Grants : The Devil really IS in the details

1. Grants : The Devil really IS in the details Presbyterian College School of Pharmacy October 24, 2011 Genevra Kelly

2. Recap – what we know thus far • There are multiple grant sources one can approach – federal, corporate, private • An understanding of the funding source – priorities, process, and timelines - is critical to success • Good proposals don’t happen overnight – planning is essential • A “cold” approach usually means a cold response • Read the fine print; never assume • Follow the rules

3. Things to remember • We are new at sponsored research administration. • We would rather over document something to be sure we have addressed all liability issues. • Some things (forms, processes, protocols) we are inventing as we go. • We will refine and improve the things we invent as we have more time. • Goal is to be 100% compliant with federal, funding source, and college regulations. • Eventually this will be as natural as breathing.

4. The Big Stuff- IRBs, budgets, and other “stuff” • Proposals have multiple components. The areas that can cause long term issues if we don’t do them right are: • Overall chain of command approval- department Chair, Dean • IRB approval • Budget • Requested documentation • Reporting • Legal

5. In the beginning – Internal protocol • Grant ideas and grant announcements – approval to pursue • Review your idea with your department chair and get approval to pursue. • Write a focused paragraph describing what you wish to do, how much money you think you will need to do it, and an estimated timeline for completion. • Discuss initial IRB and budget needs with your department chair. • Talk to GK about where you might look for a funding source, IRB, and budget.

6. Internal Protocol: A brief word about IRBs Institutional Review Boards (IRBs) are administrative bodies with authority to approve, require modifications, or discontinue research at their institutions. Compliance may also be ensured by FDA audits where appropriate. IRB guidelines address protection of subjects’ rights and welfare, minimization of risks, risk: benefit ratios, recruitment and selection of subjects, informed consent, and confidentiality.

7. PCSP - IRB approval • For the purposes of the IRB, research falls into three categories: • EXEMPT—No review required but there are additional requirements regarding confidentiality, possible damage (criminal or civil), participation, relationships to researcher (students to faculty), children or other subjects with impaired abilities. Some examples of exempt research are: • Research involving the collection or study of existing data that is publicly available or recorded so that subjects may not be identified • Research conducted in established or commonly accepted education settings involving normal educational practices • Research involving only observation of public behavior • Research involving only surveys or interviews • Research involving only taste and food quality evaluations

8. IRB approval- continued • EXPEDITED REVIEW—review of protocol by one or two members of the IRB. Applies to certain types of low or minimal risk research. Minimal risk means that probability or magnitude of physical or psychological harm does not exceed that encountered in ordinary life or during routine physical or psychological examination or tests. Some examples of research requiring expedited review are: • Collection of hair or nail clippings (in a non-disfiguring way), deciduous teen and permanent teeth if patient care indicated need for extraction • Collection of dental plaque, e.g., calculus • Voice recordings

9. IRB approval: expedited, continued • Moderate exercise by healthy volunteers (Follow: ACSM's guidelines for exercise testing and prescription. Schoenbaum Library call number 615.824 B18a6 2000) • Study of identifiable existing data, documents, records, specimens not otherwise exempt • Research on individual or group behavior or characteristics (e.g., game theory) • Collection of excreta and external secretions • Recording of data using noninvasive procedures • Collection of blood samples by venipuncture

10. IRB approval- continued • FULL REVIEW—review of protocol by a quorum of IRB members from a federally assured IRB. Necessary for research involving risk of physical or psychological harms greater than that encountered in daily life or during routine examinations or tests. • PLEASE NOTE: There are additional requirements regarding consent and protection of identity whenever children (under age 18) or subjects with impaired ability to consent are involved.

11. PC and PCSP- IRBs Currently, we have access to two IRBs. There is an internal IRB that we estimate will handle 65%-80% of our current IRB needs. Dr. Meg Franklin is the chair. We are contracting with an federally assured IRB at Self Regional Hospital System to cover the remaining IRB needs. Access to this IRB also works through Dr. Franklin.

12. When do I need an IRB? • All proposals that have any kind of human subject contact should have formal IRB documentation for one of the three categories on file. • Discuss with your department chair what type of IRB approval you think you will need. Once you have your paragraph description, confirm your need on the front end of the proposal process with Meg and Genevra. • If in doubt, ask. We would rather ere on the side of being too cautious than not cautious enough. • Carefully review your proposal preparation window. If your proposal falls outside the exempt category, be sure that you have enough time to prepare your proposal and get IRB approval before the proposal is due. • Coming soon- website with more details

13. Budgets x 2 There are two types of budget rules to follow as you develop a grant: • Those set by the funding agency; and • Those set by the college. The college rules rule (except when they don’t - example: ACC) There are two types of budgets and budget categories with which you will work during the life of your grant: • The actual research grant budget in the format required by the funding source; and • The college budget as it relates to your research grant budget.

14. Budgets- how do I find the rules? Grant – in the fine print in the RFPs. Read carefully to determine format, allowable costs, time period, etc. Note that part of your budget will also involve tracking your time and this is cumulative across all your grants. College- college website at www.presby.edu/busofc. (Currently under revision so if you don’t see something you need, check with me). Ask for help in developing your budget if you need it. Talk to your department chair, me, or our colleagues in the business office. Note: Our business office colleagues would much rather start you off with a correct budget on the front end than deny reimbursement on the back. Indirect cost rates are currently in negotiation.

15. Budgets – another word • All grant proposals will require detailed budget review by your department chair, me, the college business office, and the Dean before they can be finalized and approved for submission. • Why the order? • Your department chair and I will plant and weed. • The business office will help you do the math according to the rules. Their help on the front end will render the required reporting and reimbursement processes much easier. It also avoids issues with auditors. • By the time your budget gets to the Dean for his final approval, it should be complete and correct.

16. The best laid plans… • Read thoroughly not only the RFP, but the application guidelines. • Look for issues – a too short application window, qualifications we don’t meet, documentation we may not yet have, etc. Ask others (me included) to look as well – things get buried. • Don’t assume (particularly with the feds) that something that looks like a small thing is actually a small thing you can fix with a phone call or send later. Better to ask up front. • We find new stuff every day.

17. Examples of said “plans”, in the eyes of the feds • Sometimes you have to go through steps you didn’t know about that require registration and approval. Federal approval is not usually a next day thing. • Sometimes federal funding agencies require written institutional policies that we may not yet have. • Sometimes the application windows are too short to be viable or even already closed before the announcement is posted. • Sometimes the thing that disqualifies you is on page 159 of a 237 page application guide. You want to find this before you invest time in the proposal. • Sometimes looks can be deceiving. While the federal agencies may all look the same, rules vary.

18. Requested, reporting, and legal • Requested documentation – • Check to see if we have “it” Examples of “it”- policies, procedures, forms, etc. • If we don’t have it and you know you are going to need it, let me know immediately what it is. I’ll try and find it. • We may have it but have to rewrite it, or we may not have it so we have to create or invent it. In either case, the sooner we know the better.

19. More r,r, and l • Keep an electronic paper trail of everything you do, preferably by grant project. • Copy me on what you do. We will be keeping a database to house the details (i.e. official paperwork) of your funded research and project work. The documentation will be necessary for both your reporting and overall institutional accountability. If you are not sure you should keep something, ere on the side of caution. Think 3-7 years, like the IRS.

20. Reporting x 2 (déjà vu’) Two types of reporting: • reports required by the funding source or agency; and • reports required by your department. Review and understand what the reporting requirements are. Note the dates. Be realistic in your estimates of time needed to prepare. Note what help you may need and from whom. Ask for it early. Note on help: The raw materials of these reports are required and your responsibility. I and others may help you and I may submit them, but you construct them.

21. Legal eagles • The college has good legal counsel available when needed. • This requires approval from the Dean and EVP for Finance (it’s expensive). • Keep me and your department chair posted on anything you think might be a legal issue. Examples include intellectual property questions or human subject research that goes horribly wrong (i.e. Frankenstein). • Not everything that appears to be a legal issue is; in most cases we will be able to resolve either through internal resources, consulting with a program officer at the agency or funding source, or consulting with a sponsored research office at another institution.

22. Now that all is clear (as mud) for today… The big stuff: • Chain of approval • IRBs and budgets • Documentation and reporting • Resources • Genevra Kelly – gkelly@presby.edu, 938-3831 • Meg Franklin – mafrank@presby.edu, 938-3835 • Business office - Min Zhang – mzhang@presby.edu • The buddy system- your chair, your colleagues, your former colleagues