Applying for IRB Approval

New Study Requiring IRB Review

Steps for submitting your new IRB application:

  • Go to “Forms and Applications” on the IRB home page at http://www.ccny.cuny.edu/irb.

  • Select "Application" Form.

  • Make sure to submit the 7 copies if requesting a full committee review, or 3 copies of requesting an expedited or exempt review

  • Complete the certification requirement by going to www.citiprogram.org . Include copies of the completion certificate for PI, Co-PI and all key personnel with the final application.

  • Include all relevant documents and materials, such as the following:

  • Study instruments {i.e., questionnaire(s) or survey(s)}

  • IND/IDE documentation

  • Non-CUNY site approvals (e.g., IRB approvals from other institutions, Department of Education)

  • HIPPA forms

  • Consent forms, assent forms, parental permission forms, information sheets

  • Funding proposal (grant or contract)

  • Students must be guided by a faculty advisor who has also completed the CITI requirement.

 

Types of IRB Review

  • Full Board (Standard Review): Review of proposed research at a convened meeting where a quorum of IRB members is present.

  • Expedited Review: Review of proposed research by the IRB Chair or a designated voting member or group of voting members, rather than by the entire IRB Committee. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research.

  • Exemption: A research project is exempt from the requirement for IRB approval when it is determined that the only involvement of human subjects is in one of the categories listed under 45 CFR 46 Section 101(b)(1)-(6) and 21 CFR 56. 104(d). Human subjects regulations do not apply to exempt projects. Any research project involving human subjects thought to be exempt must be submitted to the IRB for determination of exempt status.

 

Types of Informed Consent Documents and Terms

Vulnerable Populations : Some participants may require special considerations, such as children, prisoners, cognitively impaired individuals, economically or educationally disadvantaged individuals and others.

  • Legally Authorized Representative: An individual legally authorized to consent on behalf of a research participant. In New York State, a legally authorized representative is the parent of a minor or a court appointed guardian.

  • Consent Form: A written document that embodies the elements of informed consent required by 45CFR46.116. The consent form may be signed by the participant or the participant’s legally authorized representative. The principal investigator is obligated to give either the participant or the representative sufficient time to read the consent form and ask questions about the research before the participant or the representative signs the consent form or provides oral consent to participate in the study. 

  • Assent: A written or oral agreement by an individual to participate in research. This individual is not able to give legally valid informed consent because s/he is a minor or cognitively impaired person. In such cases, it is recommended that the researcher (or key personnel authorized to perform the assent process) ask the participant open ended questions about the research and their understanding of what participating entails.

  • Parental Permission Form: A form signed by one or both parents giving permission to their child to participate in research. The parental permission form must include all the elements of consent.

  • Information Sheet: Document provided to research participant that contains the elements of informed consent but which does not require a signature. An information sheet may be used in lieu of an consent form when the research is exempt (and the situation of the exempt project is appropriate), or when documentation of informed consent has been waived by the IRB in accordance with 45CFR 46.117(c). The Principal investigator must receive formal approval from the IRB before waiving the written documentation of the informed consent process.