Full Review

IRB review applications under Full Review will be reviewed with multiple reviewers depending on the complexity of the case. In complex cases, the entire board will deliberate on the application. For research projects approved under Full Review, an end of research final report is to be submitted to the IRB by the investigators. Studies that obtain data from vulnerable populations, use deception, or those that pose more than minimal risk to human subjects are usually subjected to Full Review. Applicants are reminded to ensure all documents and details of the protocol are submitted. Due to assessment by multiple reviewers, clarifications of your application’s protocol may be needed leading to decisions being deferred to the next review period. A minimal 15 working days is required for the decision by the IRB. However, when the decision is made, the IRB will seek to inform the applicant at the earliest possible date.

Your application for Full Review should contain:

  1. Duly filled Application Form
  2. Attachment of research protocol and supplementary materials (questionnaire, stimuli and/or interview questions etc.)
  3. Proof of Completion of the Research Ethics and Compliance course.
  4. Copies of your research protocol and instruments might include, but not limited to:
  • The list of interview questions you will be asking your participants or representative set stimuli that your participants will see
  • Separate and complete lists of interview questions if you will be interviewing different groups (e.g., managers and employees) and tailoring the interviews accordingly
  • Description of procedures for all study conditions, including the control condition
  • Copies of all questionnaires or instruments
  • Copies of your consent form, a script for oral consent which explains why consent is necessary, and a copy of the handout you will give to participants telling them how to contact you and the IRB if they have any questions. A separate video or photo consent form, if necessary. Translations of materials into the language of the participants, if your participants will be using a language other than English.
  • An explanation of how the confidentiality of participants will be maintained.

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*All attachments and supplementary materials containing identifying information of investigators should be submitted as .doc. Files. The IRB will attempt to remove or mask identifying information about the investigators to enable a double-blind process in the ethics review.

 

Providing information at this level of detail is necessary so that the Committee can make an informed decision about potential risks to participants. Insufficient information provided may result in clarifications needed or a deferred decision.

© 2018, AUCA Institutional Review Board