Office of Grants and Sponsored Research IRB, IACUC and Grants Administration Coastal Carolina University

1. Office of Grants and Sponsored ResearchIRB, IACUC and Grants AdministrationCoastal Carolina University

2. Institutional Animal Care & Use Committee (IACUC) Regulatory Agencies • USDA: United States Department of Welfare • AWA: Animal Welfare Act • OLAW: Office for Laboratory Animal Welfare • NIH and NSF • AAALAC: association for the Assessment and accreditation of laboratory animal care • AALA: American Association of Laboratory Animal Science

3. The IACUC committee is composed of: • Compliance officer (non voting) • Chair • Veterinarian • Users (4 to 6) • Non scientific non user • Community member

4. Role of the IACUC • Protocol Review • Program Review • Facilities Review • Address animal concerns • If any employee, student or guest feels that there is animal abuse, they can contact the Institutional program officer and file a report through the Office of Grants and Sponsored Research. • Must meet at least twice a year; generally meet monthly • Inspect all animal use facilities (vivarium, labs, farm) at least twice yearly

5. Areas of Oversight • General Animal use: • Oversees the use of ALL vertebrate animals for teaching and research • Where, how, when and how many • Housing and general care of animals • Includes standard operating procedures and sick animal procedures • Oversees all surgery procedures and research protocols • Record keeping for animals • Drugs: DEA and other drug use • Euthanasia training and oversight • Occupational health and safety • Chemical use • Certifications for staff: researchers and caretakers • Training: • General IACUC policy/procedure • Care and handling of animals

6. IACUC protocols: • Deal with several different issues than IRB protocols • Animal species, number and source • Pain and stress classification and justification • Housing • Infectious disease, chemicals, food chain issues, etc. • Description of study/experimental methods • Justification of numbers/species/alternatives to animal research • Prevention/monitoring of Pain and distress • Euthanasia • Alternatives to animal research must be addressed and you must demonstrate why your research cannot be implemented without the use of animals.

7. Pain and Stress Classifications • Classification A No pain, distress, or use of pain-killing drugs. (i.e. post-mortem tissue harvest; and routine procedures causing only transitory discomfort such as venipuncture, injections, ear tagging, use of non-inflammatory adjuvants) • Classification B Pain/distress with appropriate analgesic/anesthesia/tranquilizers. Procedures involving accompanying pain or distress to the animals and for which the appropriate anesthetic (for surgery), analgesic (for inflammation or pain) or tranquilizing drugs are used. • Classification C Pain/distress without appropriate analgesic/anesthesia/tranquilizers. Procedures involving accompanying pain or distress to the animals and for which the appropriate anesthetic, analgesics or tranquilizing drugs are not used.

8. Must be able to answer to several following committees and issues: • _____Yes _____No Behavioral Studies • _____Yes _____No Trauma • _____Yes _____No Client-owned animals (provide a copy of the consent form the owners will sign) • _____Yes _____No Animals are sent to slaughter or put into the human food chain • _____Yes _____No Euthanasia and harvesting of tissue only • _____Yes _____ No Chemicals (i.e. carcinogens, mutagens, reproductive toxins, or highly toxic substances) • _____Yes _____No Radiation (i.e. irradiation, radio labeled substances, sealed radioactive sources, lasers, etc.) • _____Yes _____No Infectious Agents (bacterial, viral, fungal, etc, human blood and bodily fluids are considered potentially infectious) • _____Yes _____No Use of recombinant DNA • Please note for any of the items below checked “yes” you must attach the designated completed appendices (All protocols must include a completed Environmental Health & Safety Risk Assessment, Appendix A) • _____Yes _____No Included a completed Appendix A • _____Yes _____No Animals classified in stress levels B or C from Section II –Appendix B • _____Yes _____No Housing of animals outside of the approved housing areas for more than 12 hours – Appendix C • _____Yes _____No Survival Surgery – Appendix D • _____Yes _____No Non-Survival Surgery – Appendix D • _____Yes _____No Immunization, antibody production, ascities production, or collection of other body fluids. – Appendix E • _____Yes _____No Dietary manipulations or fluid restriction – Appendix F • _____Yes _____No Conscious Physical Restraint – Appendix G • _____Yes _____No Free-ranging wildlife – Appendix H • _____Yes _____No Breeding of Animals – Appendix I

9. Protocol Review • Any animal used in teaching or research must be covered by an approved IACUC protocol. • PI’s name is on the protocol • Any graduate students • Any other students who will work on the protocol • Also any staff • All must pass the IACUC quiz to demonstrate knowledge of the guidelines • Protocols are initially approved for 1 year, and can be renewed for up to three years. After that, the project must be completely re-reviewed. • Research can proceed or continue only with an approved IACUC approved protocol • Cannot keep animals that are not covered by an approved protocol. • Any significant change to the protocol MUST be approved before implemented. • Only faculty can serve as principal investigators • They are criminally liable for any abuse • The appropriate care and use is part of their job description, and faculty can be fired for misuse. • Faculty are responsible for overseeing students and their staff, and are responsible for reporting abuse, etc.

10. Office of Grants and Sponsored Research What Needs IRB Review and Approval? Coastal Carolina University

11. Research with Human Subjects • Any research activity involving human subjects conducted by CCU faculty, staff, and students must be reviewed and approved for compliance with regulatory and ethical requirements before it may be undertaken. • These activities include a wide variety of procedures such as, but not limited to, collection of data through surveys or observation, collection of data from subjects exercising or participating in an activity, research on medical records, and research using existing pathological specimens, discarded tissue or secretions.

12. Research • A systematic investigation, including research development, testing and evaluation, designed to develop or to contribute to generalizable knowledge, or • Activities portrayed (explicitly or implicitly) by faculty, students, or staff as “research”, or • Work that is intended to fulfill requirements for a master’s thesis, doctoral dissertation, or other research requirements of the University.

13. Not Research • Data collection for internal departmental or other University administrative purposes. • Program evaluation carried out under independent contract for an external agency that is for their internal purposes only. • Course-related activities (research methods instruction), unless these lead to public presentation or publication • Faculty may certify these as Exempt (or not).

14. Human Subjects • A living individual about whom an investigator conducting research obtains • 1) data through intervention or interaction with the individual, or • 2) identifiable private information. • Intervention includes both physical procedures by which data are gathered or manipulations of the subject or the subject’s environment that are performed for research purposes. • Interaction includes communications or interpersonal contact between investigator and subject.

15. Exempt Research (45 CFR 46.101b(#)) • A project is exempt from IRB review if all of the research activities fall into one or more of the categories designated by federal regulation. • Exemptions pertain to legal adults in non-compromised situations. Projects involving interaction with prisoners, persons incompetent to provide valid consent, pregnant women where pregnancy is the focus of the research, and fetuses in utero cannot be exempt. • Experiments, interviews, and surveys with children are not exempt.

16. Categories of Exempt Research • 1. Research conducted in established or commonly accepted educational settings, involving normal educational practices. • 2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation. • 3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. • 4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. • 5. Research and demonstration projects, which are conducted by or subject to the approval of the federal government, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. • 6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the federal government.

17. Pre-Award Issues • Pre-Award Spending is any spending incurred by the PI in advance of the award start date. Pre-award spending is only allowed when a sponsor authorizes such spending in writing. Most government grant sponsors allow pre-award spending within the 90 days prior to the start of the award if the advanced funding is necessary for the effective and economical conduct of the project.However, other sponsors limit or do not allow pre-award costs. The University policy, contract, or award letter will specify if pre-award expenses are allowed. • CATCH: If the award does not materialize or the start date of the project is delayed the award will not cover the expenses incurred and the Principal Investigator will most likely have to pay for the expenses from his or her unrestricted funds. Pre-award expenditures are made at the PI’s own risk!

18. Pre-Award Issues • Federal and state requirements place restrictions on the total amount of time available for research, service and instructional activities. Overload is specifically described in the Faculty Manual.In general, combined individual effort on grants and contracts and all other activity cannot exceed 100%. • If a grant involves human subjects, animals, or biohazardous materials, the PI must obtain IRB approval prior to submitting/ beginning the funded research. Although most federal agencies no longer require approval at the time the proposal is submitted, you need to seek immediate approval when you know that your grant is going to be funded. CCU’s IRB MUST have at least two weeks to review a submission. Additionally, you need to be aware that some sponsors will not process a proposal without IRB approval.

19. Post-Award Issues • OGSR accepts the award. • Grants Accounting sets up an account for the project at the request of OGSR. • OGSR will issue a Notice of Award to be sent to the PI, Dean, Grants Accounting, Media Relations and any other required departments. • The PI conducts the research, spends the funds in accordance to sponsor requirements. • OGSR and/or Grants Accounting notifies the PI of close-out dates. • The PI submits its final technical report, Grants Accounting submits the final financial report. All numbers match, the account is audited and closed. The PI publishes its paper and moves on to other projects. • In a perfect world this is how a grant proceeds!

20. Post-Award Issues • You have been awarded but the budget was increased or reduced, and you need to revise your budget. • Pre-Award spending may take a large amount of your budget. Additional university resources are needed to conduct the project. • The PI will have to renegotiate and/or adjust the parts of the project such as: subcontracts, material, travel expenses, supplies, etc. • Your senior personnel is no longer available/willing to conduct the project or have moved to another institutions. You may have to change or increase the effort of other senior personnel effort has been increased. CCU will have to approve and changes in the time-commitment, which may conflict with other previous commitments. • A subcontractor may be unable to participate in the project if the funds have been reduced. • Your F&A costs have been decreased by more than 25% and additional in-kind and/or matching funds are required. • Solution: negotiation! That’s why we have a grant proposal and not a contract! Once you receive your award and you verify the need for adjustment please contact the OGSR to start the negotiation process. • CATCH: Negotiations need to start in the beginning of the project. If a PI waits until the last month of the project to point out discrepancies between the proposal and award the sponsor is unlikely to negotiate terms & conditions.

21. Post-Award Issues • Allgrants/contract/subcontracts must be reviewed and approved by OGSR and, if necessary, by risk management and legal departments. OGSR needs to ensure that: • Terms and conditions that negatively affect the University or that are inconsistent with the State or CCU’s guidelines have been removed; • Legal issues such as: applicable state law, venue, insurance, indemnification, etc. have been addressed in accordance with SC Law; • SC State Restrictions have been taken into consideration; • Changes in scope of work and/or in the budget are acceptable; • Billing issues; • Procurement issues. • Program and/or policy changes within CCU may impact the project. CCU will require further review and possible declination of the award. • CCU reserves the right to decline any award. Before an award can be accepted, a formal notice and/or agreement binding the sponsor to pay the costs of the grant must have been received and approved by the university.

22. Funding Issues • The most common misconception in research is the idea that because the project was developed by the PI, that the funds awarded by the sponsor belong to the PI, when in fact the money is awarded to the University. So how does CCU receive the money? • Grants expenditures – basics • Cost-reimbursable: The PI spends the funds through a University account. The University bills the sponsor and the sponsor reimburses CCU for those funds that were spent. • Fixed price: All costs are allowable and the money is generally paid up front. • % Completion or Task Completion: The PI completes pre-determined phases or milestones and the sponsor pays for that portion of the work. • Fee for service. More common in contractual arrangements. Fee for service can be measured by task, hour, etc. • Please remember that all awards are accepted by CCU. CCU is the steward of the money and the responsible party if any project funds are mismanaged.

23. What You Need to Know on Spending • Allowable Costs - Almost all sponsors put restrictions on what can and can’t be purchased with grant funds. These vary from grant to grant and there are significant differences between requirements of federal and non-federal sponsors. Federal Grants require that a cost be determined and reported in accordance with accepted accounting principles. For general grant conditions, see OMB Circular A-21 andA-122. • Also, a PI must be able to demonstrate that charges can be directly tied to the unique needs of the project. For example, a generic computer would not be allocable. A special software to be used exclusively for project needs would be allowed. In addition, other costs such as communication costs, conferences, equipment, travel, etc. may be considered as unallowable if the sponsor determines that said costs were not directly related to the project. • Except as provided by Federal Law, an allowable cost cannot be included as a cost or used to meet cost sharing or matching requirements of any other Federal award in either the current or a prior period, not prohibited under State or local laws or regulations, and be accorded consistent treatment. (i.e., direct versus indirect costs) • Reasonableness of costs – a charge must reflect the price range that a prudent individual would pay for the item or service. • Consistency – All charges must be consistent with university standards. For example, you cannot pay students an excessive amount because they are grant supported. Their pay must fall within the consistent patterns of compensation on the campus. • BE ADEQUATELY DOCUMENTED. In case of doubt ask for guidance !!! University guidelines on procurement can be found on the CCU website: http://www.coastal.edu/procurement/

24. What You Need to Know on Budgets • Some sponsors allow for great flexibility in budgets as long as the project is appropriately managed, however, some will place restrictions on these lines and how you may move money between them. • How do you know? Check with the OGSR or Grants Accounting. This information also appears on the Notice of Award. • Does this means that as long as the my account is in the black I can spend the money? No!!!Over expense can bring a world of problems. The best way to do it is to re-budget within the grant guidelines. • Why is this a problem? Over expense in one category may affect the fringe benefit line or alter the Indirect Cost line; sometimes this won’t be apparent until the end of the grant, not to mention that if the sponsor elects to keep the budget as it is someone will have to absorb the cost of “over expense”. • The PI needs to see and approve all transactions; for example, the office doesn’t approve timesheets or see when a purchase order has been modified. • Once the PI approved the expenses Grants Accounting process the invoices in accordance with the grant guidelines. • Please remember that budget flexibility is not a synonym for budget creativity!!!!

25. What You Need to Know on Budgets • Budget – A PI should consider the budget as a financial blueprint designed to help the project to meet its goals and objectives. A budget is a tool to help ensure that the project is on track. Changes in scope, objectives or goals of program will affect the budget. Depending on the grant, CCU has expanded authority to re-allocate up to 10% of the budget. • Personnel – Substantial changes in level of participation by any personnel have to be approved by the PI and by the sponsor. • Cost sharing – Any and all cost sharing must be verifiable from CCU’s records. Cost sharing is considered as necessary for accomplishing program objectives; thus, all cost sharing has to be considered as an allowable cost in accordance to the OMB cost principles (OMB Circulars) and grant provisions. (i.e. Must not be included as contribution for other federally-assisted programs) • In-Kind - In-kind contributions have to be documented using the same standards as other expenditures, and they must be entered into the general ledger and financial reports submitted to our sponsors. • Report Requirements - Why is this a problem? Sometimes PIs forget to tell Grants Accounting that they have turned in a report; or worse, sometimes the PI does not turn in a report and Grants Accounting cannot send the final invoice without that information. Late reports reflect on the University. A sponsor may decline to pay if the bill comes in too late. Additionally, some sponsors are restricting access to new funding opportunities if a PI does not deliver a final report.

26. What You Need to Know on Budgets When in doubt ask for help!!!Even experienced research administratorsmay have problems navigating a complex budget… • Expenditures past end date • Keeping up with salaries as encumbrances • Monitoring expenses on multiple awards • Reconciling grant budgets • Unallowable expenses in last month of project; for example, some sponsors will not allow purchase of equipment during the last quarter of a grant period • P Card, phone and postage charges that may be posted several weeks after the end of a project • Monthly Fund Review - The single most important thing a PI can do to ensure good financial management of a grant is to schedule 30 minutes per month to review expenditure activity for the previous month. Monthly transaction review enables prompt correction of errors. Monthly status review enables the PI to assess the spending rate. (If 50% of the grant has been spent after only 30% of the time has elapsed, the spending rate may need to be reduced to enable funds to cover the entire project period. Alternatively, if 50% of the grant period has elapsed and 75% of the funds remain, adjustments may be made to devote more resources to the project.)

27. Subcontracts, Amendments & Extensions • Technically, any subcontractor is bound by the same terms and conditions as CCU. Therefore, the PI – not OGSR or Grants Accounting – is responsible for the review and approval of any invoices submitted by a subcontractor. • In the event a project changes and you need to modify the scope of work and budget of your subcontract, an amendment has to be processed by OGSR BEFORE Grants Accounting starts paying the subcontractor for the revised services. • CCU reserves the right to decline any invoice that is discrepant or not submitted in accordance with the budget lines of any approved subcontract. • No-cost extensions can be requested prior to the end of an award to obtain additional time to complete the work of the study and/or prepare technical reports. This also extends the time until final financial reports are due. No-cost extensions are NOT appropriate to provide time to spend down balances left at the end of the grant. Granting of no-cost extensions can vary greatly between federal and non-federal sponsors.Please remember that any no-cost extension will likely impact the subcontracts you may have, and it is important to submit the OGSR-4 form to the Grants Office within at 90 days prior to the end date.

28. A Word on Accountability • CCU holds the PI accountable for the conduct of a funded project. • All financial items must be signed by the PI unless he/she has designated someone else. • Any charges “left over” OR “disallowed” by the sponsor are the responsibility of department. • Any time a PI suspects a budget error, the PI should contact Grants Accounting and ask for assistance. • PIs and departments are strongly encouraged to maintain a mechanism of internal control in order to avoid overdrafts on grant accounts.

29. Account Close Out • Close outs should be added to the PI’s calendar at the beginning of the grant • PI is responsible for final program reports. The schedule for reporting is included on the original Notice of Award. • PI’s and their departments should be sure to terminate all open personnel actions and p.o.’s, & reconcile open travel requests and reimbursements prior to the end date of the grant award. No expenditures allowed past end date.

30. Unspent Grant Funds • Grants – if CCU was paid in advance, unspent funds usually have to be returned to the sponsor • Contracts – If awarded as a fixed price agreement and balance remains after deliverables met, a “residual” fund or 17 account may be established to continue research or scope of project. 17 account funds should be spent within two years of the end of the grant. • All other agreements are subject to return of unspent funds. • Some sponsors require notification of unspent funds so they can re-appropriate.