VII.01 |
Investigator Responsibilities for Conducting Human Subjects Research |
Objective
Investigators conducting research under the jurisdiction of
The University of Texas Health Science Center at
Policy/Procedure
I. All investigators conducting human subject research shall follow Good Clinical Practice guidelines and other federal regulations applicable to human subject research. These practices include the following.
a. All
trials are conducted ethically, as defined by Declaration of Helsinki,
rigorously, as defined by
b. Benefits outweigh risks for each patient.
c. Rights, safety and well-being of patients prevail over science.
d. All available non-clinical and clinical information on any investigational agent can support the trial as designed.
e. All trials are scientifically sound and clearly described.
f. All clinical trials have current IRB approval.
g. Medical decisions and care are the responsibility of qualified health care professionals, specifically physicians and if applicable dentists.
h. Everyone involved in the study is qualified by training, education and experience.
i. Informed consent is given freely by every participant.
j. All study documentation is recorded, handled and stored to allow accurate reporting, interpretation and verification.
k. Confidentiality of subjects is respected and protected.
l. Investigational products maintain Good Manufacturing Practice in storage, manufacturing and handling.
m. Systems to ensure quality are implemented in all aspects of the trial.
II. The PI of a human subjects protocol is ultimately responsible for ensuring the conduct of the study complies with UTHSC-H policies/procedures and applicable federal/state laws and regulations and institutional policies. These responsibilities include the following.
A. Be qualified by education, training and experience to lead the study.
1. Be familiar with any investigative agents/devices used in the study.
2. Provide or ensure adequate medical care is given to subjects (including adverse events, undercurrent illnesses).
3. Ensure accountability of investigative product and proper instruction to subjects.
4. Follow randomization procedures outlined in approved protocol.
5. With subject permission, if appropriate, inform subject's primary physician of participation.
B. Serve as the responsible leader of the team who directs this study.
1. Ensure there are adequate resources to conduct the research, and these resources include:
a) PI time to oversee and manage the study;
b) a sufficient number of qualified staff; and
c) sufficient funds to cover all services required in the study.
2. Ensure the research team understands the study protocol and their responsibilities.
C. Conduct the study in accordance with the protocol reviewed/approved by the CPHS.
1. Ensure informed consent form is approved by the CPHS, requirements for obtaining consent are met, and communication of information is documented.
2. Obtain CPHS approval prior to implementing changes to the approved protocol. If the change prevents an immediate hazard to a patient, it is carried out before CPHS approval.
3. Provide the CPHS all necessary documents, including written summaries of study and final report on the outcome of the study.
4. Explain all study deviations to the CPHS.
5. Immediately report all severe adverse events (SAE) and submit follow-up reports with subject identifiers to the sponsor and CPHS.
D. Know and comply with Good Clinical Practice as it relates to this study.
1. Maintain a regulatory binder with complete documentation and in compliance with records retention requirements.
2. Ensure accuracy, completeness, legibility and timeliness of data reported.
3. Ensure data entered in the case report form is consistent with source documents.
Applicable Regulations and Guidelines 21CFR 50 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr50_04.html) 38CFR 16 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/38cfr16_04.html) 45CFR 46 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/45cfr46_04.html) ICH E6 (http://www.ich.org/MediaServer.jser?@_ID=482&@_MODE=GLB) |
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Updated 8/23/07, Report broken links |