IRB Submission Instructions and Checklists
General Guidelines for Submission of IRB Applications for Approval for Use of Human Participants in Research
These general guidelines are presented to aid the researcher in the preparation of their research protocol, including IRB Application Form and all supporting documents, for submission to the SPU Institutional Review Board (IRB).
- The completed IRB Application and all supporting documents, including Informed Consent Form(s) (ICF), questionnaires, surveys, recruitment materials, site permission letter, etc. should be saved and sent to the IRB electronically via one e-mail to email@example.com, and a hard copy of the IRB application package, with all required signatures, should also be delivered to the IRB Office, c/o Philosophy Department, 51 Glenwood, Room 205, Saint Peter’s University, Jersey City, NJ 07306.
- In completing the IRB Application electronically please note that space is limited. Additional pages may be added to the document, if necessary, and attached to both the electronic and printed version. Note: all small boxes should be marked with a capital X, as appropriate.
- The printed hard copy of the completed IRB application should include all supporting documents and necessary signatures in order to avoid delays in the reviewing process. See IRB Checklist for a summary of required documents.
- All researchers must submit NIH or CITI research training certificate (no more than two years old).
- Saint Peter’s University faculty are not permitted to use students who are currently enrolled in any of their courses as research subjects, unless such students were randomly selected from a larger research subjects pool.
- In cases where students are research subjects, grades, services, class standing, etc., are not to be negatively affected if the student subject refuses to participate or withdraws from the study.
- The researcher must provide all solicitation letters, scripts, instructions to the subjects, introductory remarks, etc., to the IRB for review.
- Applications not typed, or with multiple grammatical and spelling errors, or missing a substantial amount of information will be returned to researcher without review.
- Total chapters from dissertations or class projects should not be attached as the description of methodology, etc. Rather, the researcher should provide concise answers to the questions on the application. Attach additional pages, if necessary.
- All data should be recorded anonymously or identifying information deleted at the end of the study. The coding system to protect research participants’ identity should not use subjects’ initials, social security numbers, SPIRIT-ID, addresses, etc., in place of names. Such information could readily be used to identify subjects. In cases where follow-up is important, a master key could be maintained with the subject’s name and number in a separate place from the data. The master key, as well as the data, should be secured in a locked drawer or file cabinet. When the final analyses are completed and no follow-up is planned, this key is then destroyed.
- When required, parental permission for the use of minor subjects must always be in the form of written permission that is returned to the researcher. There should be a separate Assent Form for subjects under age 18, along with parental/legal guardian Consent Form. For children under age 12, there should be an Oral Assent Procedure or Script.
- Subjects should be given a copy of the signed Consent Forms for their records. It should be stated in the Consent Form that a copy will be provided.
- If a control group is used as part of a treatment-type study, the advantages derived from the research should be made available to the control group or the control group told of the advantages.
- Participants should be given the office address and phone number of the researcher in order to request details of the research study. If the researcher is a student, subjects should be told to contact him/her through the department in which the student is studying. Home addresses and phone numbers should never be given out. In the Informed Consent and the Solicitation Recruitment Letter, the researcher should specify his/her institutional affiliation with Saint Peter’s University by identifying the department and college/school.
- If requested, results generally should be given to the participants in aggregate or group form. As a rule, individual results, especially those which could require professional interpretation, should not be reported back to the participants.
- Letters of authorization/permission from IRBs of cooperating institutions, school districts, hospitals, clinics, etc., must be on the institution’s letterhead and included in the IRB application package.
- Approval to conduct research: (1) Outside the University – permission on letterhead from appropriate administrative or faculty authority. (2) Within Saint Peter’s University – letter of approval from faculty or staff member who oversees the subjects who are anticipated to participate in research, if applicable.
- All non-SPU affiliated researchers conducting research at Saint Peter’s University must have an SPU faculty or administrator sponsor, who will provide SPU site-approval letter.
- All SPU student researchers must have an SPU faculty mentor/advisor to approve their research project, as well as review the IRB application. Doctoral candidates must submit appropriate dissertation/project approval form along with the IRB application.
- If the study is carried out outside of Saint Peter’s University (e.g. hospitals, clinics, schools, etc.), approval of the site institution needs to be added to the material submitted to the IRB. If the institution has a local IRB (e.g. hospitals, colleges, universities), its approval of the study is also required.