As many of you are aware, the U.S. Department of Health and Human Services (HHS) and several other federal agencies and departments recently issued an interim final rule governing federally funded/supported human subject research. The implementation of the revised version of the regulation has been delayed until July 19, 2018. Despite this delay, the Institutional Review Boards at UConn Health and UConn-Storrs will begin implementing some policy changes that are aimed at reducing administrative burden on investigators while still affording sufficient protections to research participants.
SUMMARY OF CHANGES:
Compliance with human subject training requirements will be verified at the time of initial approval and at the time an individual is being added to a study through a request for modification. Training must be current for the individual being added. To be considered current, training must have been completed and passed within the past three years.
Continuing Review for Non-Federally Funded/Supported Research and Non-FDA Regulated Research:
Non-federally funded/supported research and non-FDA regulated minimal risk research that qualifies for expedited review will be approved for either the anticipated time frame of the project or one year from the date of approval, whichever is greater. Unless specifically required by the IRB, annual continuing review will no longer be required for this type of research.
As the anticipated completion date of the research draws near, investigators may extend the expected completion date if necessary through a request for modification. Research cannot be conducted beyond the approval period. If any federal support is obtained after the initial approval the investigator is obligated to inform the IRB, via a request for modification, and annual continuing review will become required.
For studies previously approved through the expedited review process, investigators may request transition to this new policy at the time the next continuing review is due or sooner by submitting a request for modification. Any document currently stamped with an expiration date that is still used in the research would need to be attached to the submission to allow for removal of the expiration date.
Please note that federally funded or supported research and FDA regulated research must continue to receive IRB review and approval on an annual basis, at a minimum.
Consent – Additional Elements
The proposed regulation contained new elements of consent. Those elements have been incorporated into the consent form template and the consent checklist used by UConn Health. Investigators are encouraged to include these new elements in consent documents, but the elements will not be mandated until such time as the revised regulation takes effect.
Consent – Waiver or Alteration
The proposed regulation put forth an additional criteria for granting a waiver of consent that requires an explanation as to why the research could not be practicably carried out without using identifiable private information and/or identifiable biospecimens. This additional criteria has been incorporated into the request for waiver/alteration forms and will be applied to all research going forward.
Consent – Waiver of Documentation
The proposed regulation would have allowed for waiver of documentation of consent when the subjects (or legally authorized representatives of the subjects) are members of a distinct cultural group or community in which signing forms is not the norm, when the research presents no more than minimal risk of harm to subjects, and when there is an appropriate alternative mechanism for documenting that informed consent was obtained. This option may be utilized for non-federally funded/supported research and non-FDA regulated research.
Activity Related to Screening, Recruiting and Determining Eligibility:
For non-federally funded/supported research, a partial waiver of consent will no longer be required for the purpose of screening, recruiting or determining eligibility if either of the following is true:
- The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative of the subject (e.g. telephone screening), or
- The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored biospecimens.
- In order to access records or specimens for such purposes, there must be an established relationship between the investigator and the individuals whose records/specimens will be reviewed.
- The investigator may delegate the review to appropriately designated research personnel
Investigators are obligated to protect the confidentiality of information collected prior to consent and HIPAA (primarily a concern for UConn Health investigators). This must still be appropriately addressed when protected health information is utilized.
Stamping of Documents:
The expiration date will no longer be noted on documents. Documents will continue to be stamped with the approval date and investigators will be responsible for ensuring that the most recently approved version of documents are being utilized.
We expect that proactively implementing these changes will help to ease administrative burdens associated with minimal risk research and also to prepare investigators for compliance with the proposed revised regulation, should it be implemented.
If you have questions regarding how these changes impact your current approval or planned submission to the IRB, please contact the IRB Office:
The InfoEd IRB-1 and IRB9 study protocol forms as well as the consent form, information sheet, parental permission form and parental notification form templates, were revised to incorporate these changes. DOWNLOAD THE NEW FORMS PRIOR TO SUBMISSIION OF A NEW STUDY.
Mayra Cagganello – 860-679-8802 or by email firstname.lastname@example.org
Doug Bradway – 860-486-0986 or by email at email@example.com
Jerry McMurray – 860-486-5756 or by email at firstname.lastname@example.org