Important Notice Regarding IRB Protocol Submissions

Regulations inform that protocol projects submitted to an IRB may be reviewed by Full Committee Review, Expedited Review, or Exempt from review. Regulations further inform that only the Chair or other designated IRB member may determine the level of review assigned to individual protocol projects. Many times, Investigators have the knowledge to pre-determine the level of review most likely to be assigned by the IRB. The following guidance is provided in selecting the review level – however, only the IRB can make the final determination of the level of review the will be assigned. If the planned protocol project does not clearly fit into an expedited or exempt category, prepare the submission for full committee review.

I. Full Committee Review

If your protocol requires full review by the Institutional Review Board you must submit 30 copies of your protocol with the first 5 items collated in this order:

  1. Request for Review (with appropriate signatures) 30 Copies

Link: Request for Review

  1. Initial Review30 Copies
    Link:Initial Review Form
  2. Protocol Summary on original letterhead (in Temple IRB Format)30 Copies
    Link: IRB Guidelines
  3. CFon original letterhead (in Temple IRB Format) 30 Copies
    Link:IRB Guidelines
  4. HIPAA Authorization Form30 Copies
    Link: HIPAA Authorization Form
  5. Investigational Drug Data Sheet (if applicable)2 Copies
    Link: IDDS
  6. Conflict of Interest Form (for each investigator)1 Copy
    Link: Conflict of Interest Form
  7. CV (for each investigator) 1 Copy
  8. Professional License (if applicable for each investigator) 1 Copy
  9. Proof of Training in Human Research Protection (for each investigator) 1 Copy
  10. Investigational Drug Brochure or Package Insert (if applicable) 4 Copies
  11. Full Protocol or Grant Application 4 Copies
  12. FDA Form 1572 (on one page front and back if applicable) 2 Copies

Additionally: If there are recruitment materials, surveys, subject diaries, subject information sheets, other scales (pain, satisfaction) – copies must be included in the collated materials. Please add each item for review to the collated copies noted above.

At the time of final approval of the protocol and consent two (2) final originals of the consent will be required for stamping by the IRB.

II.Expedited Review – Generally protocols that involve no more than minimal risks include those where only drawing blood is required (under certain restrictions), using physical sensors, and observing moderate exercise. (The Code of Federal Regulations definition is, "Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." {45 CFR 46 102i}). While the review process is expedited, the investigator should be aware that the protocol and consent form submitted must be complete in every detail. Consequently, the same level of information required for a full committee review must be submitted. For expedited review, please provide 3 copies of the documents identified above (include those appropriate): 1-13.

Additionally: If there are recruitment materials, surveys, subject diaries, subject information sheets, other scales (pain, satisfaction) – copies must be included in the collated materials. Please add each item for review to the copies noted above.

III.Exempt - Protocols involving the use of existing data, documents, records, or pathological specimens, or using educational tests or survey procedures with questionnaires may be exempt from compliance with Department of Health and Human Services (DHHS) requirements. Investigators should know that to qualify as an exempt protocol all data or specimens must be in existence at the time the data collection starts. If there is a need to collect additional data or specimens at some time in the future, the protocol will not be eligible for exempt status.

  1. Request for Review (with appropriate signatures) 1 Copy
    Link: Request for Review
  2. A detailed letter describing the protocol project. What you plan to do, how you plan to do it, how you will protect confidentiality of data/subjects, how you have access to data or other materials – enough information to fully inform the IRB of the protocol project.

1 Copy

  1. A data collection form – needed to ensure that all data are HIPAA compliant. 1 Copy
  2. Proof of Training in Human Research Protection (for each investigator) 1 Copy