Guarding the Rights of Individuals and Society as Research Advances

Goal of the DOE Human Subject Research Program

To ensure that the rights and welfare of human research subjects are protected while advances in biomedical, environmental, nuclear, and other research continue to lead to discoveries that benefit humanity.

Accomplished through:

• Institutional Review Boards
• Informed Consent Documentation
• Federal Policy for the Protection of Human Subjects (10 CFR Part 745) - Common Rule
• DOE 1300.3, Policy on the Protection of Human Subjects

Elements of Informed Consent

• Purpose of research
• Length of participation
• Experimental procedures to be followed
• Foreseeable risks or discomforts
• Compensation
• Understanding that participation is voluntary and may be discontinued at any time

Human subjects used in testing devices such as this noninvasive glucose sensor, developed at Sandia National Laboratories, are protected by federal regulations.

Human subject research uses. . .

• Humans to test devices or products or materials
• Data collected through intervention (e.g., drawing blood) and interaction (e.g., surveys)
• Private information (e.g., birth dates, medical history)
• Bodily materials (e.g., cells, tissues)
• Humans to evaluate environmental alterations (e.g., habitat modifications)

Devices such as this cobalt-60 teletherapy unit were important in research related to the use of radiation in treating and diagnosing cancer.

Ethical, Legal, and Social Issues and the Human Genome Project

• Privacy of genetic information
• Safe and effective introduction of genetic information in clinical settings
• Fairness in the use of genetic information
• Professional and public education

The low-exposure total-body irradiation facility at the Oak Ridge Institute of Nuclear Studies was an experimental facility used to treat cancer patients in the mid 1960s. Although not required at the time, informed consent forms were signed by all patients treated there.

DOE funds ELSI educational programs that. . .

• Develop and distribute bilingual curricula for Hispanic students and parents on ELSI and the human genome project
• Integrate current genetics research into high school biology curricula
• Prepare community college students for working in biotechnology
• Provide national distribution of public radio programs that discuss the human genome project

DOE-funded education initiatives are helping to bring current genetic research into biology curricula nationwide.

A Sandia National Laboratories researcher uses human subject data to examine the effectiveness of newly developed computer software that analyzes x-ray films for distortions in breast tissue.

DOE's Protecting Human Subjects Program Web Site

http://www.er.doe.gov/production/oher/humsubj/index.html

• Protecting Human Subjects newsletter
• Sample informed consent documents
• Current events
• Human subjects research projects database

ELSI Web Site

http://www.ornl.gov/TechResources/Human_Genome/resource/elsi.html

• Abstracts to Contractor-Grantee Workshops
• Articles in Human Genome News
• Educational outreach efforts
• ELSI research and related products

Significant Milestones

1949
Nuremberg Code established to encourage consideration of ethical, moral,and legal standards in human experimentation

1964
World Medical Association Declaration of Helsinki established code of ethics for clinical research; adopted worldwide

1974
National Research Act of 1974 mandated Institutional Review Boards to approve all federally funded human subject research

1975
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research established; became basis of DHHS regulations

1978
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research; work evolved into 10 CFR 745

1979
NIH published The Belmont Report, which identifies basic ethical principles that underlie biomedical and behavioral research

1982
Ad Hoc Committee for the Protection of Human Research Subjects formed at federal level

1983
Interagency Human Subjects Coordinating Committee chartered

1989
Joint DOE/NIH ELSI Working Group established

1991
Common Rule (10 CFR 745) adopted

1993
U.S. Secretary of Energy announced the Openness Initiative to find and make publicly available DOE's records on human experimentation with radiation

1995
National Bioethics Advisory Commission formed to address rights and welfare of human subjects and issues related to use of genetic information

Final Report of Presidential Advisory Committee on Human Radiation Experiments completed

Genetic Privacy Act proposed for federal legislation

1996
Joint DOE/NIH Guidance on Human Subjects Issues in Large-Scale DNA Sequencingissued

Joint DOE/NIH Committee to Evaluate Ethical, Legal, and Social ImplicationsProgram of the Human Genome Project formed in April and presented recommendationsin December

Contributing Laboratories:

Oak Ridge Institute for Science and Education

Oak Ridge National Laboratory

Exhibit developed by the Oak Ridge Institute for Science and Education