Office for Protection from Office for Protection from Research Risks (OPRR)Research Risks (OPRR)

Department of Health and

Human Services

National Institutes of Health

OPRR Dissolved June, 2000OPRR Dissolved June, 2000

Office for Human Research Office for Human Research Protections (OHRP)Protections (OHRP)

Department of Health and

Human Services

Office of Public Health and Science

Director: Greg Koski, Ph.D. M.D.

OHRP ResponsibilitiesOHRP Responsibilities

Implementation and interpretation of federal regulations and policy

Educational programs Negotiation of assurances Evaluation of compliance

OHRP Electronic AccessOHRP Electronic Access

E-mail: ohrp@osophs.dhhs.gov

Web Site: http://ohrp.osophs.dhhs.gov

Federal Regulations and PolicyFederal Regulations and Policy

45 CFR 46 - Basic DHHS Policy for Protection of Human Research Subjects - Subpart A

Originally adopted January 13, 1981 Revised June 18, 1991

“The Common Rule” - Federal Policy for the Protection of Human Subjects June 18, 1991Departments of Agriculture, Energy, Commerce, HUD, Justice,

Defense, Education, Veterans Affairs, Transportation, and HHS. NSF, NASA, EPA, AID, Social Security Administration, CIA, and the Consumer Product Safety Commission.

Food and Drug AdministrationFood and Drug Administration

Regulations: IRB - 21 CFR 56 Informed Consent - 21 CFR 50

OHRP OrganizationOHRP Organization

Office of the Director• Greg Koski – Director• Melody Lin – Deputy Director

– Division of Education• Jeffrey Cohen – Director

– Division of Assurance Support & Quality Improvement

• George Gasparis – Acting Director

– Division of Compliance Oversight• Michael Carome - Director

EducationEducation

EducationEducation

Presentations and Training Programs Workshops and Town Meetings

– For further information on both of the above contact Darlene Ross (dr20a@nih.gov)

Educational Materials– “IRB Guidebook”

http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm

– Videotape Series: "Protecting Human Subjects“ http://ohrp.osophs.dhhs.gov/references/resource.htm

OHRP/FDA/VA WorkshopsOHRP/FDA/VA Workshops

"Current Human Research Issues & Solutions: Regulatory Overview & Investigator/Institutional Sponsor Partnerships ", May 10-11, 2001, Newark, NJ.

"Evolving Concern for Protection of Human Subjects“, June 8, 2001, St. Louis MO. (Town Meeting)

"Current Human Research Issues & Solutions: Regulatory Overview & Hot Topics", June 21-22, 2001, Charleston, SC

"Current Human Research Issues & Solutions: Regulatory Overview & Social/Behavioral Research" July 16-17, 2001, Los Angeles, CA.

"Current Human Research Issues & Solutions: Regulatory Overview & TBD", September 20-21, 2001, Minneapolis, MN.

Assurance Support & Assurance Support & Quality ImprovementQuality Improvement

OHRP Federalwide AssuranceOHRP Federalwide Assurance

Single Assurance Document - Federalwide Assurance (FWA)– MPAs, CPAs, SPAs, CAs, IIAs, AIIs, NIAs

eliminated– FWAs will cover all of the institution’s

Federally-supported human subject research.

– No OHRP review of individual applications, protocols, consent documents

http://ohrp.osophs.dhhs.gov/irbasur.htm

OHRP Federalwide AssuranceOHRP Federalwide Assurance

Each legally separate institution will need its own FWA

International Standards OK All Institutions Eligible – no longer limited to

those receiving Federal funds Web-Based Application Process IRB Registration Rely on own institutional IRB, other

institutional IRB, commercial

OHRP Federalwide AssuranceOHRP Federalwide Assurance

Current Status– Currently in pilot phase– FWA is voluntary– OHRP will continue to accept SPAs and

CPAs– All MPAs extended until FWA becomes

mandatory

OHRP Federalwide AssuranceOHRP Federalwide Assurance

Required completion of OHRP Assurance Training Modules

– The Institutional Signatory Official– The Human Protections Administrator (e.g.,

Human Subjects Administrator or Human Subjects Contact Person)

– IRB Chairperson(s) Institutions must establish education

programs for IRB members and investigators– Completion by investigators must be documented

URL: ohrp-ed.nih.gov

IRB/Investigator EducationIRB/Investigator Education

Recommended Features: Ongoing

– One-time presentations inadequate Broad based

– Institutional Officials– IRB members– Investigators– Staff

Not voluntary

IRB/Investigator EducationIRB/Investigator Education

Content: Ethical principles of human subject research Requirements of the Federal regulations Applicable state law Provisions of Institutional Assurance Institutional policies and procedures for the

protection of human subjects

Quality ImprovementQuality Improvement

Consultation to improve institutional programs of human subjects protections– Voluntary– Separate from Compliance Oversight

Multiple methodologies– Self evaluation tools– Teleconference/Videoconference

consultations– Site visits

Compliance OversightCompliance Oversight

Compliance ProcessCompliance Process

OHRP discovers or receives an allegation or indication of non-compliance

• COMPLAINT(S)– PI, IRB MEMBER, SUBJECT, PRIVATE CITIZEN, ETC.

• SELF REPORTING– INSTITUTION, PI

• MEDIA• OTHER INCIDENT REPORT

– FDA INSPECTION– NIH PSV REPORT– COOPERATIVE GROUP AUDIT

Compliance ProcessCompliance Process

OHRP determines if it has jurisdiction OHRP notifies institution and requests

institutional response (may include additional documentation, institutional investigation and report, etc.)

OHRP may take immediate action if protection of human subjects warrants

Compliance ProcessCompliance Process

OHRP evaluates institutional response

OHRP issues a report of findings

OR OHRP performs site visit

Compliance ProcessCompliance Process

Most compliance oversight evaluations can be resolved through correspondence with the institution and do not require an on-site review or a formal report of findings.

Compliance ConcernsCompliance Concerns

OPRR Compliance Activities: Common Findings and

Guidance

http://ohrp.osophs.dhhs.gov/references/findings.pdf

Does the institution support and respect the IRB and its mission?

Is there a “culture of compliance”?Are IRB members and investigators

knowledgeable about regulatory requirements?

Is there adequate documentation of IRB findings and actions?