AAPCHO IRB Application Process

Please review AAPCHO IRB Policies & Procedures for detailed requirements.

Applicants are encouraged to notify AAPCHO with an “Intent to Submit” to help ensure that protocols will be reviewed in a timely manner.

Guidelines for notifying “Intent to Submit”

3 weeks before IRB submission deadline (6 weeks before upcoming IRB meeting date): Applicants should inform the IRB Coordinator of their intent to submit, along with a brief abstract/protocol description that includes research background, objectives, methodology with target population, and risks to participants. Please see sample description. If you have more than one submission, please list by priority.

Please note: Applicants must intend to submit a complete application by the deadline date before it can be reviewed. Applications that are incomplete will not be reviewed. Please click here to view the required components. If you need assistance completing your application, please contact the IRB Coordinator.

2 weeks before IRB submission deadline: The IRB Coordinator will notify the applicants if and when their applications will be reviewed. For those with more than one submission, all except one may be put on queue for the next round of review.

Priority will be given to members who have had fewer past submissions.

AAPCHO will notify members that submission is closed after the submission limit is reached for an upcoming meeting.

If applicants do not send in an intent to submit, review will be conducted on a first-come, first-served basis until the submission limit is reached. Applicants may be denied review for an upcoming meeting and will be put on queue for future meetings.

Preparing your application

A. Face Page
Based on the type of review, please submit the appropriate application form as described below.

B. Research Narrative/Proposal
The full protocol is to be included in the application. Please review section 3.1.B in the Policies and Procedures for detailed requirements.

C. Technical Assistance
Please contact the IRB coordinator if technical assistance is required.

Submitting your application

A. New concept for IRB Review
Submit the following in one package:

  1. Request for IRB Review form
  2. Full narrative
  3. Informed consent materials. Please see OHRP’s required elements for informed consent. A template can be found here.
  4. Questionnaires, survey instruments, focus group guides, outlines for semi-structured interviews, advertisements, phone scripts (as appropriate)
  5. Financial Conflict of Interest Disclosure form
  6. An Institutional Review Board (IRB) Authorization Agreement B form
  7. If you would like to request data from AAPCHO, you must include a signed AAPCHO Data Request form.
  8. Request for Waiver of Informed Consent form, if applicable.
  9. If you are requesting a Waiver of Authorization for protected health information, please complete the Request for Waiver of Authorization form.

Researchers may submit a copy of the completed application to the IRB Coordinator at research@aapcho.org or a hard copy to:

Nicole Nguyen
IRB Coordinator
AAPCHO
101 Callan Ave., Ste 400
San Leandro, CA 94577

B. Continuation Approval
Submissions for Continuation Approval must include:

  1. IRB Continuing Review/Study Closure Application form, including status report
  2. A photocopy of the current IRB approved informed consent form
  3. Any proposed revisions to the research

C. Submissions for Modification
Modification submissions must include:

  1. An explanation of the requested modification, its purpose, and its justification
  2. Modification to Approved Protocol form
  3. Revised forms, if appropriate (contact letter, consent form, advertisements, etc.)
  4. Supporting documentation

Submission and Project Tracking

Receipt

          Three weeks before Review

Review of Application

          Second Tuesday quarterly – tentative

Notification of Results

          Two weeks after Review

          NOTE** for expedited reviews (e.g. for proposed modifications or IRB                         requested revisions) Four weeks after receipt

 

 IRB Meeting Dates and Deadlines

Intent to Submit

Deadline

Application

Deadline

IRB

Meeting

Notification

of Results

October 3, 2017 October 24, 2017 November 14, 2017 November 28, 2017
January 2, 2018 January 23, 2018 February 13, 2018 February 27, 2018
March 27, 2018 April 17, 2018 May 8, 2018 May 22, 2018
July 3, 2018 July 24, 2018 August 14, 2018 August 28, 2018
October 2, 2018 October 23, 2018 November 13, 2018 November 27, 2018

 

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