[Federal Register Volume 64, Number 192 (Tuesday, October 5, 1999)]
[Notices]
[Pages 54023-54028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25663]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES


Notice of Publication of the Executive Summary of the Report, 
Research Involving Human Biological Materials: Ethical Issues and 
Policy Guidance, by the National Bioethics Advisory Commission (NBAC)

SUPPLEMENTARY INFORMATION: The President established the National 
Bioethics Advisory Commission (NBAC) on October 3, 1995 by Executive 
Order 12975 as amended. The functions of NBAC are as follows:
    (a) Provide advice and make recommendations to the National Science 
and Technology Council and to other appropriate government entities 
regarding the following matters:
    (1) The appropriateness of departmental, agency or other 
governmental programs, policies, assignments, missions, guidelines, and 
regulations as they relate to bioethical issues arising from research 
on human biology and behavior; and (2) applications, including the 
clinical applications, of that research.
    (b) Identify broad principles to govern the ethical conduct of 
research, citing specific projects only as illustrations for such 
principles.
    (c) Shall not be responsible for the review and approval of 
specific projects.
    (d) In addition to responding to requests for advice and 
recommendations from the National Science and Technology Council, NBAC 
also may accept suggestions of issues for consideration from both the 
Congress and the public. NBAC may also identify other bioethical issues 
for the purpose of providing advice and recommendations, subject to the 
approval of the National Science and Technology Council. The members of 
NBAC are as follows:

Harold T. Shapiro, Ph.D., Chair
Patricia Backlar
Arturo Brito, M.D.
Alexander Morgan Capron, LL.B.
Eric J. Cassell, M.D., M.A.C.P.
R. Alta Charo, J.D.
James F. Childress, Ph.D.
David R. Cox, M.D., Ph.D.
Rhetaugh G. Dumas, Ph.D., R.N.
Laurie M. Flynn
Carol W. Greider, Ph.D.
Steven H. Holtzman
Bernard Lo, M.D.
Lawrence H. Miike, M.D., J.D.
Thomas H. Murray, Ph.D.
William C. Oldaker, L.L.B.
Diane Scott-Jones, Ph.D.

Research Involving Human Biological Materials: Ethical Issues and 
Policy Guidance; Executive Summary

Introduction

    Biomedical researchers have long studied human biological 
materials--such as cells collected in research projects, biopsy 
specimens obtained for diagnostic purposes, and organs and tissues 
removed during surgery--to increase knowledge about human diseases and 
to develop better means of preventing, diagnosing, and treating these 
diseases. Today, new technologies and advances in biology provide even 
more effective tools for using such resources to improve medicine's 
diagnostic and therapeutic potential. Yet, the very power of these new 
technologies raises a number of important ethical issues.
    Is it appropriate to use stored biological materials in ways that 
originally were not contemplated either by the people from whom the 
materials came or by those who collected the materials? Does such use 
harm anyone's interest? Does it matter whether the material is 
identified, or identifiable, as to its source, or is linked, or 
linkable, to other medical or personal data regarding the source? The 
extent to which a research sample can be linked with the identity of 
its source is a significant determination in assessing the risks and 
potential benefits that might occur to human subjects. For this reason, 
the National Bioethics Advisory Commission (NBAC) has developed a 
schema to describe the character of the personal information associated 
with particular samples of human biological materials as they exist in 
clinical facilities or other repositories and in the hands of 
researchers. (See Table 1.)

           Table 1.--Categories of Human Biological Materials
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Repository Collections.
    Unidentified specimens: For these specimens, identifiable personal
     information was not collected or, if collected, was not maintained
     and cannot be retrieved by the repository.
    Identified specimens: These specimens are linked to personal
     information in such a way that the person from whom the material
     was obtained could be identified by name, patient number, or clear
     pedigree location (i.e., his or her relationship to a family member
     whose identity is known).
Research Samples:
    Unidentified samples: Sometimes termed ``anonymous,'' these samples
     are supplied by repositories to investigators from a collection of
     unidentified human biological specimens.
    Unlinked samples: Sometimes termed ``anonymized,'' these samples
     lack identifiers or codes that can link a particular sample to an
     identified specimen or a particular human being.
    Coded samples: Sometimes termed ``linked'' or ``identifiable,''
     these samples are supplied by repositories to investigators from
     identified specimens with a code rather than with personally
     identifying information, such as a name or Social Security number.
    Identified samples: These samples are supplied by repositories from
     identified specimens with a personal identifier (such as a name or
     patient number) that would allow the researcher to link the
     biological information derived from the research directly to the
     individual from whom the material was obtained.
------------------------------------------------------------------------

    Ethical researchers must pursue their scientific aims without 
compromising the rights and welfare of human subjects. However, 
achieving such a balance is a particular challenge in rapidly advancing 
fields, such as human genetics, in which the tantalizing potential for 
major advances can make research activities seem especially important 
and compelling. At the same time, the novelty of many of these fields 
can mean that potential harms to individuals who are the subjects of 
such research are poorly understood and hence can be over-or 
underestimated. This is particularly true of nonphysical harms, which 
can occur in research conducted on previously collected human 
biological materials when investigators do not directly interact with 
the persons whose tissues, cells, or DNA they are studying.
    Increasing concerns about the use of genetic and other medical 
information

[[Page 54024]]

have fueled the current debate about medical privacy and 
discrimination. Because medical research can reveal clinically relevant 
information about individuals, scientists must ensure that those who 
participate in research are adequately protected from unwarranted harms 
resulting from the inadvertent release of such information. Although 
protection of human subjects in research is of primary concern in the 
U.S. biomedical research system, research that uses biological 
materials--materials that often are distanced in time and space from 
the persons from whom they were obtained--raises unique challenges 
regarding the appropriate protection of research subjects.
    Research sponsors, investigators, and Institutional Review Boards 
(IRBs) thus must exercise great care and sensitivity in applying 
professional guidelines and government regulations to protect subjects 
whose biological materials are used in research. Properly interpreted 
and modestly modified, present federal regulations can protect 
subjects' rights and interests and at the same time permit well-
designed research to go forward using materials already in storage as 
well as those newly collected by investigators and others. 
Fundamentally, the interests of subjects and those of researchers are 
not in conflict. Rather, appropriate protection of subjects provides 
the reassurance needed if individuals are to continue to make their 
tissue, blood, or DNA available for research. Indeed, public confidence 
in the ethics and integrity of the research process translates into 
popular support for research in general.
    Policies and guidelines governing human subjects research should 
permit investigators--under certain circumstances and with the 
informed, voluntary consent of sample sources--to have access to 
identifying information sufficient to enable them to gather necessary 
data regarding the subjects. Provided that adequate protections exist 
(which usually, but not always, include informed consent), such 
information gathering could include ongoing collection of medical 
records data and even requests for individuals to undergo tests to 
provide additional research information. In some cases, it even will be 
acceptable for investigators to convey information about research 
results to the persons whose samples have been studied. Where 
identifying information exists, however, a well-developed system of 
protections must be implemented to ensure that risks are minimized and 
that the interests of sample sources are protected.
    Finally, any system of regulation is most likely to achieve its 
goals if it is as clear and as simple as possible. This is especially 
true in the research use of human biological materials, because the 
federal protections for research subjects require investigators to 
outline the involvement of human subjects in their studies and to 
undergo institutional review of their protocols. Thus, one reason to 
modify regulations is to clarify which protocols are subject to what 
sorts of prior review; likewise, illustrations and explanations may be 
useful in clarifying how the regulations apply to novel or complicated 
fields that use human biological materials.
    How well does the existing Federal Policy for the Protection of 
Human Subjects (the so-called Common Rule, codified at 45 CFR Part 46) 
meet these objectives? Specifically, does it provide clear direction to 
research sponsors, investigators, IRBs, and others regarding the 
conduct of research using human biological materials in an ethical 
manner? NBAC finds that it does not adequately do so. In some cases, 
present regulatory language provides ambiguous guidance for research 
using human biological materials. For example, confusion about the 
intended meaning of terms such as ``human subject,'' ``publicly 
available,'' and ``minimal risk'' has stymied investigators and IRB 
members. Beyond these ambiguities, certain parts of current regulations 
are inadequate to ensure the ethical use of human biological materials 
in research and require some modification.
    In this report, NBAC offers a series of recommendations that have 
been developed to address perceived difficulties in the interpretation 
of federal regulations and in the language of position statements of 
some professional organizations; ensure that research involving human 
biological materials will continue to benefit from appropriate 
oversight and IRB review, the additional burdens of which are kept to a 
minimum; provide investigators and IRBs with clear guidance regarding 
the use of human biological materials in research, particularly with 
regard to informed consent; provide a coherent public policy for 
research in this area that will endure for many years and be responsive 
to new developments in science; and provide the public (including 
potential research subjects) with increased confidence in research that 
makes use of human biological materials. In particular, this report 
provides interpretations of several important concepts and terms in the 
Common Rule and recommends ways both to strengthen and clarify the 
regulations and to make their implementation more consistent.

Recommendations

Interpretation of the Existing Federal Regulations

    NBAC offers the following recommendations to improve the 
interpretation and implementation of the existing federal regulations 
as they apply to research using human biological materials.
Recommendation 1
    Federal regulations governing human subjects research (45 CFR 46) 
that apply to research involving human biological materials should be 
interpreted by the Office for Protection from Research Risks (OPRR), 
other federal agencies that are signatories to the Common Rule, IRBs, 
investigators, and others, in the following specific ways:
    (a) Research conducted with unidentified samples is not human 
subjects research and is not regulated by the Common Rule.
    (b) Research conducted with unlinked samples is research on human 
subjects and is regulated by the Common Rule, but is eligible for 
exemption from IRB review pursuant to 45 CFR 46.101(b)(4).
    (c) Research conducted with coded or identified samples is research 
on human subjects and regulated by the Common Rule. It is not eligible 
for exemption unless the specimens or the samples are publicly 
available as defined by 45 CFR 46.101 (b)(4). Few collections of human 
biological materials are publicly available, although many are 
available to qualified researchers at reasonable cost. Therefore, OPRR 
should make clear in its guidance that in most cases this exemption 
does not apply to research using human biological materials.
    The current federal regulations appear to make eligible for 
expedited review research on materials that will be collected for 
clinical purposes or those that will be collected in noninvasive or 
minimally invasive ways for research purposes. NBAC finds that there is 
no need to distinguish between collections originally created for 
clinical purposes and those created for research purposes. In both 
cases, research on the collected materials should be eligible for 
expedited review if the research presents no more than a minimal risk 
to the study subjects. (See the discussion of minimal risk below.)
Recommendation 2
    OPRR should revise its guidance to make clear that all minimal-risk 
research involving human biological materials--regardless of how they 
were collected--should be eligible for expedited IRB review.

[[Page 54025]]

Special Concerns About the Use of Unlinked Samples

    Given the importance of society's interest in treating disease and 
developing new therapies, a policy that severely restricts research 
access to unidentified and unlinked samples would severely hamper 
research and could waste a valuable research resource. As noted in 
Recommendation 1, research using unlinked samples may be exempt from 
review. However, if coded or identified samples are rendered unlinked 
by the investigator, special precautions are in order.
Recommendation 3
    When an investigator proposes to create unlinked samples from coded 
or identified materials already under his or her control, an IRB (or 
other designated officials at the investigator's institution) may 
exempt the research from IRB review if it determines that:
    (a) The process used to unlink the samples will be effective, and
    (b) The unlinking of the samples will not unnecessarily reduce the 
value of the research.

Requirements for Investigators Using Coded or Identified Samples

    Repositories and IRBs share responsibility with investigators to 
ensure that research is designed and conducted in a manner that 
appropriately protects human subjects from unwarranted harms.
Recommendation 4
    Before releasing coded and/or identified samples from its 
collection, a repository should require that the investigator 
requesting the samples either provide documentation from the 
investigator's IRB that the research will be conducted in compliance 
with applicable federal regulations or explain in writing why the 
research is not subject to those regulations.
Recommendation 5
    When reviewing and approving a protocol for research on human 
biological materials, IRBs should require the investigator to set 
forth:
    (a) A thorough justification of the research design, including a 
description of procedures used to minimize risk to subjects,
    (b) A full description of the process by which samples will be 
obtained,
    (c) Any plans to obtain access to the medical records of the 
subjects, and
    (d) A full description of the mechanisms that will be used to 
maximize the protection against inadvertent release of confidential 
information.
    When an investigator obtains access to a patient's medical records, 
either to identify sample sources or to gather additional medical 
information, human subjects research is being conducted. IRBs should 
adopt policies to govern such research, consistent with existing OPRR 
guidance related to medical records research.

Obtaining Informed Consent

    Research using coded or identified samples requires the consent of 
the source, unless the criteria for a consent waiver have been 
satisfied. Unfortunately, the consent obtained at the time the specimen 
was obtained may not always be adequate to satisfy this requirement. 
When research is contemplated using existing samples, the expressed 
wishes of the individuals who provided the materials must be respected. 
Where informed consent documents exist, they may indicate whether 
individuals wanted their sample to be used in future research and in 
some instances may specify the type of research.
    When human biological materials are collected, whether in a 
research or clinical setting, it is appropriate to ask subjects for 
their consent to future use of their samples, even in cases where such 
uses are at the time unknown. In this latter case, however, particular 
considerations are needed to determine whether to honor prospective 
wishes.
    Whether obtaining consent to the research use of human biological 
materials in a research or clinical setting, and whether the consent is 
new or renewed, efforts should be made to be as explicit as possible 
about the uses to which the material might be put and whether it is 
possible that the research might be conducted in such a way that the 
individual could be identified. Obviously, different conditions will 
exist for different research protocols, in different settings, and 
among individuals. NBAC notes that the current debate about the 
appropriate use of millions of stored specimens endures because of the 
uncertain nature of past consents. Investigators and others who 
collected and stored human biological materials now have the 
opportunity to correct past inadequacies by obtaining more specific and 
clearly understood informed consent.
Recommendation 6
    When informed consent to the research use of human biological 
materials is required, it should be obtained separately from informed 
consent to clinical procedures.
Recommendation 7
    The person who obtains informed consent in clinical settings should 
make clear to potential subjects that their refusal to consent to the 
research use of biological materials will in no way affect the quality 
of their clinical care.
Recommendation 8
    When an investigator is conducting research on coded or identified 
samples obtained prior to the implementation of NBAC's recommendations, 
general releases for research given in conjunction with a clinical or 
surgical procedure must not be presumed to cover all types of research 
over an indefinite period of time. Investigators and IRBs should review 
existing consent documents to determine whether the subjects 
anticipated and agreed to participate in the type of research proposed. 
If the existing documents are inadequate and consent cannot be waived, 
the investigator must obtain informed consent from the subjects for the 
current research or in appropriate circumstances have the identifiers 
stripped so that samples are unlinked.
Recommendation 9
    To facilitate collection, storage, and appropriate use of human 
biological materials in the future, consent forms should be developed 
to provide potential subjects with a sufficient number of options to 
help them understand clearly the nature of the decision they are about 
to make. Such options might include, for example:
    (a) Refusing use of their biological materials in research,
    (b) Permitting only unidentified or unlinked use of their 
biological materials in research,
    (c) Permitting coded or identified use of their biological 
materials for one particular study only, with no further contact 
permitted to ask for permission to do further studies,
    (d) Permitting coded or identified use of their biological 
materials for one particular study only, with further contact permitted 
to ask for permission to do further studies,
    (e) Permitting coded or identified use of their biological 
materials for any study relating to the condition for which the sample 
was originally collected, with further contact allowed to seek 
permission for other types of studies, or
    (f) Permitting coded use of their biological materials for any kind 
of future study.*

Criteria for Waiver of Consent

    When an investigator proposes to conduct research with coded or 
identified samples, it is considered

[[Page 54026]]

research with human subjects. Ordinarily the potential research subject 
is asked whether he or she agrees to participate. Seeking this consent 
demonstrates respect for the person's right to choose whether to 
cooperate with the scientific enterprise, and it permits individuals to 
protect themselves against unwanted or risky invasions of privacy. But 
informed consent is merely one aspect of human subjects protection. It 
is an adjunct to--rather than a substitute for--IRB review to determine 
if the risks of a study are minimized and acceptable in relation to its 
benefits.
    When a study is of minimal risk, informed consent is no longer 
needed by a subject as a form of self-protection against research 
harms. However, it is still appropriate to seek consent in order to 
show respect for the subject, unless it is impracticable to locate him 
or her in order to obtain it. Thus, when important research poses 
little or no risk to subjects whose consent would be difficult or 
impossible to obtain, it is appropriate to waive the consent 
requirement.
Recommendation 10
    IRBs should operate on the presumption that research on coded 
samples is of minimal risk to the human subject if:
    (a) The study adequately protects the confidentiality of personally 
identifiable information obtained in the course of research,
    (b) The study does not involve the inappropriate release of 
information to third parties, and
    (c) the study design incorporates an appropriate plan for whether 
and how to reveal findings to the sources or their physicians should 
the findings merit such disclosure.
    Failure to obtain informed consent may adversely affect the rights 
and welfare of subjects in two basic ways. First, the subject may be 
improperly denied the opportunity to choose whether to assume the risks 
that the research presents, and second, the subject may be harmed or 
wronged as a result of his or her involvement in research to which he 
or she has not consented.
    Further, when state or federal law, or customary practice, gives 
subjects a right to refuse to have their biological materials used in 
research, then a consent waiver would affect their rights adversely. 
Medical records privacy statutes currently in place or under 
consideration generally allow for unconsented research use and could be 
interpreted to suggest a similar standard for research using human 
biological materials. But as new statutes are enacted, it is possible 
that subjects will be given explicit rights to limit access to their 
biological materials.

    * Commissioners Capron, Miike, and Shapiro wrote statements 
regarding their concerns about various aspects of this 
recommendation. (See page 65 of the full report.)
Recommendation 11
    In determining whether a waiver of consent would adversely affect 
subjects' rights and welfare, IRBs should be certain to consider:
    (a) Whether the waiver would violate any state or federal statute 
or customary practice regarding entitlement to privacy or 
confidentiality,
    (b) Whether the study will examine traits commonly considered to 
have political, cultural, or economic significance to the study 
subjects, and
    (c) Whether the study's results might adversely affect the welfare 
of the subject's community.
    Even when research poses no more than minimal risk and a consent 
waiver would not affect the rights and welfare of subjects, respect for 
subjects requires that their consent be sought. However, on some 
occasions, demonstrating this respect through consent requirements 
could completely halt important research. An investigator who requests 
a waiver of the informed consent requirement for research use of human 
biological materials under the current federal regulations must provide 
to the IRB evidence that it is not practicable to obtain consent. 
Unfortunately, neither the regulations nor OPRR offers any guidance on 
what defines practicability.
Recommendation 12
    If research using existing coded or identified human biological 
materials is determined to present minimal risk, IRBs may presume that 
it would be impracticable to meet the consent requirement (45 CFR 
46.116(d)(3)). This interpretation of the regulations applies only to 
the use of human biological materials collected before the adoption of 
the recommendations contained in this report (specifically 
Recommendations 6 through 9 regarding informed consent). Materials 
collected after that point must be obtained according to the 
recommended informed consent process and, therefore, IRBs should apply 
their usual standards for the practicability requirement.
    NBAC recognizes that if its recommendation that coded samples be 
treated as though they are identifiable is adopted, there may be an 
increase in the number of research protocols that will require IRB 
review. If, however, such protocols are then determined by an IRB to 
present minimal risk to a subject's rights and welfare, the requirement 
for consent may be waived if the practicability requirement is revised 
for this category of research. However, it must be noted that by 
dropping the requirement that consent must be obtained if practicable, 
NBAC does so with the expectation that the process and content of 
informed consent for the collection of new specimens will be explicit 
regarding the intentions of the subjects and the research use of their 
materials. (See Recommendations 6 through 9 concerning informed 
consent.)
    According to current regulations, the fourth condition for the 
waiver of consent stipulates that ``whenever appropriate, the subjects 
will be provided with additional pertinent information after 
participation'' (45 CFR 46.116(d)(4)). Thus, according to the 
regulations, an IRB, while waiving consent (by finding and documenting 
the first three required conditions), could require that subjects be 
informed that they were subjects of research and that they be provided 
details of the study-a so-called debriefing requirement. In general, 
NBAC concludes that this fourth criterion for waiver of consent is not 
relevant to research using human biological materials and, in fact, 
might be harmful if it forced investigators to recontact individuals 
who might not have been aware that their materials were being used in 
research.
Recommendation 13
    OPRR should make clear to investigators and IRBs that the fourth 
criterion for waiver, that ``whenever appropriate, the subjects will be 
provided with additional pertinent information after participation'' 
(45 CFR 46.116(d)(4)), usually does not apply to research using human 
biological materials.

Reporting Research Results to Subjects

    Experts disagree about whether findings from research should be 
communicated to subjects. However, most do believe that such findings 
should not be conveyed to subjects unless they are confirmed and 
reliable and constitute clinically significant or scientifically 
relevant information.
Recommendation 14
    IRBs should develop general guidelines for the disclosure of the 
results of research to subjects and require investigators to address 
these issues explicitly in their research plans.

[[Page 54027]]

In general, these guidelines should reflect the presumption that the 
disclosure of research results to subjects represents an exceptional 
circumstance. Such disclosure should occur only when all of the 
following apply:
    (a) The findings are scientifically valid and confirmed,
    (b) The findings have significant implications for the subject's 
health concerns, and
    (c) A course of action to ameliorate or treat these concerns is 
readily available.
Recommendation 15
    The investigator in his or her research protocol should describe 
anticipated research findings and circumstances that might lead to a 
decision to disclose the findings to a subject, as well as a plan for 
how to manage such a disclosure.
Recommendation 16
    When research results are disclosed to a subject, appropriate 
medical advice or referral should be provided.

Considerations of Potential Harms to Others

    The federal regulations governing the protection of research 
subjects extend only to individuals who can be identified as the 
sources of the biological samples. The exclusive focus of the 
regulations on the individual research subject is arbitrary from an 
ethical standpoint, because persons other than the subject can benefit 
or be harmed as a consequence of the research.
Recommendation 17
    Research using stored human biological materials, even when not 
potentially harmful to individuals from whom the samples are taken, may 
be potentially harmful to groups associated with the individual. To the 
extent such potential harms can be anticipated, investigators should to 
the extent possible plan their research so as to minimize such harm and 
should consult, when appropriate, representatives of the relevant 
groups regarding study design. In addition, when research on unlinked 
samples that poses a significant risk of group harms is otherwise 
eligible for exemption from IRB review, the exemption should not be 
granted if IRB review might help the investigator to design the study 
in such a way as to avoid those harms.
Recommendation 18
    If it is anticipated that a specific research protocol poses a risk 
to a specific group, this risk should be disclosed during any required 
informed consent process.

Publication and Dissemination of Research Results

    Publishing research results with identifiable information in 
scientific or medical journals and elsewhere may pose a risk to the 
privacy and confidentiality of research subjects. Public disclosure of 
such information through written descriptions or pedigrees may cause 
subjects to experience adverse psychosocial effects. In addition, 
without the informed consent of the individual, such disclosure 
infringes on the rights of the subject or patient. Because of the 
familial nature of information in pedigrees, their publication poses 
particularly difficult questions regarding consent. Investigators and 
journal editors should be aware that the ways in which research results 
are publicized or disseminated could affect the privacy of human 
subjects. NBAC believes that the source of funding, i.e., public or 
private, should not be an important consideration in determining the 
ethical acceptability of the research.
Recommendation 19
    Investigators' plans for disseminating results of research on human 
biological materials should include, when appropriate, provisions to 
minimize the potential harms to individuals or associated groups.
Recommendation 20
    Journals should adopt the policy that the published results of 
research studies involving human subjects must specify whether the 
research was conducted in compliance with the requirements of the 
Common Rule. This policy should extend to all human subjects research, 
including studies that are privately funded or are otherwise exempt 
from these requirements.

Professional Education and Responsibilities

    Public and professional education plays an essential role in 
developing and implementing effective public policy regarding use of 
human biological materials for research. By education, NBAC is 
referring not simply to the provision of information with the aim of 
adding to the net store of knowledge by any one person or group; 
rather, education refers to the ongoing effort to inform, challenge, 
and engage. Widespread and continuing deliberation on the subject of 
this report must occur to inform and educate the public about 
developments in the field of genetics and other areas in the biomedical 
sciences, especially when they affect important cultural practices, 
values, and beliefs.
Recommendation 21
    The National Institutes of Health, professional societies, and 
health care organizations should continue and expand their efforts to 
train investigators about the ethical issues and regulations regarding 
research on human biological materials and to develop exemplary 
practices for resolving such issues.
Recommendation 22
    Compliance with the recommendations set forth in this report will 
require additional resources. All research sponsors (government, 
private sector enterprises, and academic institutions) should work 
together to make these resources available.

Use of Medical Records in Research on Human Biological Materials

    In recent years, attention increasingly has been paid by 
policymakers to the need to protect the health information of the 
individual. Extensive efforts at the state and federal levels to enact 
such protections have resulted in the setting of a variety of 
limitations on access to patient medical records. NBAC notes that 
debates about medical privacy are relevant to researchers using human 
biological materials in two ways. First, these researchers often need 
access to patient medical records, either to identify research sample 
sources or to gather accompanying clinical information. Such activities 
constitute human subjects research and should be treated accordingly. 
Second, the development of statutes and regulations to protect patient 
medical records could have the unintended consequence of creating a 
dual system of protections, one for the medical record and one for 
human biological materials. Moreover, restrictions on access to the 
medical record could impede legitimate and appropriate access on the 
part of investigators whose protocols have undergone proper review.
Recommendation 23
    Because many of the same issues arise in the context of research on 
both medical records and human biological materials, when drafting 
medical records privacy laws, state and federal legislators should seek 
to harmonize rules governing both types of research. Such legislation, 
while seeking to protect patient confidentiality and autonomy, should 
also ensure that appropriate access for legitimate research purposes is 
maintained.

[[Page 54028]]

Summary

    To advance human health, it is critical that human biological 
materials continue to be available to the biomedical research 
community. Increasingly, it will be essential for investigators to 
collect human biological materials from individuals who are willing to 
share important clinical information about themselves. In addition, it 
is crucial that the more than 282 million specimens already in storage 
remain accessible under appropriate conditions and with appropriate 
protections for the individuals who supplied this material.
    The growing availability to third parties of genetic and other 
medical information about individuals has fueled the current debate 
about medical privacy and discrimination, and NBAC is sensitive to the 
possibility that the use of information obtained from human biological 
samples can lead to harms as well as benefits. These concerns require 
that those who agree to provide their DNA, cells, tissues, or organs 
for research purposes not be placed at risk. Measures to provide 
appropriate protections for individual privacy and for the 
confidentiality of clinical and research data are important if 
significant research is to continue. The recommendations provided in 
this report are intended to promote the goals of improving health 
through biomedical research while protecting the rights and welfare of 
those individuals who contribute to human knowledge through the gift of 
their biological materials.
    For further information about the report contact Eric M. Meslin, 
Ph.D., Executive Director, National Bioethics Advisory Commission or to 
obtain copies of the report contact: Ms. Patricia Norris, National 
Bioethics Advisory Commission, 6100 Executive Boulevard, Suite 5B01, 
Rockville, Maryland 20892-7508, telephone 301-402-4242, fax number 301-
480-6900. Copies may also be obtained through the NBAC website: 
www.bioethics.gov.

    Dated: September 27, 1999.
Eric M. Meslin,
Executive Director, National Bioethics Advisory Commission.
[FR Doc. 99-25663 Filed 10-4-99; 8:45 am]
BILLING CODE 4160-17-P