Institutional Review Board Review Process
The Review Process
Wabash College Principal Investigators (PI) who are planning research projects involving human subjects are responsible for initiating the review process by submitting their research proposals and all necessary forms to the appropriate individuals designated below. Non-Wabash Principal Investigators (individuals not directly affiliated with Wabash College) who propose research projects involving human subjects from the Wabash College population are required to partner with a Wabash College faculty or staff investigator who will initiate the review process.
|Glossary of Terms|
Training Requirements. Federal regulations also require that all faculty, students and staff who are engaged in human subjects research certify to the IRB that they have completed a program of training in the ethics and best practice of human subjects research before their research protocol can be approved. Wabash’s IRB requires completion of online training provided by the National Institutes of Health (http://phrp.nihtraining.com/users/login.php). Investigators should include in the packet of materials that they submit to the IRB a copy of the certificate of completion that may be printed at the conclusion of the training program.
Submission of Documents. Application materials must include the following: 1) the Research Review Declaration, stating the requested review category, 2) a certificate of completion of the online IRB training program, and 3) an application form appropriate to the category of review (Exempt, Expedited, Full) along with all materials specified by that application form. An overview of the review categories can be found below; a fuller description is available at Categories of Review.
To expedite the management of human subjects research proposals, all materials must be submitted for IRB review in electronic form. Each investigator should prepare a single, paginated Word file containing all IRB documents. Please do NOT send multiple individual files. The only items that may be forwarded separately to the IRB Chair via campus mail are the Research Review Declaration bearing the signatures of investigator and departmental reviewer; and the certificate of completion of the IRB training program.
- Faculty member - Submit proposal to the designated departmental reviewer.
- Staff member - Submit proposal to designated departmental reviewer if applicable; otherwise submit proposal directly to the chair of the IRB.
- Student - Submit proposal to the faculty advisor or sponsor, who will in turn submit it to the appropriate departmental reviewer.
- Non-Wabash investigator – Submit proposal to the Wabash College partner, who will in turn submit it to the appropriate departmental reviewer.
All research proposals are evaluated by the departmental reviewer, the chair of the IRB, or the full IRB with regard to the degree of “risk,” if any, to human subjects. Risk is conceived broadly to include the probability of harm or injury of any sort (physical, psychological, social or economic). The degree of risk can vary from “minimal” to “significant.” The concept of “minimal risk” is very important in risk assessment and is the only category of risk defined in federal regulations (Code of Federal Regulations: 45CFR46):
Minimal Risk -- A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed 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.
Once the departmental reviewer (or IRB chair) has completed a preliminary assessment of risk, s/he will assign the proposal to one of three categories of IRB review listed below. (As part of the required package of information, the Principal Investigator must also include the Research Review Declaration, stating her/his own opinion as to the project’s category of IRB review.)
Exempt - Proposals involving no foreseeable risk will be considered "exempt", and will require no "further" review beyond the departmental level before the research can be initiated. The departmental reviewer will notify the IRB Chair of each exemption decision, and forward a copy of the protocol for the IRB files.
Proposals determined by the departmental reviewer to involve minimal or more than minimal risk will be forwarded to the chair of the IRB for one of two types of review:
Expedited Review - If the proposal involves only minimal risk, an "expedited review" will be conducted by the chair or at least one other member of the IRB designated by the chair
Full IRB Review - For proposals judged by the departmental reviewer to involve greater than minimal risk), the chair of the IRB will schedule a "full IRB review."
If there is a disagreement between the IRB chair and the departmental reviewer as to the correct category of IRB review, the two individuals will discuss the matter until an agreement is reached. Failing such an agreement, the higher of the two proposed categories of review will prevail.
For additional details on the criteria for each type of review, please see Categories of Review.
Approved – A protocol that has been approved by the IRB requires no further action from the investigator prior to initiating the study. If the study should extend beyond 12 months, the investigator should send a letter to the IRB chair, informing her/him of the current status of the project, any changes in the protocol, and whether any adverse events have occurred.
Conditionally Approved – A protocol that has been approved on condition may begin as soon as the condition(s) for approval have been met. These conditions typically require only simple concurrence by the PI, who must submit appropriate documentation to the chair of the IRB before the project is initiated. No additional meeting of the full IRB is required unless the chair is not completely satisfied that the required conditions have been fully met by the investigator. In that event, the chair will refer the protocol to the full IRB for review.
Deferred – A deferred protocol typically requires substantive clarifications or modifications. A revised application must be submitted to the IRB clarifying the issues involved or providing the requested documentation. The IRB will review the revised application at its next meeting.
Denied – Projects may be denied approval only by action of the full IRB, which will provide in writing the reasons for denial. An investigator is prohibited from conducting any project that has been denied approval; however, s/he may request a reconsideration of the decision at the next regular meeting of the IRB.
Approved research that is continuing must be reviewed at least once a year by the IRB. Shorter periods of review may be required by the IRB for research that has a high degree of risk.
An e-mail message describing the decision of the IRB will be sent to the investigator. If the e-mail signifies approval, it will specify the one-year time period during which the approval remains valid. If the IRB requires revisions or denies approval of the proposed research, the PI may request that the IRB reconsider its decision at the next regularly scheduled meeting.
Upon receipt of application materials, the IRB chair will send the principal investigator an email message notifying him/her that the application has been received, and indicating whether the application is complete or requires additional materials. Expedited reviews will ordinarily be completed within 10 business days from acknowledgement of a completed application. Full reviews, which require the attention of the full committee, may take longer than 10 business days.
Investigators should notify the IRB Chair upon completion of the data-collection phase of their research so that the IRB may close its records on the project.
Review of Continuing Projects
Data collection involving human subjects that extends beyond one year must be reviewed and re-approved annually. The PI must submit a complete new protocol summary that includes the following:
- a status report on the progress of the research;
- the number of subjects processed;
- any adverse effects or unanticipated problems;
- amendments or modifications to the research;
- a copy of the current informed consent document; and
- a summary of any new literature on the research topic that is relevant to the assessment of risks and benefits and the choice of research methodology.
To avoid interruptions in an ongoing research project, the IRB recommends that this protocol package be forwarded to the individual indicated below no later than 30 days before the anniversary date of the project:
- the departmental reviewer if the original status of the research was "exempt . "(The departmental reviewer is empowered to grant re-approval unless s/he finds changes or issues that merit expedited review or consideration by the full IRB. Note that the IRB Chair must be notified of all exemptions granted by departmental reviewers.)
- the IRB chair if the original status of the research was "expedited" or "full review."
- Expedited – The IRB chair is empowered to re-approve expedited research projects unless s/he finds changes or issues that merit consideration by the full IRB.
- Full IRB review – A continuation review will be conducted at the next regularly scheduled meeting of the full IRB. All IRB members will receive in advance of the meeting a full copy of the new protocol and all attachment
External Verification – As part of each request for continuation, the IRB will consider whether to require verification from sources other than the PI (“external verification”) that no material changes have occurred since the previous IRB review. Two circumstances may justify this additional requirement:
- complex projects involving unusual levels of risk;
- projects by investigators with a history of non-compliance.
IRB Communications with Principal Investigator
- The IRB will send the PI an e-mail message communicating its findings and its action on each proposal submitted for review. IRB actions are effective as of the date of the e-mail message, and normally remain valid for a period of one year (unless a shorter term of review is specified in the e-mail message due to an unusual degree of risk). The PI should print and retain a copy of the e-mail notification with other important papers pertaining to the research project.
- The IRB will contact the PI at the end of each academic year to verify the continuing status of the research project.
Principal Investigator (PI) Communications with the IRB
- Changes in Ongoing Projects. The PI will request approval in advance of any proposed changes of the following types:
- Changes in research methodology, procedures for collecting data, or research focus. NOTE: The PI may make changes unilaterally only to mitigate an immediate hazard to subjects. These changes must be reported promptly to the IRB Chair.
- Changes in the subject pool that were not anticipated as part of the methodology outlined in the original research proposal. NOTE: The IRB recognizes that in some fields of research (e.g., sociology/ anthropology), the recruitment of new research subjects is normally expected in the course of a typical research project. Such anticipated changes should be clearly outlined in the initial proposal, along with assurances that a standardized methodology will be applied to old and new groups to provide uniform protection from any risks of the study.
Each revision in research methodology, including changes in consent forms, must be incorporated into a new, written document, so that there is only one complete protocol with revision dates noted on each revised page and on the cover page.
Minor changes may be approved by the Chair or her/his designate via expedited review. Changes will be considered minor if they (a) do not result in a significant increase in the risk profile of the project, or (b) do not change significantly the composition of the subject pool.
B. Unanticipated Problems. The PI will notify the IRB immediately in writing of the occurrence of any adverse events or unanticipated problems involving risks to human subjects. This communication will include a description of the actions that investigator has taken to respond to the problem. Depending on the nature of the changes and/or adverse events, the chair may require a review by the full IRB.
IRB Communications with the Administration. The IRB will report via e-mail to the Dean of the College in the event of (a) any unanticipated problems involving risks to human subjects, (b) any serious non-compliance by a Principal Investigator, or (c) any suspension or termination of IRB approval.
- The IRB will notify OHRP when there is a change in the members serving on the committee.
- The IRB will notify OHRP immediately in the event of any adverse or unanticipated occurrences in a research project.
- The IRB will notify OHRP if there is any persistent or unresolved non-compliance by a Principal Investigator.
Records of the research project must be retained for three (3) years after the completion of the data collection phase. Applicable records include, but are not limited to, research proposals, informed consent documents, progress reports, reports of any injuries to subjects, and all related correspondence concerning the use of human subjects. To insure that the IRB has a complete record of project documents, the PI must forward all completed consent forms to the IRB chair upon completion of the data collection phase.
If the Principal Investigator disputes a decision of the IRB (e.g., a denial), s/he may request in writing that the IRB review its decision. The PI may provide the IRB with written arguments and supporting materials in advance of the meeting, and/or may choose to appear before the IRB in person to discuss the issue. If the PI remains unsatisfied with the outcome of the IRB’s reconsideration, s/he may consult with the Dean of the College, who may choose to mediate further discussion between the PI and the IRB. Once any mediation has concluded, the decision of the IRB is final; there is no further appeal.
Questions? Contact the Wabash IRB Chair: John Lamborn, Director of Lilly Library, Telephone: 765-361-6081, Email: firstname.lastname@example.org