Additional IRB Information

Helping You Succeed

Record Keeping

An original copy of each submitted proposal, the IRB review results, and minutes of IRB meetings will be stored in the Spelman College Office of the Associate Provost of Research located in Room 151, in the Science Center. All records will be retained for at least three years after the completion of each approved research project and available for inspection by regulatory agencies during regular business hours (in accordance with the guidelines in the Protection of Human Subjects, 45 CFR §46.115).

Contacting the IRB

Additional information on the Spelman College IRB and the procedures for submission of proposals involving human subjects may be obtained by contacting the Research Development & Sponsored Programs (RDSP) at 404-270-5890, or by emailing irb@spelman.edu. Copies of the Protection of Human Subjects guidelines are available at the Office of Research, Innovation, and Collaboration.

Federalwide Assurance of Protection of Human Subjects (FWA)

The Federal wide Assurance of Compliance (FWA) is the contract which Spelman College has signed with the federal government which allows research involving human subjects to take place.

In signing the FWA, Spelman College has agreed to the following terms:

All of the institution's human subject activities, and all human subject activities supervised by the IRB, regardless of funding source, will be guided by the ethical principles in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, a report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The IRB is regarded as the final authority over human subjects research within its jurisdiction. The College commits to provide sufficient funding, meeting space and staff to insure that the IRB is able to perform its supervision and record keeping duties.

In addition, FWA requires Spelman College to insure that federally supported human subjects research complies with the Federal Policy for the Protection of Human Subjects (also known as the Common Rule), with the Code of Federal Regulations in 45 CFR 46 (Policy for Protection of Human Research Subjects), and any additional human subject regulations and policies of the specific supporting Department or Agency.

FWA requires the College to have written procedures (this document) for (a) verifying whether proposed activities qualify for exemption from, or waiver of, IRB review; (b) conducting IRB initial and continuing review, approving research, and reporting IRB findings to the investigator and the institution; (c) determining which projects require review more often than annually, and which projects need verification from sources other than the investigator that no material changes have occurred; (d) ensuring that changes in approved research are reported promptly and are not initiated without IRB approval, except when necessary to eliminate apparent immediate hazards to the subject; (e) documenting any instances in which the College IRB has agreed to allow another institution’s IRB to have controlling review authority; and (f) ensuring prompt reporting to the IRB, institutional officials, the relevant Department or Agency Head, any applicable regulatory body, and OHRP of any significant events such as serious and unanticipated problems involving risks to subjects or others in any covered research; serious or continuing noncompliance with Federal, institutional, or IRB requirements; and suspension or termination of IRB approval for Federally-supported research.

FWA requires the College to insure that members of the IRB will complete relevant training in and maintain continuing knowledge of relevant Federal, State and Local regulations and institutional policies before reviewing human subjects research. The IRB is also required to document such training from research investigators as a condition for conduction human subject research.

The FWA agreement requires the College to supply any or all of the above documentation on demand to the Office for Human Research Protection of the Department of Health and Human Services.

Discipline-specific Information

For discipline-specific information concerning protection of human subjects, please click on these links:

• American Medical Association

• Humanities

• Anthropology

• Political Science

• Psychology

• Sociology

For information about the Federal Law concerning human subject research, access the website of the Office for Human Research Protections (OHRP) at the U.S. Department of Health and Human Services.