Investigator Tips for Transitioning Studies
What does this mean?
This is not intended to be the entire list of changes
Continuing Review Requirements
Continuing review will not be required for:
- minimal risk studies, and
- greater than minimal risk studies where interventions/interaction with participants are complete.
Submission of enrollment numbers will still need to be reported annually for institutional measures
Categories of Research Excluded from Review
Research falling into these disciplines do not need IRB review:
- Scholarly and Journalistic Activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship) including collection and use of information that focus directly on specific individuals about whom the information is collected.
- Public Health Surveillance - authorized by a public health authority.
- Criminal Justice - research by or for a criminal justice agency, authorized by law or court order.
- Authorized Operational Activities - in support of intelligence, homeland security, defense or national security missions.
Exempt Categories
New categories have been added and some existing categories have been modified:
- 45 CFR 46.104(d)(1): Modified provisions, formally 45 CFR 46.101(b)(1)
- 45 CFR 46.104(d)(2): Modified provisions, formally 45 CFR 46.101(b)(2)
- 45 CFR 46.104(d)(3): New Category
- 45 CFR 46.104(d)(4): New Category
- 45 CFR 46.104(d)(5): Same as 45 CFR.46.101(b)(5)
- 45 CFR 46.104(d)(6): Same as 45 CFR 46.101(b)(6)
- 45 CFR 46.104(d)(7): New Category
- 45 CFR 46.104(d)(8): New Category
Additional Elements of Consent
Except for broad consent, informed consent must begin with a concise and focused presentation of key information that is most likely to assist a prospective participant or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. Currently, there is no federal guidance defining "key information". Additional required elements: One of the following statements about research that involves the collection of identifiable private information or identifiable biospecimens:
- A statement that identifiers may be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the participant or their legally authorized representative, if applicable; or
- A statement that the participant’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future studies.
Additional optional elements:
- A statement that the participant’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the participant will or will not share in this commercial profit;
- A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
- For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
Posting of Clinical Trial Consents
All clinical trials (studies prospectively assigning participants to one or more research interventions to study the effects of the interventions on health or behavioral health) must post a consent document no later than 60 days after the last study of a participant to ClinicalTrials.gov
Broad Consent - Currently VU and VUMC will not implement Broad Consent
Broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens collected for either research studies other than the proposed research or for non-research purposes is permitted as an alternative to the standard informed consent requirements. Required elements of broad consent.
- There are 12 required elements of broad consent.
- The IRB cannot waive or approve an alteration of broad consent.
- Further, if a participant has refused broad consent, the IRB cannot waive consent for storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens.
Single IRB
All federally funded studies where more than one site is conducting the same protocol must be reviewed by a single IRB.