PREP Workshop #18 All Things Being Equal... Ensuring Grant and Animal Protocol Congruency Presented by: Michelle Aparicio, CPIA and Diane Marbury, CRA April 17, 2018
CME Disclosure Statement Northwell Health adheres to the ACCME s new Standards for Commercial Support. Any individuals in a position to control the content of a CME activity, including faculty, planners, and managers, are required to disclose all financial relationships with commercial interests. All identified potential conflicts of interest are thoroughly vetted by Northwell Health for fair balance and scientific objectivity and to ensure appropriateness of patient care recommendations. Course Director and Course Planner, Kevin Tracey, MD and Tina Chuck, MPH have nothing to disclose. Michelle Aparicio and Diane Marbury have nothing to disclose 2
Objectives Recognize challenges faced when it comes to ensuring grant and protocol congruence. Analyze your current institutional processes in order to identify compliance risks and administrative deficiencies. Develop and establish processes to achieve this requirement maximizing resources 3
Who Is Responsible? 4
An IACUC protocol is a contract between the institution and the Principal Investigator. Ensuring IACUC congruence is an important step in maintaining good grant stewardship. 5
Checks & Balances Each year, the United States Government awards more than $500 billion in Federal Assistance Agreements, most commonly in the form of grants which includes funding for scientific research, studies, and analysis. This financial assistance provides support or stimulation to accomplish a public purpose. Unfortunately, grant dollars are susceptible to fraud, waste, and abuse. Effective and efficient congruency verification processes can protect your organization and the source of your federal funds.
What is congruence? 7
Congruence is the state achieved by coming together, the state of agreement. Congruence, as opposed to equivalence or approximation, is a relation which implies a kind of equivalence, though not complete equivalence. Wikipedia 8
Why is Congruence an Issue? 9
We ve always done it that way. NIH Grants Policy requirement IACUC QA check It s not an issue. Can disregard. 10
NIH Grants Policy Statement It is an institutional responsibility to ensure that the research described in the application is congruent with any corresponding protocols approved by the IACUC. Part II, A, 4.1.1.2 Verification of IACUC Approval 11
Who Is Required to Review the Grant Application? 12
Someone who is qualified to identify inconsistencies and understands the IACUC protocol review process 13
The IACUC protocol, research design and methods, and the vertebrate animal section of the grant are compared to determine if the proposed funded research and the IACUC protocol are congruent. This should also include the assessment of modifications made. 14
Depends on the organization and available resources. At Northwell Health, congruency review is conducted by the Director, Animal Welfare Office. Occasionally, those IACUC members (scientific reviewers) assigned by the chair to conduct a designated member review of the protocol may be asked to conduct the congruency assessment. 15
Northwell Best Practice 16
Our Grants Management Office does not set-up an account (fund #) for a new award until congruency has been verified. Additionally an account is placed on hold when subsequent years of the award are received, pending confirmation that IACUC congruency is verified and no major changes were made to the protocol. 17
18
Institutional Responsibility 19
The AOR (Authorized Organization Representative) represents the entire institution. His or her signature verifies, to the NIH, the institution's commitment to the Grants Policy Statement terms and conditions, including IACUC approval of all PHS-funded animal activities. The PI commits to meeting PHS Policy standards and to conducting animal activities according to an approved IACUC protocol. 20
The institution must document IACUC approval of the animal activities proposed in the grant The institution must be able to associate each grant(s) with relevant IACUC protocol(s) If the institution uses a protocol numbering system, it must be able to link protocol numbers to grant numbers A 1:1 ratio is not required 21
IACUC Approval 22
The IACUC reviews an animal use protocol. If the protocol complies with all applicable laws and regulations governing the use of animals in research, approval is granted by the committee and the PI may initiate the study. IACUC protocol approval does not equate to grant congruency. 23
Congruent? If an IACUC protocol is identified as federally funded, a grant congruency review is initiated. This review can occur concurrently or subsequent to the IACUC protocol review. Verification is an institutional responsibility that must occur prior to using federal funds to support animal use activities. 24
PHS Policy Include verification of approval (including the date of the most recent approval) by the IACUC of those components related to the care and use of animals. PHS awarding units may not make an award.unless the awardee institution has provided verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals No award shall be made until.the institution or institutions have provided verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals. 25
Does the protocol match the grant? 26
How do you know? Is it documented? 27
Things should match; not identically but the protocol should align with the grant. Both documents should describe the same study (objectives), species, and procedures. If not, the IACUC protocol should be amended. This is a PHS/NIH requirement ONLY. If the grant and protocol don t match, it may also be as there was a change in scope on the grant and, therefore, it s not the IACUC protocol that needs to be amended. 28
When May Congruence be Determined? 29
Any time prior to grant award Prior to the conduct of any animal work 30
Where to Look in the Grant? 31
Vertebrate Animals Section Research Strategy Section 32
PHS 398 Section 10 Vertebrate Animals 1. Description of Procedures: Provide a concise description of the proposed procedures. Identify the species, strains, ages, sex and total number of animals by species to be used. 2. Justifications: Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model. 3. Minimization of Pain and Distress: Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize pain and distress. 33
PHS 398 Cover Page Supplement - Vertebrate Animals Euthanasia - State whether the method of euthanasia is consistent with the recommendations of the AVMA Guidelines and, if not, describe the method and provide a scientific justification. 34
What if Not Congruent? 35
Procedure in the grant but not in the protocol Ask PI for clarification PI determines if there is a change in scope Modify the protocol to be consistent with the grant No plan to perform the procedure indicated in the grant Institutional documentation Further action would be determined by whether this constituted a change in scope (stay tuned..) 36
Procedure in IACUC protocol is not in grant Ask PI for clarification PI determines if there is a change in scope 37
What are Some Indicators of a Change in Scope? 38
NIH Change in Scope The grantee (PI) must make the initial determination of the significance of a change and should consult with GMO to communicate any change in scope to the NIH Grants Management Official of the Sponsor NIH Institute if the contact is determined necessary. 39
Change in the specific aims approved at the time of award Substitution of one animal model for another Change from the approved use of live vertebrate animals Shift of the research emphasis from one disease area to another 40
What if There is a Change in Scope? 41
If PI determines there IS a change in scope: PI, through the Authorized Organization Representative (AOR) at Northwell, contacts NIH Grants Management Officer to obtain approval of change (e.g., change of species or procedure) 42
What if There is No Change in Scope? 43
PI provides explanation that institution may file with the congruency review documentation 44
Scenarios 45
Scenario #1 Bill s Biotech Company is a newly formed and very small biotech company. You are the company president and also serve as the Institutional Official. The rest of your staff consists of six scientists, two animal caretakers, a facility manager, and a receptionist. Two of the scientists serve on the IACUC but both the non-affiliated and the non-scientist member of the IACUC are not employees of the company and are paid a small stipend for their services. The services of the Attending Veterinarian are secured by a contract. 46
As a startup company, it is imperative for you to conserve your resources. You need to determine who will review the grant application to ensure congruency. As a group, decide who this individual(s) will be and provide a justification for your decision. 47
Someone who is qualified to identify inconsistencies and understands the IACUC protocol review process. Since the point is to conserve resources, this could possibly be.. o the President himself, o one or both of the scientists on the IACUC o the facility manager if they are qualified o the receptionist? Doubtful. 48
A researcher in your institution has a project involving pet rocks but has determined that the use of bull frogs would be a better model for his research. 49
Would this be considered a change in scope and, if so, what actions should be taken? As a group, discuss what action should be taken. 50
Scenario #2 Key Points of Consideration Yes, it would be considered a change in scope as it s a change to the use of vertebrate animals. PI, through Authorized Organization Representative (AOR), contacts NIH Grants Management Officer to obtain approval of change (e.g., change to the use of vertebrate animals) 51
References 52
NIH Grants & Policy Statement - Part II, A, 4.1.1.2 Verification of IACUC Approval 8.1.2.5 Change in Scope https://grants.nih.gov/policy/nihgps/index.htm VAS Checklist - http://grants.nih.gov/grants/olaw/vaschecklist.pdf OLAW Frequently Asked Question D10 https://grants.nih.gov/grants/olaw/faqs.htm#623 OLAW On-line Seminar: Grants Policy and Congruence - June 7, 2012 https://grants.nih.gov/grants/olaw/educational_resources/we binar_06072012.htm Memorandums of Understanding https://grants.nih.gov/grants/olaw/references/mou_nsf.htm https://grants.nih.gov/grants/olaw/references/mou_olaw.htm 53
Thank You 54