Application Submission Process

7. Application submission Process

There are three types of application submissions; initial, renewal and modification. All materials submitted in an application should be contained in a single file, either a pdf or a Word document (preferred). IRB approval must be obtained before research is begun, no approval will be made after the fact.

7.1 Initial Proposal Submission Process

It is the responsibility of the researcher to submit the required documents to the IRBPHP. All documents should be submitted electronically. The initial application is found in Appendix A and a separate link is provided https://www.dominican.edu/directory/academic-affairs/institutional-review-board-irb. Upon receipt the proposal will be given an IRBPHP review number. It is suggested that students keep copies of the materials submitted to the IRBPHP for their personal reference. Handwritten applications will not be accepted. Incomplete applications will be returned to the researcher. Applicants may expect notification from IRBPHP 3-4 weeks following date forwarded to IRBPHP members. If the application is incomplete in some way, missing measurement instruments, unclear or inadequate descriptions of participants or of research protocol, or missing signature of faculty advisor, the review may take longer. Student applications should be submitted in accordance with department deadlines.

Applications will be reviewed in the order received. Requests for “quick review” will not be honored. Review is more rapid if all materials are complete, the research protocol is clear and scientifically sound, and all supporting materials are clear regarding protection of the human participants to be recruited for the research.

The faculty advisor and departmental committee, if applicable, prior to submission to the IRBPHP, review each application. See the flowchart on in section 13 which diagrams the review procedure. When the advisor and committee are satisfied that potential risks to human participants have been addressed and minimized and that all relevant requirements have been met, s/he submits the application to the IRBPHP Office with a recommendation for an exempt, expedited or full review.

For both exempt and expedited reviews the Chair of the IRBPHP or a member of the Board reviews the application and addresses any concerns with the advisor and the applicant, seeking expert consultancy if necessary. In a full review the three members of the IRBPHP review the proposal and recommend approval/non-approval. For all reviews, the IRBPHP may identify issues or concerns with the application that require modifications to the application, in which case the applicant will make the requested changes and resubmit the application along with a cover letter indicating the changes that have been made. Requests for changes will be identified as either (a) changes that require re-review by an IRB member (such as providing a signed permission form) or (b) changes that do not require re-review by an IRB member (such as spelling errors). When all concerns have been addressed the Chair of the IRBPHP will inform the researcher, and the faculty advisor, if the researcher is a student, of its decision. In cases where there are questions that may be answered by the faculty member, that faculty member may be invited to speak to the Board regarding those questions.

7.2 Renewal Application Submission Process

Initial approval of research involving human participants is granted for a period of one year. Researchers must obtain IRBPHP approval for continuation of the research before the year of initial approval has lapsed. Renewal approval must be obtained for students as well as faculty researchers whose research extends beyond the 12-month approval period. The procedures for review of a Renewal Application are the same as those of the Initial Application.

It is the responsibility of the researcher to initiate a Renewal Application, allowing sufficient time for review and approval prior to expiration of the initial approval. If research continues after the expiration date without renewal approval, the research is out of compliance with federal regulations and university policy. In the case of an emergency preventing a researcher from completing the renewal procedures, the Chair of the IRBPHP may grant an extension for up to one month. Request for extension must be made in writing to the IRBPHP Office and will be granted only for substantive reasons for failure to complete a timely Renewal Application.

7.3 Modification Application Submission Process

The IRBPHP approval is based on the document submitted with the Initial Application and/or Renewal Application. If the researcher desired any change in protocol, including changing participants, timelines, procedures, wording of documents, or instruments, it must be summarized in an IRBPHP Modification Application. Approval of the Modification Application must occur prior to implementation of changes. Procedures for review of Modifications Application are the same as review of the Initial Application. Approval of the Modifications Application extends only until the expiration date of the Initial Application. If research is to continue beyond this date the researcher needs to submit a Renewal Application prior to the expiration date.

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