A. Fiscal Procedures and Policies:
1. Facilities to be provided by Grantee Institution:
a. The grantee institution is expected to provide all necessary basic facilities and services. These include those that normally could be expected to exist in any institution qualified to undertake orthopaedic research.
b. In particular, it is expected that the grantee institution will provide, whether from its own funds or from grant funds other than those of the Association:
i. Laboratory space
ii. Maintenance service, including maintenance, supplies and service contracts
iii. Telephone services
iv. Library service, including subscriptions to periodicals and the purchase of books
v. Laboratory furniture/equipment and office equipment (including electronics - computers, tablets e.t.c.)
vi. Salary of principal investigator, co-principal investigator and of secretarial personnel
vii. Worker's compensation, public liability or other hazard and special insurance
viii. Employee group life, disability, medical expense or hospitalization insurance
ix. Hospital bed expense, nursing or related services, even though used for research studies.
x. Indirect Costs
xi. Tuition expenses of personnel on grant.
2. Association funds may not be used for remodeling or building construction costs.
3. Any equipment purchased under Association grants become the property of the institution, unless otherwise specified by the Association before termination of the grant or its extensions.
B. Budget Policies and Reports:
1. Reports of expenditures must be prepared one year after receiving the award. For grants extending beyond one year, reports must be submitted every October 1st following the receipt of funds. Because the OTA uses this information for research donor recruitment, annual reports will be requested until the project is no longer active. The renewal of grant funding for the following year will be contingent on satisfactory progress during the previous funding period. Expenses must be submitted by category, i.e., Salary and Wages, Equipment, Supplies, Animals, Other. All final reports should be submitted to the OTA sixty (60) days after the grant has terminated.
2. Research reports must be prepared and submitted with the financial reports.
3. At the expiration of the grant, any unexpended balance of $100 or more must be refunded to the OTA together with the properly submitted report of expenditures and accompanying documentation. Because the OTA uses this information for research donor recruitment, annual reports will be requested until the project is no longer active.
4. Separate accounts must be maintained for each grant. These accounts, with substantiating invoices and payrolls, must be available at all times to representatives of the OTA.
5. The grantee must request permission and receive written approval from the OTA prior to making any changes to the approved budget and moving funds between budget categories.
6. The grantee may terminate a grant prior to normal expiration date by notifying the OTA in writing and stating the reasons for termination. Unexpended funds must be returned to the OTA within sixty (60) days, together with a final report of expenditures. The OTA reserves the right to terminate grants at any time upon three months written notice.
7. If a grantee has not completed the project prior to expiration, and for just reason, grantee may submit to the OTA Research Committee thirty days prior to expiration, a request for a no-cost extension, stating reason and requested period of extension. The committee will refer the request and advise the grantee.
C. Policy on Delinquent Financial/Research Reports
The OTA reserves the right to deny additional grants to any individual or institution where after proper notification, an investigator has not submitted his/her final financial and research reports. This policy will be enforced when reports are one year past the final due date (14 months after the project ends). Upon receipt of these reports, the institution shall again become eligible for OTA grants.
D. Scientific Integrity
The following policies and procedures are meant to promote the scientific integrity of OTA Research Committee (RC) sponsored research and establish an ethical foundation for fair peer-review, funding, conduct of research and dissemination of findings supported by the Association.
Peer-review and Conflicts of Interest
The peer-review process ensures the quality, relevance and feasibility of OTA funded research. It requires disclosure and resolution of all potential conflicts of interest on the parts of investigators as well as Research Committee members designated as reviewers. RC members will be selected based on content expertise and provide detailed disclosures of relevant conflicts that inform the RC chair as to review assignments. Whenever possible, such conflicts will be investigated and resolved by OTA staff and the RC Chair prior to review assignments being made. A two-tier review process will generally be followed for member grants in which initial technical and scientific merits of a pre-proposal will be peer-reviewed after which qualified full proposals will be solicited for peer-review. Resident Grants as well as certain directed topic funding mechanisms may forgo the two-tier process per the discretion of the RC or Strategic Research Initiatives (SRI) Chair, Research Council or BOD.
The Association will endeavor to create competitive funding opportunities for both open and directed topics. The RC and SRI will determine timing and member category eligibility for each designated funding mechanism, and justify any limitations to competition.
Standards of Research Conduct
E. Animal Welfare
1. The use of animals and the number of animals requested for a project must be justified by the institution. If applicable the grantee must provide IACUC approval, regarding use of and number of animals requested for a project.
2. All animals used in research supported by OTA grants must be acquired lawfully and be transported, cared for, treated and used in accordance with existing laws, regulations and guidelines. Decisions as to the kind and sources of animals that are most appropriate for particular studies must be made by scientists and institutions. OTA policy requires that such decisions be subject to institutional and peer review for scientific merit and ethical concerns and that appropriate assurances be given that NIH principles governing the use of animals are followed.
F. Human Subjects Research
1. The use of human subjects and sample size must be justified. If applicable, IRB statements from the institution's human subjects committee must be provided. IRB approval is required for patients' retrospective reviews and the review of medical records, including radiographic studies.
2. OTA grantees are entrusted to assure adequate protection of human subjects. NIH regulations regarding human subjects should be followed.
G. conflict of Interest
All potential conflicts of interest will be investigated and resolved by OTA staff and the RC Chair prior to proposal review assignments. Should additional/new conflicts come to light during the review process or anywhere during the execution of the work, the RC should be immediately notified in order to begin an inquiry and reconciliation process with the grantee. The RC reserves the right to suspend or terminate funding should the conflict fail to be resolved.
H. Research Misconduct
Research misconduct is defined as plagiarism, fabrication or falsification in proposing, performing or reporting research. A finding of research misconduct requires a significant departure from norms accepted by the research community; must have been committed intentionally or recklessly; and allegations must be supported by a preponderance of evidence. Suspected cases of research misconduct will be reviewed by the RC chair who will present allegations to the investigator of interest and invite a response. Based on this information, the RC chair, in deliberation with the Ex-officio Research Council Chair and BOD, will have the authority to determine whether research misconduct has been performed and determine the appropriate action. Depending on the severity of the allegations, such actions may include conditional consideration for funding, disqualification of a proposal, or suspension of a particular individual or group from future OTA funding.
I. Policy on Transfer of Grant
3. If the Grant has not started at the first institution and the principal investigator moves to a new institution, the principal investigator can request a transfer of funding to the new institution.
4. If the principal investigator is an orthopaedic surgeon and moves during the course of the grant, the request to take the grant to the new institution will be referred to the Research Committee. The investigator also must submit a letter enclosing resources, personnel and curriculum vitae of investigators at the new institution.
J. Policy on Changing Aims of Grant
If the principal investigator and collaborators find that the original aims of the grant cannot be accomplished, and that to continue the project
substantial changes in aims or methodology must be considered, the principal investigator must write to OTA, requesting permission to change the procedure and state the reasons for the change. The Grants Board will respond to the principal investigator.
K. Delay in Grant Activation
The activation of a research development grant by the Principal Investigator must start no later than 12 months from grant award notification letter. A Principal Investigator who is unable to begin his or her grant on its designated start date must relinquish the award and reapply.
The Association encourages free publication of research findings by grantees but requires that the following acknowledgment be used as a footnote on the first page of the text:
AIDED BY A (corporate sponsor, if any) GRANT FROM THE
ORTHOPAEDIC TRAUMA ASSOCIATION
Also, when a grantee presents a paper at a professional scientific meeting, the above credit line must be included.
The OTA imposes no restrictions on copyrighting publication by grantees.