IRB APPLICATION SUBMISSION PROCEDURE
The responsibilities of being an investigator conducting human research necessarily raises a number of important ethical issues. It is hoped that these guidelines will aid in clarifying these issues, and provide useful information as to the appropriate conduct of research involving human participants at Widener University. The researchers’ needs must be balanced with respect for the person and rights of participants and of the social groups to which they may belong. Thus, the elements of protection discussed here are intended to be guides by which the researcher plans an investigation that is mindful of and takes into consideration basic ethical principles.
In many cases, the determination of whether a particular research activity involves human subjects is not difficult. However, in some cases, the line can be blurred. When it is not clear to an investigator whether research activities involve human subjects, he or she is encouraged to seek the advice of others, which can include the IRB members or the chairperson. In questionable cases, final responsibility for determining whether human subjects are involved rests with the IRB.
Under limited circumstances and with the written authorization of the chair of the IRB, approval by another IRB may be acceptable in lieu of approval by the Widener University IRB. Prior approval of the Widener University IRB is not required when part-time or unpaid faculty are not acting as a staff member, employee, or agent of the university, or when the activity does not involve the university, either as represented to subjects or in subsequent publication. However, in such cases investigators holding university appointments must nevertheless obtain approval for the use of human subjects from a duly constituted IRB.
It is the principal investigator’s responsibility to adhere to the protocol as it has been approved by the IRB.
Guidance in Picking a Review Category
This link will help you to determine if your research requires review by the IRB based on principles contained in Title 45 CFR Part 46. The Office for Protection from Research Risks (OPRR) provides the associated graphic aids to clarify portions of the Department of Health and Human Services (DHHS) human subject regulations at Title 45 Code of Federal Regulations Part 46 (45 CFR 46).
Instructions for Submission of an Application for IRB Review
Full Review Applications. Please complete and submit one electronic copy of the proposal application as an email attachment to the following address, firstname.lastname@example.org.
The electronic application submission and all support materials must arrive no later than two weeks prior to the scheduled IRB committee meeting. Please see the application review procedures tab to determine if your application qualifies for full review status. You may contact Sue Costello, email@example.com at 610-499-4211 with any questions.
Exempt Applications and Expedited Review Applications require the submission of one electronic copy of the new proposal application to the following address, firstname.lastname@example.org .
Please see the application review procedure tab to see if your application may qualify for exempt status.
Student Research Projects: Students who wish to carry out research projects involving human subjects may also be required to submit their applications to the IRB Committee. The student must first obtain agreement from such a faculty member to sponsor and supervise the research, and must secure written approval of the protocol from the sponsoring faculty member before submitting it for IRB review.
Please allow two weeks following the meeting date for the committee to respond to a first time submission. Incomplete applications or resubmissions will be returned for correction and will not be reviewed until the next meeting.
Resubmitting a Previously Reviewed Application
If you are requested by the IRB to resubmit your documents please adhere to the following procedure:
- Reprint your newest version, and use the track changes feature in Microsoft Word to identify edits so that the committee can quickly find the parts of the application that need reviewing;
- Submit a separate letter responding with bullets or outline the specific changes that were made to the application for each recommendation made by the committee;
- Resubmit the requested application to the managing reviewer listed in the email that was sent to you.
Please allow two weeks following the meeting date for the committee to respond to a first time resubmission. Incomplete applications or resubmissions will be returned for correction and will not be reviewed until the next meeting.
Amending a Protocol for Approved Research
If, for any reason, the approved research data collection method changes significantly during the study, you are required to notify the IRB, in writing, of such changes. Please submit an electronic copy of the revised protocol form to the IRB at email@example.com. The new protocol may need to be reviewed by the committee.
Please allow two weeks following the meeting date for the committee to respond to the submission.
Approved Research Protocols Extending Beyond the Expiration Date for Your Protocol
All IRB approved research protocols that extend beyond one year require annual review by the IRB. Prior to the IRB expiration date, a brief one-page summary of the status of the research project with a memo formally requesting an extension is required. In addition, please complete and submit the Research Status Form .
Requests for an extension of the IRB approval are submitted electronically to firstname.lastname@example.org Please allow two weeks for a response to the request.
Completion of Approved Research
Upon completion of a study that has received IRB approval, a final written report summarizing the outcomes of research is to be submitted to the IRB. The formal report must be submitted within 90 days.
The report should be submitted in the form of an abstract listing the purpose of the study and briefly summarizing the major findings from the project. Project summaries are limited to two type written pages.
Please include with the report the title of the project and list all investigators. The final written report is submitted electronically to email@example.com.