Human Research Subjects

Policy for the Protection of Human Research Subjects

In order to assure that the rights of humans involved in research are adequately protected, the federal government has instituted a series of regulations (53 FR 45660, 45 CFR 46 and 21 CFR 50) governing the use of human subjects in research projects, whether conducted by faculty or students. Fisk University must also assure that the rights and interests of human subjects are protected in the conduct of research. All research projects involving human subjects, including many research surveys and questionnaires, conducted by faculty or students, must be reviewed by the Fisk Institutional Review Board (IRB). Exemptions are described later in this section. The OSP must be notified if the faculty investigator is proposing human research, including that done by students under faculty direction or guidance. This can be accomplished by completing the “Information Form to Accompany All Proposals” (Appendix F, also available in the OSP). Copies of the NIH regulations governing research on human subjects are available in the OSP. For each application involving human research subjects, the President of the University must certify to the NIH Office for Protection from Research Risks (OPRR) that the IRB has reviewed and approved the application and associated Informed Consent Protocol, determining that there is minimal or acceptable risk to the subjects.

The Fisk IRB has responsibilities and authority in accordance with institutional policy and federal regulations. It is charged to:

  1. Determine whether a given activity should be considered to involve human subjects.
  2. Review and approve, require modification, or disapprove research activities which involve human subjects.
  3. Minimize risks to subjects by using procedures of sound research design which do not unnecessarily expose subjects to risk and by using, whenever appropriate, procedures already being performed on subjects for diagnostic or treatment purposes.
  4. Determine that risks to subjects are reasonable in relation to anticipated benefits and the importance of knowledge that may reasonably be expected to result.
  5. Determine that the selection of subjects is equitable, wherever possible, among age, gender and race.
  6. Require that information given to subjects as a part of informed consent is in accordance with policy and regulations and require that additional information be given to subjects when the Board determines that the information would meaningfully add to the protection of the rights and welfare of the subject.
  7. Require documentation of informed consent.
  8. Assure that the research plan makes adequate provision for monitoring the data collected to ensure the safety of the subject.
  9. Assure that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
  10. Conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year, including observing, or having a third party to observe the consent process and research.
  11. Determine which research projects need verification from sources other than the investigator, that no material changes have occurred since the previous IRB review.
  12. Report to appropriate officials and, when appropriate, the OPRR, any serious or continuing noncompliance by an investigator, with the requirements and determinations of the committee.
  13. Suspend or terminate approval of research that is not being conducted in accordance with the approved plan, the Board’s requirements, or has been associated with unexpected serious harm to subjects.

In compliance with federal regulations, the IRB is composed of persons with diverse backgrounds and with the professional competence necessary to review specific research activities. A variety of professions are represented with at least one person whose primary expertise is in a non-scientific area and at least one person who is not otherwise affiliated with Fisk University personally or through an immediate family member.

Investigator Responsibilities

It is the responsibility of the investigator to:

  1. Inform the appropriate Department Chair, Division Director and the OSP that a proposal will be submitted involving human subjects.
  2. Complete the IRB Form (Appendix C) and provide a protocol for review. Forms may be obtained from the OSP.
  3. Meet with the IRB.
  4. Obtain informed consent from the subjects, maintaining a signed copy of the consent as an official University research record. A signed copy is to be provided to each subject. The Investigator is responsible for maintaining all subject data relevant to the study as official University research records. These records should be retained for at least three years beyond the termination of the last IRB approval period.
  5. Notify the IRB, through the OSP, of any modifications to the protocol, deviations from the protocol or adverse events associated with the research. Any new information which becomes available and which could alter the risk/benefit ratio must be reported. The investigator should notify the IRB (through the OSP) when a protocol becomes inactive or is withdrawn. The IRB must be provided, at least annually, with information requested during the continuing review process.
  6. Inform all students and employees that might engage in human subject research, of the obligations and requirements of the policies stated here and of government regulations.
  7. Not initiate any research activity involving human subjects until the IRB has completed their review and approval of protocol. Investigators will be responsible for complying with all IRB decisions, conditions and requirements.
  8. Be responsible for immediately reporting in writing to the Office of Sponsored Programs, any injuries to human subjects and any unanticipated problems which involve risks to the human subjects or others.

The OSP will be the official contact with the IRB and will convene the Board when necessary, providing the members with materials provided by the investigator, which are necessary for the Board review. The OSP will communicate Board decisions to the investigator. Any questions about human research protocols or regulations should be directed to the Office of Sponsored Programs.