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 Research: Systematic Investigation Generalizable Knowledge Human Subjects: Living individuals Data about the subjects Through intervention or interaction; OR Identifiable private information CUNY is Engaged: Agent or employee On behalf of CUNY Obtain data about subjects through intervention or interaction Obtain identifiable private information Obtain informed consent from the subjects CUNY receives funding 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 Non-human subjects research determination: Exempt from IRB Review: Expedited Review: Convened IRB Review: Reviewed by:Researcher / HRPP Coordinator HRPP Coordinator IRB Member(s)1 of 4 CUNY UI- IRBs Criteria:Human subjects research & engagement definitions 6 categories defined by federal regulations Belmont principles still apply Poses minimal risk to subjects; AND 9 categories defined by federal regulations Poses greater than minimal risk to subjects

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 arita.winter@cuny.edu

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