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STEP 1 - Complete, sign, and submit a Human Subject Research Determination Form, along with required attachments, to the IRB Manager. (Email submissions are acceptable.)

THEN WHAT? 

President's Staff Approval - According to MECC Policy, all IRB applications must be approved by the President's Staff before they can proceed with IRB review.  A summary of the application will be presented to the President's Staff for approval within 30 days of submission.

Human Subject Research Determination - If approved by the President's Staff, the application is forwarded to the IRB Chair to determine whether the project qualifies as human subject research.  If the Chair determines that further review is required, the IRB Manager will work with the applicant to determine which IRB review form is most appropriate.

IRB Review - Once the appropriate review form is completed and submitted with all required attachments, the IRB Manager will coordinate with IRB members to schedule the review.  If a meeting of the full committee is required, every effort will be made to ensure that the applicant has an opportunity to attend the  meeting and respond to members' questions.

   *For additional information about the IRB review process, contact the IRB Manager, Nikki Morrison.

MECC IRB Forms

U.S. Department of Health & Human Services
Office for Human Research Protections (OHRP) Decision Charts
OHRP developed a series of graphic aids to assist IRBs, institutions, and investigators in their decision-making process.  Investigators are welcomed to use these charts as a reference.
  1. Does the Activity Qualify as Human Subject Research Covered by 45 CFR part 46?
  2. Is the Research Exempt?
  3. Does the Education Exemption Apply?
  4. Does the Survey Exemption Apply?
  5. Does the Existing Data Exemption Apply?
  6. Does the Public Benefit Exemption Apply?
  7. Does the Food Exemption Apply?
  8. Does the Research Qualify for Expedited Review?
  9. Can Continuing Review be Expedited?
  10. Can Informed Consent be Waived?
  11. Can Documentation of Informed Consent be Waived?

Informed Consent
Informed consent helps ensure that prospective research participants will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate.  For detailed informed consent guidelines, see the MECC IRB Operational Manual.

The following templates and samples are offered as points of reference. The exact language is at the discretion of the researcher. The Institutional Review Board will evaluate all informed consent documents and determine whether they meet the appropriate criteria.

  1. Informed Consent Template
  2. Sample Informed Consent/Assent Letter
  3. Sample Informed Consent for Photo/Video/Media Materials

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Last updated: 2/6/2014 11:11:05 AM