Successful Site Visit for USC Reaccreditation

The site visit for reaccreditation of the USC Human Subjects Protection Program was a success thanks to 65 excellent interviews that included faculty, staff, students, and administration. Site visitors from the Association for the Accreditation of Human Subjects Protection Programs (AAHRPP) had only 3 findings in their site visit report:

IRB Feedback needed on Conflict of Interest management plans
Annual IRB appointment letters required
Certain Full Board contingencies must return to convened IRB for approval

A response has been submitted and AAHRPP will vote on USC's accreditation status in September 2015.

Big Response to Annual IRB Survey

More than 500 responses were collected this year for the IRB/Human Subjects Protection Program annual survey. Your feedback is appreciated. Comments from the USC research community are used to improve the IRB, ISTAR, and OPRS.
For example, survey responses in 2014 led to the establishment of additional resources for Research Coordinators and IRB Office Hours at both campuses.

Results from this year indicate investigators want:

More direct communication (phone, in-person) with the IRB
More examples/guidance for determining level of IRB review
A chart encompassing the research approval process at USC (IRB and beyond)

New IRB Student Mentor

Natalie Aguilar is the Human Subjects Protection Program's new IRB Student Mentor. Natalie is available to answer questions and assist students preparing research protocols for IRB review. To schedule an appointment or ask question, contact the IRB Student Mentor at (213) 821-4219 or irbgara@usc.edu

Office Hours - Summer 2015

Tue 7:30 am - 4:00 pm
Wed 7:00 am - 11:30 am
Thu 8:00 am - 12:00 pm
Fri 1:00 pm - 5:00 pm

New Law on Blood Spot Research

The "Newborn Screening Saves Lives" Reauthorization Act of 2014 is a new law that applies only to HHS-funded research.
The law includes two significant changes to the human subjects regulations as they apply to research with newborn dried blood spots. First, the law requires that all HHS funded research with newborn dried spots be considered human subjects research regardless of whether the specimens are identifiable. Second, the law eliminates the ability of the IRB to waive informed consent for research involving newborn dried blood spots.

The California state assembly is considering additional legislation that would require parents to be notified their child’s blood and DNA will be kept for purposes of experimentation and require the state to obtain a signature from parents acknowledging they received information about the storage of their child’s blood sample and subsequent use in research.

Read the HHS Press Release on Blood Spot Research

Read about the California DNA Privacy Bill

FDA Guidance on e-Consent

The FDA Draft Guidance on Use of Electronic Informed Consent in Clinical Investigations addresses several important questions:

How and where may the e-consent process be conducted?
Does FDA allow the use of electronic signatures to document e-consent?
Can HIPAA authorizations for research be obtained electronically?
What materials or documents will FDA require during an inspection?

Read the Draft Guidance

Securing Research Data

Investigators and research staff have a responsibility to securely store data collected from human subjects. The USC Information Security Policy describes the oversight structure and data classification system used at USC. Investigators should consult the policy at policy.usc.edu/info-security/ .

Senators Tackle Obstacles to Biomedical Research

A 42-page report has been issued by Senators Lamar Alexander and Richard Burr, titled "Innovation for Healthier Americans: Identifying Opportunities for Meaningful Reform to Our Nation's Product Discovery and Development." Their efforts look to address key issues
like requirements for multiple Institutional Review Board approvals for multiple trial sites, challenges in patient recruitment for clinical trials, and inefficient data collection and monitoring.

Read the Report

New Data Sharing Requirement

The NIH Institue of Mental Health (NIMH) has established an infrastructure to promote sharing and use of data collected from human subject in clinical research. As of May 1, 2015 NIMH expects investigators and their institutions to provide basic data sharing plans in grant applications. Compliance with the data sharing plan will become a term and condition in the Notice of Award.

Read the NIH Notice

Read the USC Research Coordinator Bulletin

Did you know USC has an online bulletin just for Clinical Research Coordinators? The RC Bulletin is used to announce coordinator education lunches, policy changes, and other news for the USC clinical research community. All interested study personnel are welcome to join.

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