VCU IRB Reviewer Guide

TABLE OF CONTENTS:
Chapter 1: About the VCU IRB Reviewer Guide
Chapter 2: Tips for IRB Reviewers
Chapter 3: Exempt Review Guide

Chapter 1:  About the IRB Reviewer Guide

The VCU IRB Reviewer Guide was developed to assist reviewers in the process of conducting and documenting reviews.  The Reviewer Toolkit consists of streamlined review sheets that are simplified, yet rich with embedded links to an all-new electronic guide for reviewers.  This “toolkit concept” has been developed with valuable input from exempt and expedited reviewers and is now available for testing in the exempt review process.

In practice, the review sheets may be used by the reviewer at any stage of the review process in print or electronic form (as preferred).  However, in order to approve a study via exempt procedures, the reviewer must transmit a completed exempt review sheet to the IRB Coordinator via email attachment.  The review sheet will then serve as the official documentation of reviewer action.  Any changed documents that have been approved will also need to be attached to the email.

The electronic review guide can be accessed by clicking on embedded links within the review sheet.  The links within the review sheet will point to key areas of the “guide” where the reviewer will find only pertinent regulatory definitions, references, guidance documents, and access to related VCU IRB Written Policies and Procedures. 

Currently, the IRB Reviewer Toolkit is only for Exempt Review.
As more Review Sheets are added, the toolkit will expand.

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Chapter 2:  Tips for IRB Reviewers

A. Suggested Steps for Approaching a Review
B. Communication in the Review Process
C. Official Reviewer Documentation

A.   Suggested Steps for Approaching a Review (Steps 1-4):

1. Do the rationale and experimental design suggest that useful information is likely to result?
2. If federally funded, does the protocol match the grant proposal?
3. Is a detailed protocol provided?
4. Is a detailed protocol needed, to know just what it is that we're approving?
5. Does the protocol specify criteria for stopping (for a subject or for the project)?
6. (Detailed protocol needed if study is complex or risk is high)

1. What is the target for enrollment (specific number requested)?
2. Is the sample reasonable in order to answer the research question (not too small or too large as to unnecessarily expose participants to the risk of participation)?
3. Does the sample specifically include groups who might be vulnerable or have special concerns?
4. Do the inclusion/exclusion criteria or gender/ethnic balance raise special justice or safety issues?

1. Are the risks to the research participants well-described and managed where possible?
2. Are the potential benefits to the research participants realistic and clear?
3. Are risks and possible benefits in balance?
4. Does the information provided convince you that the study is appropriate?

1. Are the investigators qualified and have the experience to oversee all aspects of the study?
2. Does the study involve high-risk procedures for which special expertise or special monitoring may be needed?
3. Do you need any special assurances to be certain that this is really OK (e.g., additional monitoring, checking back with the IRB following 2 or 3 enrollees, observation of the informed consent process)?

1. Is an IND or IDE likely to be needed?
2. Does the study require review for safety considerations, conflict of interest, etc.?
3. Are any special provisions of the federal regulations invoked (e.g. waiver of consent)?
4. Do other committees need to approve it (e.g., Biosafety, Radiation)

1. Does the document look okay, overall (with none, little or only minor editing needed)?  NOTE:  The reviewer should just note exactly what needs to be changed on paper to present at the meeting.  Engage the secondary reviewer in this process.
2. Does the document look haphazard (with many or major revisions needed and possibly unanswered questions)?  NOTE:  The reviewer should do some homework before the meeting by contacting the investigator.  The secondary reviewer will prove valuable in this process in order to ensure that the questions are fairly posed and addressed by the investigator.  Focus on questions in Step 4.

1. Of the PI or study team - give them a change to clarify discrepancies or provide missing info.
2. Of your IRB chair or fellow IRB members.
3. Of the ORSP Director or OECO Director.

The burden of proof rests with the investigator.  But, the IRB can help the investigator see clearly what needs to be spelled out more clearly or documented within the IRB application.

1. Complete the review checklist including your recommendations for action.
2. Be prepared to discuss substantive concerns during the IRB meeting if the protocol requires full board review.

B.   Communication in the Review Process:

1. Communicate with the PI in an open manner by email or phone, as needed to answer questions for exempt or expedited procedures.
2. Communicating with other reviewers (secondary or special population reviewers) will be very helpful
3. Communicating with the IRB Coordinator will ensure that VCU IRB procedures are followed and be an essential resource to you.
4. Preparing for an IRB meeting (full board review only) is important, including bringing the completed checklist to the meeting as well as your comments and edits to the consent document.

C.   Reviewer Documentation (to approve) - Important Things to Remember as a Reviewer:

1. Your primary job is the protection of human research subjects
2. An important secondary job is helping investigators deal with human subjects issues in their research
3. There should be a presumption of best effort, even though the burden of proof is on the investigator
4. Most research is ultimately approvable
5. Most researchers have the best interests of their subjects at heart
6. Many investigators find the rules perplexing and/or haven't been trained to write for a lay audience
7. The IRB can hold investigators to a high standard, while also trying to give them good service
8. A helpful and collegial relationship between investigators and the IRB encourages compliance and a serious attitude toward human subjects' protection
9. Individual IRB members can make a huge difference through their review behavior
10. Protocols need to be complete but succinct and include all required documents (e.g., surveys, emails, information sheets, advertisements).

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Chapter 3:  Exempt Review Guide

1. Exclusions:  This section notes several exclusions from review for an exemption.  (no prisoner research; not greater than minimal risk).
   1. The reviewer may recommend restrictions with other vulnerable populations, such as decisionally impaired persons. Please contact the PI to consider excluding specific vulnerable populations and/or upgrading the review to expedited or full-board review (with the addition of appropriate consent materials).
      
      
2. Review Criteria:  Two general conditions are noted. 
   1. LINKS/NOTES:
      • ‘human subjects' and ‘research’ (DHHS 45 CFR46.101)
      • ‘human subject’ and ‘clinical investigation’ [FDA 56.102(c) and (e)]
      • VCU IRB WPP VIII-1 for additional guidance on making this determination
      • If this activity does not meet one or both sets of definitions, IRB review is not required. OHRP offers the following flowchart for help in making this determination for research that is not regulated by the FDA:  (1) OHRP Decision Chart 1; (2) Engagement in Research; (3) Coded Private Information or Biological Specimens.
   2. LINKS/NOTES:
      • In order to qualify for a determination of exemption, the research must qualify as no greater than minimal risk to the research participants.
      • Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [45 CFR 46.102(i)].
      • NOTE: Research submitted for a determination of exemption that involves greater than minimal risk must be referred for Full Board review (it will also not qualify for Expedited review based upon the risk level).
      • If the research does not meet minimal risk requirements, even after consideration of modifications or clarifications to reduce the risk, the reviewer is responsible for informing the IRB Coordinator of the upgraded review and continuing the review using the paper version Full-Board Review Sheet and process.
        
        
3. Exempt Categories:
   The federal regulations at 45 CFR 46.101 and 21 CFR 50.104 allow for specific categories of research to be exempt from the requirements set forth in the Code of Federal Regulations (Title 45 Part 46).  All research submitted under one of these categories must also be no greater than minimal risk.  Of these categories, only category 6 is permissible if the research falls under Food and Drug Administration regulations.  As a reminder, the PI may be advised to make modifications to the research so that one of the Exempt categories applies. In this case, the reviewer should communicate directly with the PI to consider appropriate changes.
   
   1. Category 1 LINKS/NOTES:
      • (Category 1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
      • §46.101(b)(1)
      • OHRP Decision Chart 3.
   2. Category 2 LINKS/NOTES: 
      • (Category 2)  Research involving the use of educational tests, survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
      • POPULATION RESTRICTION:  Category 2 does not apply if the research allows for the inclusion of data on children and involves surveys, interview procedures, or observation of public behavior where the investigator participates in the activities being observed, [§46.101(b)(2)(footnote 1)]. 
      • §46.101(b)(2)
      • OHRP Decision Chart 4
   3. Category 3 LINKS/NOTES: 
      • (Category 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 paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
      • §46.101(b)(3)
      • OHRP Decision Chart 4
   4. Category 4 LINKS/NOTES: 
      • (Category 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 subjects cannot be identified, directly or through identifiers linked to the subjects.
      • Note: ‘existing data’ applies to data previously generated and in actual existence at the time of IRB submission.  Category 4 does not allow for the collection of data that is being prospectively collected.
      • §46.101(b)(4)
      • OHRP Decision Chart 5.
   5. Category 5 LINKS/NOTES: 
      • (Category 5)  Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
      • Additional Required Findings: OHRP has determined that the following criteria must be satisfied to be considered under this category:
        1. The program under study must deliver a public benefit (e.g. financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act).
        2. The research or demonstration project must be conducted pursuant to specific federal statutory authority.
        3. There must be no statutory requirement that the project be reviewed by an Institutional Review Board.
        4. The project must not involve significant physical invasions or intrusions upon the privacy of participants.
        5. The funding agency must be contacted and provide approval to utilize this exemption category.
      • §46.101(b)(5)
      • OHRP: Public Service/Benefit Programs
      • OHRP Decision Chart 6.
   6. Category 6 LINKS/NOTES: 
      • (Category 6)  Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
      • §46.101(b)(6)
      • OHRP Decision Chart 7.
        
        
4. Other Considerations: 
   1. Verbal explanation of the research activity and/or written description is not required for observation of public behavior or other activities where there is no contact between the investigator and the research subjects.  In all other cases, a verbal or written explanation should disclose that the activity involves research and that participation is voluntary.  Any written document or verbal script must be approved by the reviewer.  In the review of a document or script, there are no regulatory requirements for inclusion of specific elements of consent.  However, at a minimum, the following should be included:
      • Statement that the activity involves research
      • Statement that participation is voluntary.
   2. PI Qualifications:  Is the PI generally qualified by training and/or experience to carry out the responsibilities of this protocol?  [As of November 1, 2005, CITI Basic Training is required of all investigators and key personnel, including students (for all protocols submitted to the VCU IRB/WIRB), including submissions for exemption.]
   3. Conflict of Interest:  If the conflict of interest committee has identified a potential conflict of interest, is their management plan sufficient?  Note:  COI Committee Review is concurrent with VCU IRB Review. If no potential COI is disclosed, then submission to the COI Committee is not necessary.
   4. Involvement of Non-VCU Institutions/Sites (Foreign and/or Domestic):  If the PI has identified any non-VCU institutions involved in this research protocol (e.g., any elementary school or place of business), it is the responsibility of the PI to ensure that permissions are in place.  If a foreign institution/site is listed, the reviewer should consult with the ORSP Director and the IRB Chairperson prior to completing this review.  NOTE:  The reviewer/IRB may request documentation of permissions.  Additional VCU guidance is available at VCU IRB WPP: XVII-6.
   5. Funding Considerations:  The protocol must be designed to meet the objectives described in the funding proposal and appropriately represent the risks, benefits, procedures, and research subject populations also described in the funding proposal.
   6. Other Issues: Are there any other issues that need to be addressed?  If you have requested clarification on an issue, that clarification should be reflected in a revised version of the protocol requested from the PI.  If it is a multi-center study and the PI cannot revise the protocol document, the clarification should be in the form of a memo from the PI and is to be permanently affixed to the protocol document. Future protocol submissions should include any affixed memos.

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