DRAFT: This module has unpublished changes.

IRB SUBMISSION AND APPROVAL

 

Use the steps below to help determine what to submit for IRB approval: 

 

STEP ONE: Is your project “research” and does it involve “human subjects”?
  • Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. (Note: an investigator may be a faculty member, student or staff person.)

-->  If your project is research and involves human subjectsIRB review is required. Proceed to Step Two. 

-->  If your project does not meet one or both of the above definitions, IRB review is not required. You are still responsible for abiding by ethical principles, including informed consent, protection of confidentiality, and minimization of potential risk or harm to human participants. Please see CUNY’s HRPP Policies, Procedures & Guidelines for more information and resources.

STEP TWO: Does your research qualify for exemption? 

Note that exemption is a formal status, regulated by the US Department of Health and Human Services, under the Code of Federal Regulations (45 CFR part 46), and must be determined by the IRB, not by the investigator. The following questions will help you identify what information to submit to the IRB so that it can make this determination.

 

  • Does participation involve no risk or minimal risk (i.e., physical and/or mental harm or discomfort is anticipated to be no greater than ordinarily encountered in daily life)?
  • Can subjects give free and informed consent (i.e., they are not minors, are not prisoners, are not under coercion, and can fully understand the nature of the research, potential risks, and potential benefits)?
  • Can release of data cause NO potential harm to subjects (i.e., if identifiable data were released, subpoenaed, or if subjects' identities were deduced, this would cause NO legal or financial harm, nor would it damage their reputation, employability or personal or business relationships)?

 

-->  If you answered YES to ALL of the above questions, proceed to Step Three.

-->  If you answered NO to ANY of the above questions, or if you are not sure, create a new IRB application in Ideate to request IRB review of your research. For more information on how to use Ideate, click here

STEP THREE: Does your research qualify for exemption (continued)?

  • Is the research in an educational setting and involve only normal educational practices (e.g., instructional techniques or strategies, curricula, classroom management)?
  • Does the research involve only the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior AND does NOT involve elected or appointed public officials or candidates for public office?
  • Does the research involve only the collection or study of existing data, documents, records, or specimens AND the information is either publically available OR recorded in such a manner that subjects cannot be identified, directly or indirectly?

 

-->  If you answered YES to ANY of the above questions, you may be eligible for exemption from IRB review. Create a new IRB application in Ideate to request IRB review of your research and indicate that you are seeking an exemption on the Summary tab. For more information on how to use Ideate, click here

-->  If you answered NO to ALL of the above questions, or if you are not sure, create a new IRB application in Ideate to request IRB review of your research. For more information on how to use Ideate, click here

 

 

For more information, please see the following:

When is CUNY HRPP or IRB Review Required?

Where to Submit?

Criteria for IRB Approval

 

DRAFT: This module has unpublished changes.