Criteria for Approval of Research Using Expedited Review

In addition to meeting the general eligibility criteria previously indicated, research qualifying for expedited review must also meet the approval criteria defined by DHHS as summarized below:

1. The proposed procedures must be consistent with sound research design, and when possible, procedure already being performed on subjects should be utilized. For example, obtaining an additional amount of blood at the time of routine venipuncture is preferred rather than doing an additional needle stick to obtain the research sample.
2. The risks of the research must be reasonable in relation to the anticipated benefits, if any, to the subjects and the importance of the knowledge that may be gained.
3. Subject selection must be equitable.
4. Informed consent should be sought and documented unless a waiver of consent has met the waiver criteria at 45 CFR 46.
5. Where appropriate, there is a plan to collect and monitor data to ensure subject safety.
6. The privacy of subjects and maintenance of confidentiality of data is protected.
7. Where necessary, additional safeguards have been included to protect vulnerable subjects.