  Yes, I think that is a fair assessment.  We are balancing a lot of different factors here.  There is also the biologic parent and what role they should have.  Some States allow both or even require both be appointed.  Those kinds of decisions in many cases are best made locally by the people who know the State, know the procedures, know what is going on there.  There is room for Colorado to make modifications in keeping with the broad set of Federal basic requirements. 

Mr. BEAUPREZ.  Which gets me to, I guess, the next question I would raise of you.  I understand that we have got Federal guidelines, but as you testified just moments ago to us, really it is up to State and local and many cases city and/or county officials to not only apply the rules, but in some cases, I suppose, adjust the rules.  They have some local flexibility.  Is there more than ought to be done at the Federal level to protect certainly the interests of the child?   I will emphasize again, the interest of the child can go both ways.  We certainly don't want them to get put into a clinical trial situation that we would all think was inappropriate, too great a risk, but we also don't want to somehow subjectively preclude them from having the opportunity to have access to the latest state-of-the-art medical techniques.  What should we be doing at the Federal level? 

Dr. YOUNG.  I think your points are good ones.   I think one of the things the Department will be doing very closely is, following this hearing, following what you are learning and hearing from the witnesses.  We are not aware of any changes that we believe need to be made.  If they are identified, we will be very happy to consider them and make a decision as how best to proceed.  We share with you the concern about the adequate protection of foster children.  At the same time, the opportunity to let them participate and get the advantage of clinical research, if that is theirs and their guardian's decision. 

Mr. BEAUPREZ.  If there is a second left, can you comment on the difference between assent and consent.

Dr. YOUNG.  Consent means that you have the legal authority to agree to participate, in this case in research.  A minor, generally under 18, legally cannot consent by law, but the minor can assent.  There are requirements that the subjects need to assent to.  That is to say, yes, I am willing to do this.  That doesn't carry the legal weight of consent, but it says that the minor has agreed to participate.  One is a legal concept; one is a concept of agreeing. 

Mr. BEAUPREZ.  Thank you.  Thank you, Mr. Chairman. 

Chairman HERGER.  Thank you.  The gentleman from California, Mr. Becerra, to inquire. 

Mr. BECERRA.  Thank you, Mr. Chairman.  Dr. Young, thank you for being with us and thank you for your testimony.  Let me ask a preliminary question, because I am not real familiar with how this all works.  How much knowledge does HHS have, first of all, with regard to the number of foster care children who participate in these different studies? 

Dr. YOUNG.  We do not have good detailed information on that to answer that question. 

Mr. BECERRA.  Let me back up even further then.  We know there is value in some of the research and the clinical trials that occur, and we know that, oftentimes, we want to be able to help children because they have so many years of life ahead of them if we are able to do some good work and help them medically.  At what point do we believe that our responsibility by using taxpayer dollars to help fund some of this research or these trials extends to ensuring that we know who those who are conducting the trials or the research are when they approach these children, especially foster children, are trying to protect their rights?  Dr. YOUNG.  That is where the Department's compliance activities come into place.  As I said, we will follow up where we hear reports.  We will do random surveys periodically.  We will talk to the State agencies, but that then becomes an issue of Federal checking, investigation, if you would, of compliance to identify problems and to correct those problems. 

Mr. BECERRA.  Now, how large is your Office of Human Research Protection?

Dr. YOUNG.  I am sorry.  I will have to submit that for the record.  I do not know that. 

Mr. BECERRA.  Any idea?  How many folks do you have to investigate?

Dr. YOUNG.  I am not in the Office of Human Protection and Research.  I am in HHS assistant secretary for planning and evaluation.   I just don't have that information. 

Mr. BECERRA.  Do you have anybody here with you who might be able to answer that question?

Dr. YOUNG.  I don't believe so. 

Mr. BECERRA.  Well, give me your sense from what you know of how much--how much in resources do we have to try to provide some surveillance, some oversight to ensure that, in the first instance, those who are using Federal tax dollars to conduct their research or these clinical trials are at least trying to follow Federal law?  Certainly, there must be State law that is implicated because the State has custody of these foster care children.  Do you have any sense of what kind of resources we spend? 

Dr. YOUNG.  I am sorry, sir, I just don't.  As I say, that is not an issue that I looked at in preparation for this hearing. 

Mr. BECERRA.  Mr. Chairman, perhaps what we could do is ask Dr. Young to see if HHS could get back to us with some information.

Dr. YOUNG.  I would be happy to. 

Mr. BECERRA.  To get a better sense, because I suspect one of the problems we have is you all just don't have the resources to try to be more vigilant about how these clinical trials or this research is being conducted.  So, the first thing is, we have to get a handle on whether or not folks are following through and at least abiding by their commitments when they obtain Federal funding to follow Federal law.   I suspect that the State probably would respond the same way and all the different States would respond the same way, saying they probably don't have enough money to probably do some oversight over their wards, the children that are within their custody through the foster care system.  Let me ask.  In terms of the type of oversight that you might think would be helpful--because we can't have someone overseeing every clinical trial or every bit of research that we fund.  Is there some guidance you can give us on what we should be looking to see HHS do when it comes to protecting the interest of that child as we try to promote their well-being?

Dr. YOUNG.  First, let me remind you again that the first level of oversight is at the local institution, and there is substantial oversight at that level; that these research protocols are on patients who have physicians taking care of them, who may or may not be involved in the research, who provide oversight.  The Institutional Review Board will provide oversight. 

Mr. BECERRA.  Dr. Young, how do we ensure that that first instance of oversight is occurring?  We are giving Federal tax dollars.  Most of the research will be done locally in a particular State.  States have obligation to take care of these wards, the wards of the State or kids who are in foster care.  How do we ensure that, when we release those Federal dollars, that in fact, at that local level, that oversight will occur?  While locally there is more control and responsibility for the child, I think all of us would still believe that we should not relinquish whatever rights we have to ensure that that child is taken care of or handled properly.

Dr. YOUNG.  I absolutely agree with you.  There is the level that is local at the physician, the physician caring for the patient.  There is the Institutional Review Board.  There is the institution, that may be a hospital, in which the Institutional Review Board is housed.  There are the State agencies on foster care, and then there is the Federal rules on compliance and on investigations that flow from that compliance.  We will get back to you with the information you asked in terms of the size of the agency budget, et cetera. 

Mr. BECERRA.  Mr. Chairman, may I ask one last question, quick question? 

Chairman HERGER.  The gentleman's time has expired. 

Mr. BECERRA.  Fifteen seconds. 

Chairman HERGER.  One other quick question.

Mr. BECERRA.  Just a quick comment.  Then maybe what we can do is, if you can tell us if there are any consequences for those who we have found to not be following Federal regulations or even State law in the--as they use these Federal tax dollars to do their research or trials, clinical trials, to see how we can try to get to those who aren't following through with their own responsibility.

Dr. YOUNG.  A very quick answer.  Yes, there are ways to do that.  The FDA regulations in fact lay out, specifically, sanctions that can be brought towards those who do not follow the rules. 

Mr. BECERRA.  Thank you.  Thank you, Mr. Chairman. 

Chairman HERGER.  Thank you.  The gentleman from Michigan, Mr. Camp, to inquire. 

Mr. CAMP.  Well, thank you, Mr. Chairman.  I want to follow up on that compliance line of questioning that Congressman Becerra brought up.  I realize you can't talk about ongoing HHS investigations, but can you tell us about any previous findings of noncompliance with HHS regulations involving children in foster care and their participation in clinical trials?

Dr. YOUNG.  I cannot.  I simply don't have that information as to the past history of any investigations and the outcome of those. 

Mr. CAMP.  What happens if an institution is found to be out of compliance in such cases?  Are you aware of that?

Dr. YOUNG.  Yes.  Individuals cannot be allowed to participate in research if the findings are egregious enough from the research side.  Or the Institutional Review Board will be asked to restructure and to change its membership to get a better mix of membership that is more appropriate to dealing with the problems so that there are a number of ways that there can be changes made if there are deficiencies going on.  The ultimate is, of course, not funding the research. 

Mr. CAMP.  Has that actually happened?  Have institutions been suspended from receiving Federal funding or declared ineligible to participate? 

Dr. YOUNG.  As I said a moment ago, I simply don't know the answer to that question. 

Mr. CAMP.  All right, so we don't know what institutions.  For what reasons? 

Dr. YOUNG.  There may be some information on that that I simply don't have. 

Mr. CAMP.  All right, to Congressman Nunes, I believe your response was that you don't have any knowledge of the number of children in foster care in clinical trials.

Dr. YOUNG.  That is correct. 

Mr. CAMP.  Are you making attempts to find that out?  Is there a process in place to determine that?  Or is that not something you are pursuing?

Dr. YOUNG.  The Chairman mentioned the survey that is ongoing, and I will have to look in more detail to see what the content of that survey will be. 

Mr. CAMP.  All right.  Do we have any idea of whether there are any States that require independent advocates for children to be--any foster children who might be participating in the clinical trials?

Dr. YOUNG.  The anecdotal reports, including those in the press, suggested that there are some States.  I do not have any primary knowledge on that question one way or the other. 

Mr. CAMP.   Federal regulations require advocates under certain circumstances, do you know how many persons have served as advocates for children in clinical trials?  Do you know of any number.

Dr. YOUNG.  I do not have information on that. 

Mr. CAMP.  I guess what I am trying to get at is, how do we know about the nature of the trials, the relative risk and benefit for children without that information?

Dr. YOUNG.  We are depending primarily, again, at the local level, on the Institutional Review Boards, the institutions, and the oversight that is provided there.  We in turn then at the Federal level will do the investigations as currently being reported in the press and the compliance activities.  There is a lot of reliance on what is happening locally, the medical and research community at the local level. 

Mr. CAMP.  The Institutional Review Boards are charged with determining how and under what conditions children may participate in those trials.  To what extent does that information get back to HHS?

Dr. YOUNG.  We don't routinely collect information from the IRBs.  We have the broad set of rules, and we will check compliance overall, but we will not collect information. 

Mr. CAMP.  All right.  Thank you, Mr. Chairman. 

Chairman HERGER.  Thank you.  Dr. Young, there were several questions that Mr. Camp inquired of and I believe another Member.  So, would you mind responding in writing to the Subcommittee on that?  Our record will be open for 2 weeks.

Dr. YOUNG.  Yes. 

Chairman HERGER.  Thank you.  The gentleman from California, Mr. Stark, to inquire. 

Mr. STARK.  Dr. Young, I am sorry I missed your testimony, but we did have a chance to review it.  I want to go back to this, as I just heard in the few minutes that you have been responding to questions, that you feel that having an independent advocate for each foster child is taken care of locally, but in the Federal regulations, the rules state, for example, that in experiments involving prisoners, the IRB has to include a prisoner advocate to protect the rights of prisoners.  Why shouldn't children get that same protection?

Dr. YOUNG.  The same rules apply to children as to--

Mr. STARK.  No.

Dr. YOUNG.  Well, just a moment.  As to prisoners, there, the rules are that, where there is a frequent IRB interaction, if there is one prison study and a lot of others that are not, the IRB does not have to.  They are encouraged to have people who understand and know the situation, whether it is children or prisoners, but they do not have to have a prisoner if there is a single research protocol that has gone forward through the IRB. 

Mr. STARK.  Well, I am not at all sure that you and the inspector of the GAO agree, but let us come back.  I am going to stick with my assertion from the CRS that the Federal regulations in fact do require that the IRB has to include a prisoner advocate if there is in fact a prisoner involved in the study.  Now, we can find that out subsequently, and I am sure that your knowledge of the law is superior to mine.  Based on that, why in the world wouldn't it be--what would be wrong with requiring an advocate for a child, for a foster care child in these experiments?

Dr. YOUNG.  The current rules do require an advocate.  Now, I am making a distinction between the IRB's composition and the advocate.  The advocate requirement is above and beyond the IRB, and the advocate requirement is there when there is more than minimal risk--

Mr. STARK.  Okay.

Dr. YOUNG.  When there is more than minimal risk and where the value of it is not commensurate with that.  There needs to be--

Mr. STARK.  Who decides whether there is more than minimal risk? 

Dr. YOUNG.  The IRB. 

Mr. STARK.  You don't think it would be necessary on the IRB to have a child's advocate?

Dr. YOUNG.  If the IRB is involved in looking at a substantial number of research protocols, for example, in a pediatric hospital, then, yes, I think that is a very reasonable requirement. 

Mr. STARK.  What about any program in which a foster child is involved?  Why shouldn't the IRB include an advocate for that child? 

Dr. YOUNG.  If there is a--let me make sure I understand your question.  If there is a research protocol going through that is no more than minimal risk, then the IRB will look at it.  That IRB does not need to have a pediatrician on the IRB, and there is no requirement separate from that for an advocate.   I think that gives adequate protection. 

Mr. STARK.  Dr. McDermott, would you yield to me?  Do you think that is adequate protection? 

Mr. MCDERMOTT.  I don't know.  Let me think about it. 

Mr. STARK.  Okay.  I am talking to a pediatrician in his former life. 

Mr. MCDERMOTT.  Psychiatrist. 

Mr. STARK.  Well, pediatric psychiatrist, as I recall, and it just troubles me that my suspicion is that we have more concern about prisoners and more protections than we do for kids.  We have seen so many examples of minimal risk in drug testing, for instance.  We have got to bring the pharmaceutical industry to heel.  They have been testing things, you know, giving drugs to kids without involving them in tests.  My feeling is that children, and particularly children in foster care who perhaps have a higher--we have an adverse selection there.  I would guess that it is fair to suggest, Mr. Chairman, that children in foster care children tend to be poorer and perhaps have had poorer health care for whatever reason as a population and would be more apt to show up in many of these studies.   I am worried that the tendency is to say, well, it is okay to let the local people take care of that, because I am not sure that all local jurisdictions would be--for instance, here in Washington, D.C., and I conclude, they can't find half the kids in foster care.  How would you like to have a foster care child from the District of Columbia when its present foster care system is in a State of upheaval and say, Gee, they will take care of it?  I don't think I believe that.  I would rather you doing it.  I trust you. 

Chairman HERGER.  The gentleman's time has expired.  Dr. Young, what do Federal regulations require in terms of the naming of independent advocates for foster children in clinical trials?

Dr. YOUNG.  If the clinical trial involves more than minimal risk and if the value of the clinical trial is not commensurate with that for the individual patient, then the advocate must be appointed to make the decision for the child in foster care. 

Chairman HERGER.  Is there evidence to suggest that children with advocates who participated in these trials had better outcomes, they live longer, had better health, are still alive today than those without advocates?

Dr. YOUNG.  I don't believe there is any information on that subject.  I would not see why there would be any particular difference related to the variable of an advocate only.  The advocate is there for a decision-making of yes or no.  It is the ethical structure of the clinical trial that determines whether it is appropriate, number one, for the individual to even be eligible for the trial.  So, I don't know information of that, but I would not expect that that would be a variable. 

Chairman HERGER.  Well, I thank you very much, Dr. Young, for your testimony.  With that, I would like to invite our next panel to have seats at the table.  On this panel we will be hearing from Dr. Alan Fleischman, senior advisor at the New York Academy of Medicine; Ms. Roberta Harris, Deputy Secretary of the Wisconsin Department of Health and Family Services; Dr. Marjorie Speers, executive director of the Association of Accreditation of Human Research Protection Programs; and Dr. Moira Szilagyi, on behalf of the American Academy of Pediatrics.  Dr. Fleischman.

STATEMENT OF ALAN FLEISCHMAN, M.D., SENIOR ADVISOR, THE NEW YORK ACADEMY OF MEDICINE, NEW YORK, NEW YORK

Dr. FLEISCHMAN.  Mr. Chairman, Subcommittee Members, thank you for inviting me.  My name is Alan Fleischman.  I am a physician, pediatrician and medical ethicist.  My professional background and expertise is in the written testimony, but I speak today as and individual.  Clinical research with therapeutic intent involving children in foster care is an ethical imperative and can, and was, performed in an appropriate manner fully consistent with good ethical practice and compliant with Federal regulations that govern research.  In order to understand the issue of enrollment, I will share with you some of the data that Dr. Young did as well about the late 1980s and early 1990s in HIV care and treatment of children. 

Twenty-five percent of babies born to women who were HIV-infected developed HIV, AIDS was universally fatal in children, and 25 percent of infected children died by age 5.  Many of the young children with HIV were boarder-babies, were in foster care because they had become orphans due to the death of their mothers or because their mothers were impaired.  Great strides were being made at that time with new drugs developed for the treatment of HIV and AIDS and its complications, but initial trials were only in adults.  These new treatments were not available for children, and there weren't any pediatric formulations of the drugs available to the doctors caring for such children. 

The National Institutes of Health developed clinical research trials, and that is our first step of safety for the children in order to study the effectiveness of the various new treatments in children.  Some of the drugs had potential for side effects.  They were serious drugs.  They were against a serious virus, but those possible risks were far outweighed, as doctors would know, by the potential therapeutic benefits.  In New York City, the agency responsible for supervision of foster children developed mechanisms that made enrollment of foster children in clinical trials possible, because it would have been unjust not to offer these children the very best prospect of life-saving treatments. The first protection was that individual medical institutions conducted the trials only after Institutional Review Board prospective review and approval.

The consent of biologic mothers or legal guardians was obtained when possible.  An agency permission on an individual basis was required before the child could be enrolled in the trial, and foster parents were involved in these discussions because of their need to administer treatments and bring children back for follow-up visits to the hospital in order to be successful in the trials. The appointment of advocates for the children, while a laudable procedural approach, was not required.  We did choose that approach in the Bronx, but we were not required to do that by the Federal regulations. 

Today, pediatric AIDS treatment in the United States is different, because of clinical trials there are effective treatments to prevent children from becoming infected in utero, and there are effective treatments to prevent children from--there are effective standard treatments for the smaller number of children who are now infected.  AIDS in children has become a chronic disease with less than 1 percent mortality each year for children treated in AIDS centers in the United States.  Children in foster care who are infected with AIDS today are getting standard treatments and are rarely participating in clinical trials because it is no longer a matter of life and death.  There may be a time in the future, perhaps with the emergence of a new dreaded disease, when we will once again be faced with the critical need to enroll foster children in clinical trials in order to provide needed life-saving treatments.  Our past experience with HIV and AIDS and the present Federal regulatory structure on research allows us to do that, if we need to. 

In conclusion, those of us involved in the treatment of children infected with HIV knew that a large percentage of our patients were poor, minority children, and many of those children were in foster care.  We demanded the very best treatment for these vulnerable children.  The only way to provide it, in fact, to provide treatment in HIV care to any child with AIDS, at that time was through clinical trials. We enrolled children in treatment trials and gathered information on the effects of the new drugs on children while we attempted to save and enhance lives of our patients.  It would have been unethical to have behaved in any other way.  Thank you.

[The prepared statement of Dr. Fleischman follows:]

Chairman HERGER.  Thank you, Dr. Fleischman.  Ms. Harris.

STATEMENT OF ROBERTA HARRIS, DEPUTY SECRETARY, WISCONSIN DEPARTMENT OF HEALTH AND FAMILY SERVICES, MADISON, WISCONSIN 

Ms. HARRIS.  Mr. Chairman, Members of the Subcommittee, thank you for this opportunity to provide information to the Subcommittee on this important topic.  Children in the child welfare system, whether in their own homes or in some form of out-of-home care, are some of the most vulnerable children in our country.  We must do everything that we can to ensure that these children are protected from any additional trauma. Clearly we need legitimate medical and other research.  Significant advances are made every day as a result of well-designed and implemented research studies. In Wisconsin, we have not approved medical research on foster children or any subgroup of foster children as a class.  In the child welfare system, we believe it is our responsibility to provide as much safe--as much of a safe and nurturing environment for the children in foster care as possible.

Today I would like to make some comments related to the lack of homogeneity of foster children, the problems with voluntary participation on the part of families, and the legal framework of our authority to consent to such research.  Let me begin with lack of homogeneity.  Research, whether medical or otherwise, should not be limited to a particular group unless there is some homogeneity within that group that is unique.  In this regard, there is very little, if anything, that can be regarded as homogeneous among children in foster care other than that they have been removed from their homes.

As many of us know, children in foster care are there for a variety of reasons; abuse or neglect of themselves or their siblings, mental health issues of a severe nature, medical or developmental disabilities with special care and treatment needs that cannot be provided by their parents, and/or delinquency.  Many of our children are also from low-income families.  As has been mentioned here today, recent news articles have indicated that foster children have participated in medical studies related to research endeavors dealing with acquired immunodeficiency syndrome.  It is true that some children in foster care have HIV or AIDS.  It is also true that many children not in foster care have HIV or AIDS.  To focus a study on medication related to that condition only on children in foster care where there are potential negative effects of those medications certainly leads to a perception that somehow foster children are valued less than other children.

In Wisconsin, our position on the involvement of foster children in research, especially medical research, is based in large part on a variety of ethical codes related to medicine, social work, and mental health.  These codes place great emphasis on the voluntary nature of participation research.  We believe that our children and our child welfare system are vulnerable, and it is our role to do what we can to ensure the safety and welfare of the children in our system. In addition, as I testified to earlier, many children in the child welfare system are economically disadvantaged.  We must recognize this position and protect the family from giving consent under duress.  Voluntary consent goes to the heart of the nature of the relationships among children, their families, and the child welfare system.  "Voluntary" is defined as acting or performing without external persuasion or compulsion. 

Generally, out-of-home placements are ordered by the court.  When the agency that has authority to determine when a child be returned to the parent recommends to that parent that the child's participation in medical research--recommends to that parent that that parent approve the child's participation in medical research, at least on a perceived basis it is questionable whether the parent would feel that his or her approval is truly voluntary. 

This brings me to legal status.  We need to look at the issue of who can approve the involvement of a foster child in any type of research, medical or otherwise.  In the child welfare system, there are generally four types of legal relationship between a child and an individual agency acting on behalf of that child:  physical custody, legal custody, guardianship and parental relationship.  In most cases in Wisconsin, the legal custody of a child in foster care remains with the parent, because under Wisconsin statutes, there shall be a policy of transferring custody of a child from the parent only when there is no less drastic alternative.

If the parent's rights have not been terminated, and if guardianship has not been inferred on another party, then it is clear that the parent should make the medical decisions for the child.  As noted previously, however, if the request for research participation comes to the parent through the agency having the authority to decide when the child is returned to the parent, one must legitimately question whether the approval of the parent is given freely and voluntarily.  If a representative of the Wisconsin child welfare system has court-appointed legal custody or guardianship and has the authority to approve the participation of the foster child in medical research, it is our position that the approval for such participation should not be given solely on the basis of the child being a foster child. 

We are not opposed to the participation of a child--of a foster child in appropriate and beneficial medical research on a case-by-case basis if a foster children meets the requirements for a medical research study based on some physical, mental, emotional or developmental condition; and the child's parent or parents were informed and, as is appropriate to their legal status, approved of their child's participation; and the child's personal physician, therapist and other qualified professional recommends to the system authority the child be involved in that research; and children with similar or related conditions will also participate; and the group of children, and other individuals in the study, include children outside of the child welfare system; and finally, the child is appointed an advocate with the express responsibility for determining whether participation is in the child's best interest, including, if possible, ascertaining the child's position.  If all of these are met, we would consider granting that authority.

In summary, in Wisconsin, we believe it is our responsibility to help provide a safe, nurturing environment for the children in our foster care system so that they may become thriving, healthy adults.  We are opposed to a foster child being involved in any such research solely because the child is a foster children.  It is inappropriate to single out foster care children as a group for medical research based simply on the fact that they are children in the child welfare system.  Thank you again for your invitation to address this important issue.  I trust that the legislative initiatives that will be forwarded will reflect the values Wisconsin uses with regard to foster child protection in medical studies.

[The prepared statement of Ms. Harris follows:]

Chairman HERGER.  Thank you, Ms. Harris.  Dr. Speers to testify.

STATEMENT OF MARJORIE SPEERS, Ph.D., EXECUTIVE DIRECTOR, ASSOCIATION FOR THE ACCREDITATION OF HUMAN RESEARCH PROTECTION PROGRAMS, INC. 

Ms. SPEERS.  Good afternoon, and thank you for inviting me to speak about the roles of IRBs and protections for children when they are research subjects.  IRBs have a broad responsibility to safeguard the rights and welfare of research subjects.  Thus, they should be sufficiently qualified to review the research that comes before them and to ascertain the acceptability of proposed studies in terms of institutional commitments and requirements, applicable law and standards of professional practice. IRBs and institutions that receive funds from the Department of Health and Human Services or review research that the Food and Drug Administration regulates must abide by Federal regulations to protect research subjects and Subpart D, which provides additional protections for children participating in research. As stipulated in the regulations, IRBs must have at least five members with varying backgrounds to promote complete and adequate review of research.  At least one member must have primary concerns in the scientific area, at least one member must have primary concerns in nonscientific areas, and at least one member must not be otherwise affiliated with the institution.

The primary role of the IRB is to determine whether a proposed study is ethically justifiable.  The Federal regulations lay out seven criteria for IRB approval of research.  They include risks to subjects are minimized; risks to subjects are reasonable in relation to potential benefits, including direct benefits to subjects and the importance of the knowledge that might be gained; subjects are selected equitably; informed consent is sought from each prospective subject or legally authorized representative and documented; and when appropriate, the research plan includes monitoring the data to ensure the safety of subjects and includes provisions to protect the privacy of subjects and to maintain the confidentiality of the data.  IRBs use written procedures, checklists and other tools to assist them in complying with the regulations.  During IRB meetings, an IRB member usually describes the proposed study, and all members discuss and debate the ethical and scientific issues relating to the protection of prospective subjects.  In the end, they come to a conclusion to approve or disapprove the study, request more information, or require modifications of the study in order to approve it.

Involving children in research poses special ethical dilemmas.  Aside from State laws governing the age of majority and who may consent on behalf of the child to participate in research, children, by nature of their developing cognitive abilities, are unable to give voluntary informed consent to participate in a study.  IRBs consider this carefully in research involving children.  IRBs must make specific determinations regarding the level of risk involved in a proposed study and whether there is a prospect of direct benefit to the individual subject.  They may approve research only when it falls into one of four permitted categories.  Research involving greater than minimal risk can only be approved when it meets certain regulatory criteria.  These determinations are not easy to make because IRBs must interpret regulatory terms such as "minimal risk" or "minor increase over minimal risk."

One of the main protections for children is the requirement that IRB approve research in which investigators solicit assent from the child and permission from the parents or guardians, individuals who are authorized under law to consent on behalf of a child.  Under the regulations, IRBs may approve research involving children who are wards.  Depending on the level of risk and whether there is a possibility of direct benefit to the child-subject, a child advocate might be required. For example, in order to approve a study involving greater than minimal risk and no prospect of direct benefit to the individual subjects, IRBs must find that the research is related to their status as wards or is conducted in settings such as schools where the majority of children involved as subjects are not wards.  Further, IRBs must require the appointment of an advocate for each child who is a ward, in addition to anyone who is acting on behalf of the child as a guardian. 

In summary, there are a number of regulatory requirements to ensure that children participating in research are adequately protected.  When IRBs and investigators implement these additional protections, the system works well.  Thank you for the opportunity to address the Subcommittee.

[The prepared statement of Dr. Speers follows:]

Chairman HERGER.  Thank you, Dr. Speers.  Dr. Szilagyi to testify.

STATEMENT OF MOIRA SZILAGYI, M.D., Ph.D., FELLOW OF THE AMERICAN ACADEMY OF PEDIATRICS, ON BEHALF OF THE AMERICAN ACADEMY OF PEDIATRICS 

Dr. SZILAGYI.  Mr. Chairman, I am grateful for the opportunity to testify as this important hearing on children in foster care and clinical trials.  My name is Dr. Moira Ann Szilagyi, and I am proud to speak on behalf of 60,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists of the American Academy of Pediatrics.  For the past 19 years, I have specialized in the medical care and developmental issues of children in foster care.  I am an associate professor of pediatrics at the University of Rochester Medical Center in Rochester, New York; a medical director of Monroe County Department of Health's Foster Care Pediatrics Clinic.  I also serve on the American Academy of Pediatrics Committee on Early Childhood, Adoption and Dependent Care.  The academy has a deep and abiding interest in the health care provided to children in the child welfare system.  In fact, the academy has numerous published policy statements, clinical guidelines and studies regarding children in foster care, including this, a 170-page handbook for pediatricians on health care standards for children in foster care.  I was proud to chair the District II Task Force on Health Care for Children in Foster Care, which authored this resource manual. 

The 540,000 children in foster care comprise one of many vulnerable populations to which the academy urges special attention in the provision of health care.  Compared with children from the same socioeconomic background, children in foster care have much higher rates of serious emotional and behavioral problems, chronic physical disabilities, birth defects, developmental delays, and poor school achievement.  Typically these conditions are chronic, underidentified, and undertreated, and they have an ongoing impact on all aspects of their lives, even long after these children and adolescents have left the foster care system.  As a result, children in foster care warrant special attention in all aspects of their health care.  One aspect in which children in foster care deserve particularly close and special consideration is their inclusion in clinical trials.  It is the position of the American Academy of Pediatrics that drugs be studied in children to determine their safety and efficacy in this age group.  Indeed, the academy considers it a moral imperative to formally study drugs in children so that they can enjoy equal access to existing as well as new therapeutic agents. 

Research participation is often beneficial to participants and may allow them access to care they could not otherwise receive.  Therefore, children in foster care, as a population that tends to have a greater preponderance of special health care needs, should be afforded the same opportunities and access to safe and effective treatments.  However, special consideration is necessary when allowing children in foster care who are in the care and custody of the State to take part in certain studies that may contain greater than minimal risk to the child. 

The academy has developed extensive guidelines and standards related to the ethical conduct of clinical trials involving children.  The academy also agrees with the Department of Health and Human Services' regulations governing the inclusion of children in clinical research.  For the purposes of today's hearings, however, perhaps the most relevant standards deal with consent.  Young children are, by definition, incapable of consenting to medical procedures.  Consent must be given on their behalf by a parent, a legal guardian or an individual or institution acting in loco parentis; that is, in place the of the parent.  In all cases, however, the overriding consideration must be the best interest of the child. 

HHS regulations outline issues of consent.  Consent must be obtained from the adult acting legally on behalf of the child.  When developmentally appropriate, the assent of the child must be gained prior to participation in any clinical trial.  The question, then, for children in foster care is whether adequate safeguards are established when consent is obtained for trials that contain above minimal risk to the child or when the research does not hold the prospect of providing direct medical benefit to the child him or herself. 

For children in the foster care system, an important safeguard is a special advocate who can help the foster family or State agency navigate medical issues, ensure that the child's medical care needs are being met, assist the child in determining whether or not he or she should participate, and provide a source of continuity for the child and the legal guardians throughout the duration of the study.  Even in cases of less than minimal risk or studies with prospect of direct benefit, an advocate, while not required, could play an important role in the child's support system.  It is my understanding that the Subcommittee is concerned by press reports about the participation of children in foster care in clinical trials of HIV drug treatments that began in the late 1980s.  My own professional experience includes a number of cases of HIV-positive children in foster care in my community who received HIV multidrug treatments during the early 1990s.  When our patients took these drug combinations, we saw a startling improvement in life span and quality of life.  Before the introduction of these combination drugs, our HIV-positive children in care were literally wasting away before our eyes. 

There were some side effects with the drugs, but not that many, and the side effects were nothing compared to the devastation of the disease.  I recall one 2-year-old child in particular who was literally dying.  One year after receiving combination therapy, he was essentially indistinguishable from his healthy peers.  He was able to go to preschool, live in a family instead of the hospital, and have hope for a longer life.  He is still alive today and was eventually adopted by his foster family.  Mr. Chairman, the decision to enroll a child in a clinical trial is never an easy one, even in a traditional family structure.  While the headlines seem to suggest that children in foster care were somehow singled out as hapless guinea pigs, my experience indicates that children in foster care are actually less likely than other children to be considered for participation in a clinical trial.  In fact, numerous barriers exist for children in foster care to even obtain routine health care and necessary health services.  Participation in a clinical trial where access would be far more complex is even less likely to occur.

The American Academy of Pediatrics believes that children in foster care deserve to be offered the same opportunities as other children to benefit from newer drugs and treatment protocols, especially when a child's condition is so grave that there are few options available to them.  Indeed, it would be unethical to do otherwise and systematically deny access to clinical trials that could have saved their lives or vastly improved the health of critically ill children in foster care.  It is clear that children in foster care are a special population, and that they deserve additional protections when being considered for inclusion in clinical trials.

Mr. Chairman, and Members of the Subcommittee, I deeply appreciate this opportunity to offer testimony on behalf of the American Academy of Pediatrics.  A more detailed version of my testimony has been submitted for the record.  I stand ready to answer any questions you may have, and I thank you for your commitment to the health of the children of our Nation.

[The prepared statement of Dr. Szilagyi follows:]

Chairman HERGER.  Thank you, Dr. Szilagyi.  The gentleman from Colorado Mr. Beauprez to inquire.

Mr. BEAUPREZ.  Thank you, Mr. Chairman.  Doctor, let's just start with you, if I might.  I am intrigued by your testimony and especially, I think, your closing assertion that the very children that may need the opportunity to participate in these trials, may need good health care in general, are ones that, perhaps, are being denied, foster children.  I am concerned that perhaps in our zeal to do something, we maybe do too much.  Congress sometimes can do that. If you can enlighten me a little bit, what maybe should we be doing; and even more specifically, since we're focused on HIV/AIDS, and that seems to be a situation that occurred quite a few years ago, tell me from what you know, and you would appear to be a pretty good expert at this, what sort of clinical trials are going on today?  We're talking a lot of about what went on 10 or 15 years ago.  What is going on today, and what, in your opinion, should Congress do? 

Dr. SZILAGYI.  Are you asking me about specifically what clinical drug trials or what types of trials?

Mr. BEAUPREZ.  What type of trials?

Dr. SZILAGYI.  I think most of the research that is centered on children in foster care from the health perspective now has to do with mental health interventions for children, and possibly developmental interventions for children; visitation, mentored visitation interventions.   I put those in health because I look at health as a very global issue for children in foster care.  There are still occasionally children who might be enrolled in a drug trial, but those are usually children with rare illnesses, childhood cancers that haven't responded to more traditional therapies, and that they be offered the same opportunity as any other child to become involved in a therapeutic drug trial, that may be their own only last best option for life.  That is an extremely rare event.  It has happened--I have taken care of probably close to 9,000 children in foster care over the last 19 years of my practice, and, you know, that number--those faces change all the time because of the nature of my practice.   I have really only had occasion to have that situation outside of the HIV situation come up probably two other times. So, it is not--you know, we don't have vast numbers of children involved in these randomized controlled clinical trials.

Mr. BEAUPREZ.  Ms. Harris, near the end of your testimony, I think it is on page 4 of your written testimony, you outlined, I believe, six different criteria for a child--a foster care child to be included in a clinical trial.  Are any of those--do all of those have to be met in the affirmative in order for a child to be included? 

Ms. HARRIS.  Yes, as stated.

Mr. BEAUPREZ.  Which raises, actually, another question, and I fully understand and appreciate how we could get to that point.  Another concern I actually had raised to me about the very point you're talking about, about making these kind of opportunities available, not precluding foster children from the population, is that perhaps in our concern about making sure the wrong thing doesn't happen to the wrong child for the wrong reasons, that by an abundance of regulations and hoops to jump through we actually do just that; that it is not a very attractive target--a very attractive population, excuse me--a very attractive population to even look at for clinical trials because of the regulation burden we put in front of them.

Ms. HARRIS.  Well, my guess is that most of these criteria, with the exception of appointing an advocate, would be applicable to all children that are going to be involved in medical trials.

Mr. BEAUPREZ.  So, in my case, if it were one of my children, it would be another advocate.  Would there--since I am the parent, the biological parent, I have legal custody, we wouldn't be setting up another hurdle, would we? 

Ms. HARRIS.  No, not with respect to the advocate.

Mr. BEAUPREZ.  I am not suggesting the advocate go away.  Actually, Dr. Fleischman, I wanted to pursue that a little bit with you.  What exactly did you do in the Bronx?   I want to be sure and ask, I think, two related questions:  Why is this-- if most of this occurred--most of what we read in the press occurred 10, 15 years ago, why are we just now kind of hearing about it?  It is being brought to light, and I think HHS regulations neither preclude now nor mandate certainly that there be any payment made, but are you familiar with payments ever being made; and, if so, who gets paid for these clinical trials? 

Dr. FLEISCHMAN.  The why now question, I think you're going to have to ask people other than myself.  I have no idea why now.  I find no rational reason for what I thought was a rewriting of history in much of the media circus.  In terms of the question of why, what we did in the Bronx, we did appoint a physician advocate who was in one of our public hospitals to share his views on these trials with each of the foster families, and we did use his expertise to help the foster families, help decide whether the child ought to be in the trial after the other steps had been gone through of individualized consent from the agency, legal guardian or parent, review.  This was an adjunct, an added thing, that we at the Albert Einstein College of Medicine felt was important.  In terms of the payment, families who enroll children in clinical trials generally do receive some compensation for their efforts in bringing the child to the clinic; transportation, time away from work, things of that sort.  To my knowledge, there were no dollars in true payment for using children or commodifying children in such clinical trials, and most IRBs would not tolerate such.

Mr. BEAUPREZ.  Good. 

Chairman HERGER.  The gentleman's time has expired.

Mr. BEAUPREZ.  Thank you, Mr. Chairman.

Chairman HERGER.  The gentleman from Washington Mr. McDermott to inquire. 

Mr. MCDERMOTT.  Thank you, Mr. Chairman.  As I listen to this panel, I come away with a question.  I guess it sounds like in Wisconsin you wouldn't get into a clinical trial like this; is that correct? 

Ms. HARRIS.  With foster care children as a class.  We are not saying that we don't think foster care children should be eligible for clinical trials.  If they are eligible, they should be treated as any other child and have parental consent or consent of the legal authority that has legal custody of the child.

Mr. MCDERMOTT.  I asked my staff after I listened to all of you, why are we here?  Not exactly Mr. Beauprez's question.   I read these articles from the Newsday and from the New York papers that covered this issue.  I tend to agree with Dr. Fleischman.  There seems to be a--this was a long time ago, and a whole different scene. What I would really like to hear from you, you all are advocates for children, all of you.  Is there anything that we should do to make a uniform system across the country so that there is no real magical difference?  This whole question about should we override what goes on at the State level, is that a good idea in this area?  Or do you see something where there is a Federal role that we should do?  None of you made any recommendations.  I don't know whether that was because you didn't have any or didn't think there should be any changes, or it was all perfect out there.  So, Dr. Fleischman? 

Dr. FLEISCHMAN.  I, individually, myself, had three opportunities through service to the government to review the regulations for children, and in each of those times, we felt those regulations were adequate.  The National Bioethics Advisory Commission, Dr. Shalala, Secretary Shalala's Human Research Protections Advisory Committee, and the now Secretary's Advisory Committee have all suggested, as well as the IOM Institute's reports, the Institute of Medicine reports, all suggested that we would benefit in this country, not specifically in the foster care, only in foster care, in a basic data collection system that would assist us in understanding who are the subjects of research in our country, what are the criteria that IRBs are using in approving research, and what are the outcomes based in those research studies.  The Office of Human Research Protection has not requested that.  They feel, I believe, that they don't have the authority to do that.  I don't speak for them, but we would be well served by having a database that at least gives us the baseline information about such.  That is one. Two, all of those groups have recommended that there be expertise in pediatrics--you can call it advocates or experts in pediatrics--on any IRB that is reviewing things related to children.  It isn't required in the regulations.  It could be strongly urged, or it could be required.  All of those learned groups have made those recommendations, and I believe for the most part IRBs fulfill those recommendations.  In these cases, since these were--these research prospects were in AIDS clinical trials centers, centers of excellence in our cities, all of those IRBs had advocates for children and had children's experts on them.  In general, if we are looking to fix, or help, or support the present regulatory structure of the data collection system and expertise in the areas related to the kinds of subjects who are being reviewed like prisoners, or children, or mentally ill people, or retarded people, or people of any variety-- 

Mr. MCDERMOTT.  Any of the others of you have a comment? 

Dr. SZILAGYI.  I probably have a broader perspective on the whole issue of health care for children in foster care than the more narrowly defined.  I agree with everything Dr. Fleischman said.  Let me start there.   I think that children in foster care have huge health care needs.  Forty-five percent of them have chronic medical illness.  Sixty percent of children under the age of 5 have developmental disabilities.  Forty-five percent of our school-age children are in special education placements, and eighty percent of children over the age of 4 have mental health needs.  Their access to health care services is abysmal in this country.  There are multiple barriers. One of you asked about barriers before.  Those barriers include their high mobility in and out of the system; the high mobility of professionals in the system; Medicaid as a funding resource, which, while it offers some benefits in terms of routine preventive care, is a barrier to many other types of care.  The whole system is underfunded and under-resourced, and I would suggest that every child in foster care deserves to have a medical home where they receive high-quality care that is comprehensive, well-coordinated, and that works very closely and in collaboration with the child welfare system.   I think that that would afford a high level of protection in terms of enrolling children in clinical research trials.  In our community, whenever a question comes up about an end-of-life issue for a child, a surgical procedure that is being offered to a child, bone marrow transplant or child with cancer who needs a more advanced protocol than is currently available as a standard of care, those questions come back to our office where we are the primary care doctor in the medical home.   I think trying to change the whole system of care for our kids so that it was much more modeled on a medical home model would go a long way towards preventing these types of issues. 

Dr. FLEISCHMAN.  Well said. 

Mr. MCDERMOTT.  If the Chairman would just give me 1 more second.  The database you are talking about, I remember when I did some research when I was in my residency, and I found the databases could give me two left-handed plumbers living in towns of less than 20,000 people. Are you suggesting a national database for all health care data so that we would then have that capacity to do that kind of research?  Do you think politically that is possible? 

Dr. FLEISCHMAN.  No.  I am suggesting that we have a database on all subjects of research in this country.

Mr. MCDERMOTT.  Oh, just research.

Dr. FLEISCHMAN.  That we ask IRBs to review research, and we ask investigators to tell IRBs and then tell the government how many subjects, what was the kind of research, what were the criteria in which the IRB reviewed the research, and move forward with it. 

Mr. MCDERMOTT.  Thank you, Mr. Chairman.

Chairman HERGER.  Thank you.  The gentleman from California Mr. Becerra to inquire. 

Mr. BECERRA.  Thank you, Mr. Chairman.  Thank you all for your testimony.   I want to go back to the gentleman of Washington's question, because I think it is the correct one.  Is there something we should be doing?  My sense is that we are trying to find out if there is this purgatory where children are where it is not clear if they really should participate in these clinical trials, and we are concerned that they actually may be used as a commodity in some of these clinical trials.   I am not sure if you have answered that question for us to leave us with a feeling that there is something we can do, or we needn't do anything.  So, if you can give us some clarity, is there something we should do?  If you say yes, please try to give us a specific.

Ms. HARRIS.  I think one of the questions that comes to mind is is the determination of whether research carries minimal risk and the child would directly benefit subjective?  Who makes that determination?  What are the criteria?  That is one of the questions I think that is unanswered, and that was sort of central to some of the HIV/AIDS research.

Mr. BECERRA.  Before anyone goes on, Ms. Harris, let me ask, are you saying then that Wisconsin, since you are more restrictive than other States, and I think my State of California is also very restrictive in requiring some judicial order to allow a child, a foster child, to participate, are you saying that there is a concern that, in fact, there might be a problem in protecting that child sufficiently through the IRB process without a child advocate? 

Ms. HARRIS.  Yes, and if there is, if there is, that right now within the IRB process, there is lack of clarity with--in that determination.

Mr. BECERRA.  Thank you. 

Ms. SPEERS.  I would suggest three items.  One is to just reinforce what Dr. Fleischman suggested, which is any IRB that is reviewing research involving children, that IRB should have expertise in pediatrics; but more than just pediatrics, in the interests of children so that it might not be a pediatrician.  It might be a social worker.  It might be an individual school, someone who understands the needs of children.  That is not a requirement in the Federal regulations at this time.  Secondly, the additional protections pertaining to children in Subpart D are not universally adopted across the Federal agencies that conduct or sponsor human research.  Subpart D is followed by the Department of Health and Human Services.  It was added in 2001 to the Food and Drug Administration regulation. 

Mr. BECERRA.  Who else would be part of that, what other agencies? 

Ms. SPEERS.  There are 16 other agencies.

Mr. BECERRA.  Can you give us those you believe should fall under the jurisdiction of Subpart D? 

Ms. SPEERS.  I want to say also that the Department of Education does have Subpart D.  Those are the three that do, but the other ones, in particular one is the National Science Foundation. 

Mr. BECERRA.  Do me a favor.  If you could just submit those so that way you can get to your third part, because otherwise I am going to run out of time.

[The information was not received at time of printing.]

Ms. SPEERS.  The third is I wanted to suggest that there should be an education requirement for IRBs.  IRB members now have no education requirement under the Federal regulation.  It would be much easier for IRBs to follow the regulations and understand the regulations if they had some type of education requirement.

Mr. BECERRA.  Dr. Szilagyi, I hope I pronounced that correctly, do you have anything you would like to add? 

Dr. SZILAGYI.  No.

Mr. BECERRA.  A quick question then before I run out of time.  Is there any standard throughout that is applied, that should be applied, a best practices standard that we could use? 

Ms. HARRIS.  I am not aware of an existing best practices.

Mr. BECERRA.  Is it good policy to allow the various States to come up with what they believe is the best practice for these decisions in regards to foster children? 

Dr. FLEISCHMAN.  One very powerful method is that Office of Human Research Protection has the ability to give guidance to all IRBs around the country.

Mr. BECERRA.  Does it do so? 

Dr. FLEISCHMAN.  They do.  They have not yet done that in this area.  The Secretary has an advisory committee to that office on human research protection.

Mr. BECERRA.  Should they do so? 

Dr. FLEISCHMAN.  I believe they should, as well as to clarify for Ms. Harris the definitions of minimal risk, and minor increase over minimal risk, and prospect of direct benefit, which the Subcommittee on children has already provided and requested that a guidance be produced.

Mr. BECERRA.  One last question as my time runs out.  If the best interest of a child is not upheld, who should be responsible? 

Dr. FLEISCHMAN.  Everyone.  Starting with the investigators, starting with those people in agencies who are responsible for those children, and going back toward the IRB, the institution that conducted that IRB.  Ultimately, at the Federal level, there is some responsibility.  The real responsibility stands at the local level.

Mr. BECERRA.  Anyone else?

Chairman HERGER.  Thank you.  The gentleman from California Mr. Stark may inquire. 

Mr. STARK.  Thank you, Mr. Chairman.  Just a couple of comments.  Dr. Szilagyi, I am a little bit concerned.  I appreciate your idea that it is through experiments, and the poor children can get health care, but I wonder is it right in this country, and this is just an aside, should they have to be guinea pigs to get health care?   I think that is wrong.

Dr. SZILAGYI.  I don't believe I said that. 

Mr. STARK.  Well, you didn't say that.  To me it implies that.  One of the good things about getting foster children into these programs is that they wouldn't get health care otherwise.   I am suggesting to you that that is a travesty.  It is has nothing to do with these rules, but that is one of the travesties of having uninsured children.

Dr. SZILAGYI.  Then I would like to clarify.  What I intended to say was that for some children in certain circumstances, and the HIV/AIDS phenomenon of the early 1990s was one of those--

Mr. STARK.  Let's move ahead, though.  Dr. Slagyi. --the only way for them to get certain kinds of care was actually for them to be enrolled in studies because that was the only way to obtain these drugs. 

Mr. STARK.  Going back, very quickly, and, Mr. Chairman, I ask unanimous consent to put both subpart C and subpart D of 45(c) in the record. 

[The information is pending:]

Basically, there is a difference.  Young was wrong.  There are additional protections for prisoners; and basically, if I can just paraphrase in the time allowed, it says that all regulations relative to prisoners will be enforced regardless of other regulations in this subpart.  It goes on to say that because prisoners may be coerced, they have got to have an advocate; yet subpart D for kids, and that is not there. There is in my mind a question.  If you still had an Eloise Anderson around someplace, she would sacrifice children for--you don't know who she was, do you?  You dumped her from Wisconsin, did the California, thank you very much, send her back and give you three free kicks.  There is a question that perhaps foster children are--present company completely excepted--you and the committee are an easy target because they are there, and they may not have to go through as much pleading with the parent and explaining because it is a much more institutionalized group of children, and you are able to find research subjects in that population.  That worries me.  It would be a simple thing, it seems to me, for us--what is good enough for Haldeman, Erlichman or Martha Stewart ought to be good enough for my kids, right?  Prisoners can have an advocate required; it doesn't seem to prohibit us from using prisoners in these cases. I think maybe we could make some simple changes, which--in States other than the ones represented here which don't have such good protection.   I think there are some States, Mr. Chairman, where we find it has been more casual in their outlook as to how foster children are protected.  I don't think we would impose any great impact or regulatory burden by considering in this Subcommittee whether we might coordinate the requirements for prisoners and children.  I hope you all will have staff look at these requirements, and we could ask the witnesses perhaps to respond to us later whether the prisoner requirements would unduly hamper research and the opportunity for children to participate in these programs.  Then we could sleep a little better at night knowing that at least we put in the requirement, the children would have adequate advocates in the program.  If anybody wants to disagree with that, that is fine with me, but that is what I am reading here. 

Dr. FLEISCHMAN.  As long as you are aware of that, the Office of Human Research Protection has just created the Institute of Medicine broad-based study on prisoners research, and the Secretary's Advisory Committee is taking up that issue as well.  There is a broad-based review of research with prisoners that is going on as we speak.  We need to be sure to coordinate that thinking with whatever thinking you have. 

Mr. STARK.  I think, Mr. Chairman, with foster kids, they don't have the complete freedom, just as a prisoner doesn't, and it is that minor extra protection that we might want to consider in any legislation that you might consider, Mr. Chairman.  I thank all of you for taking the time, and your concerns.  I thank you all for everything, except Eloise Anderson.  You can have her back.

Chairman HERGER.  I thank the gentleman.  Ms. Harris, beyond participation in clinical trials, could you tell me about drug use of children in foster care more generally?  For example, who decides whether children are to receive medications such as antidepressants or stimulants, the doctors, foster parents, caseworkers, all of the above?  What do we know about the medications provided children in foster care; for example, what share are on medication and for how long? 

Ms. HARRIS.  I can't speak specifically to certain medications.  We can certainly get that information to the Subcommittee.  The determination is parents retain the rights of any other parent with respect to children in Wisconsin's foster care system, unless the parent is incapacitated or for some other reason incapable of making that decision.  Then the court can grant authority for decision making, either a temporary--through temporary guardianship through the system. Generally, even if the child is not physically placed with the parent, the parent retains the right to make all decisions with respect to all medical decisions. 

Chairman HERGER.  Thank you.  Dr. Fleischman, the purpose of this hearing this afternoon is that there has been some very serious allegations made recently, especially about the treatment of children in New York City, in clinical trials for AIDS medicines in the late 1980s and 1990s.  These go to race and whether certain children were targeted because of their race or their being in foster care. Our purpose today is to review whether current protections are adequate or not.  Obviously, we are concerned about the allegations that have been raised.  You were not only there, but you treated many of these children and sat on the Institutional Review Boards, whose purpose was to determine the propriety of their participation.  Would you care to comment directly about some of the more inflammatory charges that have been made of late? 

Dr. FLEISCHMAN.  The charges saddened me.  I thought they were extremely inaccurate; that the doctors, the Institutional Review Boards and the institutions caring for children with HIV and AIDS were extremely sensitive to the areas of cultural sensitivity, race, ethnicity, the concerns of poverty.  Our children, all of our children with HIV, the vast majority, were from poor families and minority families.  We were very sensitive to those issues.  The IRBs were extremely concerned.  We believe we developed procedures that protected their interests and enhanced their quality of life and their lives in general. 

Chairman HERGER.  Thank you.  I want to thank each of our witnesses this afternoon for taking the time to appear here today.  I appreciate your help in understanding this issue further.  With that, the Subcommittee stands adjourned.

[Whereupon, at 3:55 p.m., the hearing was adjourned.]
[Submissions for the record follow:]

Ablechild.org, New Canaan, CT, Sheila Matthews and Gloria M. Wright, statement and attachment

Alliance for Human Research Protection, New York, NY, Vera Hassner Sharav and John H. Noble, Jr., Ph.D., statement

American Family Rights Association, Morongo Valley, CA, Cheri Carlene Campbell, statement

Asplund, Linn, Waterbury, CT, statement

Child Welfare League of America, Alexandra Yoffie, statement

Jacobi Medical Center, Bronx, NY, Andrew Wiznia, letter

Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Alfred Sommer, M.D., letter

National Institute of Allergy and Infectious Diseases, Division of Aids, Office for Policy in Clinical Research Operations, Potomac, MD, Jonathan M. Fishbein, M.D., letter

New York City Administration for Children's Services, New York, NY, John Mattingly, statement

Pediatric Aids Clinical Trials Group, University of California, San Diego, La Jolla, CA, Stephen A. Spector, M.D., statement

Sabato, Patricia, Sandy Hook, CT, statement

Schuldt, Sharon, Rockford, IL, letter

William Glasser, Inc., Chatsworth, CA, William Glasser, M.D., letter