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 UTHealth 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 UTHealth; OR
- Completing an online course offered by: CITI - (Course in The Protection of Human Research Subjects)(https://www.citiprogram.org/default.asp)
**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 UTHealth employees serving as Principal Investigators (PI's) on sponsored projects are required to take the UTHealth’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.
• Online Informed Consent Training
• Preparation of Informed Consent Documents
• CPHS-required language for Informed Consent Documents
• Translations
• Glossary
Responsible Conduct of Research - UTHealth 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 - UTHealth’s Research Conflicts of Interest Policy (HOOP 94) 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 training requirements.
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:
• Clinical Research Budgeting / Billing
• Clinical Research Nurse / Coordinator Education
• iRIS Training
General Research Support for UTHealth Investigators
• Environmental Health and Safety |
