We understand that questions have been raised regarding the language in the second sentence of Section II of the TIN Letter of Indemnification (LOI) stating that the Relying Institution is solely responsible for determining whether research reviewed by the Reviewing IRB meets “all other applicable federal” legal requirements, and whether this language is consistent with the SMART IRB Agreement. We wish to clarify these questions.
The SMART IRB team and the Trial Innovation Network team have reviewed this issue and believe that the language in the LOI is consistent with the SMART IRB Agreement and with the intended allocation of responsibilities between the Reviewing IRB and the Relying Institution.
Section 5.4 of the SMART IRB Agreement says that the Reviewing IRB’s review will be in accordance with applicable federal human subjects research regulations / human subjects protection requirements (emphasis added). In other words, the IRB is responsible for attending to requirements of federal human subjects regulations only (Common Rule, FDA, other potentially applicable human subjects regulations of non-Common Rule federal agencies). The Agreement does not require the Reviewing IRB to review research for compliance with all federal regulations generally.
For example, if a Relying Institution is subject to federal confidentiality requirements at 42 CFR Part 2 pertaining to certain substance abuse treatment records that would impose specific consent obligations on the Relying Institution in connection with a study involving such records, the Agreement does not require the Reviewing IRB to identify this issue. Rather, the Relying Institution would be responsible for identifying this issue and communicating the requirements applicable to its site to the Reviewing IRB. The Reviewing IRB would be responsible for applying this information to its review and approval of the study on behalf of the Relying Institution.
We note that Section 6.4 of the Agreement, “Local Considerations,” states that it is the Relying Institution’s responsibility to identify local context issues and requirements to the Reviewing IRB and does not currently reference federal laws or regulations. However, it was not the intent to make the Reviewing IRB responsible for the identification of the research with all federal laws/regulations (other than federal human subjects protection regulations). For this reason, language in Section II of the LOI was added to clarify this issue. The SMART IRB team has also posted an additional FAQ regarding this issue on the SMART IRB website.
As was noted by one of the institutions, the Relying Institution’s responsibility under the Agreement to identify and communicate requirements that affect the conduct or approval of a study at its site does require some level of ‘review’ of the research by the Relying Institution in order to be able to identify the applicable local requirements and communicate them to the Reviewing IRB. However, we note that that is already the case with respect to the state law issues. It is NOT the intent of the LOI language to suggest that any of the regulatory review responsibilities of an IRB under the Common Rule, FDA, or other federal human subjects regulations remain with the Relying Institution; that is, the Relying Institution/Relying Institution IRB is not being asked or required to do a ‘regulatory’ review.