Presented by the Rowan University Foundation / University Advancement a nd

1. Research Regulatory Committees on Campus:Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC) and the Institutional Biosafety Committee (IBC) Presented by the Rowan University Foundation / University Advancement and Office of Sponsored Programs April 10, 2013

2. Institutional Review Board (IRB)Origins 1947 Nuremberg Code • Established first set of codes for research on human subjects • Subjects Right to Terminate Participation • Voluntary Consent is Essential 1964 Declaration of Helsinki • Recommended creation of the Institutional Review Board – IRB Tuskegee Syphilis Study – U.S. Public Health Service (1966) • Established federal, nationwide regulations and protections for any organization that will receive federal funding to conduct human subject research

3. Institutional Review Board (IRB)Evolution 1979 Belmont Report – 1974 National Research Act • Medical practice (intervention/therapy) versus research • Established three (3) basic principles • Respect for persons (Autonomy of the individual/subject) • Beneficence (Do no harm and maximize benefits) • Justice (Burdens and Benefits) • Application Requirements • Informed Consent • Risk/Benefit Assessment • Selection of Subjects of Research

4. Institutional Review Board (IRB)Evolution 1991 Common Rule • Codified in Health & Human Services regulations, 45 CFR Part 46 • Established four major subparts: • Subpart A – Federal Policy (also known as the Common Rule) • Subpart B – Additional Protections for Pregnant Women, Human Fetuses, and Neonates • Subpart C – Additional Protections for Prisoners • Subpart D – Additional Protections for Children • 15 federal departments and agencies adopted the common rule

5. Institutional Review Board (IRB)Rowan University IRB Mission • Assure the safe and ethical treatment of human subjects in research Composition • Six (6) volunteer faculty, including Chair • Current Chair is Harriet Hartman • Ex-Officio / Administration Representative • Community Representative

6. Institutional Review Board (IRB)Rowan University IRB Policy • Human subject research conducted by or under the auspices of Rowan University will be performed in accordance with Title 45 Code of Federal Regulations (CFR), Part 46, commonly known as: • All human subject research conducted by anyone affiliated with Rowan must be reviewed and approved by the IRB Committee prior to such studies being undertaken Oral History Policy • Faculty should consult the Department Chair or Dean to determine whether a project must be submitted to the IRB for approval The Common Rule

7. Institutional Review Board (IRB)Rowan University IRB Training • Online training -Collaborative Institutional Training Initiative (CITI) http://www.citiprogram.org • Requirement for Principal Investigators and key personnel IRB Application Submissions • Due two (2) weeks prior to IRB scheduled meetings • Send Expedited and Just-In-Time review requests to the IRB Chair • Summer submissions are reviewed on a rolling basis • Protocols are either: Approved, Exempted, or Denied

8. Institutional Review Board (IRB)Rowan University IRB - Applications PDF and Word applications are available on the IRB webpage Initial Applications - submit three (3) hardcopies of the application to the Office of Research, Attention: Karen Heiser and one (1) electronic copy to Karen Heiser and Harriet Hartman • Attach surveys, questionnaires, consent forms, etc. when submitting the application If a significant change is to occur for an existing protocol, then an amendment needs to be completed and submitted to the IRB Committee • Use IRB Revision Request Form • Required for exempted research

9. Institutional Review Board (IRB)Rowan University IRB – Consent Forms Pertinent consent form information and language : • Study participation is voluntary • Expectations of the subjects • State the purpose and reason for the study • Confidentiality/anonymity of the data • Risks to the subjects • If video or audiotapes are being used, a separate place for the participant to sign or initial

10. Institutional Review Board (IRB)Rowan University IRB – Consent Forms – Legal Guardians and Alternate Consent Form Legal Guardians • Expectations of the child • Participation is voluntary • Participation will not affect class standing Alternate Consent Form • Need approval from IRB to use in research • Use onlywhen the identifiable link between the subject and research is the consent form • Use of alternate consent form is a waiver of parental consent

11. Institutional Review Board (IRB)Rowan University IRB – Expedited Review Presents no more than minimal risk Reviewed by the IRB Chair or appointed designee Research has to meet federal categories • Categories include all subjects, regardless of their age • Research involving materials – (data, documents, records) • Collection of data, voice, video recordings • Research on group or individual characteristics or behavior Must be anonymous unless reasonable safeguards are established Cannot be classified research Standard requirements still apply

12. Institutional Review Board (IRB)Rowan University IRB – Exempted Review Investigators cannot “self-exempt” from IRB Review Determined by an IRB committee member Does not apply to research involving: • Deception • Sensitive behavioral research • Pregnant women and in vitro fertilization • Prisoners • Mentally impaired Meets one of six (6) federal research categories Presents no more than minimal risk IMPORTANT: Investigators need to report any changes to exempt human subject research; for example, changes to consent forms

13. Institutional Review Board (IRB)Rowan University IRB – Adverse Event Reporting Adverse events need to be reportedby the Investigator if: • One or more human subjects experiences an unanticipated event that involves increased risk to themselves or others Component of mandatory continuing review of Approvedprotocols Immediately report serious adverse events

14. Institutional Review Board (IRB)Rowan University IRB – Continuing Review/Final Report Form Continuing review forms are only required for Approvedprotocols Important -If work is performed after the protocol has expired and the protocol was not continued, then it is a violation of the regulations, Rowan’s federal assurance, and Rowan policy Faculty Advisors need to ensure timely submission of the Continuing Review/Final Report form for their students’ applications/protocols that are Approved

15. Institutional Review Board (IRB)Student Research Projects Need to obtain Faculty Advisor approval and signature Education Doctoral students need to obtain Doctoral Advisor approval and signature • Current Doctoral Advisor is James Coaxum Students-Class projects course is available in CITI training to supplement classroom instruction Faculty Research Classroom Exercise guide is available on the IRB webpage

16. Office of Institutional Effectiveness, Research & Planning (IERP) IERP and IRB online surveys Contact IERP upon receipt of IRB approval/exemption of protocol for research requiring online surveys • IERP survey support role does not supersede the policies and procedures of the IRB • IERP’s goal is to: • Protect the rights, privacy, and safety of potential survey respondents and populations protected by FERPA • Minimize survey fatigue • Eliminate collection of duplicate information

17. Office of Institutional Effectiveness, Research & Planning (IERP) Verint (formerly Vovici) IERP approved online software that provides tools for designing, distributing and analyzing surveys • FERPA compliant • Stringent information security requirements not found in most free online survey tools • 128 bit SSL encryption, intrusion detection, 24x7 monitoring, and redundant sets of firewalls • Free services offer no protection of data and may use data for other purposes in exchange for giving you the service

18. Office of Institutional Effectiveness, Research & Planning (IERP) Verint design highlights • Unlimited number of questions per page and per survey • 11 different question types • Skip/branch/display logic • Piping from responses or panels Verint distribution highlights • Deploy surveys via the Web, email, mobile, Facebook, etc. • Email campaign management • Personalized email invitations • Automation of reminder scheduling • View and report on open, click-through, and survey completion rates

19. Office of Institutional Effectiveness, Research & Planning (IERP) IERP requirements for survey research support • Check IERP Survey Calendar on website • Detailed description of your population/sample • Questionnaire w/logic • Invitation/reminders • Proof of IRB approval

20. Cooper Health System, Cooper Medical School at Rowan University (CMSRU), and Rowan University IRB IRB policy between Cooper Health System, CMSRU and Rowan exists Differences between Cooper Health System and Rowan University: • Training requirements • Application procedures Important: Check which IRB will need to review the research well in advance of submitting the IRB application

21. Institutional Animal Care and Use Committee (IACUC)Origins 1966 Animal Welfare Act (AWA) • Minimum standards of care and treatment • Act is enforced by the Food and Drug Administration (FDA) and Animal and Plant Health Inspection Service (APHIS) • Charged institutions to create an Institutional Animal Care and Use Committee (IACUC) to evaluate all aspects of the animal care and use program of the facility or entity

22. Institutional Animal Care and Use Committee (IACUC)Evolution Health Research Extension Act of 1985 “Animals in Research” • Established National Institutes of Health (NIH) guidelines for: • Proper care of animals in biomedical and behavioral studies • Proper treatment of animals in research • Organization and operation of animal care committees Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals • Second major set of regulations related to laboratory animals • Applicable to all PHS supported activities involving animals

23. Institutional Animal Care and Use Committee (IACUC)Rowan University Mission • Assure the safe and ethical treatment of animals in research Composition • Four (4) volunteer faculty, including Chair • Current Chair is Alison Krufka • Veterinarian • Community Member • Administration Representative

24. Institutional Animal Care and Use Committee (IACUC)Rowan University - Policy Animal research conducted and performed at Rowan University owned premises or under the auspices of Rowan University are under the purview of the IACUC All animals used in a research capacity, housed in an animal facility, or specific animal studies require the drafting and submission of an IACUC Protocol to be reviewed by the Rowan University IACUC

25. Institutional Animal Care and Use Committee (IACUC)Rowan University Applications • Available in PDF and Word format • Complete in its entirety and submit to Sponsoredprograms@rowan.edu • Handled on a rolling basis • Committee reviews will result in either the protocol being Approved, Require Modifications, or Withhold Approval Training • Principal Investigator (PI) led training • CITI training has available animal research courses • Environmental, Health and Safety Office can provide occupational and laboratory safety training

26. Institutional Animal Care and Use Committee (IACUC)Rowan University Employee Animal Worker Health Screening and Certification • Physician must complete questionnaire and sign certification • Only forward the completed and signed certification to the Research Office or Sponsoredprograms@rowan.edu Other Pertinent Forms • Animal Adoption Release Form • Field Studies and Biological Surveys Supplement • Surgical Intervention Form

27. Institutional Animal Care and Use Committee (IACUC)Cooper Medical School atRowan University Agreement with University Sciences of Philadelphia (USP) • USP will manage the Vivaria on the Camden Campus • CMSRU faculty and student workers will be required to follow USP policies and procedures as it relates to the Vivaria and IACUC • USP IACUC will be the IACUC charged to review protocols submitted by CMSRU investigators • Agreement will be in effect by the beginning of Fall 2013 (FY14) • Contact the Cooper School of Medicine at Rowan University administration

28. Institutional Biosafety Committee (IBC)Origins and Evolution Asilomar – Pacific Grove California - 1975 • Accepted Principles in Planning Safe Experiments • Accepted Responsibilities of Investigators NIH Guidelines around Recombinant DNA – 1976 & 1978 • Established institutional responsibilities and IBC • IBC Membership Requirements • Changed focus from biohazard to biosafety • Training & health surveillance • Independent determination of required safeguards

29. Institutional Biosafety Committee (IBC)Rowan University Mission • Ensure activities involving recombinant DNA and other bio-hazardous agents meet the ethical and legal requirements for the responsible use of these agents in an academic workplace Composition • Seven (7) volunteer faculty, including Chair • Current Chair is Dr. Gregory Hecht • Public Safety Representative • Two (2) Outside Community Members • Administration Representatives

30. Institutional Biosafety Committee (IBC)Rowan University Policy • Rowan employees and all users of Rowan facilities are expected to comply with the U.S. NIH Guidelines • University shall maintain an active IBC • IBC must maintain a list of: • Risk Group (RG) 2, RG3, and RG4 agents stored, handled, and used on Rowan property • HHS/USDA Select Agents and Toxins • Recombinant organisms (viruses) • Activities of recombinant organisms or viruses • RG3 and RG4 agents are prohibited until the proper facilities are available

31. Institutional Biosafety Committee (IBC)Rowan University Registrations and Notifications of bioagents • Contact Dr. Gregory Hecht • Ensure that safety training and adequate lab, building, or facility safety measures are in place prior to any bioagents brought onto campus Electronic Bioagent Registry • Coming Soon! • Database in Banner • To be completed by researchers and departmental employees • Creates central repository for bioagents retained by researchers and colleges/departments • Completed and certified registries will be good for 1 year

32. Institutional Review Board – Q & A Question #1: Do I need to provide a statement on the consent form describing the extent, if any, to which confidentiality of records identifying the subject will be maintained? Answer:Yes, a human subject should have knowledge that their participation will be confidential and how confidentiality will be maintained – Title 45: Part 46; Subpart A – Section 46.116(a)(5). Question #2: Do I need to send an application to the IRB Committee when submitting a research training proposal (institutional type of grants and contracts) to a sponsor, of which it is known that future activities will involve human subjects yet the extent of human research is unknown? Answer:No, the proposal can be awarded without submitting an IRB application – Title 45: Part 46; Subpart A – Section 46.118 Note:Prior to starting any human subject research, IRB Review Committee review and approval is required.

33. Webpage links Citations and Sources Rowan University Foundation / University Advancement Office http://rufoundation.org/ Rowan University: Office of Sponsored Programs http://www.rowan.edu/provost/grants/index.cfm Rowan University: Office of Research http://www.rowan.edu/provost/research/index.cfm Rowan University Committee and Department webpages: IRB - http://www.rowan.edu/provost/research/Integrity_and_compliance/Irb/Irb.cfm IACUC - http://www.rowan.edu/provost/research/Integrity_and_compliance/Iacuc/Iacuc.cfm IBC - http://www.rowan.edu/provost/research/biosafety/index.cfm IERP - http://www.rowan.edu/president/ierp/ Environment, Health and Safety Office - http://www.rowan.edu/adminfinance/facilities/ehs/ Barkley, W. Emmett. (December 2001).The History and Origin of IBC’s in the NIH Guidelines: Asilomar Revisited. Compliance workshop presented during IBCs in a Changing Research Landscape: A Policy Conference Office of Human Research Protections - http://www.hhs.gov/ohrp/ Office of Laboratory Animal Welfare - http://grants.nih.gov/grants/olaw/olaw.htm Office of Biotechnology Activities - http://oba.od.nih.gov/rdna/nih_guidelines_oba.html