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

andOffice of Sponsored Programs

April 10, 2013

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

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

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

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

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

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

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

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

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 only when the identifiable link between the subject and

research is the consent form• Use of alternate consent form is a waiver of parental consent

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

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

Institutional Review Board (IRB)Rowan University IRB – Adverse Event Reporting

Adverse events need to be reported by 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 Approved protocols

Immediately report serious adverse events

Institutional Review Board (IRB)Rowan University IRB – Continuing Review/Final Report

Form

Continuing review forms are only required for Approved protocols

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

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

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

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

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

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

Cooper Health System, Cooper Medical School at Rowan University (CMSRU), and Rowan

University IRBIRB 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

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

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

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

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

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

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

Institutional Animal Care and Use Committee (IACUC)

Cooper Medical School at Rowan 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

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

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

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

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

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.

Citations and Sources

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.htmOffice of Biotechnology Activities - http://oba.od.nih.gov/rdna/nih_guidelines_oba.html

Webpage links

Rowan University Foundation / University Advancement Officehttp://rufoundation.org/

Rowan University: Office of Sponsored Programshttp://www.rowan.edu/provost/grants/index.cfm

Rowan University: Office of Researchhttp://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.cfmIACUC - http://www.rowan.edu/provost/research/Integrity_and_compliance/Iacuc/Iacuc.cfmIBC - http://www.rowan.edu/provost/research/biosafety/index.cfmIERP - http://www.rowan.edu/president/ierp/Environment, Health and Safety Office - http://www.rowan.edu/adminfinance/facilities/ehs/