The OORHS has developed a Online Handbook for Biomedical Researchers to provide faculty in the Schools of the Health Sciences with information and important links that will assist them in establishing robust research programs. The handbook is intended to act as a guide to University requirements and recommendations for research compliance and includes a section on research with animal subjects as well as a section on research with human subjects.

CONFLICT OF INTEREST OFFICE
Hieber Building
3500 Fifth Avenue, Suite 206
Pittsburgh, PA 15213
412-383-1774 (phone)
412-383-1769 (fax)
http://www.coi.pitt.edu
Disclosure of outside interests and commitments by faculty, designated administrators and staff, and employees to their deans, chairs, directors, or direct higher-level supervisors must be made upon appointment and each April 15 thereafter.  Updated disclosures must be made if new outside interests arise during the year.  The University's Conflict of Interest (COI) Office provides a Step-by-Step Guide to Completing the COI Disclosure form (http://www.coi.pitt.edu/COIforms.htm).  Forms, Frequently Asked Questions, and additional information can be found at the COI Superform Website  (https://coi.hs.pitt.edu).  All University policies pertaining to conflict of interest can be found at http://www.bc.pitt.edu/policies/.

Individuals who are required to complete Part II of the Faculty/Researcher conflict of interest form and those who are engaged in industry-sponsored research must complete the Research Practice Fundamentals computerized training module on conflicts of interest. (http://rpf.health.pitt.edu/rpf/)

If a significant financial conflict of interest with respect to research funded by the Public Health Service (PHS) is identified, prior to the expenditure of any federal funds, the University is required to notify the PHS Awarding Component of the conflict and provide assurance that it has been managed, eliminated or reduced. A significant financial interest is defined as "anything of monetary value, including, but not limited to, salary...equity interests...and intellectual property rights." Federal regulations exempt from the disclosure requirements salary or other payments from a non-University source totaling less than $10,000 in any one year; salary, royalties and other remuneration from the University; and equity that is both less than 5% of the outstanding equity of a company and is valued at less than $10,000 based on fair market value. If a conflict is identified after funds have been expended on a grant, the University must notify the PHS Awarding Component within sixty days of identification of the conflict. Prompt notification of such conflicts should be provided to the Chair of the Conflict of Interest Committee, who is responsible for providing such notices to the PHS.

The Conflict of Interest Committee, which was created in keeping with the University's Conflict of Interest Policy, has faculty, staff and student representation and provides, among other things, advice on novel or difficult conflict cases. Additional information pertaining to the Conflict of Interest Committee and other relevant links surrounding conflicts of interest can be found at << http://www.rcco.pitt.edu/coi/Committee/COICommittee.htm>>.

Technology transfer activities can lead to conflicts that are particularly difficult to manage. In recognition of the unique issues presented by these activities, the University adopted Policy 11-02-03: Commercialization of Inventions Through Independent Companies. (http://www.bc.pitt.edu/policies/policy/11/11-02-03.html) This policy specifically addresses issues such as: whether a faculty member may hold equity in a start-up company that has an option or license to technology discovered or invented by the faculty member; whether a faculty member may hold an operating position or board seat in such a company; and whether a faculty member may serve as principal investigator on sponsored research from the start-up company. The Commercialization of Inventions Policy also provided for an Entrepreneurial Oversight Committee (EOC), which is a standing sub-committee of the COI Committee that reviews proposed technology transfer activities that may pose conflicts of interest. The EOC must review any transaction in which the University or a faculty member accepts equity in a start-up company that has an option or license to utilize University technology. Submissions by a faculty member to the EOC require the prior approval of the dean or department chair.

If an individual is conducting pre-clinical animal or human subject research in the same area in which a financial conflict of interest exists, the University's Institutional Animal Care and Use Committee (IACUC) and Institutional Review Board (IRB) have adopted specific policies requiring the disclosure of pertinent significant financial interests of research investigators. The Committee for Oversight of Research Involving the Dead (CORID) has also adopted a similar policy. Such researchers are generally prohibited from serving as Principal Investigator, but may serve as a co-investigator with the implementation of additional steps to manage their potential conflict. A standard management plan is invoked for potential conflicts involving human subject research. Exceptions requested to the standard plan should be communicated to the COI Office, which will then be forwarded to the appropriate party for consideration. Further information on these policies is available on the IRB website, << http://www.irb.pitt.edu/>>, the IACUC website, << http://www.iacuc.pitt.edu/Policies.asp>>, the Office of Clinical Research, Health Sciences website << http://www.clinicalresearch.pitt.edu/>>, and the COI Office’s website.

All consultants retained by the University must complete a conflict of interest form with each appointment or reappointment, and thereafter annually, and submit it promptly to their program director or unit head, as appropriate. An updated form should be completed if new outside interests arise during the year. Consultants should complete the conflict of interest form found in University Policy 11-01-04 (http://www.bc.pitt.edu/policies/policy/11/11-01-04.html).

Subject to advance permission from their supervisor, faculty members are permitted to engage in outside consulting relationships so long as the aggregate amount of time spent on such matters does not exceed one day per week. (See University Policy 02-06-01 - http://www.bc.pitt.edu/policies/policy/02/02-06-01.html) The faculty member should not make more than incidental use of University facilities in carrying out such consulting activities, and care should be taken to distinguish the faculty member's role as a consultant from the faculty role. Such consulting relationships, even if they do not pose a conflict of commitment, can pose a conflict of interest and should be disclosed in publications, presentations, press releases and in research grant applications. If the amount received by a faculty member for such consulting activities exceeds $10,000 per year, it represents a significant financial interest which may require further review and management.

EDUCATION AND CERTIFICATION PROGRAM IN RESEARCH AND PRACTICE FUNDAMENTALS
Website address: http://cme.hs.pitt.edu/
Requirements charts:
http://cme.hs.pitt.edu/servlet/IteachControllerServlet?actiontotake=faq&source=required
The Education and Certification Program in Research and Practice Fundamentals (RPF) is the result of an observed need for the University of Pittsburgh to develop an on-line education and certification program in the fundamentals of research. The RPF program has been designed to provide training to individuals at the University of Pittsburgh, and its affiliated institutions, who wish to participate in research activities. Currently, the RPF program has completed development of modules covering the topics of Research Integrity, Human Subjects Research, Use of Laboratory Animals in Research & Education, Conflict of Interest, Human Embryonic & Fetal Stem Cell Research, Bloodborne Pathogens Training, Chemical Hygiene Training, Responsible Literature Searching, IRB Member Education, Research with Children and Good Clinical Practice and six modules related to HIPAA for researchers, staff and University health care providers. Please review the module requirements chart or speak with your department chair if you have questions about required training associated with RPF.

EDUCATION AND COMPLIANCE OFFICE – for Human Subject Research
Hieber Building
3500 Fifth Avenue, Suite 205
Pittsburgh, PA 15213
412-383-1711 (phone)
412-383-1388 (fax)
http://www.rcco.pitt.edu/educ/ed_index.htm
The mission of the Education and Compliance Office for Human Subject Research (ECO-HSR) is to provide education to individuals involved in the conduct of clinical research at the University of Pittsburgh and to strive for research excellence and integrity throughout the University. The goal of the Compliance Program is to routinely audit clinical activities conducted under the approval of the University’s Institutional Review Board in order to enhance the quality of clinical research and to ensure proper documentation, record keeping, and adherence to all components that constitute good academic research practice. Contact the Education and Compliance Office for specific information on the programs and services provided. The office also monitors the informed consent process.

EDUCATION AND COMPLIANCE OFFICE – for Laboratory Animal Research
Hieber Building
3500 Fifth Avenue, Suite 200
Pittsburgh, PA 15213
412-383-2008 (phone)
412-383-2020 (fax)
http://www.iacuc.pitt.edu/iac_abouttrng.htm
The mission of the Education and Compliance Office for Laboratory Animal Research (ECO-LAR) is to provide education to all individuals involved in the conduct of laboratory animal research at the University of Pittsburgh and to strive for research excellence and integrity throughout the University. The role of the compliance component associated with the Laboratory Animal Research Program is oversight through (a) random protocol reviews, (b) “for cause” protocol audits, and (c) semi-annual site visits to animal housing and use areas. There is a close association with the University Animal Care and Use Committee. Contact the Education and Compliance Office for specific information on the programs and services provided.

ENVIRONMENTAL HEALTH and SAFETY DEPARTMENT
B-50 Benedum Hall
3700 O’Hara Street
Pittsburgh, PA 15261
412-624-9505 (phone)
412-624-8524 (fax)
http://www.ehs.pitt.edu
The Environmental Health and Safety (EH&S) Department provides direction in matters of health, safety, and the environment for the University of Pittsburgh. The EH&S mission is to serve faculty, staff and students in the achievement of safe and healthful working environments in support of the University’s education and research mission.

EH&S provides education through consultation, inspections and formal training. Faculty and staff conducting research utilizing biohazardous agents must complete a blood borne pathogen exposure control training conducted by EH&S within each twelve-month period. Faculty and staff working with chemicals are required by University Policy to attend EH&S Chemical Hygiene Training every three years. These training efforts are offered in person or as on-line modules. All research protocols utilizing animals or rDNA must be registered with EH&S. There is also an annual EH&S inspection of all laboratories, which should be viewed as an educational opportunity to review laboratory safety practices.

All hazardous waste generated during research must be properly disposed of per University Policy and regulation. EH&S manages programs for the disposal of biological wastes and the recycling or disposal of all chemicals.

EH&S also offers training and provides guidance in injury prevention, on-the-job injury, fire safety, emergency response, laser safety, environmental compliance, ergonomics, indoor air quality, and occupational safety and health.

INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE
Hieber Building
3500 Fifth Avenue, Suite 200
Pittsburgh, PA 15213
412-383-2008 (phone)
412-383-2020 (fax)
http://www.iacuc.pitt.edu
The Institutional Animal Care and Use Committee (IACUC) provides oversight of and training related to research involving animal subjects.

All research protocols involving animal subjects must be approved by the IACUC prior to purchasing the animals and/or the initiation of any research procedures on existing animals. Submission forms and instructions are available on the IACUC Website.

Principal investigators, research technicians/assistants, animal care technicians, and other individuals involved with the design and implementation of research studies using laboratory animals must undergo training. Mandatory training includes:

• Research Practice Fundamentals Module 1, Research Integrity
• Research Practice Fundamentals Module 3, Use of Laboratory Animals in Research and Education
• Animal training specific to the animal model listed in the protocol (e.g., small animal, large animal, primate)
• Environmental Health and Safety Training depending on the risk, as determined by the Risk Assessment Officer after the protocol is submitted to the IACUC and EH&S Office for review.

Investigators should contact the IACUC training coordinator for training requirements specific to their research protocols.

Contact information for the IACUC for institutions commonly involved in collaborative research is provided below. The following guidelines should be followed for collaborative protocols:

• If funds are awarded to the University of Pittsburgh and the collaboration is with an institution that is accredited by the US Department of Health (USDA) National Institutes of Health (NIH) and the American Association for the Accreditation of Laboratory Animal Care (AAALC), a copy of that institution’s approved protocol should be submitted to the University’s IACUC.
• If funds are awarded to the University of Pittsburgh and the collaboration is with an institution that is not accredited by the USDA, NIH and AAALAC, the protocol must be submitted to the University’s IACUC using the standard submission forms and process.

Investigators can determine the accreditation status of collaborative sites by contacting the University IACUC Office.

INSTITUTIONAL REVIEW BOARD
Hieber Building
3500 Fifth Avenue, Ground Floor
Pittsburgh, PA 15213
412-383-1480 (phone)
412-383-1508 (fax)
http://www.irb.pitt.edu
The Institutional Review Board (IRB) of the University of Pittsburgh is an appropriately constituted administrative body established to protect the rights and welfare of human subjects recruited to participate in research activities. In accordance with the regulations of the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA), the IRB has the authority to approve, require modifications in (in order to approve) or disapprove all research activities involving humans that fall within its jurisdiction.

Research involving human subjects must be reviewed and approved by the University of Pittsburgh IRB prior to the initiation of the research study. This applies to research that:

• is sponsored by the University; or
• is conducted by or under the direction of any employee or agent of the University in connection with his or her institutional responsibilities; or
• is conducted under the direction of any employee or agent of the University using any property or facility of the University; or
• involves the use of the University’s non-public information to identify or contact human research subjects or prospective subjects.

Studies to be conducted at or involve the staff or patients of outside facilities must also be approved by the appropriate institutional review board(s).

• The University of Pittsburgh IRB is designated as the institutional review board of record for all medical institutions associated with UPMC, including Children’s Hospital and Magee Womens Hospital. The University IRB is the IRB of record for all human subject research conducted by UPP or UPMC employees.
• The University of Pittsburgh has a Cooperative Agreement with the institutional review board of the Veterans Affairs Pittsburgh Health Care System (VAPHCS). Approval should be obtained from the institutional review board as defined by the Cooperative Agreement. Investigators should consult with the University IRB Office to identify the appropriate institutional review board for the specific research study. Contact information for the VAPHCS institutional review board is provided below.
• In the absence of a Cooperative Agreement, investigators must obtain approval of the University IRB as well as the institutional review board for the other institution

The conduct of federally sponsored research at another institution may be subject to the requirement that the other institution have an assurance agreement with the Office for Human Research Protections (OHRP). Contact the University IRB Office for clarification of this requirement as it pertains to the specific federally-funded research activities to be performed at other institutions.

IRB submission requirements are addressed, in detail, in the University of Pittsburgh IRB Reference Manual for the Use of Human Subjects in Research, which is available on the IRB website. The University IRB Office staff is available to answer questions and to provide assistance to investigators and research staff regarding IRB submission requirements and ethical issues related to conduct of human subject research.

The IRB review committees are composed largely of faculty volunteers. Those faculty who submit research protocols for IRB review are encouraged to serve on an IRB review committee. IRB membership not only provides a valuable and vital service to the University and peer investigators, but will also ensure a solid grounding in the regulations and procedures governing human subject protections.

VA Pittsburgh Health Care System
Institutional Review Board
University Drive
Pittsburgh, PA 15240
412-688-6104 (phone)
412-688-6945 (fax)
http://www.vaphs.research.med.va.gov/

INVESTIGATIONAL DRUG SERVICE

The Investigational Drug Service (IDS), UPMC Department of Pharmacy, evaluates planned procedures for ordering, receipt, storage, preparation, dispensing, and billing of drugs used in research studies. The IDS also evaluates procedures to ensure the accountability of investigational new drugs, compliance with informed consent documentation, and the provision of critical information on investigational new drugs to the Study Coordinators, Investigators and Pharmacy Staff.

The IDS must be notified of all human subject research involving the administration of an investigational new drug or an approved drug. Notification of IDS receipt of this information must accompany the initial submission to the University Institutional Review Board. For protocols involving oncology patients, contact the University of Pittsburgh Cancer Institute (UPCI) IDS. For all other protocols, including those involving psychiatric patients at Western Psychiatric Institute and Clinic and the Children’s Hospital of Pittsburgh, contact the UPMC Presbyterian University Hospital IDS. Contact information is provided below.

INVESTIGATIONAL NEW DRUG APPLICATIONS (INDs) and INVESTIGATIONAL DEVICE EXEMPTIONS (IDEs)

OFFICE FOR INVESTIGATOR-SPONSORED IND and IDE SUPPORT(O3IS)
Suite 204, Hieber Building
3500 Fifth Avenue
Pittsburgh, PA 15213
412-383-1399 (tel)
www.O3IS.pitt.edu

The conduct of clinical research studies (i.e., clinical trials) under an FDA-accepted IND or IDE involves a complex set of regulations, requirements, and obligations associated with the submission of initial and supplemental IND or IDE applications; continuing oversight of the preparation of the investigational drug or device and the conduct of the clinical trials; and the requisite reporting, at specified times, of clinical trial outcomes. The FDA holds the “sponsor” of the IND or IDE application responsible for ensuring that all of these regulations, requirements and obligations are being met.

Although sponsors of IND and IDE applications are typically pharmaceutical and device companies, the FDA regulations do recognize the concept of an “investigator-sponsored” IND or IDE application (the respective FDA terminology is “sponsor-investigator” IND or IDE). These regulations specify that the requirements to an investigator-sponsor of an IND or IDE application include both the FDA requirements applicable to an “investigator” and the FDA requirements applicable to a “sponsor.”

Potential risks associated with an investigator-sponsored IND or IDE application include morbidity and mortality of clinical trial participants; tort liability claims; federal citations and sanctions; and the FDA’s non-acceptance of accrued clinical trial data submitted in support of subsequent University or industry-sponsored IND or IDE applications.

The FDA does not include or copy the University in any of its notifications or comments related to investigator-sponsored IND or IDE applications; the FDA communicates directly with the investigator-sponsor and holds these communications confidential.  However, the University is potentially liable for the actions of its faculty members and must therefore be engaged in the communications between the FDA and investigator-sponsors and in the initial and continuing oversight of drug and device preparation and the conduct of clinical trials under investigator-sponsored INDs and IDEs accepted by the FDA. Information on the University’s IND and IDE policies and procedures are available on the O3IS Web site. These policies and procedures are applicable to all investigator-sponsored IND and IDE applications submitted, or pending submission, by University of Pittsburgh faculty and staff that involve the use of University laboratories or facilities.

University of Pittsburgh’s Office for Investigator-Sponsored IND and IDE Support

All investigator-sponsored IND and IDE applications and all documents relevant to such applications shall be submitted to the FDA by the University’s Office for Investigator-Sponsored IND and IDE Support (O3IS). Investigator-sponsored IND and IDE applications are restricted to single site clinical trials conducted by University faculty or staff at a University or UPMC facility; multi-center clinical trials may not be conducted under an investigator-sponsored IND or IDE application.

The Vice Chancellor for Research Conduct and Compliance, in consultation with the Senior Vice Chancellor for Health Sciences and the Director of the Office for Investigator-Sponsored IND and IDE Support, has the right to disapprove the submission, to the FDA, of an investigator-sponsored or University-sponsored IND or IDE application and/or to terminate the approval of an FDA-accepted, investigator-sponsored or University-sponsored IND or IDE. 

Please see the O3IS Website (http://www.O3IS.pitt.edu) for a full listing of the Office’s objectives, services, policies, and procedures and relevant guidance, templates, and forms for IND and IDE applications.

RADIATION SAFETY OFFICE
G-07 Parran Hall
130 DeSoto Street
Pittsburgh, PA 15261
412-624-2728 (phone)
412-624-3562 (fax)
http://www.radsafe.pitt.edu
The mission of the Radiation Safety Office is to assure the safety of individuals who use sources of ionizing radiation such as x-ray machines, sealed nuclear sources, and radio-labeled chemicals both clinically and in research. The office is also responsible for assuring compliance with all applicable state and federal regulations in the use of sources of ionizing radiation. This office offers training to users, monitors work places and controls the receipt and disposal of radioactive material and radiation producing machines.

The use of all radioactive material must be under the supervision of an authorized user. Individuals who are engaged as a principal investigator and/or have significant responsibility for administrative, medical, academic or experimental functions involving the use of radioactive material may apply to become an authorized user by submitting an application to the Radiation Safety Office. Approval to use radioactive material will be based upon the type and quantity of radioactive materials use requested, and the applicant’s training and experience qualifications. For the administration of radioactive materials to humans, an individual must meet the training and experience requirements of the Nuclear Regulatory Commission (10CFR 35) to become an authorized user.

Research involving the exposure of human subjects to sources of ionizing radiation must be approved by the appropriate radiation safety subcommittee. This approval should be obtained by submitting the research study to the Institutional Review Board (IRB). The IRB office will forward the protocol to the appropriate subcommittee of the Radiation Safety Committee. Exposure of human subjects to ionizing radiation in the course of a biomedical research study involves several considerations in addition to those applied to clinical research studies that do not incorporate such an intervention. General guidelines for required review and approval are provided below; however, investigators should refer to the IRB Reference Manual for the Use of Human Subjects in Research and to the Radiation Safety Manual, Regulations Regarding the Safe Use of Sources of Ionizing Radiation.

• Biomedical research studies involving the use of standard diagnostic procedures (e.g., chest X-ray, angiography, nuclear medicine procedure) for subject screening or follow-up or a standard radiation therapy indicated for routine medical management generally do not require prior approval by the Human Use Subcommittee (HUSC).
• Biomedical research studies directed at evaluating the safety and/or effectiveness of an experimental drug or device that emits ionizing radiation must be approved by the Radioactive Drug Research Committee.
• Research involving the use of a radioactive drug that has FDA approval or for which an IND has been filed must be reviewed and approved by the Human Use Subcommittee.
• Research involving the use of radiographic or fluoroscopic procedures in which radiation use is dictated by the experimental protocol must be reviewed and approved by the X Ray Subcommittee.

The in vitro use of radioactive materials and the administration of radioactive materials to animals must also be prior approved by the Radiation Safety Office. Research involving the exposure of animal subjects to ionizing radiation involves several considerations in addition to those applied to research studies that do not incorporate such an intervention. Investigators should refer to the IACUC Reference Manual and the Radiation Safety Manual, Regulations Regarding the Safe Use of Sources of Ionizing Radiation.

RECOMBINANT DNA OFFICE
Hieber Building
3500 Fifth Avenue, Suite 206
Pittsburgh, PA 15213
412-383-1768 (phone)
412-383-1769 (fax)
http://www.rcco.pitt.edu/rdna
The University of Pittsburgh Institutional Biosafety Committee for rDNA Research (IBC-rDNA) is responsible for monitoring and ensuring compliance with National Institutes of Health (NIH) Guidelines on all activities that involve recombinant DNA, including gene therapy. The rDNA Office coordinates and guides the IBC –rDNA review process. The focus of the IBC-rDNA and rDNA Office is to facilitate the compliance efforts of individual researchers and technical staff, assist other University compliance offices regarding rDNA crossover issues, and to ensure the University is in compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules.

The University of Pittsburgh’s policy regarding recombinant DNA activities requires that all recombinant DNA work being conducted must be registered with the rDNA Office, including:

• All teaching and research protocols must be reviewed and approved by the IBC-rDNA if they involve (a) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell or (b) molecules that result from the replication from those molecules described in (a);
• Research protocols that involve human participants in the testing of materials containing rDNA (e.g., human gene therapy or gene transfer protocols) must be approved by the IBC-rDNA prior to submission to the Institutional Review Board (IRB);
• Research protocols that involve the use of animal participants in the testing of materials containing rDNA must be approved by both the IBC-rDNA and the Institutional Animal Care and Use Committee (IACUC) prior to animal purchasing;
• Any change or modification to a currently approved or registered rDNA protocol must be prior approved by the IBC-rDNA.

RESEARCH CONDUCT AND COMPLIANCE OFFICE (RCCO)
Hieber Building
3500 Fifth Avenue, Suite 205
Pittsburgh, PA 15213
412-383-1399 (phone)
412-383-1388 (fax)
http://www.rcco.pitt.edu
The Research Conduct and Compliance Office (RCCO) was created in 1999 as an umbrella organization for the purpose of organizing administratively the various offices that support the committees involved in the oversight (non-financial) of the University’s research enterprise.

The mission of the Research Conduct and Compliance Office is to oversee and facilitate the conduct of ethical and regulation-compliant human and animal subject research through an integrated system of research review, audit and educational programs established in a manner that maximizes institutional effectiveness.

The RCCO consists of the following offices: the Institutional Review Board Office, the Institutional Animal Care and Use Committee Office, the Conflict of Interest Office, the Education and Compliance Offices for Human Subject Research and Animal Research, the Radiation Safety Office and the Recombinant DNA Office. A description of each of the respective offices is included in this guide.

RESEARCH INTEGRITY OFFICE
1710 Cathedral of Learning
4200 Fifth Avenue
Pittsburgh, PA 15260
412-624-3007 (phone)
412-624-1606 (fax)
The research integrity officer provides confidential consultation and information on the University’s Research Integrity Policy and Procedures and on the organization of departmental and school-wide workshops on topics in research integrity. For additional information, contact the Research Integrity Office or refer to University Policy 11-01-01, Research Integrity, accessible at http://www.bc.pitt.edu/policies/policy/11/11-01-01.html

UNIVERSITY OF PITTSBURGH MEDICAL CENTER

FISCAL AND COMPLIANCE REVIEW
Murdoch Building, Suite 219
3434 Forbes Avenue
Pittsburgh, PA 15213
412-647-0621/412-647-4396 (phone)
412-647-8237 (fax)
http://www.irb.pitt.edu/upmcforms/fiscal.htm
It is the policy of the University of Pittsburgh Medical Center (UPMC) that all clinical research studies involving UPMC facilities, staff, and/or patients are fiscally reviewed and approved in writing by a UPMC authorized representative before approval by either the University of Pittsburgh Institutional Review Board (IRB) or by a UPMC Clinical Trials Office (CTO) approved IRB. The Chief Financial Officer, Academic and Community Hospitals (ACHCFO), or designee will review and may impose written limitations upon the conduct of research studies at UPMC based upon reimbursement, fiscal, legal or compliance issues

The ACHCFO has been granted the authority for this fiscal review for all UPMC institutions located in Allegheny County for which that individual has administrative responsibility. Studies conducted at Children’s Hospital of Pittsburgh and outlying UPMC facilities beyond Allegheny County will be reviewed and approved by the CFO of that UPMC facility.

For studies involving care at a UPMC facility other than Children’s Hospital of Pittsburgh (Children’s), certain information must be submitted for Research Fiscal Review. This can be accomplished by emailing the information to the “Clinical Trials Fiscal Review” shared mailbox ( clinicaltrialsfiscalreview@upmc.edu or ctfreview@upmc.edu). If studies are being submitted to the Clinical Trials Office (CTO) or the Office of Contracts, Grants and Intellectual Property (CGIP) for processing, the fiscal and legal reviews will be initiated by those offices. For studies performed at a UPMC facility other than Children’s, the Clinical Research Agreement(CRA) must be reviewed by Al Ciocca, UPMC Associate Counsel ( cioccaaj@upmc.edu, telephone 412-647-8478). The CRA should be emailed to Al Ciocca or faxed to him at 412-647-7852.

If you will be providing services at Presbyterian, Shadyside, WPIC, South Side, Braddock, McKeesport or St. Margaret, a Research Institutional Account will need to be established for the hospital/technical-related services in the research study by completing the “ Institutional Account Request Form”. Contact the facility billing office at non-MediPac facilities for information on how to set up a Research Account. If you will be providing services at a MediPac billing hospital (Presbyterian, Shadyside, WPIC, South Side, Braddock, McKeesport or St. Margaret), obtain the research rates for the hospital/technical related services that will be paid for by the protocol from the Institutional Account/Research Billing Office by calling 412- 432-5465. Research rates for services at Magee can be obtained by calling 412- 641-4383.

Questions regarding Research Rates for Physician Fees or Physician Fee Institutional Accounts can be obtained by calling Karen Krapp at the Physician Services Division Billing Office at 412-432-7579.

WESTERN PSYCHIATRIC INSTITUTE AND CLINIC RESEARCH COMMITTEE
Room 438 WPIC
Pittsburgh, PA 15213
412-246-5067 (phone)
412-246-5070 (fax)
http://www.wpic.pitt.edu/research/rescomm/default.htm
All research protocols conducted by faculty or staff of the Department of Psychiatry and/or involving psychiatric patients or the use of Western Psychiatric Institute and Clinic (WPIC) resources must be reviewed and approved by the WPIC Research Committee. This requirement includes research sponsored by the pharmaceutical industry and research reviewed by an external scientific review committee as a condition of research funding or for inclusion in cooperative group trials.