Office of Responsible Research

 

IRB Application Submission

Step 1

Step 2

  • Complete IRB Application For all new and/or revised or amended projects.
    Revision Applications MUST include strike-through as opposed to deletions of original material. In addition, all new/changed material MUST be highlighted.
  • Complete a Continuation Application for previously approved projects expected to continue beyond the approved period of study. NOTE: No project may exceed 365 days between reviews.

Step 3

  • Complete Informed Consent Documentation
    • What documents do I need?
      • If you requested a waiver of Informed Consent (and justified this) in your IRB Application, proceed to step 4 below.
      • If subjects are 18 years or older and capable of offering informed consent, complete the Informed Consent Form.
      • If subjects are less than 18 years old, complete the Parental Consent and (when necessary) Child Assent Forms.
      • The HHS regulations do not require documentation of assent. The IRB has the discretion to determine the appropriate manner, if any, of documenting child assent. Based on such considerations as the child’s age, maturity, and degree of literacy, the IRB should decide what form of documentation, if any, is most appropriate. If adolescents are involved in research where a consent form would have been used if the subjects were adults, it would generally be appropriate to use a similar form to document an adolescent’s assent. If young children are involved who are as yet unable to read, documentation should take a form that is appropriate for the purpose of recording that assent took place. The IRB may also decide that documentation of assent is not warranted. Please address questions to the IRB chair.

Step 4

  • Gather Supporting Materials
    • Recruitment or informational materials: recruitment scripts, e-mail scripts, fliers, debriefing statements, etc.
    • Data Instruments: copies of surveys, interview questions, tests, web-surveys, etc.
    • Intervention Instruments: any video clips, music clips, photos that subjects will be exposed to as part of your study.
    • Grant description, if study is funded.
  •  Collate All Materials
    • All items should be collated into a single Word or PDF document for submission.

Step 5

  • Submit Application to irb@bw.edu
  • If the primary investigator is a student, the faculty mentor overseeing the project must be cc’d on the submission e-mail.

 

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