CUNY Human Research Protection Program (HRPP)

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