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CUNY HRPP Guidelines for Research Compliance

Understand the responsibilities and structure of CUNY HRPP, types of review required, submission process, criteria for approval by CUNY IRB, and faculty advisor responsibilities for human subjects research.

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CUNY HRPP Guidelines for Research Compliance

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  1. CUNY Human Research Protection Program (HRPP) School of Professional Studies April 18, 2013 http://www.cuny.edu/research/compliance/human-subjects-research-1.html

  2. CUNY HRPP - Responsibilities • Ensure protection of human subjects in research • Ensure compliance with federal regulations, State law & CUNY policies

  3. CUNY HRPP - Structure • College specific HRPP Coordinators at most Colleges • 2 IRB Administrators • 4 Convened IRB Panels • 1 Expedited Review Panel

  4. CUNY HRPP – Oversight Each of the following three criteria must be met:

  5. CUNY HRPP – Is Review Required? • Class assignments / program evaluation / SOTL • Yes: IF intended for generalizable knowledge • Publications • Conference presentations • Making available in the public domain • No: IF data to be presented within the confines of the institution

  6. CUNY HRPP – Types of Review

  7. CUNY HRPP - Submission • Submission Process: • IRB Net: https://www.irbnet.org • New User Registration • Submit to CUNY Central Office HRPP • Guidance: • Arita Winter, CUNY Central Office HRPP Coordinator • arita.winter@cuny.edu; 646-664-8919

  8. CUNY HRPP - Submission • Application Part I = basic information • Required for all studies • Request for Exemption • Application Part II • Required for non-exempt human subjects research • For review via expedited review procedures • For review by convened IRB • Various Supplements

  9. CUNY IRB – Criteria for Approval • Experimental Design and Scientific Validity • Ensure that risks are minimized • Risk / Benefit Analysis • Minimize risks • Examples of safeguards: 1) adequate training of research personnel; 2) exclusion of populations at increased risk; 3) adequate data protection; 4) adequate safety monitoring • Ensure risks are reasonable in relation to benefits • Types of risks: physical; psychological; social; legal; economic; invasion of privacy; breach of confidentiality

  10. CUNY IRB – Criteria for Approval • Subject Identification & Recruitment • Fair & equitable • Inclusion/exclusion criteria • Free of coercion, undue influence & invasion of privacy • Appropriate recruitment tools • Student / Employee Recruitment • No effect on grades, employment or standing with CUNY • Local campus policy

  11. CUNY IRB – Criteria for Approval • Screening Activities • Adequate evaluation of inclusion/exclusion criteria • Informed consent considerations • Appropriate screening tools

  12. CUNY IRB – Criteria for Approval • Informed Consent Process & Documentation • Process takes place in a manner & at location that ensure privacy • Information is provided in a manner & language understood by subject • Sufficient opportunity to consider participation • Subject’s questions are answered • Voluntary consent • Voluntary withdrawal without penalty • Individual obtaining consent is qualified to do so • Legal rights – no exculpatory language

  13. CUNY IRB – Criteria for Approval • Waivers of informed consent • Waiver of documented informed consent • Waiver of informed consent • Alteration of informed consent • Conflict of Interest • Existing or potential financial conflict • Conflict of commitment

  14. Faculty Advisor Responsibilities • Overall project • Ensure feasibility of project • Ensure that there are sufficient resources to complete the project • Ensure that student is adequately trained to conduct the project • Review of HRPP/IRB submission • Ensure completeness & accuracy • Ensure consistencies across documents • Check language & grammar • Ensure compliance with CUNY policies, applicable regulations & sponsor requirements

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