Approval Criteria

Criteria for IRB Approval and Notification Guidelines

In order to approve research, the IRB must determine, within its sole discretion, that the following requirements are satisfied:

• There are no unnecessary risks to subjects;
• The risks to subjects are reasonable in relation to anticipated benefits;
• The selection of subjects will be equitable;
• Informed consent will be sought and appropriately documented;
• Adequate provision has been made for monitoring data collection to ensure safety of subjects;
• Adequate provision has been made to protect the privacy and dignity of subjects;
• Necessary additional safeguards have been included to protect subjects who are likely to be vulnerable to coercion or undue influence; and
• The research will be conducted in a manner sensitive to the setting in which it takes place

Notification of Approval

Following review by the IRB for initial or continuing approval, notification will be made in two ways. Initially, the PI will receive an electronic message indicating the results of the review from the Co-chair of record. Following this, the IRB Administrator will send a written notification to the principal investigator, copied to the Spelman College Human Subjects Administrator (Associate Provost of Research).

Written notification will clearly indicate either approval or non-approval. When a proposal is not approved, the Co-chair of record will provide a statement of the reasons for the IRB decision, provide the principal investigator with an opportunity to respond either in person or in writing, and typically will provide instructions to principal investigators on proposal modifications that would increase the likelihood of approval upon resubmission. However, the IRB is not obliged to approve any research proposals that may present risks to human subjects, regardless of the proposed benefits foreseen by the principal investigator.