[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]
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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
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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.
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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
