Creating an academic career with a perfect blend of clinical work and protected time for productive research is a struggle for many surgeon-scientists. Many have viewed a surgical career in the Veterans Health Administration as a perfect opportunity to achieve that amalgamation. The 2018 revision to the Common Rule has simplified and increased the efficiency of the regulatory components for human subject research.
The Common Rule, established in 1981, is a code of ethics that governs biomedical and behavioral research for human subjects in the United States at the level of the Institutional Review Board (IRB). It followed the 1975 Declaration of Helsinki and is included in the 1991 U.S. Department of Health and Human Services (Title 45 CFR 46 Subparts A, B, C and D). The Common Rule is considered the baseline code of ethics for government-funded research in the U.S.
The details for Common Rule compliance can be tedious and burdensome, deterring some from pursuing human subject research. The 2018 revision simplified some of this tediousness, with leaders hoping to maintain human subject safety while decreasing the administrative burden. Major changes in Common Rule regulations that impact surgeon-scientists include development of 1) new exemption categories, 2) allowance of a Limited IRB, 3) allowance of a Single IRB Mandate, and 4) implementation of a Designated Research and Development Review. The new categories are summarized below.
New exemption categories (after 1/29/2019)
Studies qualified for exemption are not subject to the requirements of the Common Rule. Oversight of exempt studies are reviewed by the IRB and the Veterans Affairs (VA) Research and Development Committee (R&D) for continuing reviews and amendments and must still remain compliant with the Privacy Rule or Act. In addition, the Research Compliance Office (RCO) retains the right to audit these studies for compliance. The new exempt categories are as follows:
- Exemption category 1: Education research (38 CFR 16.104d(1)) “Research conducted in established or commonly accepted education settings, that specifically involved normal education practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction.” Broadly speaking, this pertains to research on education strategies or the effectiveness and/or comparison of strategies, curricula or classroom management.
- Category 2: Education tests/survey/ interviews/observations (§ 16.104(d) (2)) “Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording),” as long as one of the following is met: 1) Identity cannot be readily ascertained, 2) there is no risk of criminal/ civil liability/ financial standing/ employability/ educational advancement/ reputation or 3) the IRB conducts a limited review.
- Category 3: Benign behavioral interventions (brief, harmless, painless) (§ 16.104(d)(3)) “Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry), or audiovisual recording” as long as one of the following is met: 1) Identity cannot be readily ascertained, 2) there is no risk of criminal/ civil liability/ financial standing/ employability/ educational advancement/ reputation or 3) the IRB carries out a limited review.
- Category 4: Secondary research (§ 16.104(d)(4)) “Secondary research for which consent is not required, secondary research use of identifiable private information or identifiable biospecimens,” as long as one of the following is met: 1) Information is publicly available or 2) Subject specimen is not identifiable and the investigator does not contact or try to re-identify subjects.
Limited IRB Review
One of the changes to the Common Rule also allows for the use of the Limited IRB Review, permitting the initial approval to be expedited. After the initial approval, the study still falls under IRB oversight (amendment, reporting, etc.), but the study no longer requires a Continuing Review. Most local policies still request an “Annual Update” submission. However, there is no regulatory requirements of a continuing review in order for the study to continue. The Limited IRB review category is allowed for Exemption categories 2 and 3—as long as the IRB can assure the privacy of patients and confidentiality of their data (HIPAA waiver).
Single IRB Mandate
The Single IRB Mandate is simplifying the ability for Veterans Affairs (VA) studies to be part of multi-institutional studies outside of a VA Cooperative Study. The VA can now enter into agreements to rely on commercial IRBs as IRBs of record for multicenter trials to have only one IRB review. The Single IRB allows for increased ability to bring in funded, sponsored research in addition to collaborating as a trial site for other government institutions, such as the National Institutes of Health (NIH).
R&D designated review process
The inclusion of this new category is intended to increase efficiency for review of appropriate studies.
Rather than follow through with the tedious process of initially undergoing an IRB review only to be subsequently sent for a full R&D Committee review, the following activities may be approved by the chair of the R&D Committee, or a voting member designated by the chair:
- Minor changes to a protocol required by the R&D Committee, following full board review
- Final approval for protocols approved contingent on the full approval of a subcommittee, if the subcommittee had not required major changes (as defined in local standard operating procedures) to the protocol since the R&D Committee conducted its review
- Final approval for protocols approved contingent upon completion of the privacy officer (PO) and information system security officer (ISSO) review
- Exempt human subject research protocols and protocols approved by expedited review by the IRB
- Single patient expanded access protocols approved by the IRB chair or another appropriate IRB voting member
- Protocols that do not involve human subjects; biosafety level (BSL-3) or higher containment; use of select agents or non-exempt quantities of select toxins; U.S. Department of Agriculture (USDA)-regulated animal species or any animal research involving more than momentary pain or distress to the animals
A robust research program is critical to not only the faculty, but also to the new faculty just starting their academic careers. The new changes in the common rule ease the administrative burden and increase the efficiency of the regulatory process, thus encouraging a lifelong career of cutting-edge clinical practice alongside a productive research enterprise for young faculty joining the VA.
Sharon C. Kiang, MD, chief of the division of vascular surgery at the VA Loma Linda Healthcare System in Loma Linda, California, is a member of the Society for Vascular Surgery VA Vascular Surgeons Committee.