Institutional Responsibilities Under A Federalwide Assurance Lisa A. Rooney, JD Director Aegis Compliance & Ethics Center, LLP June 6, 2013 1
Questions There will be a q&a session at the end of the program. To submit a question, please email it to: questions@aegis-compliance.com We will do our best to address all of your questions within the allotted time. 2
Agenda Federalwide Assurance (FWA) Overview Institutional (Official) Responsibilities Under a FWA Questions? 3
What is a Federalwide Assurance (FWA)? A written document, submitted by an institution, outlining institution s commitment to Department of Health and Human Services (HHS) that it will comply with 45 CFR part 46 when the institution becomes engaged in human subjects research covered by the institution s FWA. A document that: An institution must have to receive federal support for conducting nonexempt human subjects research (NEHSR); and Common rule agencies must have to expend federal funds to an institution for conducting NEHSR. 4
When Does an Institution Become Engaged? When an institution s employees or agents obtain: Data about living individuals for research purposes through intervention or interaction; Individually identifiable private information for research purposes; or Informed consent of human subjects. When an institution receives a direct HHS award for NEHSR, even if all activities performed by employees/agents of another institution, unless an exception has been granted. 5
What Type of Research Is Covered by a FWA? Under current regulations: NEHSR that is conducted or supported by HHS; and NEHSR that is conducted or supported by non-hhs federal departments or agencies that have adopted the Common Rule and is covered by a FWA; or All NEHSR, regardless of funding source if institution checked box 4 of FWA. 6
What Type of Research Is Covered by a FWA? Under Advanced Notice of Proposed Rulemaking (ANPRM): All NEHSR, regardless of funding source US institutions receiving some Federal funding from any Common Rule agency may be required to extend 45 CFR 46 to all research studies conducted at their institutions. 7
Agency for International Development 22 CFR 225 Common Rule Departments & Agencies National Science Foundation 45 CFR 690 National Aeronautics & Space Administration 14 CFR 1230 Environmental Protection Agency 40 CFR 26 Department of Agriculture 7 CFR 1c Consumer Product Safety Commission 16 CFR 1028 Department of Veterans Affairs 38 CFR 16 Department of Commerce 15 CFR 27 Federal Policy for the Protection of Human Subjects (Common Rule 45 CFR 46, Subpart A) Department of Transportation 49 CFR 11 Department of Defense 32 CFR 219 Department of Justice 28 CFR 46 Department of Education 34 CFR 97 Department of Energy 10 CFR 745 Department of Health & Human Services 45 CFR 46, subpart A Plus subparts B, C, D Food & Drug Administration Department of Housing & Urban Development 24 CFR 60 Central Intelligence Agency Department of Homeland Security Social Security Administration
HHS Agencies Administration for Children & Families Administration for Community Living Agency for Healthcare Research & Quality Agency for Toxic Substances & Disease Centers for Disease Control & Prevention Centers for Medicare & Medicaid Services Food & Drug Administration Health Resources & Services Administration Indian Health Service National Institutes of Health Substance Abuse & Mental Health Services Administration 9
Institutional (Official) Responsibilities Under a FWA 10
Institutional (Official) Responsibilities Fulfill institutional obligations under 45 CFR 46 and the terms of the institutions FWA: Understand responsibilities involved in a Human Research Protection Program (HRPP); Set "tone" for culture of respect for human subjects & compliance with 45 CFR 46; Designate IRBs to review research covered by FWA; Provide training/educational opportunities for IRB members/staff/investigators, as appropriate; 11
Institutional (Official) Responsibilities cont d Provide/ensure sufficient resources, space, and staff to support the IRB's review and record keeping duties; Appoint IRB members; Suspend/terminate IRB members; Provide/ensure IRB oversight; Operates in accordance with 45 CFR 46 & Functions independently, without undue influence Sign memoranda of understandings/agreements regarding HRPP oversight and operations; Collaborating Individual Investigator Agreements; IRB Authorization Agreements, etc. 12
Institutional (Official) Responsibilities cont d Ensure institution/irb has requisite written procedures; Ensure institution receives required reports; Ensure reports are submitted to Federal agencies; Provide/ensure investigator oversight; Provide HRPP communication and guidance; Ensure Assurances in place and IRB reviews/ certifications submitted to appropriate authorities for HHS-sponsored NEHSR being conducted: By institution s own employees or agents; and At any collaborating performance sites for which the institution has agreed to accept oversight responsibility. 13
Institutional (Official) Responsibilities cont d Not approve research disapproved by IRB; Renew and update FWA, as appropriate; and Serve as knowledgeable point of contact for OHRP. 14
Institutional Responsibilities - Internal IRB Renew Update FWA Set Tone of Respect & Compliance Understand HRPP Related Responsibilities Designate IRBs to Review Research Provide IRB sufficient Resources, Space & Staff Don t Approve Research Disapproved by IRB Ensure Assurances are in Place & IRB Certifications Submitted Be Knowledgeable POC for OHRP Fulfill Obligations Under 45 CFR 46 & Terms of Institutions FWA Appoint IRB Members Suspend/Terminate IRB Members Ensure Institution & IRB Written Procedures Ensure Federal Agencies Get Reports Provide IRB Oversight Sign HRPP MOAs & Agreements Provide Investigator Oversight Provide HRPP Communication & Guidance Provide Training Opportunities for IRB Members/Staff/Investigators
Institutional Responsibilities - External IRB Renew Update FWA Set Tone of Respect & Compliance Understand HRPP Related Responsibilities Designate IRBs to Review Research Ensure IRB sufficient Resources, Space & Staff Don t Approve Research Disapproved by IRB Ensure Assurances are in Place & IRB Certifications Submitted Be Knowledgeable POC for OHRP Fulfill Obligations Under 45 CFR 46 & Terms of Institutions FWA Ensure Institution & IRB Written Procedures Ensure Institution Gets Reports Ensure Federal Agencies Get Reports Ensure IRB Oversight Sign HRPP MOAs & Agreements Ensure Investigator Oversight Provide HRPP Communication & Guidance Provide/Ensure Training Opportunities for institution s staff & Investigators, as appropriate
Institutional (Official) Responsibilities cont d Most responsibilities can be delegated to an appropriate person; some should not Responsibilities that should not be delegated: Setting tone of respect and compliance; Completing recommended IO Assurance Training; http://ohrp-ed.od.nih.gov/cbts/assurance/login.asp Ensuring IRB independence & Adequate IRB resources, space & staff. Even if delegate responsibilities, IO ultimately responsible for all noncompliance occurring at institution. 17
Institutional (Official) Responsibilities cont d Under 45 CFR 46 and terms of institution s FWA, IOs are responsible for any and all noncompliance resulting from: IOs own acts and omissions; IRB acts and omissions & Investigator acts and omissions. Why OHRP Determination Letters are Addressed to IOs; Not investigators or IRBs! Under FDA regulations, IOs are not responsible for any acts or omissions because IOs are not recognized! 18
Noncompliance Findings Associated with Institutional Official (IO) Acts or Omissions OHRP determined that an IO failed to fulfill his obligations when IO: (a) failed to promptly report to OHRP suspensions of IRB approval; (b) attended IRB meetings as investigator advocate where IO negotiated alternatives to or appealed IRB sanctions that were imposed upon investigators as a result of serious or continuing noncompliance; & (c) requested limitations on scope of investigator audits required by IRB. IO actions/inactions resulted in a new IO. 19
Noncompliance Findings Associated with IO Acts or Omissions OHRP determined that an IO failed to fulfill his obligations when IO: (a) fired an individual after the individual requested that the IRB be allowed to audit protocols associated with a external audit report reflecting unanticipated problems (UPs); (b) did not approve the IRB audit to be conducted; (c) did not have the IRB review and take action on the external audit report reflecting UPs; (d) did not report the UPs to OHRP; (e) did not support the IRB when IRB had issues with investigator associated with external audit report; (f) did not ensure IRB had adequate written procedures; (g) did not provide IRB with sufficient resources & staff; & (h) admitted he was not aware of his responsibilities. IO actions/inactions resulted in a new IO. 20
Requisite Written Procedures Magnificent 7 The institution (official) submitting the FWA ensures that IRBs reviewing research covered by the institution s FWA have established written procedures for: Conducting initial review of research; Conducting continuing review of research; Reporting IRB findings & actions to investigators & institution; Determining which projects need review more than annually; Determining which projects need verification that no material changes have occurred since prior IRB review; 21
Requisite Written Procedures Magnificent 7 Ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that such changes in approved research are not initiated without IRB review and approval, except when necessary to eliminate apparent immediate hazards to the subjects; The institution (official) submitting the FWA has established written procedures for: Ensuring prompt reporting to IRB, institutional official, sponsor/funding agency & OHRP of UPs, serious or continuing noncompliance & suspension or termination of IRB approval. 22
IRB Oversight Ensure that IRBs: Required written procedures for conducting IRB business that Provide sufficient operational detail; Are compliant with the regulations & Are being followed. Review research at convened meeting, with majority of members present, including at least one nonscientific member; Capture IRB meeting minutes appropriately; Members with conflicts are not participating in review of projects in which member has a conflict; Take appropriate IRB actions; Approve research only if satisfies 45 CFR 46.111 (and applicable subpart) approval criteria; 23
IRB Oversight Ensure that IRBs: Make additional findings when required; Conduct continuing reviews at least once per year; Exempt research appropriately; Use expedited review procedures appropriately; Review and approve modifications appropriately; Utilize IRB consultants when review requires expertise beyond or in addition to IRB; Suspend or terminate IRB approval when necessary and communicating such actions; & Maintain IRB records. 24
Investigator Oversight Ensure that investigators: Knowledgeable about HHS regulations, applicable state law, institution's FWA, and institutional procedures for the protection of human subjects; Obtain IRB approval prior to conducting NEHSR: Meet protocol requirements; Obtain and document informed consent of subjects prior to their participation in research, unless waived/altered; Obtain prior IRB approval for modifications to approved research, except when necessary to eliminate apparent immediate hazards to subjects; and Submit progress & continuing review reports to IRB in accordance with IRB policies, procedures & actions. 25
Investigator Oversight Ensure that, when necessary, investigators: Provide the IRB with prompt reports of any unanticipated problems involving risks to subjects or others; Provide the IRB with prompt reports of serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB; and Keep certain records as required by the HHS regulations for at least three years after completion of the study. 26
Citations Terms of the FWA, http://www.hhs.gov/ohrp/assurances/assurances/filasurt.h tml OHRP Guidance on Engagement of Institutions in Human Subjects Research, http://www.hhs.gov/ohrp/policy/engage08.html ANPRM, http://www.gpo.gov/fdsys/pkg/fr-2011-07- 26/html/2011-18792.htm OHRP Database for Registered IORGs & IRBs, Approved FWAs, and Documents Received in Last 60 Days, http://ohrp.cit.nih.gov/search/search.aspx?styp=bsc OHRP Recent Compliance Oversight Determinations, http://www.hhs.gov/ohrp/compliance/findings/index.html OHRP Guidance on Written IRB Procedures, http://www.hhs.gov/ohrp/policy/irbgd107.html OHRP Guidance IRB Approval of Research with Conditions, http://www.hhs.gov/ohrp/policy/conditionalapproval2010. html 27
Next Lecture: Reporting Obligations under 45 CFR Part 46 Thursday, June 13, 2013 12pmCT/1pmET 28
Questions? Lisa A. Rooney, JD 4147 Ravenswood Avenue Chicago, IL 60613 301-933-3913 (office) 202-361-7241 (cell) lrooney@aegis-compliance.com 29