FREQUENTLY ASKED QUESTIONS
MUOT Sponsored Projects
Policy (# 03-001)
Who's Who in MUOT Research and Grants Administration?
Are There MUOT Policies Particularly Important to Investigators?Archive of Previous "Do You Know" Queries
Are There MUOT Committees Which Are Particularly Important to Investigators?
Did My Proposal Arrive in Time? [Provides Links to Overnight Courier Tracking Sites]
ABOUT NIH GRANT PROPOSALS:
ABOUT OTHER RESEARCH-RELATED TOPICS:
WHY IS A WRITTEN AGREEMENT NECESSARY FOR A CLINICAL TRIAL?
WHO IS AUTHORIZED TO SIGN A RESEARCH AGREEMENT FOR MUOT?
HOW LONG DOES IT TAKE FOR A CLINICAL STUDY AGREEMENT TO BE APPROVED?
HOW SHOULD PAYMENTS FROM THE SPONSOR BE SCHEDULED AND HOW DO I SPEND THE MONEY?
HOW ARE FACILITIES & ADMINISTRATIVE COSTS (FAC) DETERMINED?
HOW ARE PUBLICATION RIGHTS PROTECTED?
HOW IS CONFIDENTIAL INFORMATION PROTECTED?
WHAT ABOUT PATENT RIGHTS?
WHY IS IT NECESSARY FOR THE SPONSOR TO INDEMNIFY (i.e., HOLD BLAMELESS OR HOLD HARMLESS) MUOT?
WHY CAN'T MUOT INDEMNIFY A SPONSOR?
WHAT IF THE STUDY IS TERMINATED EARLY?
WHY IS IT NECESSARY FOR HOSPITAL ADMINISTRATION TO REVIEW CLINICAL RESEARCH BUDGETS?
WHEN IS INSTITUTIONAL REVIEW BOARD (IRB) APPROVAL NECESSARY FOR A STUDY?
AT WHAT POINT SHOULD THE PROCESS FOR IRB APPROVAL BE INITIATED?
MUST I CONTINUE TO MAINTAIN IRB APPROVAL EVEN IF PATIENT ACCRUALS HAVE BEEN CLOSED?
WHAT IS THE INTERNAL REVENUE SERVICE FORM W-9, WHICH THE SPONSOR ALWAYS SENDS?
DO I HAVE A CONFLICT-OF-INTEREST IN PERFORMING RESEARCH FOR A PARTICULAR SPONSOR?
CAN THE PRINCIPAL INVESTIGATOR OR CO-INVESTIGATORS/COLLABORATORS BILL THE GRANT ACCOUNT THROUGH APMUOT FOR PROFESSIONAL SERVICES PROVIDED FOR STUDY SUBJECTS?
WHAT HAPPENS TO MONEY REMAINING IN THE GRANT ACCOUNT WHEN THE STUDY IS COMPLETED?
WHO OWNS EQUIPMENT PURCHASED WITH GRANT FUNDS OR PROVIDED TO MUOT BY A SPONSOR IN ASSOCIATION WITH A GRANT OR RESEARCH AGREEMENT?
TO WHOM SHOULD SPONSOR'S CHECKS BE MADE PAYABLE AND WHERE SHOULD THEY BE SENT?
CAN TREATMENT OF A SINGLE PATIENT CONSTITUTE "RESEARCH"?
When a pharmaceutical company or any other Sponsor funds research at MUOT, the parties must sign a written agreement (contract) that defines the scope of work, establishes acceptable payment arrangements, and addresses important issues such as the right to publish research results, protection of confidential information, assignment of patent rights (in the event a patentable discovery is made), and indemnification in case of injury. MUOT, as a state institution, also has certain statutory restrictions under the Ohio Revised Code which must be adhered to in these contracts.
MUOT has developed a standard research agreement that can be used for investigator-initiated research sponsored by a company or for company-initiated research in which an investigator participates, if the Sponsor will accept the terms of this agreement. The terms of this agreement have received prior approval of the MUOT legal counsel, thus minimizing approval delays.
2. WHO IS AUTHORIZED TO SIGN A RESEARCH AGREEMENT FOR MUOT?
Authority to negotiate and execute research agreements is delegated by the Board of Trustees to a few MUOT officials. This responsibility for research agreements rests with Research and Grants Administration. Research agreements are generally signed by the Associate Vice President for Research. The Board of Trustees has authorized certain MUOT officials (including the Associate Vice President for Research) to commit the institution to externally sponsored programs. See (
Grants or agreements, for clinical trials or other research, involving MUOT faculty cannot be entered into between individual faculty members and a sponsoring agency or corporation. Such agreements must be between MUOT and the agency or corporation, with the faculty member designated as the Principal Investigator. Individual faculty members are not authorized to sign research agreements on behalf of MUOT. THE SIGNATURE OF AN AUTHORIZED MUOT OFICIAL IS REQUIRED BY MUOT, EVEN IF IT IS NOT A REQUIREMENT OF THE SPONSOR.
3. HOW LONG DOES IT TAKE FOR A CLINICAL STUDY AGREEMENT TO BE APPROVED?
The length of time required depends on several factors:
1. Whether RGA receives early notification so that contact can be made with the Sponsor's contract office
2. Necessary internal approvals (e.g. IRB, and mch charges) being obtained as early as possible
3. The length of time required by the Sponsor for legal and other internal review of the agreement
4. The extent to which the Sponsor or MUOT needs to negotiate terms and conditions that are acceptable to both (if the standard MUOT research agreement is acceptable to the Sponsor, this time is minimal)If the Sponsor will not accept conditions in the MUOT agreement which are mandated by the Ohio Revised Code, or if the Sponsor has a slow internal review process, substantial delays can occur. In such cases, the process may take months. Research and Grants Administration rarely takes more than a few days to handle their side of the negotiations, unless the MUOT legal counsel requires more time. A common reason for delay is negotiation of the indemnification clause which appears in every agreement. As a state supported institution, MUOT is statutorily forbidden by the Ohio Revised Code to indemnify (i.e., hold blameless or hold harmless) anyone.
4. HOW SHOULD PAYMENTS FROM THE SPONSOR BE SCHEDULED AND HOW DO I SPEND THE MONEY?
Although the actual payment schedule is subject to negotiation with the Sponsor, Research and Grants Administration, and the P.I., a suggested payment schedule that is based upon the anticipated spending pattern should be developed by the P.I. MUOT cannot underwrite extensive expenses for the Sponsor, and reimbursement to MUOT should remain current with expenditures throughout the life of the study. A minimum payment of 10-20% (or payment for approximately 10-20% of the anticipated number of patients to be entered) should be requested upon execution of the research agreement. If there are unusually large start-up costs, a larger initial payment may be required. The P.I. should notify RGA if unusual costs are anticipated at the beginning of the study so that this fact may be considered in payment negotiations with the Sponsor.
Payment of the contract balance may be in installments, paid either periodically or upon enrollment of a certain number or percentage of anticipated subjects. A portion of the contract total, usually about 10% may be held as the final payment, pending receipt by the Sponsor of all completed case reports. Since most clinical trial payments are based on patient accrual, it is the responsibility of the P.I. to maintain accurate records of patient reports submitted to the Sponsor and amounts due. Research and Grants Administration may periodically request the patient enrollment status to determine if the level of expenditures is proportional to patient enrollment.
Although payments from the Sponsor are usually received by MUOT in installments, MUOT allows deficit spending in the account, to an agreed upon limit, upon execution of the agreement. This "loan" provides the P.I. with funds to begin the study, but it imposes a responsibility upon the P.I. and departmental administrators. For example, if the number of subjects enrolled in the study, or the rate of enrollment is less than anticipated, spending should be reduced accordingly. RGA should be informed of any change in conditions that may result in reduced or delayed payments from the Sponsor. The primary department/unit of the P.I. has fiscal responsibility for the account and for any overexpenditures, as agreed to on the MUOT Review and Approval Form signed by the P.I. and the departmental chair.
When checks are received from Sponsors, they are deposited into the appropriate MUOT grant account. The principal investigator, in conjunction with his or her department chair, must designate the individuals who will have authority to approve expenditures from this account. This is done on a form provided by the MUOT accounting department. Monthly budget reports describing activity in the account are mailed to the first two authorized signers. Expenditures from these accounts are monitored by Research and Grants Administration to assure compliance with appropriate restrictions. Expenditures from these accounts should be initiated by the same process utilized for all other College accounts, using the unique account number for this project. Administration of research agreement funds must be in accordance with the policies of:1. The Medical University of Ohio at Toledo
2. The State of Ohio
3. The SponsorWhen none of the above have policies governing a specific issue, policies of the Public Health Service (as defined in the most recent edition of the PHS Grants Policy Statement) will be followed. PHS policy, which governs all NIH grants, allows flexibility, yet provides a consistent policy applicable to virtually every type of research expenditure.
5.
HOW ARE FACILITIES AND ADMINISTRATIVE (INDIRECT) COSTS DETERMINED?
While the Direct Costs of research are those costs, such as personnel, supplies, equipment, etc, which can be easily assigned to each sponsored project, the Facilities and Administrative (FAC) [Formerly known as Indirect Costs or IDC] of research are those institutional costs, such as facilities depreciation and maintenance, library services and administrative support, which cannot be easily assigned to specific projects. FAC are virtually always expressed as a percentage of expenditures for direct costs. Even though funds for FAC are budgeted when a grant account is established, monies are transferred from the FAC category to the MUOT general fund only in proportion to expenditures for direct costs. For example, if the FAC rate for a particular account is 25% of total direct cost (TDC), for every dollar expended by the P.I. for supplies, 25 cents is transferred from the FAC budget of that account to the MUOT general fund. A common misconception is that MUOT "takes" its FAC up-front when the grant is awarded. In fact, MUOT generally "fronts" money for a study and must invoice the Sponsor for expenditures or for specific amounts as the study progresses. Thus, the cash position of a grant account is virtually always negative. The sum of the direct costs of a study and the associated FAC is referred to as the Total Cost.
As a publicly supported institution, MUOT must recover the cost of research done for outside Sponsors, including all associated operating costs (i.e., FAC). To do otherwise would be equivalent to subsidizing corporate sponsors' private research and development programs with tax payers' money. In addition, since most research at MUOT is supported by the Federal government (i.e., NIH) we are required to "...ensure that federal sponsors do not in any way subsidize the FAC of other sponsors, specifically activities sponsored by industry and foreign governments" (Office of Management and Budget Circular A-21, Cost Principles for Educational Institutions). Accordingly, MUOT uniformly requires for-profit sponsors to pay the FAC of doing research on our campus.
Unlike NIH grants for which the P.I. submits a budget for the direct cost of the research and NIH adds an appropriate amount of money (based upon our negotiated federal IDC rate) to cover the FAC, industrial sponsors of research typically deal with the institution and the P.I. in terms of Total Cost. Thus, whereas Federal grants come to MUOT already divided into their direct and Facilities and Administrative cost components, grants from industrial sponsors are typically based upon Total Cost and must be divided into direct and indirect components internally at MUOT. For this reason, it is essential that any discussion of budget, however preliminary, with industrial sponsors include the required institutional FAC, in addition to the money required by the P.I. to support the direct costs of the project. Fortunately, industrial research sponsors understand the need for institutions to recover the FAC of research and build this into their budgeting process, although they seldom identify FAC as a separate entity.
Although OMB Circular A-21, as noted above, requires educational institutions to charge industrial research sponsors an IDC rates no lower than our Federal rate, many institutions have attempted to simplify the FAC negotiations with industrial sponsors by utilizing a lower FAC percentage, but applying it to total direct cost (TDC), rather than to modified total direct cost (MTDC), which is the base used by most educational institutions for their Federal IDC rate. Modified Total Direct Cost consists of salaries and wages, fringe benefits, materials and supplies, services, travel and subawards up to $25,000 each. Notable items not included in MTDC include equipment, renovations/alterations, and patient care expenditures. This alternative method is especially useful for clinical research agreements for two reasons:
1) In budget negotiations with pharmaceutical companies, on those ocassions when FAC rate is discussed, companies appear to be more comfortable with the lower percentage rate (regardless of the base)
2) Using the TDC basis, rather than the MTDC basis, alleviates the problem of having to treat patient care expenditures differently from other direct cost expenditures, since patient care expenditures are excluded from the MTDC basis.
This simplified, alternative approach to FAC is acceptable under OMB Circular A-21 as long as the FAC recovered by the institution using this alternative method is not less than would have been recovered using the negotiated Federal research FAC rate. That is, if the alternative rate is 25% TDC, it must be at least equivalent to the negotiated Federal research FAC rate of 47.0% MTDC. A few institutions have done careful studies comparing such an alternative rate to their negotiated Federal rate, while others (like MUOT) merely use the lower rate assuming that it makes them more competitive.
In grant budgets, FAC are budgeted separately from direct costs simply to sequester the money designated for that purpose and so the P.I. can easily know the remaining balance available to support the direct costs of his project.
Contact Research and Grants Administration prior to submission of even a preliminary budget to a sponsor for MUOT's current FAC rate.
6. HOW ARE PUBLICATION RIGHTS PROTECTED?
A faculty member's freedom to publish research results is fundamental. Therefore, MUOT will agree to outside sponsorship of research only if the Sponsor agrees that the scientific results can be freely published. (All expenditures from any grant account MUST be justifiable as research-related. Typically, corporate sponsors claim research grants/agreements as tax deductible research expenditures. For this reason, if MUOT cannot clearly justify the research-related nature of all expenditures from grant accounts, the College may incur a tax liability for Unrelated Business Income. Recent IRS rulings suggest that a record of publication of research supported from a grant account is a key factor in determining that monies in that account are NOT Unrelated Business Income.) The Sponsor, on the other hand, may want to exercise control over publication of results by requesting publication delays, deletion of portions of a manuscript, or placing limits on the types of issues which can be discussed.
There are several reasons why the Sponsor may want to restrict a faculty member's freedom to publish:1. To prevent disclosure of confidential information shared with a faculty member
2. To prevent disclosure of information that would compromise the Sponsor's ability to patent inventions or discoveries
3. To coordinate the disclosure of results when a study is being conducted at multiple sites.These are legitimate business concerns, but they must be addressed in a way that does not restrict a faculty member's right to freely disseminate research results. The standard MUOT agreement language should meet the needs of both the faculty and the Sponsor by providing a reasonable pre-publication review and comment period. The agreement does NOT allow the Sponsor to delete material, otherwise exercise editorial control over the manuscript, or retain any right to deny publication rights.
7. HOW IS CONFIDENTIAL INFORMATION PROTECTED?
Faculty members should consult with Research and Grants Administration prior to signing any Confidential Disclosure Agreement with a Sponsor.
MUOT is committed to maintaining an open teaching and research environment. Projects requiring access to a Sponsor's confidential information will not be accepted if they entail overly broad access and use restrictions, elaborate data protection procedures or excessively long duration of guaranteed confidentiality.
Clinical studies involving use of a Sponsor's confidential information will be accepted if:1. The extent of the confidential information shared with MUOT is limited
2. The information is clearly identified by the Sponsor as being confidential
As a Ohio Public institution, MUOT is statutorily bound by the Ohio Revised Code to retain patent rights to inventions or discoveries made using State facilities. The standard MUOT agreement language does make provision for shared rights where that is appropriate. With respect to inventions by an MUOT employee or student that do not result from the direct performance of a Sponsor designed protocol, MUOT retains all patent rights. This policy is not negotiable, although MUOT may grant a right of first refusal to the Sponsor for an exclusive or nonexclusive license, depending upon the level of Sponsor funding.
9. WHY IS IT NECESSARY FOR THE SPONSOR TO INDEMNIFY (i.e., Hold Blameless or Hold Harmless) MUOT?
In the case of a Sponsor-designed research protocol, MUOT simply follows the Sponsor's instructions in carrying out the clinical study. If someone is injured as a result of the study, the Sponsor should bear the ultimate financial responsibility, NOT MUOT or the P.I. The Sponsor's obligation to assume all financial responsibility does not apply when an injury is caused by the negligence of an MUOT employee or the institution.
10. WHY CAN'T MUOT INDEMNIFY A SPONSOR?
As an instrumentality of the state of Ohio, MUOT is statutorily forbidden by the Ohio Revised Code to indemnify anyone. This is NON-NEGOTIABLE.
11. WHAT IF THE STUDY IS TERMINATED EARLY?
The research agreement for any study should state that either party may cancel the agreement simply by giving a specified number of days notice (generally 30 or 60 days). Because MUOT, as a publicly supported educational institution, cannot accept the risk of loss in the event of early termination, the Sponsor must agree to reimburse MUOT for all allowable costs and non-cancellable obligations incurred up to the termination date. This also protects the P.I.'s department, which has accepted fiscal responsibility for any overexpenditures in the grant account supporting the study.
If the MUOT P.I. wishes to withdraw from a study prior to meeting all of the commitments of the research agreement, he or she MUST consult with Research and Grants Administration PRIOR to contacting the sponsor. If costs incurred by the project, prior to termination, exceed the amount of money received or due from the sponsor, the primary department of the P.I. has the responsibility to cover all expenditures not covered by the sponsor. By signing the MUOT Proposal Review and Approval form prior to submission of a research agreement, the chairman of the primary department of the P.I. accepts responsibility for any overexpenditures in the grant account.
12. WHY IS IT NECESSARY FOR HOSPITAL ADMINISTRATION TO REVIEW CLINICAL RESEARCH BUDGETS?
Whenever research projects utilize hospital/clinic facilities or other patient services that should be charged to the grant account supporting the study, charges for these services should be budgeted in consultation with the appropriate department manager. The hospital administrator or her/his designee must provide final "sign-off" on budgeted prices for hospital or clinical laboratory services. This review ensures that adequate funds have been budgeted for patient care and that any known increases in fees are adequately planned for in the budgeting process. Approval by hospital administration will assist in assuring that patients and/or insurance companies are not inappropriately billed for patient care services required only as part of a research project.
13. WHEN IS INSTITUTIONAL REVIEW BOARD (IRB) APPROVAL NECESSARY FOR A STUDY?
[Also see Decision-Support Flow Chart]
The basic requirements are contained in the Code of Federal Regulations (Title 45, Part 46, Section 102) which is quoted below. It is necessary to obtain MUOT IRB approval for any RESEARCH which involves HUMAN SUBJECTS. That is, research involving a living individual about whom an investigator (whether professional or student) conducting research obtains:
1. Data through interventions or interactions with the individual, or
2. Identifiable private informationINTERVENTION includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. INTERACTION includes communication or interpersonal contact between investigator and subject. PRIVATE INFORMATION includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place and information which has been provided for specific purposes by an individual which the individual can reasonably expect will not be made public (e.g., a medical record). Private information is any information which is individually identifiable with a study subject. See Question #15 below for more details about how long IRB approval last for a study.
Special note should be made of the fact that, although not required by federal regulations, it is MUOT policy that IRB approval must be obtained for research use of all autopsy material, cadavers, and cadaveric material.
These Federal and Institutional requirements for MUOT IRB approval are the subject of
If you have any questions concerning whether a protocol you are contemplating requires IRB approval please call Research and Grants Administration.
14. AT WHAT POINT SHOULD THE PROCESS FOR IRB APPROVAL BE INITIATED?
IRB approval is required before any study involving human subjects can begin. The MUOT IRB meets monthly. A minimum of eight (8) weeks is generally recommended to secure IRB approval of a protocol requiring full committee review. Because the IRB may have questions or suggest revisions in the informed consent form or the protocol, materials should be submitted to the IRB as early as possible. The deadline for protocols requiring full committee review is the last Monday of each month. Those studies which involve no more than minimal risk (e.g., only venipuncture) or no risk to living subjects (e.g., use of autopsy material) may be approved through the expedited or exempt review process. These may be submitted at any time and generally review takes 2-3 weeks. An MUOT grant account cannot be established to support the study until IRB approval is obtained and a written research agreement is executed between the sponsor and MUOT. In general, it is a good idea to initiate the IRB approval process in parallel with review and approval of the research agreement and study budget.
15. MUST I CONTINUE TO MAINTAIN IRB APPROVAL EVEN IF PATIENT ACCRUALS HAVE BEEN CLOSED?
Yes, IRB approval is required not only during the period when patients are being entered into the study, but for the entire time that Private Information about study subjects, as defined in question 13 above, is being collected/analyzed for an organized research project. When the study is completely finished, a final report must be submitted to the IRB. This report must contain the total number of MUOT subjects enrolled in the study and a description of any adverse events that occurred, or a statement that no adverse events occurred.
16. WHAT IS THE INTERNAL REVENUE SERVICE FORM W-9, WHICH THE SPONSOR ALWAYS SENDS?
This is the form utilized by the IRS to assign tax liability for the monies supporting this research. You should NEVER put your own Social Security number on this form or you may incur the tax liability for any money supplied by the Sponsor. This form should be completed by RGA and must contain the institutional tax I.D. number of MUOT (34-0967014) and be signed by an authorized MUOT official, not the P.I.
17. DO I HAVE A CONFLICT-OF-INTEREST IN PERFORMING RESEARCH FOR A PARTICULAR SPONSOR?
Although conflicts-of-interest (COI) may take numerous forms, financial conflicts-of-interest may be broadly defined by the following: "...[conflict-of-interest] arises when an academic staff member is or may be in a position to influence university business, research or other decisions in ways that could lead to any form of personal gain for the academic staff member or the staff member's family, or give improper advantage to others to the university's detriment" (Association of American Universities, Framework Document on Managing Financial Conflicts of Interest, May, 1993). The AAMC defines COI as "...situations in which financial or other personal considerations may compromise, or have the appearance of compromising, an investigator's professional judgment in conducting or reporting research". In virtually every instance, only the investigator knows or suspects that an actual or apparent conflict-of-interest may exist with a particular sponsor. Thus, it becomes an individual's responsibility to avoid situations that are or may have the appearance of being conflicts-of-interest. For example, only the investigator knows whether he or an immediate family member has a financial interest in outside entities that sponsor research. The Conflict-of-Interest Policy adopted by MUOT in October, 1995 (
18. CAN THE PRINCIPAL INVESTIGATOR OR CO-INVESTIGATORS/COLLABORATORS BILL THE GRANT ACCOUNT THROUGH APMUOT FOR PROFESSIONAL SERVICES PROVIDED FOR STUDY SUBJECTS?
No, any compensation paid to the P.I. or co-investigators/collaborators from the grant account must be paid through the MUOT payroll system as a part of that individual's academic salary (see
Other MUOT physicians who are not collaborators on the study, but who provide their regular clinical services to study subjects (e.g., interpreting X-rays, MRI images, clinical laboratory data or ECG tracings) as a part of the study protocol may bill their services to the grant account through APMUOT.
19. WHAT HAPPENS TO MONEY REMAINING IN THE GRANT ACCOUNT WHEN THE STUDY IS COMPLETED?
Most research grants/agreements have a termination date specified in the written agreement. To extend the agreement beyond that date generally requires a written modification to the agreement. When this is possible (and it generally is), the account remains active. If the project has terminated, the P.I. must request an extension for use of the remaining funds.
All expenditures from any grant account MUST be justifiable as research-related. Typically, corporate sponsors claim research grants/agreements as tax deductible research expenditures. For this reason, if MUOT cannot clearly justify the research-related nature of all expenditures from grant accounts, the College may incur a tax liability for Unrelated Business Income. Recent IRS rulings suggest that a record of publication of research supported from a grant account is a key factor in determining that monies in that account are NOT Unrelated Business Income.
20. WHO OWNS EQUIPMENT PURCHASED WITH GRANT FUNDS OR
PROVIDED TO MUOT BY A SPONSOR IN ASSOCIATION WITH A GRANT OR RESEARCH AGREEMENT?
Unless stated in the research agreement that the sponsor will retain title to the equipment, all equipment items purchased with grant funds or provided in association with a research agreement is titled to MUOT and must be entered into the college's equipment inventory and must have a numbered MUOT property tag affixed to it. If equipment is received at MUOT via any avenue other than through a purchase order processed by the MUOT Materials Management Department, it is the responsibility of the P.I. to request that the MUOT Receiving Department tag the equipment.
21. TO WHOM SHOULD CHECKS BE MADE PAYABLE AND WHERE SHOULD THEY BE SENT?
Checks should be made payable to The Medical University of Ohio at Toledo and should be sent to the following address:
Grants Management
Research & Grants Administration
Medical University of Ohio at Toledo
Block Health Science Bldg., Rm. 148
3035 Arlington Ave.
Toledo, OH 43614-5804
22. CAN TREATMENT OF A SINGLE PATIENT CONSTITUTE
"RESEARCH"?
Yes, if there is clear intent before treating the patient to use systematically collected data that would not ordinarily be collected in the course of clinical practice in reporting and publishing a case study. Treating with a research intent should be distinguished from the use of innovative treatment practices.
Page Updated: 11/19/2002
research@meduohio.edu
