Analysis and Proposed Actions Regarding the NBAC Report: Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. Appendix B



DHHS Research and Training Activities
Addressing Protections of Human Subjects

  1. NIH Research Activities
    1. 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.
    2. 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.
    3. 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
    4. 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.
    5. 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.
  2. NM Training Activities
    1. 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.
    2. 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.
    3. 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.
    4. 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:
    5. 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 ( 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 ( are underway.
    6. 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.
    7. 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.
    8. 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:
    9. 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:
    10. 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.
    11. 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.”
  3. CDC Training Activities
    1. 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.
    2. 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.
    3. 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.
    4. “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.
    5. 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.
    6. International Human Subjects Research Web Page. This page ( 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.
    7. 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.
    8. 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.

    9. IRB Training for Community Partners. CDC has been invited by a number of state health departments to provide IRB training.
    10. Human Subjects Web Page. The Associate Director for Science hosts a Human Subjects home page ( Highlights include:
      1. 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.
      2. 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.
      3. 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.
      4. 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.
  4. CDC Reports on Human Subject Participation in Research
    1. 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
    2. 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

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