Human Subjects Research Policy

Section 4C1d: “The appropriate faculty must submit a course-level IRB application if one or more students in the course will be presenting on the assigned project at the college, outside of the classroom. If the assignment changes after IRB approval, the appropriate faculty is responsible for submitting a modification to the application for IRB review.”

This new requirement will make it a lot more onerous for faculty to have their students take part in the UPRC conference at SLCC. I anticipate that this will greatly decrease participation in this event.

F4 a       4.       Full Review
The SLCC IRB, at its sole discretion, may refer research studies that require full IRB review to an external IRB with which SLCC has an active reliance agreement.

A list of these external IRB groups should be made known to the IRB applicants – this process needs to be transparent.

I would also suggest that the IRB assigns a contact or “mentor” for at least the non-expedited and non-exempt applicants to ensure correct completion of the application per G1

1. Section F.4(a–d)

   This section describes the use of an external IRB for Full Review and any subsequent IRB-related needs for a project. It may be useful for the policy to establish clearer criteria—or link to relevant procedures—regarding:

   • When a study will be referred to an external IRB,
   • Who is responsible for associated costs, and
   • What submission or decision timelines the external IRB will typically follow/require.

   In some cases, IRB applications and amendments require full IRB review on short timelines dictated by sponsor requirements. While requiring PIs to submit IRB applications prior to award notification may help reduce timing risks, it also presents challenges: the time needed to prepare an application and the cost of external review can be burdensome, particularly when the award is not guaranteed.

   The policy also notes that once an external IRB is engaged, it will remain the IRB of record for the duration of the award. It would be helpful to clarify whether the external IRB offers defined processes or expedited pathways for request with sponsor-mandated deadlines, as well as how ongoing costs are managed.

2. Section H.1

   This section outlines the internal IRB review process and states that submissions will be reviewed in the order received, with a recommended two-month lead time. Although we encourage early IRB submission, many PI’s cannot commit the necessary time before knowing whether they will receive an award. When they wait for award notification, the two month lead time is often not feasible without risking the award or delaying participant engagement past the project start date.

1. Policy
   1. The Policy Statement buries the lead. Because the substance of this section is operationally centered on the role of the IRB, the final sentence—describing the IRB’s function and oversight—should be moved to the beginning. Leading with the IRB’s authority frames the rest of the section more clearly and aligns with how end users approach compliance guidance.
   2. The Policy Statement should clearly highlight the core directive: If an employee, student, or agent believes their activity may constitute human subjects research, they must consult the IRB. This expectation should be stated plainly and placed prominently so it is not overlooked. Including a direct hyperlink to the IRB webpage ensures users can immediately access guidance and application requirements rather than searching through internal pages or documents.
2. References
   1. References: Can you link directly to the IRB Site in the references section, alongside the statute https://slccbruins.sharepoint.com/sites/IRBInstitutionalReviewBoard/SitePages/Human-Subjects-Research-Guidance-Page.aspx?ga=1
3. Definitions
   1. The current definition of Faculty Sponsor appears to allow non faculty individuals to serve in this role (“These individuals include non faculty members…”), which creates a naming mismatch and potential confusion for users. If the intent is to permit any qualified SLCC employee, not just faculty, to fulfill the sponsor function, the terminology should be broadened for clarity and accuracy.
      1. i.e. if a nonfaculty member wanted to collect data to publish a paper, do they need a faculty sponsor? (i.e. Dr. Madore isn’t faculty but wanted a survey on student success for a paper she is publishing)
   2. Consider adding transferable knowledge definition alongside generalized knowledge for things like qualitative data
   3. In the Minimal Risk definition, the sentence beginning with “Inadequate data handling practices…” is not part of the definition itself but rather a consequence of failing to maintain proper data practices. It does not describe what Minimal Risk is but instead describes what can increase risk. To maintain definitional clarity, this sentence should be removed or relocated to a section addressing data privacy, risk factors, or compliance considerations.
   4. The definition of Vulnerable Populations currently uses the term “individuals who are in prison.” Because incarceration occurs in multiple forms (e.g., jail, detention centers, community corrections, and other custodial settings), using “incarcerated individuals” is more accurate and inclusive. This terminology aligns with broader correctional categories and better reflects the range of restricted liberty environments encountered in research contexts.
4. Procedures
   1. 4.A.3, the phrase “planning to conduct research involving human subjects” should be revised to read “planning to conduct human subjects research.” Because Human Subjects Research is a defined term within the policy, using the exact defined term improves internal consistency and ensures alignment with the Common Rule and the Definitions section.
   2. 4.B.3 establishes that the IRB Chair retains final judgment regarding whether an activity qualifies as human subjects research. However, the procedure does not explain how researchers can know in advance whether their project meets the definition before investing significant time in training, application drafting, and document preparation. As currently written, users may spend hours completing required training and paperwork only to be informed afterward that their activity never required IRB submission.
      1. This creates unnecessary workload both for research personnel and for the IRB, which is already experiencing backlog pressures. It also reduces trust in the process, as the workflow invites avoidable frustration: “Why did you submit this form? This doesn’t apply.”
      2. There should be a decision tree or click through to figure out whether this applies.
   3. B.2: Why are we redefining research?
      1. Why are we using the word intervention? Does intervention need to be defined? What does it mean?
      2. Some committee members think defining intervention opens a can of worms because there’s a lot of definitions in the training
      3. How much of the policy do we need, and how much should be cited to the CFR
   4. B.4: Can we state who the chair is so that people know who to reach out to, rather than making it vague?
   5. B.5 references situations where the IRB is used but does not provide any criteria or framework for determining when an external IRB should be used, nor does it address who is responsible for paying for an external IRB review. This leaves a critical gap in procedural guidance. Because guardrails and cost related considerations are addressed later in the document, B.5 is incomplete and potentially misleading in this location.
   6. 4.C.1.a(4) triggers IRB submission when “the study data will be used for external purposes such as publications.” The policy does not specify whether student portfolios/e portfolios qualify as “publications.” Because e portfolios are often publicly accessible artifacts that disseminate project results beyond the classroom, they can functionally operate as publications. The policy should explicitly state whether posting study materials or findings in a student portfolio/e portfolio is considered an external use/publication for IRB trigger purposes.
   7. C.1.b places responsibility on faculty, including adjunct faculty, to ensure that student research activities comply with the Common Rule and ethical principles. However, the procedure does not explain how much training adjuncts receive, nor does it identify who pays for the additional training or certification required for them to competently serve as faculty sponsors. Adjunct faculty are often hired semester to semester, paid at lower rates, and may not receive the same onboarding or institutional training resources as full time faculty. Requiring them to take on regulatory oversight responsibilities without clear guidance on training expectations or cost coverage creates operational uncertainty, compliance risk, and inequity across faculty roles.
   8. Is there a timeline on section D for when they need to submit the applications?
   9. The current SLCC operational process does not effectively support the expectations set in the policy regarding student research activities. When students want to complete a research project as part of a course, the IRB review process is cumbersome, time intensive, and not aligned with typical course timelines. Students often must complete lengthy human subjects training and wait through IRB review queues—steps that can significantly delay or even prevent completion of required coursework.
   10. C.1.b outlines faculty responsibility for ensuring student compliance with the Common Rule but does not place any reciprocal obligation on the IRB to communicate with researchers in a timely manner. Because student projects operate under strict academic timelines, delays in IRB communication can prevent students from completing coursework, impede faculty planning, and increase overall administrative burden. Incorporating a timeliness requirement would bring needed balance and predictability to the process.
   11. There is a direct internal contradiction between Section 4.C.1.d, which requires faculty to submit a modification to an already approved IRB application when a student’s assignment changes, and Section 4.F, which states that IRB approval cannot be granted retroactively. Because assignment changes typically occur after the initial approval has been issued, the modification process essentially requires the IRB to engage in retroactive approval, which Section 4.F explicitly prohibits. This creates procedural confusion for faculty, students, and the IRB, leaving them without a clear pathway when project parameters shift during a semester—something that happens frequently in a classroom setting.
   12. 4.D.1: assure → ensure
   13. 4.D.3 places the responsibility solely on the PI to communicate promptly with the IRB, but does not impose a corresponding requirement on the IRB to communicate promptly with the PI. For a functioning review process—especially within academic timelines—it is essential that timeliness be mutual. As written, the policy is unbalanced and may lead to delays attributable to the IRB without any procedural accountability.
   14. 4.E reads as though it was drafted in response to a specific negative experience, rather than functioning as a neutral, procedural description of IRB review categories. The tone appears overly cautionary and prescriptive in places, which can unintentionally suggest frustration or defensiveness rather than clear procedural guidance. To maintain consistency with the rest of the policy and ensure a professional, neutral tone, this section should be revised to focus on objective criteria, standard regulatory language, and actionable steps for researchers.
   15. E.1 should be reframed to clearly state that, as a matter of institutional practice, SLCC generally will not engage in external IRB review. If SLCC must participate in an external IRB process, it should only occur under a properly executed reliance agreement or other mechanism explicitly permitted under the Common Rule (e.g., designated IRB arrangements under 45 CFR 46). The current language is ambiguous and gives the impression of ad hoc decision making, which increases risk and creates potential confusion for faculty, students, and external researchers.