Mr. WAXMAN. Our next witness is Dr. Edward Brandt, former Assistant Secretary for Health of the Department of Health and Human Services, and now chancellor at the University of Maryland at Baltimore.

Dr. Brandt, it is a pleasure to welcome you back to our subcommittee, now in a different capacity, but here always as an expert on the subject at hand.

Your prepared statement will be made a part of the record in full.

STATEMENT OF EDWARD N. BRANDT, JR., M.D., CHANCELLOR, UNIVERSITY OF MARYLAND AT BALTIMORE

Dr. BRANDT. It is a pleasure to appear before you, especially now that I have reassumed my role as a private citizen.

The subject of confidentiality of research subjects and of blood donors is a very important one, and I am pleased to see the subcommittee consider it.

These thoughts are entirely my own. However, they have been strongly influenced by the writings of a number of people in this

area.

My comments will be limited primarily to biomedical research, although there is research in other fields involving human subjects. For example, the social sciences, education, and law enforcement are examples.

In my view, all of the principles that I present are applicable to such research, but their precise implementation may be somewhat different. The same thing is true about blood donors.

Our ability to advance in medicine is highly dependent upon clinical research and that, in turn, is dependent upon voluntary participation by individuals. Indeed, all of us owe a great deal of gratitude to those who do volunteer, especially when they receive no direct benefit from their participation.

All people deserve to be treated with dignity and compassion. The preservation of their privacy is important to both aspects. Therefore, the medical research community has the responsibility to observe, in as strict a form as possible, confidentiality, to treat their subjects with dignity and compassion, and to respect and applaud their voluntary contributions.

To summarize my position, the confidentiality of research subjects should be violated only under the most limited of circumstances. Furthermore, the burden of proof for the violation of confidentiality must be assumed by the person who considers such violation. Clearly, the release of any information about any person can be accomplished with the full informed consent of that person.

There are some special circumstances in which the violation of confidentiality can be justified; however, even in those, the consent of the subject should be sought and obtained, if possible.

For example, an acute medical condition requiring treatment of the subject in those circumstances in which knowledge of the research participation is important to the therapy would certainly be justification.

A second example would be a necessary audit or investigation of scientific research, especially when scientific misconduct is either

suspected or charged. In those instances, however, identifying information about subjects should be revealed only if it can be demonstrated that such is essential to the conduct of the investigation and, if so, the auditors or investigators should be sworn to uphold confidentiality.

As this subcommittee is aware, I have had some modest experience with congressional and other investigations.

Although I am unaware of any violation of confidentiality as a result of these investigations, I am also unable to recall any situations in which the use of identifiers was required to accomplish the objectives of the investigations.

I would suggest that this subcommittee might consider the development of guidelines for auditors/investigators that would emphasize the need for preservation of confidentiality.

Perhaps the most controversial of the justifications involves subjects with communicable disease. Almost all local and State jurisdictions have laws mandating the reporting of communicable disorders, in many instances, including the use of identifying information. This reporting has a valid purpose.

In some circumstances, such as the sexually transmitted diseases, and especially AIDS, such reporting may have significant negative social ramifications for the individual with the disorder.

Many informed, concerned, and dedicated public health officials would argue that the benefits to the population outweigh the negative effects on a few individuals. As a general statement, I believe that communicable disease should be reported to health officials without identifying information.

If identifying information is determined to be essential and, again, I would stress that the burden of proof is on those persons who would so determine, then the information reported should be treated with the strictest confidence and exposed to the minimum number of persons possible to accomplish the goal.

The principle of strict confidentiality except under special circumstances has been recognized in both Federal law and policies. And I detail some of these in my testimony.

One special aspect: The regulations of the National Institutes of Health, which are also observed by other components of the Department of Health and Human Services include in paragraph 46.116 entitled, "General Requirements for Informed Consent," paragraph 5 which reads as follows:

A statement describing the extent if any to which confidentiality of records identifying the subject will be maintained.

Although this section does not mandate confidentiality for research subjects, it does mandate that all subjects be informed as to the extent to which confidentiality of records will be maintained. This, of course, permits the subject to decide whether or not to consent to participation.

When I was Assistant Secretary for Health, I was privileged to serve as chairman of an ad hoc committee for the protection of human research subjects which developed a model policy for the protection of human subjects.

Some aspects of that model policy are germane to our discussion today.

Section 111, entitled "Criteria for Institutional Review Board Approval of Research," includes paragraph 7, which reads as follows:

When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Section 116, entitled, "General Requirements of Informed Consent," includes paragraph 5 which reads as follows:

A statement describing the extent, if any, to which confidentiality of records identifying the subjects will be maintained.

Finally, section 117, entitled, "Documentation of Informed Consent," permits an IRB to waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds that the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality.

It further provides that each subject will be asked whether the subject wants documentation linking the subject with research and the subject's wishes will govern. It is my understanding that this model policy document will soon be published for public review and

comment.

In summary, there are provisions and regulations for the protection of the privacy of research subjects developed by those Federal agencies funding biomedical research. Although I have heard of anecdotes of violation of these provisions, I know of no documentation as to the extent of such.

I, personally, doubt that it is very widespread. I believe that confidentiality for research subjects is of great importance and requires thoughtful consideration by all investigators. Furthermore, Federal officials, and this subcommittee, should continue to address this issue.

Should they determine that further steps are required, such should be taken. I would caution that very careful thought be given if it is determined that new legislation or regulations are necessary to avoid requiring unnecessary steps that primarily accomplish additional paperwork.

As I said before, in the final analysis, the protection of the privacy of research subjects is dependent upon the awareness and appreciation by investigators and their research staff of the dignity of their subjects and the embarrassment or harm that may come from either deliberate or inadvertent revelation of private information.

I firmly believe that such is the case, and would recommend two steps to assist them. First, the implementation of court orders to violate privacy should be delayed to permit the affected individuals an opportunity to argue their case.

Second, the Freedom of Information Act should be strengthened to make explicit the protection of confidentiality of individuals. Thank you very much for this opportunity and I would be pleased to try to respond to questions.

[The statement of Dr. Brandt follows:]

Edward N. Brandt, Jr., M.D.

Chancellor, University of Maryland at Baltimore

It is a plea

Mr. Chairman and Members of the Subcommittee. sure to appear before you, especially now that I have reassumed my role as a private citizen. The subject of confidentiality of research subjects is a very important one and I am pleased to see this Subcommittee consider it.

Although I am empowered to represent the entire University of Maryland, these thoughts are entirely my own. They have been strongly influenced by the writings of others and I am grateful particularly to Dr. Ronald Bauer and his colleages at the Bastings Center and Dr. Alvin Novick of Yale University for their writings on this subject.

My comments will be limited primarily to biomedical research, although there is research in other fields involving human subjects. As examples, please consider the social sciences, education and law enforcement. In my view, all of the principles that I present are applicable to such research, but their precise implementation may be different.

Our ability to advance in medicine is highly dependent upon clinical research and that, in turn, is dependent upon voluntary participation by individuals. Indeed, all of us owe a great deal of gratitude to persons who do volunteer, especially when they receive no direct benefit from their participation. As members of the human family, all people deserve to be treated with dignity and compassion. The preservation of their privacy is important to both aspects. Therefore, the medical research community

has the responsibility to observe in as strict a form as pos

sible

confidentiality, to treat their subjects with dignity and compassion. and to respect their voluntary contributions.

Let me first state some of my basic beliefs to give perspective.

First, as I said before, all people deserve treatment with dignity and compassion.

Second, confidentiality has long been a part of the ethical code of medicine. Preservation of the confidentiality of the physician/patient relationship is critical to the provision of the highest possible quality of care. The relationship between a researcher and subject should be considered no different than that of physician/patient.

Third, government at the local, state or federal level is inherently political in the finest sense of that term. As such, government will always work to avoid, or minimize, criticism yet will stimulate conflict. Conflict in medical research, in my view, arises from two sources: a clash of value systems and lack of complete understanding (on the part of at least one of the parties) about the issues being investigated. My experience is that the level of conflict is inversely proportional to the level of understanding of a biological or social phenomenon. Indeed, Robert Quillen once said that, "argument (is) an exchange of ignorance". In the issue of confidentiality of research subjects, both sources of conflict are at work.