Submit an IRB Proposal

Incomplete submissions will result in 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 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.

Proposals are submitted through Microsoft Forms along with an email acknowledging submission sent to the IRB email (). The subject line for the email should include one of the following: “initial proposal” or “revisions to proposal.” The person designated to approve the research should be copied on the initial proposal email.

To submit an IRB proposal for Cedar Crest College faculty, staff, and students, please follow this procedure:

• Download and complete the documents from the IRB web page. Please save documents by adding your name and date to the end of the documents.
  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.
  • 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).

Revisions to proposals: If a proposal has been returned for revisions, complete 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.

Proposal documents to be included as attachments to the Microsoft Forms application for all types of review:

1. 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. 
2. 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. 
3. Assent Form – if subjects are <18 years of age.
4. 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.
5. 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)

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 ().