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New Proposal Submission Checklist
New Proposal Submission Checklist
(rev. 07/ 2019)
A printable version of this checklist is available.
(If you are submitting revisions, please review this checklist AND the instructions on submitting revisions that immediately follow.)
Use this checklist AND instructions to ensure a complete submission package.
Use this checklist AND instructions to ensure a complete submission package.
Documents required for a new project submission will depend on the nature of the project.
Documents that the researcher and IRB will see do/may include:
Research Project Protocol (required)
Application signed by PI, and Co-PI if applicable (required). Note: Electronic signature only accepted for applications submitted in PDF. All other formats require handwritten signature. Learn how to include your electronic signature using Adobe Acrobat (Windows, Mac) or Preview (Mac only) HERE.
Training Certification (required of PI and Co-PI). Due to changes in the Common Rule effective 2018, PI's must demonstrate successful completion of training on the revised Common Rule.
CV (required of PI and Co-PI)
Site Permission Letters, Letters of Support, Other IRB Approvals, Data Transfer Agreements, Certificates of Confidentiality, Request for Waiver of HIPAA Authorization
Other, depending upon project
Documents that the research subjects will see/hear:
Consent, Assent, HIPAA Authorization (must be submitted to IRB in MS Word or editable Google.docx format)
Recruitment or Screening Materials (e.g. Flyers, Postcards, Posters, Print Media, Audio/Video, Online Content, Scripts)
Surveys, Questionnaires, Data Collection Tools, Interview Scripts/Questions
Other: Appointment/Postcards, Flair/Swag, Translations of any document
ADDITIONAL INSTRUCTIONS:
Follow the file naming instructions ("save as") on templates and forms. The filename will include the date on which the document is submitted to the IRB.
Submit all documents as Word documents if possible; use PDF's only if required (e.g. signature pages); and keep all documents unprotected/unlocked. You MAY NOT link to or provide a shortcut to documents on your personal drive. You MUST be able to attached the document to the submission form.
Combined PDFs are not accepted; attach documents separately.
IRB committee members cannot submit documents on behalf of the researcher; we can only provide guidance.
Inform the IRB of any special circumstances that may impact the review of your submission.
ONCE YOU HAVE REVIEWED YOUR PROPOSAL USING THE CHECK SHEET, FOLLOW THE INSTRUCTIONS FOR SENDING YOUR PROPOSAL FOR REVIEW
Contact the IRB Chairperson if you have questions before submitting.
Submitting Revised Proposals and/or Supporting Documents
Submitting Revised Proposals and/or Supporting Documents
(If you are submitting revisions, please review the above checklist for new proposals AND the instructions on submitting revisions below.)
The process for submitting revisions is similar to the process for submitting new proposals (see checklist above) with a few important exceptions:
You must record all changes to the original document (e.g. protocol, application, survey instrument) using the Track Changes function (found under the "Review" tab in MS Word), and save as a separate document using the original filename.
You must then "Accept" all changes made and save as a new (separate) file. The revised document is submitted according to the date the revision is submitted. At the end of the filename, include the following: _REV
You must submit BOTH the revised document, and the original document with track changes visible to show all modifications made to original document that are reflected in the revised version.
FOR EXAMPLE: Imagine that you submitted the "Application for Expedited or Full Review" to the IRB on September 10, 2019. You received a letter from IRB notifying you that you need to make revisions to the application and submit your revisions for review. To prepare and submit your revision of the "Application for Expedited or Full Review" on November 30, 2019, you would:
Make all necessary changes to the original Application you submitted on September 10th using MS Word Track Changes function.
BEFORE accepting the changes, you would save the Track Changes document (with editing/changes tracked and visible) under the original filename: irbreviewapp_10-09-2019
Then, you would "Accept all changes" you've made using the Track Changes function. The editing notes are no longer visible, the changes are made, and the document is finalized. Save the Revised document as a separate file, with the following filename: irbreviewapp_30-11-2019_REV
Submit BOTH the Track Changes version and the Revised version to the IRB.
Electronic (email) submissions only. Printed proposals will not be accepted or reviewed.
Include all necessary attachments in a single email.
You MUST use your Keuka College email account to access the Google form.
Make sure you've reviewed the applicable checklist and instructions before submitting your proposal package.
For information on submission deadlines and the expected length of the review process, return to Submitting a Research Proposal to IRB
Electronic (email) submissions only. Printed requests will not be accepted or reviewed.
NEW REQUIREMENT: If the RFD is for student research associated with a credit-bearing course, internship, or practicum, the faculty mentor/instructor is responsible for preparing and submitting the RFD, and should sign the completed form.
Use your Keuka College email account. Requests from other email accounts will not be opened.
To ensure your request is processed in a timely manner, use "IRB Request" and your last name as the subject line.
Attach the appropriate completed request for determination form and other documents as needed.
Please allow 14 days for a determination. You will be notified by email.
Criteria for IRB Approval
(rev. 08-04-2019)
It is the responsibility of the IRB to ensure research is approved only when all of the requirements in 45 CFR 46.111 or 21 CFR 56.111 (for FDA-regulated research) are met.
Scientific Merit and Feasibility. In its review of research applications, the IRB considers whether research procedures are consistent with sound research design in order to yield the expected knowledge. Scientific merit is examined in relationship to the risks and benefits of the research. The IRB may fulfill its obligation to evaluate proposed research for scientific or scholarly validity by ensuring its membership includes individuals with appropriate scientific background to determine whether the research can reasonably be expected to answer its proposed question and whether the importance of the knowledge to be gained is sufficient to justify any risks associated with the conduct of the project.
Minimizing Risk. A research plan approved by an IRB must ensure that risks to subjects are minimized by using procedures consistent with a sound research design that do not unnecessarily expose subjects to risk, and whenever appropriate, by using procedures already being performed on subjects for diagnostic and treatment purposes. When ensuring that risk is minimized, the IRB should evaluate the resources available at each site where research will be conducted, for example, by reviewing descriptions provided by investigators of facilities and personnel involved in the study.
Risk-Benefit Analysis. Research may be approved only if the risks to subjects are reasonable in relation to any anticipated benefits to subjects and to the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies that subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks or benefits that fall within the purview of its responsibility.
Equitable Subject Selection. An IRB must determine that recruitment and enrollment plans will promote equitable subject selection. In making this assessment, the
IRB will review any proposed direct advertising to prospective subjects (i.e., communications intended to be seen or heard by potential subjects to solicit their participation in a study) and take into account the purposes of the research and the setting in which the research will be conducted.
The IRB will be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, persons who are cognitively impaired or lack decision-making capacity, or economically or educationally disadvantaged persons.
Trouble accessing page content? Make sure you are using your Keuka College email account. Still having difficulty? Contact the IRB Chairperson - voconnor@keuka.edu
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