SPECIFIC TO UNC ASHEVILLE
- Student-led Activities: Student-led activities may be subject to requirements that are in addition to those for non-student studies. Check out this Does Your Student-led Activity Require UNC Asheville IRB Review? decision tree to see the requirements.
- What activities require IRB review? [Under Construction] Click on our Engagement algorithm to find out.
- Exempt and Limited Review Studies: Follow our Exempt and Limited Review decision tree to determine the process for completing the required materials for IRB review.
- Review Process: [Under Construction] Follow our Review Pathway for Human Research for a high-level overview of key IRB decision points.
- HIPAA Privacy Rule and Research: Click on our HIPAA Privacy Rule & Research Requirements algorithm to see what requirements apply to use or disclosure of health information.
- Clinical Trials: Specific legal requirements apply to clinical trials (evaluating effects of interventions on biomedical or behavioral health-related outcomes); refer to our draft Clinical Trials/Human Research Workflows algorithm to learn more.
- FDA-regulated Products and Test Articles: [Under Construction] See our interim FDA Drug or Device algorithms for special requirements for research using drugs, devices, including software considered a “device”, biological products or dietary supplements.
- Quality Improvement (QI): To see how QI may be distinguished from research, use our Quality Improvement or Research? algorithm.
APPLICABLE TO RESEARCH GENERALLY
Provided below are other charts and graphic aids published by the U.S. government with regard to more specific human research protection requirements; these address the following: whether an activity is research that must be reviewed by an IRB, whether the review may be performed by expedited procedures, and whether informed consent or its documentation may be waived.
- 2018 Requirements—Studies that are initially approved or determined to be exempt on or after 21 January 2019 are governed by the 2018 Requirements (i.e., the Revised Common Rule).
- Pre-2018 Requirements—Studies with an initial approval or exemption determination before 21 January 2019 are by default subject to the pre-2018 Requirements (i.e., the Common Rule as published in the 2016 edition of the CFR).
The federal charts are intended only as guidance and are not intended substitutes for consulting the regulations or obtaining official UNC Asheville regulatory determinations. Note that these charts are necessarily generalizations and may not be specific enough for or applicable to particular situations. Other guidance documents are available related to specific topics, at http://www.hhs.gov/ohrp/policy/index.html#topics. These charts do not address requirements that may be imposed by other organizations, such as the Food and Drug Administration, National Institutes of Health, other sponsors, state or local governments or UNC Asheville policy.