STVHCS Human Research Protection Program. Kimberly Summers, PharmD Assistant Chief for Clinical Research South Texas Veterans Health Care System Research & Development Service. Human Research Protection Program (HRPP).
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Kimberly Summers, PharmD
Assistant Chief for Clinical Research
South Texas Veterans Health Care System
Research & Development Service
Unanticipated Problem Involving Risk to Subjects or Others
Report to IRB as an UPIRSO adverse event occurs that is not related to the study?
Must be reported by investigator within 48 hours (consider all UPIRSO criteria in order)
IRB reports UPIRSO to Office of Human Research Protection (OHRP)
IRB reports UPIRSO to VA R&D office
VA R&D office reports UPIRSO to Office of Research Oversight (ORO)What are the reporting requirements for deaths that may be related to study participation?
The STVHCS R&D Committee can disapproval a human subject research protocol that has been approved by the UTHSCSA IRB
Study problem subject?
Relevance of the project
Specific study objectives
Selection of subjects and recruitment
Statistical considerationsWhat are the elements of sound study design?
Which of these educational programs and activities are required to conduct research at the VA?What educational programs and activities are available to investigators and their study staff?
UTHSCSA IRB regulations is conducted by who at the STVHCS?
STVHCS R&D Office
Research non-compliance or alleged improprieties may be identified through self-reporting by the PI or by other members of the study team.To whom should research non-compliance be reported?
Preserves the public trust in the integrity and quality of research carried out by the investigators at the STVHCSWhat is the importance of disclosing financial conflicts of interest in the conduct of human research?
To eliminate an immediate hazard for enrolled subjects research carried out by the investigators at the STVHCS
This includes calling subjects to let them know about a new risk to determine if they want to continue, halt or not start enrollment until new consent form is approvedWhen can you implement a change in your study without having IRB approval?
Advertisements should include: the VA?
The name and address of
investigator and/or research facility
The condition under study and/or
purpose of the study
A summary of the criteria used to
A brief list of participation benefits,
The amount of time or other
commitment required of subjects
The location of the research
A person or office to contact for
Advertisements should not include:
Claims that the test article is safe or effective for the purpose of the investigation
Claims that the test article is known to be equivalent or superior to any other drug
Terms which imply the receipt of newly improved products of proven worth such as “new treatment”, “new medication”, or “new drug”. The advertisement must explain that the drug or device is investigational.
Promises of free medical treatment when intent is only to state that subjects will not be charged for taking part in the investigation
Emphasis of payment for participationWhat are the requirements for recruitment ads for research protocols?
Prohibited by UTHSCSA and STVHCS
Prohibited UTHSCSA and STVHCSWhat incentives are allowed that assist in recruiting patients into studies?
Local PI Responsibilities