Session C: What Deans Should Know About the IRB Process Presiding: Carmen R. Cid, Eastern Connecticut State University Panelists: – Roy Barnes, University

Session C: What Deans Should Know About the IRB Process

• Presiding: Carmen R. Cid, Eastern Connecticut State University

• Panelists: – Roy Barnes, University of Michigan-Flint– Michelle Feige, Office for Human Research

Protections– David Bozak, State University of New York at Oswego– Laura Argys, University of Colorado Denver

The “TOP 10” Things Deans Should Know About the IRB

Roy C. BarnesAssistant Dean

College of Arts and SciencesUniversity of Michigan-Flint

10. Human Subjects Protection is important and serious

business

9. IRBs view RISK broadly – immediate risk from participation and risks to reputation

8. Key Historical Document, the 1979 Belmont Report

7. Key Regulation: CFR 45-46 on Protection of Human Subjects

6. Vulnerable populations require additional protections

5. IRBs do not evaluate the quality of the proposed research – per se

4. IRBs oversee RESEARCH. If is not “research,” it is not subject

to IRB approval

3. As a corollary, Assessment Data are not subject to IRB approval

2. You cannot retroactively seek IRB approval for data you have

already collected

1. IRBs do not deal only with biomedical research

CCAS Annual Conference:CCAS Annual Conference:New Orleans, LANew Orleans, LA

November 11, 2010November 11, 2010

The Role of Deans:

Regulatory & Administrative

Responsibilities Michelle Feige, MSWPublic Health AnalystDivision of Education and Development (DED)Office for Human Research Protections (OHRP)Department of Health & Human Services (DHHS)

Office for Human Research Protections

Presentation Overview

• What is OHRP?• Regulatory Provisions• What is Non-Exempt Human Subjects Research?• Terms of the FWA & Role of Institutional Official• Compliance• Contact Information

What is OHRP?

11 11

OHRP’s Organizational Structure

OHRP, Office of the DirectorJerry Menikoff, DirectorMelody Lin, Deputy DirectorMichael Carome, Associate Director for Regulatory Affairs

Division of ComplianceOversightKristina Borror Director

Division of Policy and AssurancesIrene Stith-ColemanDirector

Division of Education and DevelopmentElyse I. SummersDirector

HHS Kathleen Sebelius, Secretary Other HHS Agencies (FDA, NIH, CDC, etc)

International ActivitiesMelody Lin, Deputy Director

Office of the Assistant Secretary for Health Howard Koh, Assistant Secretary for Health

12

Title 45 Code of Federal Regulations

Part 46

Regulations for Protection of Human Subjects

HHS regulations: Title 45 CFR part 46

• Subpart A – basic HHS Policy - “The Common Rule” or Federal Policy - Basic IRB & informed consent requirements - Other federal departments & agencies have

adopted – FDA has its own

Departments of Agriculture, Energy, Commerce, HUD, Justice, Defense, Education, Veterans Affairs, Transportation, HHS, & Homeland Security. NSF, NASA, EPA, AID, Social Security Administration*, CIA, and the Consumer Product Safety Commission

*only in part

HHS Regulations: Title 45 CFR part 46, cont’d

• Subpart B - Pregnant Women, Human Fetuses, and Neonates

• Subpart C - Prisoners

• Subpart D - Children

• Subpart E – IRB Registration (effective 7/2009)

Other Regulatory Entities…

• FDA Regulations

• Other Dept/Agencies

• State and Local Laws

• Institutional Policies

The Regulations Apply When:

• Research involving human subjects conducted or supported by HHS that is not otherwise exempt

-OR-

• Non-exempt human subject research covered by

Assurance of Compliance

Do the Regulations Apply?

1. Does activity involve Research?2. Does research involve Human

Subjects? 3. Is human subjects research Exempt?

ASK QUESTIONS IN THIS ORDER!

What is Research?

Research - a systematic investigation designed to develop or contribute to generalizable knowledge

– includes research development, testing, evaluation, e.g., pilot studies

§46.102(c)

Where Can You Find Help?

• Human Subject Regulations Decision Charts

hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm

• FAQs on Quality Improvement Activitieshhs.gov/ohrp/qualityfaq.html

• Guidance on Engagement in Human Subjects Researchhhs.gov/ohrp/humansubjects/guidance/engage08.html

CALL US!!!

Basic Protections

Assurance of Compliance

Institutional Review Board

Legally EffectiveInformed Consent

Terms of the Federalwide Assurance (FWA) and the Institutional Official’s Role

Are you an Institutional Official?

If so, do you know the Terms of the Assurance (FWA)?

Responsibilities of Institutional (FWA Signatory) Officials

•Providing sufficient resources, space, and staff to support the IRB's review and record keeping duties

•Setting the "tone" for an institutional culture of respect for human subjects

•Ensuring that investigators fulfill their responsibilities

•Implementing appropriate oversight mechanisms to ensure compliance with HHS regulations and effective administration of the HRPP

Common Determinations of Non-Compliance

What should you worry about?

Percentage of Citations of Noncompliance and Deficiencies

34

20

15

5 5 InformedConsent

IRB InitialReview

Written SOP

IRB Reviewof ProtocolChanges

ContinuingReview

Solutions to Correct/Prevent Noncompliance

• Education• Adequate IRB staff and resources• Adequate IRB documentation (in particular, adequate

minutes of IRB meetings)• Periodic self-assessment of institutional system for

protecting human subjects & self reporting• Adequate written procedures

What Can Happen?

Restriction SuspensionTermination

of FWA

Institution/IO Held Responsible, Not IRB

Common Areas of Noncompliance-Reference

• Recent Compliance Oversight Determinations:

http://www.hhs.gov/ohrp/compliance/findings.pdf

• Determination letters: http://www.hhs.gov/ohrp/compliance/letters/index.html



http://www.hhs.gov/ohrp/compliance/letters/index.html

http://www.hhs.gov/ohrp/compliance/letters/index.html

Key Points

• Know what the regulations are and when they apply

• Understand your responsibilities under the regulations and your Federalwide Assurance

• Be compliant

• Keep in touch!

Contact Information

OHRP website: http://www.hhs.gov/ohrp/OHRP telephone: 1-866-447-4777

OHRP e-mail: [email protected]

JOIN THE OHRP LISTSERV!

Michelle Feige: Telephone: 240-453-8207

E-mail: [email protected]

29

http://www.hhs.gov/ohrp/

2010 CCAS Annual Meeting, November 11, 2010

The Other Things Deans Should Know About IRB

David BozakAssociate Dean

College of Liberal Arts and SciencesSUNY Oswego

[email protected]


The Other Things Deans Should Know About IRB

David BozakAssociate Dean

College of Liberal Arts and SciencesSUNY Oswego

[email protected]

• The psychology department will be willing participants

• The further “away” from psychology, the less likely researchers will have appropriate training or even recognize their need for IRB review


What about those other departments?

• What is the definition of “research”?

• AAUP’s Committee A, Academic Freedom, and IRBs

• Oral historians? Journalists?


Just who/what are exempt?

• osw3go.net – simulations on a non-campus computer


What does Web 2.0 do to/for us?


osw3go.net


osw3go.net


osw3go.net

• Second Life – can an avatar give informed consent?


Second Life – can an avatar give informed consent?


Second Life

• RockMelt.com – the newest browser, integrating social media

• Augmented reality browsers (acrossair, for example)

•And many, many more..2010 CCAS Annual Meeting, November 11, 2010

What’s next?

The “TOP 10” Things Deans Can Do About the IRB

Laura M. ArgysAssociate Dean for Research and Creative Activities

College of Liberal Arts and SciencesUniversity of Colorado Denver

Process for assuring responsible conduct of Human Subjects Research

1. Establish and convene an Institutional Review Board2. Develop and follow written procedures3. Review protocols for exempt status, under expedited review or under full board review.4. IRB may approve protocols, require modifications , or disallow the research.5. Review protocols at least annually.6. Maintain records of IRB activities.

Institutional IRB Priorities

• Minimizing risk to subjects

• Assuring subject privacy/confidentiality/consent

• Complying with federal and state regulations

• Avoiding delays to research faculty

• Using employee time effectively on IRB

1. Have the right people on the IRB

• Diversify the faculty on the IRB– Race/ethnicity/gender– disciplines/types of research

• Biomedical/Clinical trials• Focus groups/conducting surveys• Ethnography/qualitative research• Behavioral experiments• Educational research• Use of secondary data

– Include research active faculty– Experience with vulnerable populations– Scientific/non-scientific concerns

2. Provide resources for a successful IRB

• Provide dedicated staff – Manage paper submissions– To take minutes– Point of contact

• Remote or physical presence

• Provide sufficient time to the chair of the IRB

3. Promote responsible Human Subjects research

• Establish the expectations that all researchers undergo human subjects review

• Provide education on human subjects research– For researchers– For students

• Training on submission procedures

4. Maintain a knowledgeable IRB

• Maintain continuity of IRB members

• Provide Human Subjects and HIPAA training

• Make experts available to the IRB– International experts– Disciplinary experts

5. Ensure compliance• Have a quick process for evaluation of exempt status– Not research– Not human subjects– De-identified data

• Provide expedited review by designated committee member

• Make the full board process efficient

6. Effective communication between the IRB and researchers

• Ask the questions that will elicit the information needed by the committee.

• Embed explanations in the application materials

• Build logical skip patterns into the application

• Ensure that the committee has the expertise to understand what can be expected of the researcher.

7. Make the process interactive

• Provide opportunities for Principal Investigators to meet with committee members:– To answer questions that arise during the

committee review– To get clarification regarding modification

requests

8. Save time: Conduct business between meetings

• Provide advice and consultation for applications in preparation

• Evaluate exempt research

• Conduct expedited reviews

• Consult on modifications

9. Create focused review panels

• Clinical panels

• Behavioral and Social Science Panels

• Education Research Panels

10. Improve record keeping:Adopt/devise an electronic record

system• Provide faculty access to records of all of their

protocols.

• Provide notification of scheduled reviews

• Provide feedback from committee

Documents

Session C: What Deans Should Know About the IRB Process Presiding: Carmen R. Cid, Eastern Connecticut State University Panelists: – Roy Barnes, University