Approval Process for Human Projects

Federal regulations require that research projects involving human subjects be reviewed by an IRB. The IRB must approve or determine the project to be exempt prior to the start of any research activities. The IRB cannot provide approval or determinations for research that has already been concluded.

Before submitting an Institutional Review Board (IRB) application, first determine if IRB review is actually required for your project. IRB review and approval is required for projects that:
1.    Meet the definition of research;
2.    Involve human subjects; or
3.    Meets the FDA’s definition of research (clinical investigation).

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FDA Submissions and ClinicalTrials.gov Registration: For assistance with Registering and Reporting your clinical trial with ClinicalTrials.gov or FDA IND / IDE and Sponsor Investigator Responsibilities, please contact:

Karen Nijland, BPharm, RPH 
Research Compliance Coordinator-Senior
Office of Clinical Research (OCR)
(210) 567-8554
nijlandk@uthscsa.edu

Learn more about Clinical Trials Reporting

A sIRB (Single Institutional Review Board) is the selected IRB of record that conducts the ethical review for participating sites of the multi-site study. A relying IRB is an IRB designating an agreement to cede review to an external IRB for a particular study.

Request UT Health IRB Review as the sIRB

Request UT Health San Antonio IRB cede review to an external IRB

Cooperative Research

Storage
REDCap

UT Health San Antonio Storage Options (Server/Cloud) 

Data Sharing / Data Use Agreement

Data Acquisition, Management, Sharing, & Ownership  

What is a DUA? When do I need a DUA? Where is the DUA template form? 

Accessing existing data (medical records, etc.)
[Not sure if this is needed]

HIPAA (waivers, authorizations, disclosures)
The HIPAA Privacy Rule, at 45 CFR parts 160 and 164, defines certain health information as protected health information (PHI) which a covered entity may only use or disclose (sharing) to others in certain circumstances and under certain conditions. 

The Rule requires individuals to provide written authorization before the covered entity may use or disclose the individual’s health information for research purposes.  

A covered entity may also use and disclose PHI if a waiver or alteration of the HIPAA authorization of is granted by the Institutional Review Board as long as the criteria for waiver or alteration is satisfied:

• The PHI use or disclosure involves no more than minimal risk to the privacy of individuals provided that there is an adequate plan to protect PHI from improper use and disclosure, there is an adequate plan to destroy identifiers at the earliest opportunity, and there are adequate written assurances in place that the PHI will not be reused or disclosed to any person or entity. 
• The research could not practicably be carried out with the waiver or alteration.
• The research could not be practicably be conducted without access to and use of the PHI.

Submit the Form J - HIPAA Waiver of Authorization with your IRB submission to request access to identifiable health information without prior written permission from the subject.  A Data Use Agreement may need to be considered.

All Investigators receiving and storing investigational drugs, investigational devices , or investigational products in their clinic or office areas outside of a hospital pharmacy, hospital designated service for devices, or the Investigational Drug Section of the Mays Cancer Center are required to have a Standard Operating Procedure approved by the Office of Clinical Research.  

• SOP Template - Accountability for Investigational Drugs and/or Devices
• SOP Template - Accountability for Investigational Drugs
• SOP Template - Accountability for Investigational Devices

eConsent

The IRB allows the use of an electronic consent (eConsent).   The eConsent platform should have the ability to display or use the most current version of the IRB approved consent form, include a mechanism for the subjects or subjects LAR to document willingness to participate in the research study, and have the capability to provide the subject with a copy of the consent form.  There must be the ability to re-consent subjects who are already enrolled in the research study (if applicable) and include a method to ensure that the person signing the informed consent is the subject (or the subject’s legally authorized representative ) who will be participating in the research study.  Subjects must have an opportunity to have their questions addressed (e.g. phone, in person).  Unless the IRB waives the requirement for the investigator to obtain a signed consent or grants a waiver of documentation of consent as described above, the standard expectation is that a  signature will be handwritten using a permanent medium (i.e. ink pen) by the subject or subject’s LAR. However, agreement to participate in the research study can be documented electronically.  The developer of the eConsent platform should be listed as a disclosure in the HIPAA authorization.  Purchasing of an eConsent platform will require IMS approval.  Read more about Purchasing Considerations and eConsent.

Consent alterations and waivers

IRB has the authority to approve a consent procedure that does not include or which alters some or all of the federally mandated elements of informed consent provided the approved procedure meets applicable federal regulations in which all of the following are true:

• The research involves no more than minimal risk
• The waiver of informed consent will not adversely affect the rights and welfare of the subjects
• It is not practicable to conduct the research without the waiver or alteration
• The research could not practicably be carried out without using such information or biospecimens in an identifiable format
• Whenever appropriate, participants will be provided with additional pertinent information after their participation.

Alterations or Waivers

• An Alteration of Consent is required when all required elements of consent will not be presented.
• A Waiver of Informed Consent is required when consent will not be obtained.
• A Waiver of Documentation of Informed consent is required when consent will be obtained but a signature will not.

Consenting vulnerable populations
The procedures of obtaining informed consent from vulnerable subjects may vary according to the types of clinical studies, local ethical considerations and applicable regulations. Enrollment of the subject should require measures described in the protocol and with documented approval by the IRB for such measures. See Obtaining Informed Consent Policy for further guidance.

Conflict of Interest (COI) Reports are reviewed by the COI Manager and the appropriate academic department chair and/or Dean. The COI Manager performs an initial review of all COI Reports submitted. The COI Manager creates a Conflict Management Plan or Expedited Conflict of Interest Approval form, as applicable, for those individuals that submit identifying real or potential conflicts of interest or commitment. If the conflict can be adequately managed through the expedited approval process, the Conflict of Interest Committee Chair will review and approve the conflicted investigator’s activities.  However, if a Conflict of Interest Management Plan is required, it will be submitted to the Conflict of Interest Committee for review and disposition.  

The approved Conflict of Interest Management Plan must be reviewed by the IRB of record.  The IRB determines whether the recommendations from the COIC and the Conflict Management Plan (if applicable) adequately protect the rights and welfare of human subjects or whether other actions are necessary. Go to iDisclose for additional information.

Conflict of Interest Review

Radiation Safety Committee (RSC)/Radioactive Drug Research Committee (RDRC)
All new protocols involving the use of radiation for purposes of research or radioactive drugs not requiring an IND are submitted to the RSC/RDRC for review, preferably prior to protocol submission to the Office of the IRB. The IRB may review a new study involving radiation concurrently with the RSC/RDRC. The IRB and Radiation Safety Office requires the Form Q - Use of Radiation in Human Research and consent form (with disclosure of the type of radiation and its risks).  See Environmental Health and Safety Department – Radiation Safety Committee website for further guidance:  Use employee login (intranet site): https://wp.uthscsa.edu/safety/

Institutional Biosafety Committee (IBC)
When a PI proposes research which falls under the purview of the IBC (e.g. studies involving the deliberate transfer of DNA, or DNA or RNA derived from recombinant DNA, infectious agents and other potentially hazardous biologics which carry inherent safety risks), the PI must submit the protocol to the IBC and obtain provisional approval before submitting the IRB initial review application. The IRB will not review new protocols falling under IBC purview unless the PI has obtained IBC review and provisional approval first and has included the completed Form Q-1 - Gene Transfer Therapy in Human Research Studies and the required IBC review documentation.  See Environmental Health and Safety Department – Institutional Biosafety Committee website for further guidance:  Use employee login (intranet site): https://wp.uthscsa.edu/safety/

Protocol Review Committee (PRC) – For Cancer Studies
All non-exempt human subjects cancer studies at UT Health San Antonio require review by the Mays Cancer Center (MCC) Protocol Review Committee (PRC) for scientific review, prior to submission to the Office of the IRB or Office of Clinical Research (for external IRB studies).  Contact Melissa Nashawati, MPA at the Mays Cancer Center for further information at prc@uthscsa.edu or 210-450-3955.