5.2.4 Changes to Previously Approved Projects
5.2.5 Continuing Review of Ongoing Projects
5.2.6 Submitting a Project Previously Reviewed by one IRB to a Different IRB
5.3 Provost Review Option
5.4 IRB Review Criteria
5.5 IRB Suspension or Termination of a Protocol
5.2.4 Changes to Previously Approved Projects
Submission Requirements
The Principal Investigator shall submit as attachments to an email message to IRB@drake.edu:
- A letter that summarizes the changes and indicates their location in the protocol and/or informed consent document
- An electronic copy of the revised protocol and informed consent document. Any changes in the language of the informed consent must be noted
- A clean copy of the revised informed consent document (to be dated by the IRB upon approval)
- A copy of any revised advertising material
- A copy of any other relevant documentation
Review Process
- Expedited Review—The IRB may use the expedited review procedure to review minor changes to previously approved research projects during the period for which approval was authorized.
- Full Board Review—Amendments, addenda, supplements, or other changes that do not qualify for expedited review shall be reviewed as set forth in the preceding explanation for full board review.
5.2.5 Continuing Review of Ongoing Projects
Submission Requirements
The research investigator is solely responsible for timely submission of continuing review materials. The IRB will send a courtesy reminder and a Reporting Form for Continuing Review or Project Termination to the Principal Investigator listed on the project prior to the expiration date of the current approval period. For projects previously approved by expedited or full board review, continuing review materials should be submitted at least one month prior to the expiration date keeping in mind the date scheduled for the next IRB convened meeting. The research investigator is responsible for submitting the following documents to the IRB for continuing review. The research investigator is responsible for submitting the following documents as attachments to an email message to IRB@drake.edu for continuing review.
- A completed "Continuing Review or Project Termination" form
- A clean copy of the current consent/assent document, if subjects are still enrolled in the study
- If research subjects were enrolled in the last approval period, copies of assent/consent forms available for IRB review upon request.
Failure to complete and submit the continuing review form in the time stipulated will lead to corrective action resulting in the research project being closed. If this occurs, the research investigator will have to resubmit a new application for full board review and receive IRB approval for that submission before continuing the research.
Review Process
The IRB uses the same criteria for continuing review as it does for initial review. The IRB conducts continuing review projects previously approved by expedited or full board review and may conduct review of exempt projects.
Continuing review of a research project may not be conducted through an expedited review unless:
- The project was eligible for, and initially reviewed by an expedited procedure, or
- The study has changed such that the only activities remaining are eligible for expedited review
5.2.6 Submitting a Project Previously Reviewed by one IRB to a Different IRB
Previously Disapproved by Drake University IRB
If the Drake University IRB disapproves a research project that is subsequently submitted to one or more other IRBs, the Drake IRB disapproval must be made known by the Principal Investigator to the other IRB.
Previously Reviewed by an IRB other than Drake University IRB
If you are submitting a protocol to the Drake University IRB that has been reviewed by one or more other IRBs, then you must provide the Drake IRB with copies of the approval or disapproval letter(s) along with your initial submission.
The Institutional Official (the Provost of Drake University) may further review and/or disapprove research projects previously approved by the IRB, with the following exception: the Provost may not approve any research project that has been previously disapproved by the IRB.
The IRB will evaluate all non-exempt research projects to ensure that the defined risks to the subject are outweighed by the potential benefits. The IRB will determine that the following criteria are satisfied:
- The research is significant, has scientific merit, contributes to knowledge and research and methods are appropriate
- The investigator is qualified and research investigators have received education in human subjects protection and are certified by the University
- Risks to subjects are minimized, procedures used are consistent with sound research design and do not necessarily expose subjects to risk
- Risks to subjects are reasonable in relation to anticipated benefits
- Selection of subjects is equitable
- Informed consent will be sought and appropriately documented in accordance with and to the extent required by 45CFR4.116
- Privacy is protected and confidentiality of data is maintained
- Safeguards for those who are likely to be vulnerable to coercion or undue influence have been included to protect research subjects
- Adequate provisions are made if special issues are a component of the research study
5.5 IRB SUSPENSION OR TERMINATION OF A PROTOCOL
The IRB has the authority to suspend or terminate a protocol when 1) the protocol is not conducted in accordance with IRB requirements and/or 2) there is unexpected serious harm to subjects. The IRB shall promptly notify the Principal Investigator, Institutional Official, and, if appropriate, DHHS and other involved Federal department/agency heads or sponsor when it suspends or terminates a research project.
