Your Role in Reaccreditation

A site visit will be held May 6th-8th at USC as part of the reaccreditation process for the Human Subjects Protection Program.

Interviewees will include researchers, deans, administrators, students, IRB members, and other stakeholders. Questions will emphasize knowledge of your role, human subjects policies and procedures, and emphasis is protection of human subjects.

Interview tip-sheets are available here

Job Opening for Grad Student

Want to work in the human subjects research office? We are looking for a new IRB Student Mentor to start May 2015

Expectations:

Enrolled in Masters or PhD program with minimum 2 years remaining at USC
Up to 20 hours per week
Competitive compensation
Research track degree preferred

Send resume to oprs@usc.edu/ contact Dalar Shahnazarian irbgara@usc.edu
More info about the position can be found here

GCP Expanded Education Requirement

Announcement from Vice President of Research Dr. Randolph Hall

All studies that meet the new NIH definition of a clinical trial:
- A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.(NIH Notice)
Must satisfy the Good Clinical Practice (GCP) training requirement if they are:
- Principal Investigators and staff on new studies or,
- New staff on ongoing studies

GCP training is primarily intended for study staff who collect data through intervention or interaction with a subject, or have access to private identifiable information.

Updated Policies & Procedures

The USC Human Subjects Policies and Procedures have been revised to meet national accreditation standards, enhance human subjects protection, and reflect practices at USC. The policies provide guidance and information for investigators conducting all types of human subjects research.

Policy revisions include:

New guidance on use of electronic consent and/or signatures (Ch 10.9)
New requirement for investigators who intend to publish in an International Committee of Medical Journal Editors (ICMJE): they must register their research in clinicaltrials.gov. (Ch 13.12)
New instructions for submitting Data Safety Monitoring Reports and Investigational Device Exemption (IDE) Annual Reports (Ch 7.14)

Guidance for Standard of Care Research

Research on "standard of care" treatments is now expected under the Affordable Care Act. It is imperative that all those involved understand applicable oversight rules and ethical considerations.
Read the new "Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care" from the HHS Office for Human Research Protections (OHRP).
A critical response to the guidance is available here from the organization Public Responsibility in Medicine in Research (PRIM&R).

Updated Guide to Clinical Research at USC

The Guide to Clinical Research at USC has been updated January, 2015 edition

Major updates include:

Details from the new LAC+USC Sponsored Programs Agreement for clinical research at LAC+USC (page 6);
New section on clinical research coordinator job classifications and training (page 43);
Updated flow chart of Industry-sponsored clinical trials at USC (sponsor & PI-initiated) (Appendix I);
All contact information and hyperlinks have also been updated.

Once the new system is deployed, the guide will be updated to include the OnCore CTMS software.

New LAC + USC Sponsored Programs Agreement

Under the terms of the new LAC+USC sponsored programs agreement:

Research at LAC+USC will need review by LAC+USC Chief Medical Officer (CMO): CMO is responsible for deciding, within 15 business days, whether LAC+USC will permit the research to take place. In the absence of a decision within 15 business days, approval will be deemed granted.
Billing: LAC+USC will rely on the Medicare Coverage Analysis conducted by USC to determine which research services result from routine care (and are billable to insurance) and which services and supplies are non‐routine (i.e., added expenses attributed to a research project).
Research Order Forms: LAC+USC is developing research order forms which will be required for requesting research related services and supplies from

CTSI Grant Renewal

The Southern California Clinical Translational Science Institute has submitted its renewal grand application. Results will be determined. Learn more about the SC-CTSI

Annual IRB Survey Coming Up!

Principal Investigators on all active studies in iStar are invited to complete an online survey of satisfaction with the IRB, HSPP, and iStar systems. The survey is sent to 6000+ people, including active researchers and staff, IRB members, Department Chairs, Deans, and other university contacts. Stay tuned for the link to the survey!

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