Submit an IRB Proposal
Incomplete submissions will result in the delay of the IRB’s review of your protocol. Additionally, submissions filled with errors (e.g. spelling/grammar errors, incomplete protocols, inconsistencies between study documents, etc.) will result in the delay of the IRB’s approval process.
Submissions will not be reviewed over scheduled breaks in accordance with the published academic calendar. Proposals may be reviewed during the summer but only with prior permission from the IRB Chair.
All IRB Proposals should be submitted using Microsoft Forms (https://forms.office.com/r/huDGfp2n6m). An acknowledgement of submission should be sent the IRB email (). The subject line for the email should include one of the following: “initial proposal” or “revisions to proposal.” The lead researcher on the proposal should submit the application for review. The person designated to approve the research should be copied on the initial proposal email.
Complete the applicable documents below and the IRB Proposal Application through Microsoft Forms. The documents must be uploaded within the research application form. To preview the IRB application form for New Proposals, click here.
IRB Research Description Supplement (Template): This document is in a format that allows researchers to download and edit. The IRB Research Description Supplement Form is required for all submissions.
IRB Consent Form (Template): This document is in a format that allows researchers to download and edit. The IRB Consent Form is required for all submissions except those involving secondary analysis of existing data or projects involving deception. A copy of the consent form should be provided for participants to keep for their records for in-person research. When conducting online survey research, the informed consent form must be included on the first page of the online survey. The first survey question must ask the participant to indicate that they have read the informed consent form and agree to participate.
Memorandum of Understanding: This document is required if Cedar Crest College serves as your single Institutional Review Board (sIRB) and you are collecting data outside of Cedar Crest College.
To submit an IRB proposal for Cedar Crest College faculty, staff, and students, please follow this procedure:
The person designated to approve the research should be copied on the initial proposal email. The proposal will not be assigned to IRB committee members until an email response approving the research is received (reply to all).
Download and complete the documents. Please save the documents by adding your name and date to the end.
For example: IRBInformedConsentFormAug2024_LastName_Date
All IRB Proposals should be submitted using Microsoft Forms
(https://forms.office.com/r/huDGfp2n6m).
Student researchers should fill in the name of their faculty advisor on the application; students should work in consultation with their faculty advisor before the research proposal is submitted. All documents should be proofread before submission, and all faculty advisers should thoroughly review all documents before approving the submission.
Students working with other students in collaboration as lead co-investigators on the same research project should list all researchers on the application form.
One student will initiate the submission process using Microsoft Forms and sending the email to the IRB () with the other lead co-investigator(s) and the assigned approval person copied on the initial email.
Approval of Research
Faculty and staff researchers should be approved by the lead researcher’s dean, department chair, graduate program director, or the person to whom they directly report.
Department chairs’ research should be approved by another member of their department.
Proposal documents to be included as attachments to the Microsoft Forms application for all types of review:
- Research Description Supplement (required) – The template is constructed such that all text printed in black should be used verbatim; whereas all text printed in blue requires that investigator to tailor the wording according to the nature of the project being proposed.
- Informed Consent Form – the template is constructed such that all text printed in black should be used verbatim; whereas all text printed in blue requires that investigator to tailor the wording according to the nature of the project being proposed.
- Assent Form – if subjects are <18 years of age.
- Supplemental Documents – upload any material related to your proposal such as: sample email for recruitment, survey instruments, questionnaires, interview protocols, observation protocols, etc.
- Permission letter – if you are using secondary data from an institution/organization, upload the permission letter from the entity (signed and dated by an authorized official of the organization) on the organization’s letterhead.
- Memorandum of Understanding – this document is required if Cedar Crest College serves as your single Institutional Review Board (sIRB) and you are collecting data outside of Cedar Crest College.
- CITI training certificates (required) – all researchers and advisers must complete CITI training. From the Citi Training website, choose “register” and then choose Lehigh Valley Association of Independent Colleges (LVAIC) as your affiliation (not Cedar Crest College). You will be prompted to set up an account which you will use for future logins. You will see a list of courses that we have available through LVAIC; choose the one that makes the most sense for what you are doing (most likely biomedical research or social behavioral research).
Research, Ethics, Compliance, and Safety Training (citiprogram.org)
Revisions to proposals: If a proposal has been returned for revisions, complete the revision table, make the necessary revisions, and resubmit your revised documents via IRB email ().
When your proposal is approved, you will be contacted by email and assigned a proposal number.
Requesting a change to approved research:
All substantive changes to a protocol require IRB approval before a change is implemented. This includes but is not limited to: changes in eligibility criteria, research procedures, recruitment, advertisements, consent forms and researchers’ instruments.
Research conducted at another site:
According to the Common Rule, research projects now use a single IRB-of-Record (sIRB) for inter-institutional research. That is if your research has been approved by another institution, you do not need Cedar Crest College’s IRB review and/or approval. The sIRB does not need to be Cedar Crest College, but the Cedar Crest IRB needs to be notified of the research and receive verification of the designated sIRB. The verification should include the date of approval and the assigned approval number. This policy does not apply to the following types of participating sites:
- VA sites
- Foreign sites
- Sites involving tribal nations
- Sites for which review by the proposed sIRB is prohibited by a federal, tribal, or state law, regulation, or policy
If your research has been approved by another institution, you must send verification of prior approval via email ().