Please download and complete the current version of the applicable form(s).

Revise

Revisions or amendments to an approved study must be reviewed and approved by the IRB prior to initiating the change(s). All applicable revisions must be checked on the project revision form and must be incorporated into the relevant study documents using track changes.

For studies determined to be FLEX or exempt, the following changes do not require IRB review:

  1. Revising surveys or interview questions to make minor edits that do not alter the nature of the questions being asked (e.g., fixing typos/grammatical errors, restating the same questions for clarity, reordering the questions, splitting one question into multiple questions)
  2. Revising interview or focus group questions to include follow-up clarifying questions (i.e., questions that cannot be known to the researcher in advance because they are based on the individual responses of the participants).
  3. Adding or removing study personnel who meet all of the following criteria: (a) Are affiliated with OSU, (b) are not going to serve as the principal investigator, (c) are not a student conducting the study for a thesis or dissertation. Note: The PI is responsible for ensuring that all study staff have completed the appropriate online ethics training before they are added to the study team.
  4. Revising recruitment materials, so long as the four required elements are still present and they conform to the OSU policy

Please see the Project Revision Guidance for more information.

Project Revision and Minor Change Form

The federal regulations allow for expedited review of minor changes to studies previously approved by the full board. A minor change is one which, in the judgment of the IRB, makes no substantial alteration in:

  • the level of risks to subjects
  • the research design or methodology (adding procedures that are not eligible for expedited review would not be considered a minor change)
  • the number of subjects enrolled in the research (no greater than 10% of the total requested)
  • the qualifications of the research team (change in PI is not considered to be minor)
  • the facilities available to support safe conduct of the research, or
  • any other factor which would warrant review of the proposed changes by the convened IRB or was used to initially to evaluate the risk:benefit ratio or any other criteria for approval

The HRPP staff will make a determination regarding the appropriate review process upon receipt of the form.

Exceptions

A protocol exception is a single occurrence of an intentional action or process that departs from the IRB-approved protocol.  Exceptions will not be granted if they increase risk, decrease benefit, or could have a negative affect a participant’s rights, safety, welfare, or the integrity of the resultant data. Examples include omitting an approved procedure that is not in the best interest of a specific participant subject or seeking permission to enroll one interested individual who does not meet the eligibility criteria.

Exceptions made without prior IRB approval are deviations and constitute non-compliance.

Request for Exception Form

Renew

Expedited and Full Board studies must be reviewed and re-approved prior to the expiration date. It is the responsibility of each investigator to be aware of when their study expires and submit a continuing review application (or final report) to the HRPP Office at least 30 days prior to that date. In the event that a study expires prior to the submission of the renewal application, the study will be closed and a new application must submitted. No research activities, including data analysis, may be conducted in the absence of a current IRB approval.

Continuing Review Application

Exemptions and FLEX approvals are granted for up to five years. Continuing review of these projects is not required. If there is a plan to extend the study beyond the expiration date, the investigator must submit a new application (See step 3 on the ‘Preparing an Initial Submission’ page). Submit a final report if the project is completed prior to the expiration date.

Report

Reports related to protocol deviations, adverse events, and unanticipated problems must be submitted to the IRB within the required timeframe. Please see sections 12 and 13 of the Policy and Procedure Manual for more information.

Reportable Event Form

Close

Final reports should be submitted by the study expiration date or sooner if all study activities, including data analysis, are complete.

Final Report Form