Federalwide AssuranceFederalwide Assurance

Presentation for IRB MembersPresentation for IRB Members

Per DHHS 45 CFR Part Per DHHS 45 CFR Part 46.103:46.103:

Each institution that is engaged inEach institution that is engaged inDepartment of Health and Human ServicesDepartment of Health and Human Services(DHHS) supported or conducted human(DHHS) supported or conducted humansubject research must obtain a Federalwidesubject research must obtain a FederalwideAssurance (FWA) from the Office forAssurance (FWA) from the Office forHuman Research Protections (OHRP).Human Research Protections (OHRP).

UCI’s Federalwide UCI’s Federalwide AssuranceAssurance

FWA# 00004071FWA# 00004071 Initially approved January 31, Initially approved January 31,

20032003 Entities covered by FWA Entities covered by FWA

• UCI CampusUCI Campus• UCI Medical CenterUCI Medical Center• UCI Health Centers:UCI Health Centers:

Anaheim and Santa AnaAnaheim and Santa Ana

Terms in the FWATerms in the FWA

• Binding agreement between OHRP and UCIBinding agreement between OHRP and UCI

• Updated and renegotiable every three years; Updated and renegotiable every three years; UCI’s current FWA remains in effect through UCI’s current FWA remains in effect through January 13, 2013, unless otherwise notified January 13, 2013, unless otherwise notified

• Assures that all of UCI’s activities related to Assures that all of UCI’s activities related to human subject research, human subject research, regardless of regardless of funding sourcefunding source, will be guided by the ethical , will be guided by the ethical principles in the principles in the Belmont ReportBelmont Report and will  and will comply with 45 CFR Part 46 and all of its comply with 45 CFR Part 46 and all of its Subparts (A-D)Subparts (A-D)

Engagement in HS Engagement in HS ResearchResearch

• An institution becomes An institution becomes “engaged” in human subjects “engaged” in human subjects research when:research when:

its employees, agents (e.g., faculty, student, and staff), and its employees, agents (e.g., faculty, student, and staff), and their collaborating institutions (i) intervene or interact with their collaborating institutions (i) intervene or interact with living individuals for research purposes; or (ii) obtain living individuals for research purposes; or (ii) obtain individually identifiable private information for research individually identifiable private information for research purposes purposes [45 CFR 46.102(d),(f)].

it receives a direct DHHS award to support such research. In it receives a direct DHHS award to support such research. In such cases, the PI’s institution bears ultimate responsibility for such cases, the PI’s institution bears ultimate responsibility for protecting human subjects under the award even when all protecting human subjects under the award even when all activities are carried out by a subcontractor or collaborator. activities are carried out by a subcontractor or collaborator. The PI is also responsible for ensuring that all collaborating The PI is also responsible for ensuring that all collaborating institutions engaged in the research hold an OHRP-approved institutions engaged in the research hold an OHRP-approved Assurance prior to their initiation in research.Assurance prior to their initiation in research.

See OHRP Guidance on Institutions Engagement in Research @ See OHRP Guidance on Institutions Engagement in Research @ http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.hhttp://www.hhs.gov/ohrp/humansubjects/guidance/engage08.htmltml

Requirements in the Requirements in the FWAFWA

• Written ProceduresWritten Procedures• Responsibilities and Scope of IRBResponsibilities and Scope of IRB• Informed ConsentInformed Consent• Collaborating Institutions/InvestigatorsCollaborating Institutions/Investigators• Written Agreements with non-Affiliated Written Agreements with non-Affiliated

InvestigatorsInvestigators• Institutional SupportInstitutional Support• Compliance with TermsCompliance with Terms• Assurance TrainingAssurance Training• Educational TrainingEducational Training• Renewal of AssuranceRenewal of Assurance

Written Procedures - IWritten Procedures - IUCI should establish, and provide to OHRP UCI should establish, and provide to OHRP

uponuponrequest, written procedures for:request, written procedures for:

• ensuring prompt reporting to the IRB, appropriate ensuring prompt reporting to the IRB, appropriate institutional officials, the relevant Department or institutional officials, the relevant Department or Agency Head, any applicable regulatory body, and Agency Head, any applicable regulatory body, and OHRP of any: (i) unanticipated problems involving OHRP of any: (i) unanticipated problems involving risks to subjects or others, (ii) serious or continuing risks to subjects or others, (ii) serious or continuing noncompliance with the Federal Regulations or IRB noncompliance with the Federal Regulations or IRB requirements, and (iii) suspension or termination of requirements, and (iii) suspension or termination of IRB approval.IRB approval.

• verifying, by a qualified person or persons other than verifying, by a qualified person or persons other than the investigator or research team, whether proposed the investigator or research team, whether proposed human subject research activities qualify for human subject research activities qualify for exemption from the requirements of the Common exemption from the requirements of the Common Rule.Rule.

Written Procedures - IIWritten Procedures - II

UCI IRB has established, and will provide a UCI IRB has established, and will provide a copycopy

to OHRP upon request, written procedures for:to OHRP upon request, written procedures for:1)1) Conducting IRB initial and continuing review (not less than once Conducting IRB initial and continuing review (not less than once

per year), approving research, and reporting IRB findings to the per year), approving research, and reporting IRB findings to the investigator and the Institution;investigator and the Institution;

2)2) Determining which projects require review more often than Determining which projects require review more often than annually and which projects need verification from sources other annually and which projects need verification from sources other than the investigator that no material changes have occurred than the investigator that no material changes have occurred since the previous IRB review;since the previous IRB review;

3)3) Ensuring that changes in approved research protocols are reported Ensuring that changes in approved research protocols are reported promptly and are not initiated without IRB review and approval, promptly and are not initiated without IRB review and approval, except when necessary to eliminate apparent immediate hazards except when necessary to eliminate apparent immediate hazards to the subject. to the subject.

Responsibilities and Scope Responsibilities and Scope

of IRBof IRBAll human subject research* will be reviewed,All human subject research* will be reviewed,prospectively approved, and subject toprospectively approved, and subject tocontinuing oversight and review at least annuallycontinuing oversight and review at least annuallyby the designated IRBs. The IRBs will haveby the designated IRBs. The IRBs will haveauthority to approve, require modifications in, orauthority to approve, require modifications in, ordisapprove the covered human subject research.disapprove the covered human subject research.

*Except for research exempted or waived in accordance with Sections 101(b) or 101(i)*Except for research exempted or waived in accordance with Sections 101(b) or 101(i)of the Common Ruleof the Common Rule    

Informed Consent Informed Consent RequirementsRequirements

Informed consent will be: Informed consent will be:

a) sought from each prospective subject or the a) sought from each prospective subject or the subject's legally authorized representative, in subject's legally authorized representative, in accordance with, and to the extent required by accordance with, and to the extent required by Section 116 of the Common Rule; Section 116 of the Common Rule;

b) appropriately documented, in accordance with, b) appropriately documented, in accordance with, and to the extent required by Section 117 of the and to the extent required by Section 117 of the Common Rule.Common Rule.

c) except for research exempted or waived in c) except for research exempted or waived in accordance with Sections 101(b) or 101(i) of the accordance with Sections 101(b) or 101(i) of the Common RuleCommon Rule

Requirement for Assurances Requirement for Assurances for Collaborating for Collaborating

Institutions/InvestigatorsInstitutions/Investigators UCI is responsible for ensuring that all institutionsUCI is responsible for ensuring that all institutionsand investigators engaged in its U.S. federally-and investigators engaged in its U.S. federally-supported human subject research operate undersupported human subject research operate underan appropriate OHRP or other federally-approvedan appropriate OHRP or other federally-approvedAssurance for the protection of human subjects. InAssurance for the protection of human subjects. Insome cases, one institution may operate under ansome cases, one institution may operate under anAssurance issued to another institution with theAssurance issued to another institution with theapproval of the supporting Department or Agencyapproval of the supporting Department or Agencyand the institution holding the Assurance.and the institution holding the Assurance.

Written Agreements with Written Agreements with Non-Affiliated InvestigatorsNon-Affiliated InvestigatorsThe engagement in human research activities ofThe engagement in human research activities ofeach independent investigators who is not aneach independent investigators who is not anemployee or agent of UCI may be covered employee or agent of UCI may be covered

underunderUCI’s FWA only in accordance with a formal,UCI’s FWA only in accordance with a formal,written agreement of commitment to relevantwritten agreement of commitment to relevanthuman subject protection policies and IRBhuman subject protection policies and IRBoversight. Institutions must maintain oversight. Institutions must maintain commitment agreements on file and providecommitment agreements on file and providecopies to OHRP upon request.copies to OHRP upon request.

Institutional Support for the Institutional Support for the IRBIRB

The Institution will provide the IRB that The Institution will provide the IRB that it it

operates with resources and operates with resources and professionalprofessional

and support staff sufficient to carry outand support staff sufficient to carry out

their responsibilities under the their responsibilities under the AssuranceAssurance

effectively.effectively.

Compliance with the Terms Compliance with the Terms of Assuranceof Assurance

The Institution accepts and will follow the items above andThe Institution accepts and will follow the items above andis responsible for ensuring that:is responsible for ensuring that:

(a)(a)the IRBs designated under the Assurance agree to comply with the IRBs designated under the Assurance agree to comply with these terms; and these terms; and

(b)(b)the IRBs possesses appropriate knowledge of the local research the IRBs possesses appropriate knowledge of the local research context for all research covered under the Assurance context for all research covered under the Assurance

Any designation under this Assurance of another Institution'sAny designation under this Assurance of another Institution'sIRB or an independent IRB must be documented by a writtenIRB or an independent IRB must be documented by a writtenagreement between the Institution and the IRB organizationagreement between the Institution and the IRB organizationoutlining their relationship and include a commitment thatoutlining their relationship and include a commitment thatthe designated IRB will adhere to the requirements of thisthe designated IRB will adhere to the requirements of thisAssurance. Any agreement should be kept on file at bothAssurance. Any agreement should be kept on file at bothorganizations and made available to OHRP upon request.organizations and made available to OHRP upon request.

Assurance TrainingAssurance Training

• OHRP Assurance Training Modules describe the OHRP Assurance Training Modules describe the major responsibilities of the Institutional major responsibilities of the Institutional Signatory Official, the Human Protection Signatory Official, the Human Protection Administrator, and the IRB Chairs that must be Administrator, and the IRB Chairs that must be fulfilled under the Assurance. fulfilled under the Assurance.

• OHRP strongly recommends that the Institutional OHRP strongly recommends that the Institutional Signatory Official, the Human Protections staff, Signatory Official, the Human Protections staff, and the IRB Chairs personally complete the and the IRB Chairs personally complete the relevant OHRP Assurance Training Modules, or relevant OHRP Assurance Training Modules, or comparable training that includes the content of comparable training that includes the content of these modules, prior to submitting the these modules, prior to submitting the Assurance.Assurance.

Educational TrainingEducational Training• OHRP strongly recommends that the Institution and the OHRP strongly recommends that the Institution and the

designated IRBs establish educational training and designated IRBs establish educational training and oversight mechanisms (appropriate to the nature and oversight mechanisms (appropriate to the nature and volume of its research) to ensure that research volume of its research) to ensure that research investigators, IRB members and staff, and other investigators, IRB members and staff, and other appropriate personnel maintain continuing knowledge appropriate personnel maintain continuing knowledge of, and comply with, relevant ethical principles, of, and comply with, relevant ethical principles, relevant Federal Regulations, OHRP guidance, other relevant Federal Regulations, OHRP guidance, other applicable guidance, state and local laws, and applicable guidance, state and local laws, and institutional policies for the protection of human institutional policies for the protection of human subjects.subjects.

• Furthermore, OHRP recommends that:Furthermore, OHRP recommends that:a) IRB members and staff complete relevant educational a) IRB members and staff complete relevant educational

training before reviewing human subject research; and training before reviewing human subject research; and b) research investigators complete appropriate institutional b) research investigators complete appropriate institutional

educational training before conducting human subject educational training before conducting human subject research.research.

    Renewal of AssuranceRenewal of Assurance

All information provided under this AssuranceAll information provided under this Assurancemust be updated at least every 36 months (3must be updated at least every 36 months (3years), even if no changes have occurred, inyears), even if no changes have occurred, inorder to maintain an active Assurance. Failureorder to maintain an active Assurance. Failureto update this information may result into update this information may result inrestriction, suspension, or termination of therestriction, suspension, or termination of theInstitution's FWA for the protection of humanInstitution's FWA for the protection of humansubjects. subjects.

OHRP Compliance OHRP Compliance OversightOversight

• OHRP’s Division of Compliance Oversight (DCO) evaluates all OHRP’s Division of Compliance Oversight (DCO) evaluates all written substantive allegations or indications of noncompliance written substantive allegations or indications of noncompliance with DHHS regulations. If complaints or concerns arise with DHHS regulations. If complaints or concerns arise regarding an institution's human subject protection practices, regarding an institution's human subject protection practices, OHRP opens a formal evaluation and, if necessary, requires OHRP opens a formal evaluation and, if necessary, requires corrective action by the institution.corrective action by the institution.

• During the course of an evaluation DCO issues findings of During the course of an evaluation DCO issues findings of noncompliance in the form of determination letters. OHRP noncompliance in the form of determination letters. OHRP makes these determination letters available on their website, makes these determination letters available on their website, either 10 days after the letter is issued or when the first either 10 days after the letter is issued or when the first Freedom of Information Act (FOIA) request is made, requesting Freedom of Information Act (FOIA) request is made, requesting that letter. The publicly available determination letters are that letter. The publicly available determination letters are edited to remove those portions that relate to issues still under edited to remove those portions that relate to issues still under discussion with the institution.discussion with the institution.

• To view recent Determination letters or for a list of common To view recent Determination letters or for a list of common OHRP Compliance Oversight finding go to: OHRP Compliance Oversight finding go to: http://www.hhs.gov/ohrp/compliance/letters/index.htmlhttp://www.hhs.gov/ohrp/compliance/letters/index.html

Questions?Questions?

Please contact:Please contact:

Karen AllenKaren Allen

Director of Research Protections Director of Research Protections

@ kallen@uci.edu or 949-824-1558@ kallen@uci.edu or 949-824-1558