Conditions of IRB Approval

Reseacher Considerations

Conditions of IRB Approval
IRB approval of a proposed study is limited to the specific study described in the proposal reviewed by the IRB. Approval is limited to 12 months. An extension of IRB approval for an additional 12-month period requires that the principal investigator notify the IRB of the following information: 1) number of subjects, 2) location and number of consent forms obtained, 3) adverse reactions encountered and corrective measures taken, and 4) any changes in the research protocol. Proposals for extensions for an additional 12-month period may be submitted no later than two months prior to the expiration of the current 12-month period.

Reporting Changes
Researchers must report to the IRB any changes made to protocols, instruments, or informed consent forms during a study prior to the initiation of such changes. Changes in protocols, instruments, or informed consent forms must be approved by the IRB prior to use with human subjects, except when such change is necessary to eliminate apparent immediate hazard to the subjects.

If any such immediate changes are made, the IRB must be immediately notified and approval of the change must be sought. Any incident in which a human subject is injured must be reported immediately to the IRB. In all cases, researchers must report to the IRB on the status to their project at the end of each 12-month approval period or at shorter intervals as specified by the IRB.

High Risk Level Projects
Projects that pose a high level of risk to human subjects or that have had problems complying with IRB requirements in the past may be subject to continuing reviews at intervals more frequent than 12 months and/or verification of research activities by individuals other than the principal investigator.

The Spelman College IRB is obligated to report serious or continued noncompliance with Federal Regulations or the Spelman College IRB requirements, unanticipated problems involving risks to research subjects or others, and suspension or termination of IRB approval. Such events will be reported to the Associate Provost of Research, the Director of Sponsored Programs, the Office for Human Protections (OHRP) at the U.S. Department of Health and Human Services, and to the relevant funding and regulatory agencies specific to a given research project.

The IRB has the authority to suspend or terminate approval of any research that is not being conducted in accordance with these guidelines or that is associated with unexpected serious harm to the subjects. When approval is either suspended or terminated, the IRB will provide the principal investigator with a statement of the reasons for its decision.

Scope of IRB Approval
The Spelman IRB reviews and approves projects with respect to human subjects concerns only. Although IRB approval is necessary for a research project to be conducted by or with Spelman personnel, other approvals beyond the scope of the IRB's purview may be necessary as well.