Investigator responsibilities for research conducted under the authority of the UTHSCSA Institutional Review Board (IRB)

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1 March 1, 2006 M E M O R A N D U M F O R R E C O R D TO: FROM: SUBJECT: Deans Department Chairs Principal Investigators Brian Herman, Ph.D. Vice President for Research Investigator responsibilities for research conducted under the authority of the UTHSCSA Institutional Review Board (IRB) Clinical research has received increasing scrutiny during the past five years following the well publicized deaths of young research subjects at major universities. Audits by federal authorities of the universities receiving the highest funding levels from NIH have resulted in several of these institutions receiving a suspension of all active research due to failure to comply with federal regulations of the Food and Drug Administration (FDA) and the Office of Human Research Protection (OHRP). We are thus taking this opportunity to remind Principal Investigators (PIs) of the scope of their responsibilities regarding the conduct of the study. The entire research team must be trained to ensure that the protocol is strictly followed, the safety of all research participants is carefully monitored via a safety monitoring plan, and that all regulatory requirements are both met and documented. In order to avoid any potential ethical or safety monitoring problems, investigators must ensure that: a. signed consent documents are on file for every subject. b. no study procedures are initiated before obtaining consent.

2 c. adverse events are promptly reported to the IRB and other regulatory authorities in the time frame required. d. study eligibility criteria or study procedures not followed in accordance with the protocol are documented. Deviation reports must be submitted to the IRB and be in the study file. e. all regulatory documents (IRB approval letter, current version of protocol and consent forms, approved recruiting ads, correspondence with the FDA, etc.) must be maintained in the study file for at least six years. f. all associate investigators, research nurses, research assistants, residents, interns, and students are properly instructed in how to conduct the study. The enclosed attachment provides a brief outline of the major responsibilities of PIs, but it is not an all inclusive list for all types of protocols. Failure to conduct research in accordance with federal regulations and UTHSCSA policy jeopardizes the potential well being of our research subject participants as well as the privilege of all UTHSCSA investigators to conduct research at this institution. Any PI with questions or needing assistance in understanding the requirements of the regulation may contact the IRB staff at , your department research coordinator, or Dr. Jenice Longfield, Assistant Vice President for Research Operations, at or e mail at Your commitment to meeting all regulations covering research at this institution is critical to the Human Subject Protection Program at the UTHSCSA. BH: jl Attachment I have read this memorandum and the attachment regarding my responsibilities as a Principal Investigator. Signature Date Printed name Department Please sign and return to the Office of the Vice President for Research Maintain a copy for your files

3 Principal Investigator Responsibilities I. The principal investigator (PI) is the person, regardless of title, who is primarily responsible for: a. the development and writing of the protocol. b. the actual execution of the protocol in accordance with the research plan and with all applicable federal and institutional regulations and guidelines related to research. c. maintaining complete documentation for all aspects of the study. II. Specific responsibilities of the PI for protocols involving human subject research: a. be familiar with all applicable regulations governing research involving human subjects. b. ensure that no subjects are recruited or enrolled into the protocol until the final approval for the protocol has been provided by the IRB, and when appropriate, by SACI, or by research committees of the study site. c. ensure that the prospective subject is not participating as a subject in any other research that could increase the research risks or undermine the validity of either research project. d. ensure that all subjects enrolled in the study meet the inclusion criteria delineated in the approved protocol. For each subject enrolled, an inclusion/exclusion criteria checklist is to be completed and maintained in the research file. e. ensure that the quality of each subject s consent is in accordance with current federal regulations. This will include ensuring that any designee that obtains consent on behalf of the PI is completely familiar with the protocol and is qualified to perform this responsibility. The PI will ensure that every subject fully understands the information in the approved consent form before the subject signs the consent form and that subject s consent is voluntary and free of undue influence or coercion. f. ensure that no research procedures or interventions related to the protocol begin prior to obtaining informed written consent from the prospective subject, unless previously approved by the IRB. g. ensure Protected Health Information is obtained, used, and disclosed according to federal HIPPA regulations and institutional policies, with a valid authorization

4 or a waiver, as determined by the IRB, which serves as the UTHSCSA s privacy board for research. h. obtain the IRB approval for advertisements used to recruit research subjects. i. report immediately to the IRB and the sponsor all deaths regardless of cause. j. report to the IRB any adverse events occurring in subjects as a possible result of protocol participation. Serious adverse events must be reported to the IRB immediately whether anticipated or not. k. report serious and unexpected adverse events involving the use of investigational drugs or devices to the sponsor and/or the FDA as well as to the IRB. l. report to the IRB any significant new findings during the course of the study which might affect the risk benefit ratio or the subjects willingness to continue to participate in the protocol. m. inform the IRB of any noncompliance with the protocol or any regulation governing human subject protection. n. ensure that investigational drugs or devices are administered only to subjects under the investigator s personal supervision or that of a previously approved AI. Ensure that all records of receipt, storage, use and disposition of investigational drugs or devices are maintained and meet FDA requirements. o. submit an amendment to the IRB for review and approval prior to making any change to the protocol or consent form except where necessary to eliminate apparent immediate hazards to the subjects. Examples of changes which require an amendment include, but are not limited to: changes in the study objectives, changes in any study procedure, addition of procedures for research purposes (such as additional blood draws). p. maintain a Study File that must be kept for six years following closure or termination of the protocol. This file may be inspected at any time by the IRB office, the Food and Drug Administration (FDA), and/or other regulatory agencies responsible for the oversight of research. This file will include: 1. the approved protocol and applicable amendments/modifications 2. IRB memoranda granting approval to the initial protocol, continuing reviews, and any amendments/modifications 3. all applicable correspondence from governing committees (e.g. IRB, Radiation Safety, etc.)

5 4. each informed consent document signed and dated by the subject or a legally authorized representative and a witness 5. the inclusion /exclusion criteria checklist for each subject 6. continuing review, final/progress reports 7. reports of adverse events 8. all information pertaining to an investigational drug or device. This will include adequate records on the receipt, storage, use, and disposition of all investigational drugs issued to the investigator by the pharmacy and investigational devices issued to the investigator by the activity responsible for storing them 9. reports of any significant new finding found during the course of the study 10. all study documents generated from study data 11. publications, abstracts, or reprints resulting from study data q. fully cooperate with all audits of the protocol by IRB or compliance personnel and/or officials from any agency or institution authorized to inspect the research files. r. understand that investigators who fail to adhere to their responsibilities and follow all regulations and policies related to human subject research protocols may have their privileges to conduct research suspended or terminated.

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