Top Ten Issues to Avoid in Grant Congruency

Transcription

1 Top Ten Issues to Avoid in Grant Congruency Michelle Watkinson, CIP Senior IRB Administrator, Arts & Sciences IRB and Farah Anwar IRB Administrator, Arts & Sciences IRB

2 Objectives Learn the difference between non-human subjects research-related activities versus human subjects research activities Learn about the grant congruency process; Increase the understanding of what s required when processing funded human subjects protocols; Learn the top things to avoid in grant congruency to ensure a smooth IRB review; and Provide steps on how to work with the Institutional Review Board (IRB) to resolve any discrepancies to ensure smooth review process to release awarded funds.

3 Who is the IRB? The Institutional Review Board or IRB is the administrative body established within a research organization. The purpose of the IRB is to ensure that all human subjects participating in research are protected and that the research is conducted in accordance with all federal, institutional, and ethical guidelines. The IRB is comprised of a diverse board of physicians, nurses, pharmacists, physical scientists, social/behavioral scientists, non-scientists, and community representatives. The IRB is a resource for the research community. The IRB provides education outreach as well as perform quality assurance audits.

4 What s considered Human Subjects Research? Step one Is it Research? Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge... Systematic investigation Systematic Investigation is typically a predetermined method for studying a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing theory. Includes: observational studies, interview or survey studies, group comparison studies, test development, and interventional research. Generalizable knowledge Developing or contributing to generalizable knowledge means that intent or purpose of the systematic investigation is dissemination of findings. Common ways of disseminating results, may include publishing or presenting. Step two Does it involve human subjects? Human subjects are defined as a living individual about whom* an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. Data about living individuals through intervention or interaction (focus on what information or material is obtained from people): An intervention may be physical procedures (e.g. venipuncture) or manipulations of living individuals or the living individuals environments. An interaction may be communication or interpersonal contact between the investigator (or research team) and the living individual. Examples include interviews, questionnaires, surveys, observations, manipulations of subject behavior, diet, or environment, physical measurements, specimen collection (e.g. blood tissue), and administration of experimental drugs or devices. * Why about whom is key? Consider if the project focuses on the person or if the focus is on policies, practices or procedures about which the person is knowledgeable. Projects which collect information about policies, practices or procedures even if the person who provided that information is identified do not constitute human subject research.

5 Congruency Review: Purpose NIH Grants Policy and DHHS Regulations ( (f)) require that the institution verify that the IRB has reviewed and approved those components of grant applications and contract proposals related to the inclusion of human participants (or private, identifiable data). No grant award involving human subjects can be released without IRB approval. Institutions are responsible for ensuring that the information the IRB reviews and approves is consistent with what is in the relevant grant application/proposal. Following NIH peer review and notification of priority score/percentile in a fundable range: PI to proceed with application to the IRB for review. IRB will conduct a side-by-side comparison of the Grant proposal with the approved IRB protocol. References:

6 Congruency Review: Overview Covers all awards to Rutgers including: Grants (new and competing renewals) Non-competing continuations (aka., Progress report) Subawards Agreements/Contracts/MOU Foundation funding Congruency review criteria is based on NIH guidance Comparison of IRB protocol(s) to the work proposed in the award All work to be included in IRB protocol at time of award With progress reports -all work to be done in coming year needs to be covered (and it can change from last congruency!) Incongruence requires new protocol or amendment

7 Figure adapted from on 5/13/14

8 Rutgers Endorsement Form Rutgers internal mechanism utilized to obtain the necessary research project information in order to process a proposal to a sponsor ( Complete Endorsement package includes (ORSP-side): Narrative/Scope of Work Detailed budget/budget template Budget justification Award Documentation and Correspondence (e.g., Funder/Program Officer) As applicable, includes: Supporting documentation for any F&A exceptions or restrictions Signed cost share budget template Letter of intent Any additional required sponsor documentation Project fund source/index request & modification form

9

10 Congruency Review: Specifics What the IRB needs within the Endorsement? List of supporting IRB protocols Log # (new) and grant/award numbers (existing) The science (description of work to be done, not just an abstract) Research design / approach or full Grant Protocol IRB Approvals from Other Institutions Data Use Agreement (DUA) or Authorization from Data-holder Other Documents, as applicable

11 Sources of Delay: What To Avoid Has the Investigator listed a Protocol? Problem: Incorrect protocols provided or No protocol information provided. Does the Endorsement Form list Pending IRB Submission? Problem: Something has been submitted, already approved or in-progress for approval (lag time). Is a Faculty s protocol listed? Problem: Separate protocol has not been submitted for Graduate Student or Post-Doc s human subject work. Has there been amendment/protocol submitted? Problem: The amendment and/or protocol still isn t congruent.

12 Sources of Delay: What To Avoid Has the PI provided detailed or requested information? Problem: PI hasn t addressed outstanding conditions on IRB-Approval (e.g., TBD Research Personnel or Sites) or Clearly defined the non-human subject phase that s part of a multi-year project (e.g., clear budget). Is there a Subaward or Contract? Problem: Information Not Provided or In-Progress (e.g., Subaward PI did not obtain their institution s IRB approval or amendment). Will Funding change the IRB Review Level Type? Problem: Grant PI has responsibility for the research overall (i.e., Exempt protocol changes to Expedited protocol).

13 Sources of Delay: What To Avoid Is the IRB-approved protocol inflexible? Problem: The protocol is too specific vs. a general grant protocol (inflexibility) that causes limitations for full release of funding. What s been added onto the endorsement form? Problem: Supplements on awards cover non-human subjects work not specified in protocol but it s been added onto endorsement form. Are the budgets segmented? Problem: Budgets do not cover non-human subjects work or do not indicate that the money will be used to fund multiple protocols. Does the budget include undefined personnel? Problem: Several individuals are listed on grant but their roles have not been defined (unclear who is assisting with research vs. purely admin).

14 Impact of Incongruence Incongruence for work already conducted or performing unauthorized work is considered as noncompliance. Non-compliance can include: Off-protocol (unapproved) work Deviations from approved protocol (e.g., added more subjects/sites etc.) Not obtaining other institutions IRB approval or other authorizations (including yearly renewals) Failure to obtain executable Data Use Agreements Lack of IBC or IACUC to support human subjects work Non-compliance could lead to: Reporting to Institutional Officials, OHRP, NIH (or other funder) and, when necessary, to FDA (PI & Institutional level) Suspension of Study (PI level) Termination of IRB approval (PI level) Return of funds (PI level) Loss of funding (PI level) Loss of Assurance (Institutional level) Impacts All Researchers Cultural change or Damage to Reputation of University (Media Outlets) Audits (Federal or Internal) Increased Community Activist activity Reduced overall funding to institution (grants, contracts and subawards)

15 How to Help Resolve Issues: Seek Advice: Strongly encourage that faculty contact IRB staff to find out key review requirements/deadlines/authorizations (i.e., If I got funded, what do I need to do/know ). Review Scope of Work: At critical points (e.g., notification of fundable score or intent to collaborate), encourage faculty to submit new application or to review current IRB protocols for congruency. Indicate Phases of the Work: Grant will include human subjects research during a period of the award but plans for involvement of human subjects have not been developed yet: The PI must speak with the IRB to develop an initial protocol submission with indication of non-human subject work and to obtain some type of IRB approval, where possible. Example: Phase 1 is submitted and the IRB provides a notice of approval that includes stipulations.

16 How to Help Resolve Issues: Insure Accuracy of Information Provided: -When preparing endorsement forms, double check with PI regarding the stated information on the form. Might want to compare with prior submissions? Is the form complete and accurate? Educational Outreach: Annual Meetings or Trainings: If your institution has dedicated grant specialists (ORSP), might want to hold annual educational workshops with a IRB representative. New Faculty Orientation and a Business/Grant Manager Orientation Sessions to cover soup to nuts grant to grant congruency/irb process with Investigators or with Business/Grant managers. Fact Sheet or Checklist: Develop a tool for PIs to use as a reference guide;

17 Summary The IRB is a federally mandated entity The IRB office supports the functions of the IRB Committee ORSP supports faculty and staff seeking funding from public and private sponsors There are federal laws, FDA and NIH/NSF created policies to which the IRB is beholden IRB processes and policies are designed to ensure institutional compliance with these laws and policies When in doubt, call your IRB Administrator or ORSP Specialist! We really are here to help

18

19 Acknowledgements: Contact Information: We would like to thank the following people for support and guidance: Lauren Danridge, CPIA, Rutgers IACUC Administrator-Newark IACUC Michelle Watkinson Senior IRB Administrator Arts and Sciences IRB Phone: Camie Morrison, MBA, CRA, CAP-Director, Office of Sponsored Research, Rutgers- Camden Paula Bistak, DMH, RN, MS, CIP, CHRC- Chief/Executive Director of the Rutgers Human Subjects Protection Program Farah Anwar IRB Administrator Arts and Sciences IRB Phone: Arts and Sciences IRB Rutgers, The State University of New Jersey Office of Research Regulatory Affairs 335 George Street Liberty Plaza /Suite 3200 New Brunswick, NJ Website: