The Principal Investigator is responsible for the proper conduct of research. It is the Investigator’s responsibility to comply with CPHS policies and applicable regulatory requirements.
Qualifications and Agreements
The PI must be qualified by education, training and experience to assume responsibility for the proper conduct of a research study and should meet all qualifications specified by the applicable regulatory requirements
The PI should be thoroughly familiar with the study protocol. When conducting clinical trials, the PI should be thoroughly familiar with the investigational product as described in the Investigator’s Brochure, in the product information and other sources.
The PI should maintain a list of appropriately qualified persons to whom the PI has delegated significant research related responsibilities.
Adequate Resources
The PI should have sufficient time and adequate qualified staff to properly conduct and complete the research.
The PI should ensure that all persons assisting with the research are adequately informed about the protocol, investigational product(s) and their research related duties.
Care of Subjects
A qualified physician (or dentist, when appropriate) who is an investigator or a co-investigator for the research study should be responsible for all research related medical (or dental) decisions.
The Principal Investigator should ensure that adequate medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the research.
Conduct of Research
The PI should conduct research in compliance with all applicable regulations and the approved protocol.
The PI bears direct responsibility for conduct of the research study. The PI should employ sound study design in accordance with standards of the discipline. The study design should minimize harm and maximize benefits. In studies involving greater than minimal risk to participants, the PI must submit a data safety monitoring plan for review and approval by the CPHS and comply with the plan.
The PI or research staff must recruit participants in a fair and equitable manner, weighing potential benefits of the research to the participants against their vulnerability and risks to them.
The PI must ensure that informed consent is obtained from subjects prior to their enrollment into the research, unless waived by the CPHS. The PI must use the consent document approved by the CPHS.
PI must maintain all relevant documents and recognize that the CPHS staff and applicable regulatory authorities may inspect these records.
The PI must ensure accuracy and completeness of data in case report forms and all reports.
Additional Investigator Responsibilities Under INDs
An investigator administering an investigational drug, agent, or biologic is responsible for the research to be conducted in accordance with the plan of investigation as described in the FDA-approved IND, the signed investigator statement, and the CPHS-approved investigational plan.
Responsibility for Control of Drugs – The investigator may not give the investigational drug to any person not authorized under the protocol to receive it. The drug, agent, or biologic may only be used in subjects under the investigator’s personal supervision or under the supervision of physicians who are directly responsible to the investigator. Additionally, the investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects.
If the investigational drug is subject to the Controlled Substances Act, the investigator must take adequate precautions, including storage of the investigational drug in a securely locked, substantially constructed cabinet, or other securely locked enclosure, access to which is limited, to prevent theft or diversion of the substance into illegal channels of distribution.
Communication and Reporting
Communication with CPHS- The Principal Investigator should obtain CPHS approval before initiating a research project involving human subjects when the research is conducted by or under the direction of any employee of UTHSC-H or the research is conducted using the facilities of any UTHSC-H institution.
Serious Adverse Event Reporting - The Investigator must report all unanticipated problems that occur during the conduct of a research project to the CPHS in accordance with the timelines set by CPHS.
Compliance with Protocol - The Investigator should not implement any deviation from or changes of the protocol without agreement by the sponsor and prior review and documented approval from the CPHS of an amendment, except where necessary to eliminate an immediate hazard (s) to subjects.
Continuing Review Reports - The Investigator should submit written summaries of the trial status to the CPHS annually or more frequently, if requested by the CPHS.
Reporting Requirements to Sponsor for Industry Sponsored Projects - The investigator must provide all protocol-specified reports to the sponsor of study. The sponsor is required to submit annual reports to the FDA on the progress of the clinical investigations. Serious or unexpected adverse events must be reported to the sponsor immediately. Non-serious adverse events must be reported promptly. The investigator ust provide the sponsor with accurate financial information to allow an applicant to submit complete and accurate certification of disclosure statements as required. After completion of the study, the investigator must provide the sponsor with a report.
Responsibility to Federal Agencies - In the event that an employee of the FDA requests access to records or reports made by the investigator (at a reasonable time), the investigator may permit such access for copying or verifying. However, the investigator is not required to divulge subject names unless the records of particular individuals require a more detailed study of the cases, or unless there is reason to believe the records do not represent actual case studies.
Responsibility to Other Authorities - The PI must report to relevant authorities if any research subject is suspected of having a notifiable disease according to relevant regulations and institutional requirements. If abuse or neglect of a child or an elderly person is detected, the PI must ensure this is reported to relevant authorities according to institutional requirements.
Other Responsibilities
Conflict of Interest - The PI must disclose any real or apparent conflict of interest in the application form to the CPHS according to policy and procedure Conflict of Interest – Investigators.
. Sponsored Clinical Trials - The PI should not conduct sponsored studies without a signed Clinical Trial Agreement. The PI should ensure that the clinical trial is conducted according to the signed Agreement.
Responsibility for Maintaining Records - In order to maintain adequate records, it is expected that the investigator will keep case histories that record all observations and other data needed in the investigation for each individual receiving the investigational drug. Each case history should include the signed and dated consent forms and medical records including progress notes of the physician, the individual’s hospital chart, and the nurses’ notes. It is important to document in the case history that informed consent was obtained prior to participation in the study. The records should be retained for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated. If no application is to be filed or the application is not approved for such indication, records are kept until 2 years after the investigation is discontinued and FDA is notified. The sponsor may have record retention requirements specified in the clinical trial agreement that must be followed instead of the 2 year minimum.
Change of Principal Investigator - If the Principal Investigator is resigning from UTHSC-H or is going away for an extended duration of time, the research project should be formally transferred to another Investigator. This Investigator assumes all the responsibilities as the Principal Investigator for the conduct of the research project until the original Principal Investigator returns. This change should be reviewed and approved by the CPHS.
HUMAN SUBJECTS RESEARCH TRAINING
Human Subjects Protection training is required for all investigators conducting research involving human research subjects, human derived materials, or human derived data complete approved training on the protection of human research subjects regardless of the funding source for the research.
NIH Required Education
Approved courses to satisfy the UTHSCH requirement for education on the protection of human subjects include the following options:
Attending a course given by CPHS staff**; OR
Attending an IRB 101** course given at Baylor College of Medicine, UT MD Anderson Cancer Center, or UTHSCH; OR
**Please note that IRB 101 courses and courses taught by CPHS staff are not currently provided on a routine basis. If you are not currently certified, we recommend taking one of the above mentioned on-line courses. These on-line courses are provided to you free of charge and require approximately two hours to complete.
Re-certification is also required every two to three years (certificates from an IRB 101 class expire after 3 years while all other courses expire after two years). This may be through one of the above listed courses or through another continuing education class, although any course not listed above MUST be approved by the CPHS office.
Once the certificate is submitted, you will receive a reminder via e-mail approximately one month prior to its expiration date. For questions regarding the educational requirement, please call the CPHS office at 713-500-7942.
NIH non-competing applications must include a letter that verifies the training has been completed. The letter should be prepared/signed by the principal investigator and forwarded to OSP for signature. The letter should include: the names of the key individuals responsible for the design and conduct of the research; the title of the educational program completed by each individual identified in the letter; and a one sentence description of the educational program(s). Key personnel from other institutions are required to submit a letter to OSP that has been co-signed by one of their institutional officials and includes the required elements.
Investigator Responsibility Briefing - Effective April 1, 2006 all UTHSC-H employees serving as Principal Investigators (PI's) on sponsored projects are required to take the UTHSC-H’s Investigator's Responsibility Training before accounts for research grants/contracts can be created. Recertification through continuing education is required every three years. Courses taken to satisfy the re-certification requirement must be approved by the Executive Vice President for Research.
CME Credit: Physicians may receive 1 AMA PRA Category 1 credit for this course.
Instructor: Peter Davies, MD, PhD, Executive Vice President for Research
Informed Consent Training - Informed Consent - All studies and their informed consent documents must have been reviewed and have been stamped approved by the CPHS prior to the enrollment of any human subjects. Only copies of the consent form that includes the appropriately dated CPHS approval stamp can and must be used when obtaining consent.
Informed consent to research is not simply the signing of a document, nor verbal or implied acquiescence to participation. Instead, informed consent describes a process by which potential subjects are offered information about the research as it applies to them, followed by a reasoned and voluntary decision to participate.
Whether given verbally or in writing, specific information about each study must be tailored to the level of understanding of each person invited to consent, assent or give permission. Because research subjects come from a variety of backgrounds and educational levels and are frequently under physical and emotional stress, it is important that consent forms are easy to understand. If a medical term is essential, include a lay definition.
Only after providing sufficient opportunity to consider whether or not to participate, and after possibilities for coercion or undue influence are minimized, should prospective subjects be asked for consent.
The informed consent document provides a guide for the researcher and potential subject. The document must describe the research in such a way that the potential subject will understand the information necessary to reach an informed choice about participation.
The principal investigator is responsible for ensuring that informed consent is obtained from each research subject and that the document is signed and dated appropriately. The PI remains responsible even if the obtaining of informed consent has been delegated to other members of the research team. Informed consent must be obtained prior to initiation of any screening procedures that are performed solely for the purpose of determining eligibility for research.
Telephone consent for enrollment in a clinical trial is not permitted by this IRB. If the consent document can be faxed to the appropriate legal representative and an opportunity provided to answer questions from that person, then a faxed signed copy of the consent document can be used to enter the patient into the research study. Signed ICFs, and all study data, are to be retained by the principal investigator for a minimum of three years.
Responsible Conduct of Research - UTHSCH expects that all research will be conducted responsibly, safely, and in compliance with applicable regulations/policies. The following are resources that might be of use to faculty, staff and trainees. For more information visit the Responsible Conduct of Research website.
Research Conflicts of Interest - UTHSCH’s Research Conflicts of Interest Policy (HOOP 23.1) addresses the importance of ensuring financial interests do not affect, or
appear to affect, the design, conduct or reporting of research or compromise the protection of human subjects. The institution's applicable procedures are summarized below. Investigators disclose significant financial interests that may be impacted by proposed or ongoing research.
The Research Conflicts of Interest Committee reviews the disclosed financial interests and advises the Executive Vice President for Research if strategies should be implemented to eliminate, reduce or manage the conflicts of interest in order to approve the research. When reviewing significant financial interests in human subjects research, the institution applies the rebuttable presumption standard (i.e., individuals with significant financial interests may not conduct the research unless there are compelling circumstances). General strategies for management of conflicts typically include education/training on conflicts of interest and disclosure of financial interests in publications, presentations, and the informed consent process and to individuals/groups that may be impacted by the interests (e.g. trainees, colleagues, research sponsors). For more information visit the Research Conflict of Interest Committee online training program.
Research Misconduct (web based course) helps understand the types of research misconduct and how it is handled by universities. It is designed for research faculty, trainees and University administrators.
Clinical Research Education
The Office of Research Support Committees (ORSC) major goal is to assist the principled, meritorious scientific endeavors of the faculty, staff and students at the Health Science Center. Towards this endeavor we offer the following research support training:
The principal investigator must maintain study documents for each research project. Essential documents for the conduct of clinical trials include appropriate FDA regulatory and human subjects’ research documents. The file must include the following items:
The original signed protocol, subsequent signed protocols, and signed amendments, and sample case report form
The investigational brochure(s) with IRB submission memo(s) (if applicable)
The FDA Statement of Investigator Form 1572 (if applicable)
Investigational New Drug (IND)/Investigational Device Exemption (IDE) application, FDA form 1571, and a copy of all correspondence to and from the FDA (if applicable)
Copy of the Federal grant application (if applicable)
• Curricula vitae with date and signatures, current medical licenses, and financial disclosures for principal investigator and all co-investigators
Documentation of all CPHS approvals of protocols, consent forms, educational and recruiting materials, advertising, amendments, continuing reviews, protocol deviations, and documentation of all memos to and from the CPHS
A copy of all recruitment and advertising material
A copy of all educational or written information given to subjects
Serious adverse event reports from subjects enrolled locally, all investigator new drug (IND reports) notification reports from the sponsor, and copies of all CPHS approvals, acknowledgements and reports to and from the CPHS
Copy of IRB approvals from other institutions with collaborating investigators (if applicable)
Copies of all CPHS and collaborating IRB approved stamped and dated consent forms
Delegation of responsibilities log with authorized signatures
Screening and enrollment logs
Laboratory accreditations, normal lab values, curricula vitae for laboratory director, quality assurance information, and temperature logs (if applicable)
A copy of all communication to and from the sponsor including telephone contacts, email, memos, reports and monitor visit documentation (if applicable)
Items to file separately:
All original informed consents that are signed and dated by each subject kept securely. The investigator is responsible for ensuring that a copy of the signed and dated consent is placed in the subject’s medical record, should the subject be an inpatient.
Signed clinical trial agreement between institution and sponsor (if applicable)
Signed confidentiality agreement (if applicable)
Clinical trial budget and financial agreement (if applicable)
Overview of UTHSCH Process for Reviewing Human Subjects Research
Clinical Trials Registration
National Public Registry
The International Committee of Medical Journal Editors (ICMJE) requires that all clinical trials be entered in a public registry (such as ClinicalTrials.gov) before enrolling the first patient, as a condition of consideration for publication. The intent is "to promote the public good by ensuring that everyone can find key information about every clinical trial whose principal aim is to shape medical decision making."
The following categories of clinical trials must be registered.
• Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause and effect relationship between a medical intervention and a health outcome.
• Trials with at least one prospectively assigned concurrent control or comparison group.
• Any trials whose primary purpose is to affect clinical practice (phase 3 trials).
For more information regarding this new requirement, go to: http://prsinfo.clinicaltrials.gov/
Steps for registering clinical trials
• Contact the Protocol Registration System (PRS) Administrator at Gena.Monroe@uth.tmc.edu,or 713-500-3524.
• Request account setup for PRS users, provide user ID, full user name and email address.
• When notified of account activation (by email), access the PRS website http://register.clinicaltrials.gov.
• Log on and change password.
• Go to Main Menu, Protocol Records, select Create and follow the prompts for Clinical Trials.
UTHSC-H Clinical Trials
The UTHSC-H Clinical Trials website is available for the public to identify clinical research being conducted at UTHSC-H (http://www.uthouston.edu/clinicaltrials/). The website contains listings and descriptions of specific research studies with staff contact information as well as FAQ’s and general information about clinical research. Investigators may post their clinical trials on the website, but the study registration information must be reviewed and approved by the CPHS before it is posted.
Office of Research Support Committees (713) 500-7942
View the Informed Consent Training Video
