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READ THIS BEFORE YOU BEGIN!
READ THIS BEFORE YOU BEGIN!
IN ORDER TO EDIT FORMS & TEMPLATES, YOU MUST CREATE YOUR OWN FILE BY DOING ONE OF THE FOLLOWING:
IN ORDER TO EDIT FORMS & TEMPLATES, YOU MUST CREATE YOUR OWN FILE BY DOING ONE OF THE FOLLOWING:
USE THE MENU TO MAKE A COPY OF THE FILE WHICH IS THEN AUTOMATICALLY SAVED TO YOUR PERSONAL GOOGLE DRIVE: FILE>MAKE A COPY
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Investigator Forms
Investigator Forms
Does My Project Require IRB Review & Approval?
Does My Project Require IRB Review & Approval?
Uncertain if your research project or class project/demonstration requires IRB review? Complete the appropriate form (below) and submit to IRB to request a determination.
4 STEPS TO APPLYING FOR IRB REVIEW
4 STEPS TO APPLYING FOR IRB REVIEW
Exempt (including limited), Expedited, & Full Review
Exempt (including limited), Expedited, & Full Review
Forms may be saved in Google.docs or download and saved as MS Word file.
Planning on conducting research involving human subjects?
Planning on conducting research involving human subjects?
Avoid missed deadlines or a late start on your research activity. Review the information on Submitting a Research Proposals & Requests. You'll find information on submission deadlines, a table and flowchart outlining the review process and timeline, checklists for new proposals and revisions, and more.
STEP 1: Complete the Required Training.
STEP 1: Complete the Required Training.
Successful completion of approved training is REQUIRED for all principal investigators (PI) and faculty mentors involved in human subjects research (HSR). The training is free to all members of the college organization, and will aid you in developing a research plan and proposal that meets federal guidelines for protecting human research subjects. Documentation showing your completion of training is required as part of the research proposal package.
Successful completion of approved training is REQUIRED for all principal investigators (PI) and faculty mentors involved in human subjects research (HSR). The training is free to all members of the college organization, and will aid you in developing a research plan and proposal that meets federal guidelines for protecting human research subjects. Documentation showing your completion of training is required as part of the research proposal package.
Step 2: Prepare Research Project Protocols.
Step 2: Prepare Research Project Protocols.
Suggestion: Before completing the application and assigning start and completion dates for your project, you should carefully review the information on Submitting a Research Proposals & Requests where you can find information on submission deadlines, the general review process and timeline, and checklists to help you develop a complete proposal.
The RESEARCH PROJECT PROTOCOL must be accompanied by a completed application for exemption, expedited, or full review. Application forms are provided in the subsections below, along with informed consent templates and other documents you may need for your project proposal.
If you are uncertain which application form is appropriate for your project, please review the information available on the “Resource Library” and on the “Forms for Investigators” pages on the IRB’s website. For additional assistance, contact the IRB.
Step 3: Complete the Application Form to Accompany the Research Project Protocol--Choose Option A or B below.
Step 3: Complete the Application Form to Accompany the Research Project Protocol--Choose Option A or B below.
Suggestion: Before completing the application and assigning start and completion dates for your project, you should carefully review the information on Submitting a Research Proposals & Requests where you can find information on submission deadlines, the general review process and timeline, and checklists to help you develop a complete proposal.
Step 3 - Option A. Application for Exemption or Limited IRB Review
Step 3 - Option A. Application for Exemption or Limited IRB Review
The APPLICATION FOR EXEMPTION form is used by investigators to request an exemption from further IRB review and approval (45 CFR 46.104) . You can review Keuka College IRB's guidance on determining if your proposed research qualifies for exempt or limited review.
NOTE: Some categories of research that otherwise qualify for exemption may require a limited IRB review. In limited IRB review, the IRB must determine that certain conditions, which are specified in the regulations, are met. Limited IRB review may be done via the expedited review mechanism, that is, by the Chair or an experienced IRB member designated by the Chair (although it can also be conducted by the full IRB). Continuing review is not required. [Refer to sections 45 CFR 46.109(a) and 46.109(f)(1)(ii) of the revised Common Rule.]
Depending on the nature of your project, you may need to include additional documentation (e.g. consent, HIPAA, site permission) in your Proposal Packet. Scroll down to locate additional forms and templates.
Step 3 - Option B: Application for Expedited or Full IRB Review
Step 3 - Option B: Application for Expedited or Full IRB Review
The APPLICATION FOR EXPEDITED OR FULL REVIEW form is used by investigators to request IRB expedited or full review of their proposed research. Please review the information on the "Common Rule" page of this website for more information on these different levels of review and the IRB review process.
Depending on the nature of your project, you may need to include additional documentation (e.g. consent, HIPAA, site permission) in your Proposal Packet. Scroll down to locate additional forms and templates.
Step 4: Finalize and Submit Your Research Proposal Packet.
Step 4: Finalize and Submit Your Research Proposal Packet.
In order to submit your research proposal packet, you need to FIRST:
Evaluate your proposal packet using the checklist for new proposals (or revised if applicable)
Read and follow the instructions for submitting your packet for IRB review.
Review the information on what to expect during the review process, frequency of review, deadlines for submitting proposals, etc.
Go to the page for Submitting a Research Proposals & Requests
Additional Forms & Templates
Additional Forms & Templates
Notice: Forms or letters used by the researcher to recruit participants or obtain informed consent, assent, wavier, authorization, or permission from research subjects must be submitted to IRB in either editable Google.docx or MS Word. If submitted as Google.docx, you must give the IRB chairperson permission to edit the document to include a "stamp" indicating approval and expiration dates.
Screening, Informed Consent, and Assent Templates & Procedures
Screening, Informed Consent, and Assent Templates & Procedures
The Office of Human Research Protections (OHRP) outlines the information (elements of informed consent) that must be conveyed to subjects as part of the informed consent document and process (45 CFR 46.116 and 45 CFR 46.117).
Adult (written consent)
Adult (written consent)
Copy of Informed Consent Written Template - REV JULY 2019.docxAdult (oral or internet consent)
Adult (oral or internet consent)
Oral-and-Internet-Informed Consent-Template Updated March 25, 2019.docxSite Permission Letter Templates
Site Permission Letter Templates
For research at or about another organization/institution (other than Keuka College)
For research at or about another organization/institution (other than Keuka College)
A letter of site permission is typically required when conducting on-site research about a particular institution/office/company that does not have its own IRB. The following templates are for Keuka College faculty, staff, and students seeking to conduct on-site research at or about a site other than Keuka College.
Sample Site Permission Letter2.docxSample Site Permission Letter1.docxResearch at or about Keuka College
Research at or about Keuka College
In other cases, researchers who are members of the Keuka College organization or from another institution with its own IRB (e.g. hospital, college or university) may request to conduct research at or about Keuka College. In this case, the researcher will likely need to provide the reviewing IRB a site permission letter from a Keuka College agent who is authorized to grant such permissions, such as the Provost or President. The template below is useful to both researchers seeking permission and for KC administrators looking to grant access to research at/on Keuka College.
The following persons are authorized to grant such permission:
Dr. Carol Lugg, Associate Vice President of Institutional Effectiveness
email: clugg@keuka.edu
Dr. Heather Maldonado, Interim Provost and Vice President of Academic Affairs
email: hmaldonado@keuka.edu
Keuka College Students as Research Subjects
If you are planning to conduct research involving Keuka College students as research subjects, you should review the guidance on Students as Research Subjects at this website. Whether you are a student, faculty, staff, or administrator, the same standards apply.
Note that the language indicates that site authorization is contingent on receiving IRB approval from the committees at the specified institution(s).
Reliance Agreement/Request to Cede Authority (other institution to KC or KC to other IRB)
Reliance Agreement/Request to Cede Authority (other institution to KC or KC to other IRB)
A Reliance Agreement is a document signed by two (or more) institutions engaged in human subjects research that permit one or more institutions to cede review to another IRB. The signed agreement permits a single IRB to review human subject research activities for more than one site.
Once a reliance agreement has been executed for Keuka College (KC) to cede review to another IRB:
The KC Principal Investigator (PI) is responsible for obtaining all regulatory protocol information (approved protocol, approved consent documents, etc.) from the ‘overall PI’ who is affiliated with institution responsible for oversight of the project.
The KC Principal Investigator (PI) is responsible for submitting the research protocol, letters of approval, and any supplemental documentation to the KC IRB.
Any questions or required reporting will need to go through the PI at the reviewing IRB site. You will no longer interact with the KC IRB for protocol issues related to that research. You will be responsible to providing information needed at the time of continuing review or if any unanticipated problems occur.
All unanticipated problems, deviations, suspensions and terminations, noncompliance, subject complaints, etc. should be reported to the ‘overall PI’ at the external institution that is acting as the IRB of Record. The overall PI will be responsible for reporting these to the external IRB. The external IRB of record IRB will notify KC of any such issues.
The final Agreement will dictate any additional responsibilities the KC PI will have.
HIPAA Authorization & Waver Forms
HIPAA Authorization & Waver Forms
IMPORTANT! Researchers obtaining or using private health information should carefully review Keuka College IRB's policy on the HIPAA Privacy Rule before submitting requests or applications to IRB.
Submitting a Request for Modification of a Previously-Approved Proposal
In most cases, changes to a previously-approved study must be approved by the IRB before they can be implemented. An exception exists for changes that are needed to address “immediate apparent hazards” to subjects. In addition, minor changes to exempt studies may not require modification approval. Major modifications may require the submission of a new proposal. Please see the Modification Form, or contact the IRB chairperson (voconnor@keuka.edu) with specific questions.
Tools for Reviewers (and Investigators)
Tools for Reviewers (and Investigators)
This worksheet is to be used by members of the IRB when reviewing and evaluating advertisement meant to be seen or heard by subjects. It may also serve as guidance for researchers preparing protocols for conducting research involving human subjects. It does not have to be completed or retained.
Note: Many of the forms found at this page were adapted from those retrieved from Buffalo State University and the Veterans Affairs Office of Research & Development website. See footnote notation on forms for information on their origin.
If you have problems accessing content on this website, please first ensure you are logged in using your Keuka College email account. If you still have difficulties, please email the IRB Chairperson at voconnor@keuka.edu
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