CCAS Annual Conference: New Orleans, LA November 11, 2010

CCAS Annual Conference:New Orleans, LA

November 11, 2010

The Role of Deans:

Regulatory & Administrative

Responsibilities Michelle Feige, MSWPublic Health Analyst

Division 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?

4 4

OHRP’s Organizational Structure

OHRP, Office of the DirectorJerry Menikoff, Director

Melody Lin, Deputy DirectorMichael Carome, Associate Director for Regulatory Affairs

Division of Compliance

OversightKristina Borror

Director

Division of Policy and Assurances

Irene Stith-ColemanDirector

Division of Education and Development

Elyse 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

5

Title 45 Code of Federal

RegulationsPart 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 Chartshhs.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

AB

C

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 ProtocolChangesContinuingReview

Solutions to Correct/Prevent Noncompliance

EducationAdequate IRB staff and resourcesAdequate 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

Key PointsKnow what the regulations are and

when they apply

Understand your responsibilities under the regulations and your Federalwide Assurance

Be compliant

Keep in touch!

22

Contact Information

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

OHRP telephone: 1-866-447-4777OHRP e-mail: ohrp@hhs.gov

JOIN THE OHRP LISTSERV!

Michelle Feige: Telephone: 240-453-8207

E-mail: Michelle.Feige@hhs.gov