Timetable for Research Projects
Ethical review of human subjects research takes time. It’s important to understand what’s involved with human subjects ethics review, what to expect, and anticipate submitting early.
Most human subjects research protocols at Ursinus College fall under Exempt or Expedited Review categories. This determination is made by the Institutional Review Board in dialogue with the researcher.
Generally, the IRB expects to take two weeks after receipt of the final version of study documents to review protocols falling under Exempt and Expedited categories.
If a proposal can be reviewed through the Expedited or Exempt Review Procedure, the Board will review the proposal following its Standard Operating Procedures and regulations in 45 CFR 46, and will consult with at least one other member of the Board regarding the proposal. If a proposal is not in a category eligible for Exempt or Expedited Review, it will be considered under the Full Review procedure.
Full committee review is required when the procedures of the research present more than minimal risk to the subject (see Proposals Requiring Full Review) and/or fall into one or more of the categories specified under Full Committee Review.
Dates for full board meetings will be circulated to the college community at the beginning of each semester. IRB meetings may also be held on an as-needed basis, depending on need. These meetings will be announced to the campus community as well. Principal Investigators may be invited to, or may request to attend, IRB meetings to discuss their proposals.
Research proposals requiring Full Board review should be submitted at least two weeks before the committee meeting. Any proposal in need of full review that does not meet this deadline will be reviewed during the next scheduled meeting.
Communication of the Board’s Decision
After review of the proposal, a letter will be sent to the investigator by the IRB chair, indicating one of three possible outcomes:
Approved - A protocol which 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 may be required to submit a Continuing Review Form for further IRB review.
Revise and Resubmit - More extensive changes are required before the study may begin. A protocol that has been deferred by the IRB usually requires that additional information be submitted to the IRB prior to approval. A revised application should be submitted to the IRB clarifying the issues involved or providing the requested documentation. Depending on the nature of the concern, the revised proposal will be reviewed by the Chair, the IRB member specifically assigned to the proposal, or the full IRB at its next meeting. Principal Investigators may request the IRB to review its decision, and may write to, or appear before, the committee to discuss the decision.
Denied - The proposed research, because of the level of risk involved, cannot be initiated. Principal Investigators may request the IRB to review its decision, and may write to, or appear before, the committee to discuss the decision.
Board approval of a project is valid for 12 months. If the project closes before the year mark, a Study Closure Form should be submitted at that time. Upon the year mark, a Principal Investigator may be required to submit a Continuing Review Report Form. Research approved by the IRB that is continuing, may need to be re-reviewed every twelve months by the IRB. The IRB Chair will determine whether a full or expedited review is required. If, during the one year period, the scope of the study changes (for example, if a new experiment is designed and implemented, or if additional human subjects are enrolled in the study) a Revision Form, accompanied by a revised protocol, the most recent version of the approved consent form and the revised (if applicable) consent form, must be submitted for Board review. If there are changes made to student investigators, an Add/Remove/Change Form, including the student names and years, and the Certificate of Training, must be submitted for Board review. Once the approved research is underway, the investigators will promptly report to the IRB, via an Adverse Events/Protocol Deviation/Unanticipated Problems Report Form, any unanticipated problems that pose risks to subjects or others.
Many proposals initially receive a “Revise and Resubmit” decision. Often the required revisions are very small; sometimes they are quite extensive. The IRB works to respond to revisions as quickly as possible. To resubmit your proposal, please follow these instructions:
- Fill out a new application, checking the “Revised proposal” line in the “Review Status” section
- Write a letter or narrative in which you respond, point by point, to the issues raised in the IRB’s decision letter, explaining how you have addressed each issue.
- Submit new or revised documents (consent forms, protocols, etc.) that incorporate the required changes For instance, if the IRB requests clarification about how research participants will be recruited, do not just explain in your letter, but modify the original proposal to incorporate the clarification.
As with the original proposal, you should submit the revised proposal to email@example.com. Noncompliance will result in the termination of the study and could result in future submissions being denied. The IRB is required to report violations of the Common Rule regulations and internal policies and procedures to the Office of Human Research Protections. Further, complaints or questions regarding compliance with this Policy should be directed to the Chair of the Board. Such reports will lead to an investigation and may be cause for suspension or termination of IRB approval for the project. Research proposals in need of expedited review may be sent to the Administrator of the IRB at any time. The IRB is available as an advisory board if there are any questions regarding the review process and categories of review.
Adverse Events/ Protocol Deviation/ Unanticipated Problems Report Form.
This form is used to notify the IRB immediately if adverse events occur and what actions the investigator has taken to respond.
A Revision form must be submitted whenever there are changes in the procedures of collecting data from human subjects. The change must be re-reviewed and approved, as well as any changes to the informed Consent/Assent forms.
Add/Remove/Change IRB Study Personnel Form
Use this form for any personnel/student investigator additions or deletions.
Data collection involving human subjects that extends beyond one year must be re-reviewed, and re-approval granted, for research to continue. Begin the process by submitting a Continuing Review form. If the study requires continuing review, a continuing review form should be submitted at least one month prior to the date of expiration of IRB approval. If the form is not submitted and approval has expired all research must cease. To continue research once a protocol has expired, a new proposal will need to be submitted for review.
Based on recent research-guideline changes, continuing review of research is not required for research eligible for expedited review or research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
- (A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
- (B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
IRB approval is valid for a period set by the IRB. This is often no more than 12 months, but will be explained in your approval letter. “Continuing review” of protocols can be approved in effective perpetuity unless the protocol has any modifications. Upon closure of a study a Study Closure Form must be submitted to the IRB. The principal investigator will be sent a reminder to submit this form one month prior to the date of expiration of IRB approval. If this form is not submitted, the IRB will not be able to approve any future applications from faculty who have outstanding paperwork.