IRB Review Checklist s1

Review Checklist for an IRB Application

1. Nothing in particular to look for in terms of the title

2. Principal investigator

Ø List only one person

Ø Can be a student

Co-investigator

Ø Should be a faculty member if the principal investigator is a student

Ø Should be the teacher if class project; mentor/advisor if capstone/thesis

Remaining investigators

Ø Names only; contact information not needed

Ø Identify them as students or faculty

3. Nothing in particular to look for in terms of project type

4. Does the project relate to a previous IRB Request?

Ø If it’s similar to a protocol submitted in the past, it’s helpful to see IRB feedback to the previous project

Ø If the answer is “Yes,” the reviewer should obtain a copy of the relevant file

5. Will funding be requested for this project?

Ø If the answer is “Yes,” the source should be named

Ø If the source is ever government funds, our IRB would need to be registered with the OHRP (or the investigator would need to get approval from a registered IRB).

6. Is there potential for financial conflict of interest on the part of any investigator?

Ø If the answer is “Yes,” reviewer should probably recommend Full Review since that would be a new situation for our IRB

7. Anticipated dates for data collection:

Ø If the starting date is soon, the reviewer can try to accommodate it (depending on the reviewer’s schedule/availability)

Ø The anticipated ending date may affect the approval period that will be assigned to the project; the longest possible approval period is one year. If the project is a class project or senior capstone, it probably makes sense to set an ending date at the end of the semester/year

8. Level of Review:

Ø The default level is 2.

Ø The main objective of this question is to get investigators to look at the IRB Policy. In particular, if the project is Full Review level, the investigator needs to allow more time for review.

Ø The IRB reviewer determines the actual level of review (see the Appendix for more detail).

9. Research Objectives/procedure/etc:

Ø Is the content of questionnaires/interviews described? Is a copy of the questionnaire or list of interview questions attached? If not, reviewer should request that information.

Ø Is there sufficient information about the procedure for the reviewer to identify possible risks? (Discussion of risks will fall under # 11)

o Embarrassment

o Loss of social status

o Emotional distress

o Loss of employment

o Stress

o Guilt

o Criminal liability

10. Participants:

Ø Is each question answered fully?

Ø If anything, off-campus participants might need a closer evaluation of possible risks

Ø Vulnerable populations may need to be reviewed at the Full Review level; the reviewer determines level of review

Ø Is detail provided about the location of the research? Is there sufficient information about the location for the reviewer to identify possible risks? (Discussion of risks will fall under # 11)

Ø Is the research conducted outside the country? If so the investigator should be told that it’s his/her responsibility to learn of and comply with applicable local laws and guidelines.

Ø Is the research conducted off-campus? If so the investigator should be told that it’s his/her responsibility to get appropriate permissions for the location.

11. Risks and Benefits:

Ø Is each question answered fully?

Ø If a risk is identified, is a way to minimize it also identified?

Ø If reviewers identify additional possible risks, that feedback should be provided to the investigator (and ways to minimize it should be identified)

Ø Assessment of risk is a multiplicative function of degree of risk and probability of risk; compare to normal day-to-day risks as well as regular medical or psychological surveys or tests.

12. Informed Consent:

Ø The default is “Yes” “No” “No”; if so, is the consent form attached?

Ø If a waiver is requested, reasoning consistent with the IRB Policy should be provided.

Ø It is perfectly acceptable to waive signed consent in various circumstances, particularly for interviews or for research conducted in other countries (see the point above).

Ø If the research is international, is an email address provided?

13. Audio/video Recordings:

Ø If any type of recording will be made, that information should be in the Informed Consent form or in a separate Release Form

Ø The critical principle here is to make sure participants are aware of and consent to all possible uses of the recordings AND that participants have the right to decline any recordings.

14. Confidentiality:

Ø The default should be to include a cover sheet on a questionnaire

Ø If participants’ names are recorded (e.g. for interviews), they have the option of allowing the investigator to use or not use their names in the written report. Investigators should include a procedure for getting their agreement for that if desired.

Ø The main concern is the possibility that names could be connected to respective questionnaires. If that’s the case, precautions should be taken.

15. Debriefing:

Ø Examples of things to include in debriefing: hypothesis, explanation of deception, explanation of possible conditions of design (if project is experimental)

Ø Debriefing is only necessary when all information is not provided during Informed Consent

Ø Debriefing of participants can be delayed if the investigator is concerned about future participants learning about the study

Appendix

Exempt (see 45 CFR 46.101)

Federal guidelines label as “Exempt” research that is perceived to expose participants to no risk. It is Soka University’s policy (and a recommended federal guideline) that investigators should submit to the IRB proposals that are expected to fall in the category of Exempt.

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (a) information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to the participants; and (b) any disclosure of the human participants' responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation.

3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under the previous point in this section, if: (a) the human participants are elected or appointed public officials or candidates for public office; or (b) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants.

Expedited Review (see 45 CFR 46.110)

The Expedited Review procedure will be used for research that falls in one of the Exempt categories (see Section A, above); one of the Expedited categories, below; or for minor changes to approved Expedited-category research protocols within the approved period that involve no additional risk to participants (see Section III.C., below). In general, protocols that present no more than minimal risk to participants may qualify for Expedited Review. According to federal guidelines, minimal risk is defined as cases in which “the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”

1. Collection of data from voice, video, digital, or image recordings made for research purposes.

2. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be in the Exempt category. This listing refers only to research that is not Exempt.)

3. Continuing review of research previously approved by Expedited Review.

4. Continuing review of research previously approved by Full Review as follows:

(a) where (1) the research is permanently closed to the enrollment of new participants; (2) all participants have completed all research-related interventions; and (3) the research remains active only for long-term follow-up of participants; or

(b) where no participants have been enrolled and no additional risks have been identified; or

rev. 09-18-08