Revisions to Federal Guidelines for Human Subjects Research

 

 (Code of Federal Regulations 45 CFR 46: January 2019) 

This page provides a summary of changes to Le Moyne College’s IRB website, most of which have been prompted by revisions to the federal guidelines for human subjects research. The revisions that are listed below are those which are most relevant to Le Moyne researchers. A complete version of all the federal regulations now in effect can be found at the following link: Code of Federal Regulations 45 CFR 46. 

Changes and additions to the IRB website:

  • Form A: there is a new list of research activities that qualify for exempt status
  • Form B: researchers using audio or video recordings no longer need to submit an application for expedited review. They can submit Form A for exempt status.
  • New instructions for the Adult Research Participation Consent Form and the Sample Adult Research Participation Consent Form (see below).
  • Revisions to the instructions and guidelines for completing the Research Outline (additional details provided for specifying a study’s Rationale and Aims; obtaining permission to recruit from an external organization’s employees, students, or clientele; recruiting research participants when using email or social media; and presenting a complete statement of Potential Risks)
  • Expanded instructions on the IRB home page for registering and selecting courses to fulfill the training requirement for conducting human subjects research
  • Guidelines for Online Surveys (details on acceptable consent procedures)
  • FAQ for “What is secondary research and how do I submit an application for conducting secondary research with personal information or de-identified data?”
  • FAQ for “How do I know whether my project requires IRB review and approval?” (contains an updated list of activities not considered research by the IRB)

 

Other major changes to the federal guidelines:

  • Studies approved by expedited review (Form B) no longer require either applications for continuing review or study closure reports
  •  Studies approved by full Board review (Form C) no longer require applications for continuing review if the study has progressed to where only data analysis is being conducted
  • All consent forms must now have one of the following two statements, whichever is appropriate:

    o   A statement that identifiers might be removed from 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 subject or the legally authorized representative, if this might be a possibility; OR

    o   A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies

           Please note: If you include the first statement above, it means that you (or other investigators) may decide to use the de-identified information or biospecimens in future secondary research studies approved by the IRB. This is consistent with IRB policies and practices that were already in place prior to the recent revisions to federal guidelines; the statement that is now required simply makes this practice explicit for potential research participants. If you include the second statement, identifiable information or biospecimens collected for your study cannot be used in any future secondary research studies, without exception. Researchers applying for approval of secondary research studies will now need to provide confirmation for the IRB that the first statement above was included on the consent form at the time the data was initially collected (this applies only to data collected for primary research studies on or after January 21, 2019).

  • All consent forms must include the following when appropriate:

    o   A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;

    o   A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and

    o   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).