1. The Institutional Review Board: Membership Structure and IRB Review Types Research Education Series March 22, 2018
Amanda Goode, MA Katie Daniels, BS
IRB Coordinator IRB Coordinator
Committees A and B Committee C

2. Overview What is the IRB? IRB Evaluation Exempt Research
Expedited Research
What is the IRB Looking for?
The IRB at GHS

3. What is the Institutional Review Board (IRB)?

4. What is the IRB?
An appropriately constituted group that has been formally designated to review and monitor research involving human subjects at its affiliated institution(s).
Its purpose is to assure, in advance of research initiation and by periodic review of ongoing research, that appropriate steps are taken to protect the rights and welfare of human subjects participating in the research.
The IRB has the authority to approve, disapprove, or require modifications in (to secure approval) research studies involving human subjects.

5. What is “appropriately constituted”?
The IRB must include:
At least 5 members with varying backgrounds, areas of expertise, experiences, ages, etc.
At least one scientist and one non-scientist
At least one member who is not otherwise affiliated with the institution
Physician
Pharmacist
Clergy
Nurse
Retiree
Lab tech
MBA
Psychiatrist
Biostatistician
These requirements have been adopted by OHRP, FDA, DOD, Dept of Education, etc. At GHS, “unaffiliated” members cannot have an immediate family member who is affiliated with the institution. In order for the committee to vote on a protocol, there must be a quorum of attendants. For the IRB, quorum is defined as having more than half of the regular members in attendance, including at least one scientist and at least one non-scientist.

6. What is the IRB?
An appropriately constituted group that has been formally designated to review and monitor research involving human subjects at its affiliated institution(s).
Its purpose is to assure, in advance of research initiation and by periodic review of ongoing research, that appropriate steps are taken to protect the rights and welfare of human subjects participating in the research.
The IRB has the authority to approve, disapprove, or require modifications in (to secure approval) research studies involving human subjects.

7. Definitions (HHS)
Research: A systematic investigation designed to contribute to generalizable knowledge
Case reports, QI projects, HUD trials, etc. do not meet this definition and are not considered research.
Human Subject: A living individual about whom an investigator conducting research obtains:
data through intervention/interaction with the individual, or
identifiable private information
Data sets: If you have access to the patient’s identifying information, this is human subjects research. If you receive de-identified data with no access to the “key,” this is NOT human subjects research.
If you have interaction with an individual, even if you don’t record identifiable information, this is human subjects research.

8. Definitions (FDA)
Clinical investigation (research): any experiment that involves a test article and one or more human subjects and that is either subject to requirements for prior submission to FDA… or is not subject to these requirements but the results of which are intended to be submitted later to…the FDA.
Human subject: an individual who is or becomes a participant in research, either as a recipient of a test article or as a control. A subject may be either a healthy human or a patient.

9. IRB Evaluation
We have defined the IRB, human subjects, and research. Now, how do we determine what projects require IRB oversight?

10. IRB Evaluation Process for determining level of IRB review.
GHS’s policy is for PIs to submit all studies, and the IRB will determine whether IRB review is required, as well as the level if review is mandated.
Convened board review No
Does it meet an exemption category?
Does it meet an expedited category? No
Yes
Yes
Review by one IRB member
Yes
Does it involve living people or their data?
Yes
This is an overall schematic of the process that is used to determine whether and what kind of IRB review is required. The next few slides will explain these steps in more detail. The objective is to have a protocol reviewed at the least level of risk that is appropriate to a study. No
Is it research? No
IRB review not mandated
IRB review mandated

11. IRB Evaluation
One of the set-up pages in eIRB addresses whether a study requires IRB oversight or not.
On a practical note, there is a setup page in eIRB that helps determine if your project is considered research and/or if it involves human subjects. Your answers to these questions will determine how long your eIRB application is, because certain pages will be added to the application or not based on whether the project is considered research with humans.

12. Not Human Subjects Research
Convened board review No
Does it meet an exemption category?
Does it meet an expedited category? No
Yes
Yes
Review by one IRB member
Yes
Does it involve living people or their data?
Yes No
Is it research? No
IRB review not mandated
IRB review mandated

13. Not Human Subjects Research
Not research, not human subjects research:
One IRB member reviews the application and the protocol documents to determine if the study requires IRB oversight.
Continuing reviews are not needed
If the PI changes the study’s design or purpose, a new application must be submitted for the IRB to determine if its classification should change.
Although IRB oversight is not required for these studies, again, our policy at GHS is that the IRB makes the determination as to whether their oversight is required, so study teams should still submit everything.

14. Human Subjects Research
Convened board review No
Does it meet an exemption category?
Does it meet an expedited category? No
Yes
Yes
Review by one IRB member
Yes
Does it involve living people or their data?
Yes No
Is it research? No
IRB review not mandated
IRB review mandated

15. Human Subjects Research
Category of human subjects research is based on the level of risk:
Exempt: least risk, must fit into a federally defined category; no IRB oversight required.
Expedited: minimal risk, must fit into a federally defined category
Full (convened) board: more than minimal risk, does not fit into an exempt or expedited category

16. Exempt Research Convened board review No
Does it meet an exemption category?
Does it meet an expedited category? No
Yes
Yes
Review by one IRB member
Yes
Does it involve living people or their data?
Yes
If a study is found to be research that does involve interaction with living people or their identifiable private information, but it meets an exemption category, then IRB oversight is not required. No
Is it research? No
IRB review not mandated
IRB review mandated

17. Exempt Categories
Research conducted in educational settings and involving normal educational practices (e.g., research on regular and special educational instructional strategies)
Research using educational tests, surveys, interviews, or observations of public behavior (unless personally identifying information is recorded and disclosure of the information outside the research setting could reasonably place the subjects at risk of criminal or civil liability or be damaging to their financial standing, employability, and/or reputation)
Research not exempt under category 2, if the subjects are elected or appointed officials or candidates for office or federal statutes require without exception that data confidentiality will be maintained
Although these categories are exempt from the regulations governing human subjects research, GHS’s IRB still requests that investigators submit all studies to the IRB so that the IRB can make the determination of whether IRB oversight is needed. Studies found to be exempt do not require continuing review.

18. Exempt Categories, cont’d
Research involving the collection or study of existing data, documents, records, or specimens, if publicly available or if information is recorded in a way that subjects cannot be identified, directly or through identifiers
Research and demonstration projects conducted by or subject to approval of (federal) department or agency heads, designed to evaluate public benefit or service programs
Taste and food quality evaluation and consumer acceptance studies, if wholesome foods without additives are consumed or if the food consumed contains an ingredient at or below a level found by the federal government to be safe
**Exemption categories will change when the new Common Rule goes into effect!**

19. Expedited Research Convened board review No
Does it meet an exemption category?
Does it meet an expedited category? No
Yes
Yes
Review by one IRB member
Yes
Does it involve living people or their data?
Yes
If a human subjects research protocol does not meet an exemption category, then IRB oversight IS required, and the next step is to find out if it meets an expedited research category. No
Is it research? No
IRB review not mandated
IRB review mandated

20. Expedited Research
Research that is not more than minimal risk and that falls into at least one of these categories:
Drug trials when an IND is not required or device trials when an IDE is not required or when the device is used in accordance with its approved labeling.
Collection of blood by finger stick, heel stick, or venipuncture within certain parameters (based on subject age and weight)
Prospective collection of biological specimens obtained through non-invasive means (e.g., hair/nail clippings obtained in a non-disfiguring manner; teeth lost naturally or extracted for routine purposes; mucosal and/or skin cells obtained by buccal swab, skin swab, or mouth washings, etc.)
There is a caveat: just because research falls into one of these categories doesn’t guarantee that it can undergo expedited review. The specific circumstances of the research overall have to pose no more than minimal risk to participants. Additionally, the expedited review procedure cannot be used for classified research or when identification of the subjects in the study could place them at risk of civil or criminal liability or be damaging to their financial standing, reputation, and/or employability.

21. Expedited Research, cont’d
Collection of data through non-invasive procedures routinely used in clinical practice, excluding those involving sedations/anesthesia or x-rays/microwaves.
Research involving materials (data/specimens) collected solely for non-research purposes (e.g., retrospective medical chart review).
Collection of data from voice, video, digital, or image recordings made for research purposes.
Research on individual or group characteristics/behavior, or research involving survey, interview, focus group, oral history, program evaluation, human factors evaluation, or quality assurance methodologies.

22. Expedited Research, cont’d
(The below only apply to continuing reviews)
CR of research previously approved by the convened board when,
the research is permanently closed to new subjects; all subjects have completed research-related interventions, and the research is active only for long-term follow-up; OR
no subjects have been enrolled and no new risks identified; OR
remaining activity is limited to data analysis.
CR of research not involving an IND or IDE where categories 2-8 do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

23. Convened Board Research
Convened board review No
Does it meet an exemption category?
Does it meet an expedited category? No
Yes
Yes
Review by one IRB member
Yes
Does it involve living people or their data?
Yes
If a human subjects research protocol does not meet an expedited category, then it must be reviewed by the convened board. No
Is it research? No
IRB review not mandated
IRB review mandated

24. Examples
Pediatrics initiated a new check-in process and wants to find out if it reduced patient wait times. The information will only be used internally. Is this human subjects research? No, because this is a quality improvement project not designed to contribute to generalizable knowledge. IRB oversight is not required.

25. Examples
A graduate student wants to approach patients in a waiting room and have them complete an anonymous survey. The student will not record private information, and the survey does not ask anyone to divulge sensitive information. Is this human subjects research? Yes, because the student is interacting with patients. Is IRB oversight required? No; because the student is not recording identifiable private information, the study is exempt.

26. Examples
A physician is interested in seeing the varying levels of his/her patients’ fitness level measured by a Fitbit. The physician also plans to collect the patient’s age, gender, address, race, and diagnosis. The physician has hopes of publishing his/her results in a medical journal. Is this human subjects research? Yes, because the study is: a systematic investigation, will contribute to generalizable knowledge, involves interacting with participants, & collecting identifiable information. Is IRB oversight required? Yes, but it is no more than minimal risk. Prospectively collecting identifiable information. Expedited under Category 1.

27. What is the IRB looking for?

28. What is the IRB looking for?
Expedited and Convened Board Studies:
The IRB must ensure that applicable regulations and policies regarding human research subject protection are met
The “Common Rule,” FDA, DOD, DOJ, Department of Education
State law
GHS policies
Continuing Reviews for Expedited and Convened Board Studies:
Expedited: reviewed on a rolling basis by one IRB member
Convened board: reviewed by at least two IRB members. Discussed and voted on at the monthly meeting.

29. IRB Review
EXPEDITED ≠ A LESS STRINGENT REVIEW

30. Federal approval criteria
The findings for approval listed below must be made for convened board AND expedited studies
Risks to subjects are minimized by using procedures consistent with sound research design and that do not unnecessarily expose subjects to risk and, whenever appropriate, by using procedures already being performed on the subject for diagnostic or treatment purposes
Risks are reasonable in relation to any anticipated benefits to the subject and the importance of the knowledge reasonably expected to result
Selection of subjects is equitable

31. Federal approval criteria
Informed consent will be sought from each prospective subject or LAR, unless the IRB approves a waiver of consent
Informed consent will be documented to the extent required {by federal regulations}, unless the IRB approves of a waiver of signed consent
When appropriate, the research plan makes adequate provision for data monitoring and patient safety
When appropriate, there are adequate provisions in place to protect the subjects’ privacy and data confidentiality
There are additional approval criteria required for research involving certain vulnerable populations.

32. The IRB at GHS

33. OHRP/IRB Structure The IRB is “insulated” from institutional strategic, financial, and operational considerations.
(Mitchell)

34. IRB Committees at GHS
Three IRB Committees. Each committee has a Chair, Vice Chair, regular members, and alternate members.
Committee A: Adult medicine, 2nd Thursday monthly
Chair: Christopher Wright, MD; Vice Chair: Thomas Wheeler, MD
Committee B: Pediatrics, 4th Wednesday monthly
Chair: Robert Saul, MD; Vice Chair: Frank Boineau, MD
Committee C: Adult oncology, 3rd Tuesday monthly
Chair: John Chandler, MD; Vice Chair: Jeffrey Elder, MD
The IRB’s insulation means that it can focus without distractions on ensuring human subjects protection. It also means that the IRB has ultimate authority over human subjects research, and its decisions cannot be overturned or modified by another entity in the system. The exception is that the institution can say that an IRB-approved study cannot occur due to non-research-related issues.

35. The IRB Review Process at GHS
Start here
IRB Coordinator:
Return to study team for changes
Study Team:
Completes and submits IRB application
IRB Coordinator:
Performs pre-review of materials OR
IRB Coordinator:
Send to IRB for review
Study Team: Revise and resubmit
IRB: Reject or Defer Study
IRB Coordinator:
Communicates decision to study team
Study Team: Revise and resubmit
IRB: Approve w/ Contingencies
Study Team: Begin study!
IRB: Approve Study

36. IRB Workload

37. The IRB at GHS
In 2017, GHS’s IRBs reviewed 2611 expedited and full board items (!!!!)
PRIM&R survey: 37% of IRBs review >500 new studies per year; only 28% review >400 CRs per year; only 31% review >400 amendments per year
Committee A
Committee B
Committee C
Totals
New studies
264
180
178
622
Cont. reviews
274
185
412
871
Amendments
306
170
642
1118
To finish up, I want to provide a comparison of our IRB’s workload, compared to the workloads reported in a recent PRIMR survey. Our committees do a lot of work!

38. The IRB at GHS Office of Human Research Protection (OHRP)
701 Grove Road, Employee Services Center (ESC) Greenville, SC 29605
Matt Hudson, PhD Chris Wright, MD
OHRP Director OHRP Medical Director
Katie Daniels, BS Amanda Goode, MA
IRB Coordinator IRB Coordinator
Committee C Committees A & B

39. CME Credit
Thank you for your time. To receive CME credit for this presentation please use the code: KODTEF