The definition for L. Identifiable Information should have a comma instead of a period after "study" and say ..."in a study, including direct identifiers..."

For M. Informed Consent, I suggest revising the definition to read as follows: process of communication with potential human subjects that provides information about the study to allow for the person to have full knowledge in their decision to participate, verifies comprehension of the information provided, and ensures participant voluntarily agrees to participate in the study. (See https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html#xinform)

Under E. Categories of IRB Review, 3. Expedited Review, letter c, the semicolon should be replaced with a comma: "...may be ascertained directly or indirectly, or for modifications to previously approved research."

1. Policy Statement

a. General Comments

1. This is a much-needed policy. There is a lack of faculty awareness with regards to IRB requirements. The college does not do a good job complying with federal laws addressing Human Subject Research.
2. The college needs to do a better job with outreach to teach SLCC employees and students about Human Subject Research requirements. This training use to be done by Data Science and Analytics.
3. Given that it is the committee’s experience that there is considerable non-compliance at the college, do not assume that college employees understand the process like the IRB does. Hopefully, the proposed revisions organize the policy better, so it is more understandable without substantively changing the draft policy.

b. No comments regarding revisions to the policy statement.

2. References

a. In section 2.B, there was some discussion that the Belmont Report was updated in 2024. If that is the case, the more recent version should be linked to the policy.
b. In section 2.B, the reference publication date for the Belmont Report is 1979. It should be 1974.

3. Definitions

a. There was some discussion regarding whether several of the terms needed definitions. The definitions that were discussed were: 1) Application; 2) Class Assignment; 3) Confidentiality; 4) Consent; 5) Consent Form; 6) External and 7) Informed Consent. The rationale was that these are common terms or phrases and do not need a definition. Despite the discussion, most of the committee maintained that all the definitions should be kept in the policy.

b. In section 2.P, the definition for Principal Investigator is not the same as the definition for PI in the Sponsored Project policy. Given that both terms are used in a similar context, the definitions should be aligned.

4. Procedures

a. Consider reorganizing and changing the headings of the procedures to improve the flow and understanding of this section. The proposed reorganization is as follows:

A. General Section 4.A. This section appears to be okay.
B. What Constitutes Human Subject Research? (Section 4.B)
1. Test for What Constitutes Human Subjects Research (Section 4.B.1)

C. Institutional Review Board Composition and Duties (This needs to be added)

1. Duties
a. A short section with up to 5 duties or responsibilities of the IRB. This could be supplemented by the IRB webpage which is being constructed.
2. Composition
a. It is the Committee’s understanding that there are 6 positions on the IRB. A short section listing those positions would be helpful. It could be supplemented by a link.

D. What type of Research requires IRB Review and Approval?

1. Activities Requiring IRB Review and Approval (see section 4.C)
a. Start this section out by stating: “A college department, employee or student conducting research requires IRB approval before starting the research project in the following research activities:
(1) participation involves more than minimal risk for human subjects;
(2) activities are not within the exempt categories;
(3) involves vulnerable populations; or
(4) the study data will be used for external purposes such as publications.” (These four categories are the core to this policy. These categories are from section 4.C.1.a

Comment: As currently drafted, the policy only seems to apply to students. It is the committee’s understanding that college departments, employees and students conducting research must obtain IRB approval.

2. Activities That Do Not Require IRB Review and Approval See section 4.B.2
a. When revising this section, combine sections 4.B.2 and sections 4.C.2 because these two subsections address when IRB approval is not required.
b. Start this section and state:
A college department, employee or student conducting research does not require IRB approval in the following types of research activities:

(1) activities designed to fulfill course requirements of learning research methods;
(2) investigations conducted by a student for a class assignment designed to teach human subject research methodology.
(3) projects that are not intended to produce findings that will be applied more broadly to the population at large; or
(4) projects not intended to produce findings that will be presented external to the college. (This language come from section 4.C.1.b)
(5) Operational activities, such as studies for internal institutional purposes, program evaluation, quality assurance and/or improvement, or marketing studies.
(6) Case studies or anecdotes.
(7) Scholarly activities that do not require an intervention or interaction with human subjects.
(8) Student class assignments, such as those commonly used in courses covering research methods and ethics. (This language comes from section o4.B.2.a-d of the current draft.

c. Put section 4.B.3 at the end of this section and consider this revision.

Under the Common Rule, the The IRB Chair, after consultation with the Institutional Review Board, retains final judgment regarding whether this policy IRB approval is necessary for covers a particular research activity. This judgment shall be exercised in a manner consistent with the ethical principles of the Belmont Report.

(1) Comment: Has the IRB chair been delegated this authority by the college president? If not, this should be done.
(2) Comment: The deleted language is unnecessary because the policy statement says the college follows the Common Rule and Belmont Report.
(3) Comment: Adding the consultation requirement just makes sense.
(4) In section 4.C.1.b, the use of the word “typically” infers that there may be “exceptions” to the rule that no IRB approval is required. That could be confusing to department, employees, or students. Preferably, this should be either IRB approval “is” or “is not” required. If that is not the case, how will exceptions be determined? Consider deleting “typically.”

E. How to Submit an IRB Application? Section 4.F

1. This section should be supplemented with a link to the application form.
2. While it is hard to envision without the IRB webpage operational, ask yourself will an employee or student seeking IRB approval know what to do? It is the committee’s experience that there is considerable noncompliance at the college in this area.

F. How does the IRB conduct its review of an application? Section 4.G

1. Consider adding a “factors” section to explain what things the IRB evaluates in making its determination. As the Committee understands, those factors are:
a. Degree of Risk in Research Project
b. Efforts to Mitigate Research Risk

2. Types of IRB Review Section 4.E (Consider moving this section into the review section. At the current time, it is section 4.E which is “Categories of IRB Review.”)
a. Exempt Review
b. Expedited Review
c. Full Review

G. Role of Principal Investigators Section 4.D

1. In the Sponsored Projects policy at section 4.C.3, there is a section for the responsibilities for Principal Investigators. Make sure that these two policies sections describing the PI’s role are aligned

Definitions: Minimal Risk - the definition provided does not indicate who determines if there is minimal risk.
Section E.2.c "Studies granted exempt status do not expire, and continuing review is not required." conflicts with E.2.d "The IRB must review any modifications to a previously reviewed study to ensure it continues to meet exempt status." Suggest adding language to E.2.c stating that the exempt status is based on the proposed project design and if any changes are made to the design they must be submitted to the IRB to confirm the modifications do not change the exempt status.
Section E.2.e "Exempt studies may require an informed consent.." Does the IRB need to review and approve the informed consent form for an exempt study as is required for a non-exempt study?

Under section 4c.1b they talk about vulnerable populations. We are concerned about how to do course based undergraduate research projects in lab courses when we have students who are pregnant or have diminished autonomy. Students typically do their projects in groups. How would it work logistically if one of the groups had someone who falls under the vulnerable population classification.

Under section 4c.1b I am also concerned about if all courses presenting at UPRC need to submit a course-level IRB. How often do they need to do this? Every semester? Once and then only if significant changes are made? I can see if it is too time-consuming for faculty to submit, then UPRC participation will drop off significantly.

Under section 4c.1f, I can see a student ultimately deciding to want to present their research. Can we have the class assignment approved once and then make that option available to students on the off-chance that they are interested.

Under section 4D.3, I am worried about the training that might be required and who ultimately has to do the training. It is still not 100% clear to me based on this policy. In labs with many adjunct instructors teaching the course, do all of them need to do the training? Or just the course leads who are designing the standardized research assignment protocols? Or does this also include the students who can select from options in their research project? And how often does this need to happen? And who pays the PIs for doing this training, because it can be incredibly costly if I have to pay several adjuncts every year to do hours of training?