WVU Flex

WVU Flex

Applies to:

• Non-federally funded research
• Only minimal risk
• Research involving tissues and samples collected under standard of care procedures
• Research that would otherwise be permitted and approved under Expedited Categories 2 and 3 (45 CFR 46.110) are eligible for review using the Flex Application.
• Review of data that have been collected, or will be collected, solely for non-research purposes.
• Research that would otherwise be permitted under Exempt Category 4 (45 CFR 46.101(b)(4) or Expedited Category 5 (45 CFR 46.110) is eligible for review using the Flex Application.
• Research that would otherwise be permitted under Exempt Category 4 (45 CFR 46.101(b)(4) or Expedited Category 5 (45 CFR 46.110) is eligible for review using the Flex Application.

Does NOT Apply to:

• Federally funded research
• WV CTSI, WV-INBRE,CoBRE supported research (in whole or part) or other federally funded research
• Research with FDA regulated elements

1. Research which would otherwise be approvable under Expedited Category 1 (45 CFR 46.110) (i.e., drugs and devices used according to approved labeling).
2. Research requiring an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application(s).

• Research involving sensitive topics

1. Suicide/suicide ideation
2. Traumatic life events that may evoke powerful emotion or induce mood changes in participants.
3. Identifiable results of drug misuse/abuse, criminal history, and/or other behaviors which may put the participant at risk

• Studies with a Certificate of Confidentiality
• International research sites
• Populations targeted as part of the study:

1. Prisoners
2. Tribal members
3. Military personnel
4. Wards of the state
5. Cognitively impaired