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March 31, 2014
Dear Investigators and Study Personnel:
According to a long-standing IRB practice at UT Southwestern, the names of all study personnel authorized by the Principal Investigator (PI) to obtain consent have been required to be listed on the consent document.
Due to frequent changes in study personnel, research teams have found it difficult to keep the list of study personnel in the eIRB smart form congruent with the list of personnel on the consent form. This has led to increased stipulations from the IRB and frequent modifications to consent documents.
As a result, the IRB Executive Committee has determined that only the name of the study PI will be required to be listed on consent forms.
Please note that an accurate listing of study personnel in the eIRB smart form will still be required. In addition, investigators will be required to keep an up-to-date delegation log to indicate which members of the study team are authorized by the PI to obtain informed consent from study participants. These delegation logs must be available for audits or post-approval monitoring.
This change is effective immediately for new studies. We are in the process of changing the consent document templates to reflect this change. For already approved studies, Investigators may choose to remove the names of study personnel from the consent documents at the time of another modification that affects the consent document. PI’s may choose to continue to list other co-investigators and study personnel on consent documents if desired.
If you have questions, please contact James “Gregg” Wright at 214-648-5486 or by email. firstname.lastname@example.org
March 6, 2014
Dear Investigators and Research Personnel,
Effective January 1, 2014, Good Clinical Practice (GCP) training is required for study personnel involved in a research study involving human subjects in a Clinical Trial*. GCP is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and report of clinical trials. GCP practices provide assurance that the data and reported results are credible and accurate; and the rights, integrity and confidentiality of the trial subjects are protected.
- www.clinicaltrials.gov defines a Clinical Trial as: “A clinical study in which participants are assigned to receive one or more interventions (or no intervention [i.e., placebo]) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.”
Please note: To avoid delay in IRB approvals, please ensure that all study personnel have completed the required training and have submitted a current Statement of Financial Interest. Required training includes: Human Subjects Protection (HSP), HIPAA Research, Conflict of Interest (COI) for all study personnel; and Good Clinical Practice (GCP) for those on clinical trials.
All required training is provided as a web-based tutorial offered through the Collaborative Institutional Training Initiative (CITI Program). After finishing the required courses, please keep a copy of each training certificate for your records as the IRB does not keep copies of the certificates.
The instructions for training are outlined in the attached document and are also located on the IRB Training and Education webpage.
For questions, please contact:
or Julia Spesivtseva