1. CUNY Human Research Protection Program (HRPP)
School of Professional Studies
April 18, 2013

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
Regulatory & administrative support

4. CUNY HRPP – Oversight
Each of the following three criteria must be met:
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
Not commercial or other services – if not merit professional recognition or publication privileges

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
Scholarship of teaching and learning

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
Respect for persons / autonomy; beneficence; justice

7. CUNY HRPP - Submission Submission Process: Guidance:
IRB Net:
New User Registration
Submit to CUNY Central Office HRPP
Guidance:
Arita Winter, CUNY Central Office HRPP Coordinator

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