Office of Science and Data Policy Issues
Human Subject Protection
Prepared by
HHS Working Group on the NBAC Report
APPENDIX B
DHHS Research and Training Activities
Addressing Protections of Human Subjects
- NIH Research Activities
- NM Program Announcement on Research on Ethical Issues in Human Studies,
(highlighted in response to #19) which was released March 11, 1”9
(PA NUMBER: PA-99-079). This PA is designed to encourage empirical
studies that are expected to fill many gaps in our knowledge and understanding
of the complex ethical issues that arise’ when involving human participants
in research. Some possible research topics include:
- Evaluate the cognitive ability required to comprehend, appreciate,
and reason in order to consent to specific experimental procedures
and risks; to differentiate between research and standard treatment
(e.g., therapeutic misconception); and to distinguish between discretionary
and obligatory activities (e.g., quid pro quo add-on studies or wrap-around
studies).
- Develop and test new means of sustaining autonomy to be used in
situations of declining or loss of capacity; means can include current
yet untested advance directives for research, and consent programs
for organ donation (e.g., durable power of attorney, proxy, legally
authorized representative) and especially novel and innovative approaches.
- Investigate how potential participants weigh risks and benefits
e.g., what factors would lead individuals to participate in studies
that present significant-risk with little or no prospect of direct
benefit.
- Apply existing knowledge from cognitive, behavioral, social, and
educational fields to develop practical, reliable, valid, and efficient
methods and instruments for assessing capacity to comprehend, appreciate
and/or reason in a research setting, especially when individuals with
cognitive, psychiatric, and developmental disorders are involved;
the focus should be on functional abilities rather than on clinical
diagnosis.
- The National Institute on Deafness and Other Communication Disorders
Working Groups. One December 8, 1998, the Working Group on Considerations
for Developing and Implementing Genetic Diagnostic Tests for Hereditary
Hearing Impairment and Other Communication Disorders considered the role
of genetic testing as it pertains to the research community engaged in
the study of the genetics of hearing. Issues needing attention by these
communities before such testing should be considered include informed
consent. On May 25, 109, the National Institute on Deafness and Other
Communication Disorders (NIDCD), National Institutes of Health (NIH),
convened a day-long working group on “Communicating Informed Consent
to Individuals Who Are Deaf or Hard-of-Hearing,” in Bethesda, Maryland.
The purposes of the meeting were: (1) to clarify issues of informed consent;
(2) to develop guidelines for use by scientists who are recruiting deaf
or hard of hearing individuals to participate in clinical research; (3)
to highlight materials for the scientific community to use in facilitating
clear communication between deaf or hard-of-hearing research volunteers
and scientific investigators in clinical research; and, to propose new,
needed materials for improving communication about informed consent.
- NIH/DOE/VA RFA on Informed Consent. On September 27, 1996, NIH,
DOE, and DVA issued a jointly sponsored Request for Applications (RFA)
entitled, “Informed Consent in Research Involving Human Participants.”
Sponsored Institutes were NCI, NHGRI, NIA, NIAAA, NIAID, NICHD, NIDA,
NIMH, and NINR The goal of the RFA is to identify and validate methods
for improving the informed consent process in scientific research. Eleven
grants were funded. This RFA followed a July 1995 NIMH Program Announcement
(PA) on Informed Consent, entitled, “Informed Consent in Clinical
Mental Health Research,” to encourage research in this area
- Clinical Center Department of Clinical Bioethics. The Department
serves several functions, including conducting research on clinical and
research related bioethics issues. The Department is currently conducting
research on reasons for participation in clinical trials. A survey study
is being developed on motivation for subject participation in clinical
research. The study will begin with CC research participants and expect
to be expanded to multiple centers. Plans are also being made to conduct
further research on informed consent.
- ORWH/NCI/NAPBC/PRIM&R/ARENA Meeting, “Informed Consent
and IRB Review: A Model for Review and Discussion.” On June
2, 1997, the National Action Plan on Breast Cancers Public
Responsibility in Medicine and Research, the Applied Research Ethics National
Association, the National Cancer Institute and the NIH Office of Research
on Women’s Health cosponsored a meeting titled “Informed Consent
and IRB Review: A Model for Review and Discussion.” The National
Action Plan on Breast Cancer presented a model for obtaining specimens
for research, as well as principles to be used by IRBs in reviewing protocols
that propose to use human tissues, and a model consent form for obtaining
human tissues from routine surgical procedures. The meeting participants
discussed and commented upon the model and principles, and made suggestions
for the practical application of this model.
- NM Training Activities
- NIH/CDC/HRSA/AHCPR/SAMHSA Mentored Scientist Development Award in
Research Ethics-Program Announcement Released on January 22, 1999
and sponsored jointly with CDC, HRSA, AHCPR and SAMHSA, this award will
support training in research ethics for health professionals working at
academic and other health-related institutions in biomedical, behavioral,
or public health research, particularly research involving human participants.
This initiative follows a directive from the Secretary of Health and Human
Services in response to President Clinton’s apology to the survivors
and relatives of the men who participated in the Tuskegee Syphilis Study.
The directive requires DHHS agencies to offer training - with special
outreach to minority scientists for post-graduate training in research
ethics and for the development of short courses in research ethics.
- National Institute of Mental Health Investigators Guide. Through
a contract with the American Psychiatric Association (APA), NIMH developed
an investigators’ resource manual that addresses a wide range of
ethical issues in clinical research. The manual is envisioned as a “working
tool” for clinical investigators. The manual explores the pros and
cons of various approaches to responding to the concerns of all parties
in the research process. It was published by APA in 1999. Ethical Issues
in Psychiatric Research: A Resource Manual on Human Subjects Research.
edited by Pincus, Lieberman, and Ferris.
- Informed Consent Working Group. During the period of 1997-99,
the NCI, together with OPRR and FDA, sponsored an Informed Consent Working
Group that developed recommendations and a template for writing informed
consent documents that are simpler and easier to understand. The recommendations
and template are being used by investigators nationally and have been
distributed to all IRBs with multiple project assurances. Workshops have
been held with investigators at national meetings and with IRB members
at PRIM&R.
- National Institute of Mental Health Participants Guide to Clinical
Mental Illness Research. The guide is for participants in clinical
mental research and their families. The guide includes an overview of
the clinical research process, a discussion of ethical and legal issues
in research, questions patients should ask and consider before participating
as a research subject, and information about obtaining results of studies
in which individuals have participated. An ad hoc group of advocacy organizations
were brought together to discuss the contents of the Guide. The Guide
can be found at the URL: http://www.nimh.nih.gov/studies/clinres.htm
- Office of Intramural Research/NIH Committee on Scientific Conduct
and Ethics. The Committee on Scientific Conduct and Ethics is composed
of a broad spectrum of members from the Institutes and Centers. The committee
was established in September 1995 and its charge includes: developing
and/or refining the existing Guidelines for the Conduct of Research; developing
Guidelines for Training and Mentoring; developing effective mechanisms
for ethics training for the NIH scientific community, including the ethics
column in the NIH Catalyst. The third edition of the Guideline for the
Conduct of Research (http://www.nih.gov/news/irnews/guidelines.htm)
was published in 1997. The Guidelines for Training and Mentoring are being
developed now. Training of facilitators to lead ethics case discussions,
developed by NHGRI (http://www.nhgri.nih.gov/about_nhgri/dir/ethics/message.html)
are underway.
- Trans-NIH - Training in the Responsible Conduct of Research. Every
predoctoral and postdoctoral National Research Service Award (NRSA) trainee
supported by an institutional training grant must receive training in
the responsible conduct of research. Grant applications must include a
description of a program to provide formal or informal instruction in
scientific integrity on the responsible conduct of research. Programs
are encouraged to include topics such as: conflict of interest, responsible
authorship, policies for handling misconduct, policies regarding the use
of human and animal subjects, and data management. More details are provided
in the NIH Guide for Grants and Contracts, Volume 21, Number 43,
November 27, 1992.
- NIH/CDC/HRSA/AHCPR Program Announcement on Short-Term Courses in
Research Ethics. Bioethics Training Initiative. The National Institutes
of Health (NIH), Centers for Disease Control (CDC), Health Resources and
Services Administration (HRSA), Substance Abuse and Mental Health Services
Administration, and the Agency for Health Care Policy and Research (AHCPR)
invite applications for grants to develop, conduct, and evaluate short-term
courses on ethical issues in research, particularly those involving human
participants. Courses should improve the skills of biomedical, behavioral,
social science, and public health researchers in identifying and addressing
the ethical, legal, and social implications of their research,
especially when human participants are involved. Courses developed include
Ethics Course on ScientistParticipant Partnerships, Ethical Issues in
International Research, and Ethics of Research Participation in Vulnerable
and Special Populations.
- Office of Intramural Research/NIH Computer-Based Training for NIH
Researchers. Protecting Human Subjects in the NIH Intramural Research
Program. This computer-based training module was developed to orient NIH
research staff to the special requirements associated with research involving
human subjects. Completion of this training is required by NIH staff who
contemplate involvement with this type of research. The training is also
available for download and use by staff in other organizations beyond
the NIH. The training can be found at: http://helix.nih.gov:8001/ohsr/newcbt/
- NIH Bioethics Interest Group Website. Interest group includes
participants from the intramural and extramural communities at NIH. Topics
addressed have included: research with the decisionally impaired, bioethics
training, and end-of-life issues. Website contains resources on bioethics
issues for easy access by NIH staff: http://www.nih.gov/sigs/bioethics/index.html
- National Institutes of Environmental Health Sciences Research Ethics
Program. The Office of the Scientific Director supports several programs
designed to promote responsible conduct in research. Located within the
Division of Intramural Research at the National Institute of Environmental
Health Sciences (NIEHS), the Office coordinates educational activities,
training workshops, and conferences on ethical issues in environmental
health research. The Office of the Scientific Director works closely with
the NIEHS Institutional Review Board, the Office of Clinical Research,
the Office of the Director, and the NIEHS Division of Extramural Research
to develop institutional policies that promote research integrity. The
Office also conducts interdisciplinary research on ethical, legal, and
social issues in environmental health research, spanning such fields as
environmental toxicology, cancer research, and environmental genomics.
- National Institutes of Health (NIH) And The Food and Drug Administration
(FDA) National Human Subject Protections Education Workshop Program. The
NIH and the FDA are continuing to sponsor a series of workshop on responsibilities
of researchers, Institutional Review Boards (IRBs), and institutional
officials for the protection of human subjects in research. The workshops
are open to everyone with an interest in research involving human subjects.
The meetings should be of special interest to those persons currently
serving or about to begin serving as ‘a member of an IRB. Issues
discussed at these workshops are relevant to all other Public Health Service
agencies. Upcoming workshops include: “Human Subjects Research &
IRBs Under Fire” “Cultural Diversity in Clinical Research”
“Ethical Research in the New Millennium: What the Belmont Report
Didn’t Anticipate” and “Protection of Human Subjects:
Involving Special Populations.”
- CDC Training Activities
- Office of the Director/CDC Computer-Based Training for CDC Researchers.
Scientific Ethics training for CDC researchers involved in
intra- and extramural research. Scientific Ethics was launched
on February 17, 1999. This computer-based training program, designed in
five discrete modules, was developed to familiarize CDC scientists and
other public health professionals with basic ethical principles, policies,
and procedures for the responsible conduct of science. All scientific
staff and managers are required to complete the training within six months
of its introduction to their respective Centers/lnstitute/Offices (CIO).
New staff members will be required to complete the training before they
conduct research at CDC or ATSDR. The program is a self-directed learning
opportunity that allows users to exit and re-enter at will, choose areas
of greatest personal interest, and select levels of complexity through
optional exercises. The five modules: CDCs Mission in Science, Protection
of Human Subjects, Scientific Integrity, Science-related Responsibilities,
and Case Studies, can be studied in any order. Scientific Ethics may
be accessed via the CDC Intranet. A CD-ROM disk is available for staff
in remote locations. A passing score on the certifying exam included in
Scientific Ethics will trigger the program to print a personalized
certificate to which a unique identifier will be assigned. This identifier
will also be required on requests for Institutional Review Board-approval
of research involving human participants.
- CDC Corporate University Science Survival Skills Course. A 40
hour introductory course for CDC scientists engaged in research has been
developed by the Office of the Associate Director and the Epidemiology
Program Office to enhance scientists’ knowledge of the CDC policies
and procedures involved in the conduct of science. Sessions on scientific
integrity, misconduct, human subjects research, authorship and manuscript
clearances policies and procedures are included. In addition, a mock Institutional
Review Board (IRB) meeting is conducted with the students serving as IRB
members. CME, CNE, and CEU credits are offered upon successful completion
of the course.
- Scientific Ethics Seminar Series. During 2000 and 2001, the Office
of the Associate Director for Science will host a seminar series designed
to stimulate thought on ethical issues CDC researchers encounter while
conducting both domestic and international public health research. The
goals of the series are to introduce ethical topics of broad concern within
CDC, provide updated information on new ethical issues, and to facilitate
a networking opportunity for CDC researchers to later share, debate and
discuss related experiences. Each seminar will be two hours long, have
a public health theme, and be conducted by an experienced researcher,
philosopher, ethicist or a combination of these individuals. The format
for each seminar will vary, some will involve panel discussions with panelists
taking opposing views. All will provide time to question and interact
with the speaker/panelists.
- “Brown Bag” Seminars on Human Subjects Research. The Office
of the Associate Director for Science sponsors a series of “brown
bag” seminars throughout the year which are designed to educate
CDC scientists on human subjects issues. CDC’s Human Subjects Public
Health Educator and CDC’s Human Subjects Manager regularly team
up to present various human subjects-related topics at branch and division
meetings.
- International Ethics Working Group. The Office of the Associate
Director for Science and the Office of Global Health have formed a working
group of CDC researchers interested in the area of ethical issues related
to CDC’s international health activities. The purpose of the working
group is to discuss CDC responsibilities and needs in the area of international
ethics in relation to its mission and to identify activities that can
help CDC effectively accomplish this mission.
- International Human Subjects Research Web Page. This page (http://www.cdc.gov/od/ads/ihsr/index.htm)
was designed to keep CDC investigators involved in international researcher
involving human subjects and collaborators abreast of international ethical
codes and guidance documents; organizations involved in international
human subjects research; articles of interest in international ethics;
and meetings, conferences and training opportunities. In addition to English,
many documents may be found in Spanish, French and Russian.
- Joint CDC/University International Bioethics Fellowship Program.
Discussions are underway with a local university to co-sponsor an
international bioethics fellowship program. Such a program could provide
an opportunity for CDC collaborators in developing countries to develop
leadership skills in bioethics, and for CDC and its partner to facilitate
critical dialogue on the topic.
- Annual IRB Training. Each January CDC conducts an all-day training
session primarily for new IRB members; however, all IRB members are encouraged
to attend. In addition, CDC has invited IRB members from Morehouse School
of Medicine and Life University to participate. Topics include the Federal
regulations for protecting human subjects (45CFR46) and assurances of
compliance with 45CFR46. During the afternoon, a mock IRB meeting is held.
About two months later, a make-up training day is held for IRB members
unable to attend the January session. Interested investigators are invited
to attend the make-up session.
CDC’s IRB chairs also have instituted a mentoring program where
seasoned IRB members mentor new IRB members. Further, seasoned lRB members
are also available to sit with investigators to provide one-on-one training
in developing protocols that involve human subjects.
- IRB Training for Community Partners. CDC has been invited by
a number of state health departments to provide IRB training.
- Human Subjects Web Page. The Associate Director for Science hosts
a Human Subjects home page (http://www.cdc.gov/od/ads/hsr2.htm)
Highlights include:
- Guidelines for Developing a Consent Document. Developed
by a former CDC IRB Chair, this guide helps the investigator write
consent documents at the 8th grade reading level. The guide is also
useful to find standard wording for various parts of a consent document.
- Protocol Development Checklist. The checklist
helps guide the investigator to think about what should go into a
research protocol. It is used to prompt the investigator to include
all items that may apply to the proposed research. Not all items may
apply, however. In addition, a Human Subjects Supplement to
the checklist is included as the Protocol Development Checklist does
not include items that pertain to research involving human participants.
The Human Subjects Supplement checklist helps the investigator
think about what should go into the human subjects part of a research
protocol, when applicable.
- Informed Consent/Assent Checklist This checklist helps
guide the IRB and investigator when developing ALL research protocols
involving human participants. A separate column is for use when developing
assent forms.
- Vulnerable Populations Checklists. Three separate
checklists help guide the IRB and investigator in addressing issues
of added safeguards for research targeting pregnant women, fetuses,
and in vitro fertilization or involving prisoners or children.
- CDC Reports on Human Subject Participation in Research
- Participation of Women, Minorities and Children in CDC-Conducted
Research. A report entitled An Evaluation of the Participation
of Women, Minorities and Children in CDC-Conducted Research
was recently completed and distributed to all CDC CIOs.
The report discusses the status of CDC’s inclusion of women, minorities
and children in research in light of federal policies adopted in the 1990s
to ensure that under represented populations are included in federally
supported research. The CDC report was undertaken to (1) determine how
well CDC is implementing its policy to include women and minorities in
research and (2) determine whether a need exists to develop a formal policy
to include children in research. The report is available on the Internet
at http://www.cdc.gov/od/ads/hsr2.htm.
- State Statutes Addressing the Inclusion of Children in Research.
The Office of the Associate Director for Science and the Office of
General Counsel are nearing completion on a comprehensive report all U.S.
State statutes on the involvement of children in research. In addition,
the report will define the age of majority for each state and provide
a point-of-contact. Once complete, the report will be available on the
Internet at http://www.cdc.gov/od/ads/hsr2.htm.
