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Indiana University
Research Compliance Quarterly 7th Edition
July 8th, 2016
Comply with Me - Making it easy to do it right, and hard not to do it right
In this issue:
IU Human Research Protection Program Receives
Full Reaccreditation

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has granted Indiana University full reaccreditation status.

AAHRPP is an independent, non-profit accrediting body which uses a voluntary, peer-driven, educational model to ensure HRPPs meet rigorous standards for quality and protection. To earn accreditation, organizations must provide tangible evidence - through policies, procedures, and practices - of their commitment to scientifically and ethically sound research and to continuous improvement.

The IU HRPP has been accredited since 2005 and now includes the human research programs on all Indiana University campuses.

AAHRPP conducted its third reaccreditation site visit in Indianapolis February 23–25, 2016. During the visit, site visitors interviewed numerous Researchers, IRB members and Staff, Grants and Contracts Staff, and other Compliance Committee Staff; and additionally reviewed numerous research studies, policies, and IRB materials.

AAHRPP accreditation is an important step in strengthening protections for research participants. Each accreditation advances that objective and helps build public trust and confidence in research at IU. The Human Subjects Office offers their sincere thanks to you for supporting this important endeavor!

New Good Clinical Practice Training Requirement

The NIH's National Center for Advancing Translational Sciences (NCATS) is leading an initiative to promote Good Clinical Practice (GCP) training to ensure that investigators who conduct clinical trials are appropriately trained. The Indiana Clinical and Translational Sciences Institute (CTSI) supports this training initiative as an essential step toward further ensuring the protection of trial participants and the quality of clinical trial results.

Accordingly, the IRB will require Good Clinical Practices (GCP) training for Principal Investigators and Co-Principal Investigators beginning July 1, 2016, for interventional clinical studies. New interventional clinical studies and renewals of interventional clinical studies submitted after July 1 will invoke this training requirement.

For the purposes of consistency and tracking, GCP training must be completed through the CITI program. CITI GCP training is valid for three years, and CITI GCP training completed within the last three years will be accepted. A GCP refresher course is now available in CITI for expired GCP courses. Sponsors may accept completion of CITI GCP training in lieu of sponsor-provided GCP training.

To complete GCP training in the CITI program, visit the IU CITI Program log-in page.

New and Updated Guidance

The IRB has released two new guidance documents: FERPA and Quality Improvement vs. Research.

The FERPA (which stands for Family Educational Rights and Privacy Act) guidance was written to offer investigators additional factors to consider when designing and conducting research involving students and student records. These factors originate from the federal law governing the access of educational information and records.

Quality Improvement vs. Research guidance is intended to assist investigators in making the determination whether a project represents a quality improvement initiative, or alternatively whether it constitutes research with human subjects and thus invokes IRB oversight.

Guidance on Informed Consent has been updated to include information regarding electronic consent options. Information regarding signature requirements and options for obtaining verified, electronic signature has been added. Specifically, the guidance allows subjects to provide verified signature in lieu of a physical, “wet” signature via encrypted digital signature, electronic signature pad, voice print, digital fingerprint, or signature made with a fingerprint on a touchscreen. Studies which do not plan to obtain wet or verified signature should consider requesting a waiver of documentation of consent.

All documents are located on the Policies and Guidance webpage.

Improved Pre-Review Process

Starting June 30, 2016, study teams began receiving e-mails directly from the KC IRB system when the HSO completed pre-review on their protocols. This email provides basic protocol information, links to pre-review comments and revised documents, detailed instructions on how to respond to the pre-review, and contact information for their HSO screener.

  1. After the HSO screener completes pre-review, he/she will add comments, and upload into KC IRB any necessary documents with tracked changes, including a PDF of the KC Questionnaire(s) with comments. The screener will then take the Return to PI action in KC IRB and the status of the protocol will change to Return to PI. This status change opens the protocol for editing.
  2. An email is then sent to the study team, i.e. PI, Co-PI, aggregator, study manager, alerting them that the protocol has received pre-review and action is required on their part.
  3. The study team should review comments and attachments in KC IRB and address the screener’s requests appropriately. Detailed instructions on responding to pre-review can be found HERE.
  4. When all requests have been addressed, the researcher must take the Submit to IRB action on the Protocol Actions tab in KC IRB. This will notify the HSO screener that a response has been submitted.
IU ClinicalTrials.gov Presents at HCCA Conference

Casandra Greene, IU ClinicalTrials.gov Administrator, and Christine Caldwell, Indiana Clinical and Translational Sciences Institute (CTSI) Regulatory Knowledge and Support Program Manager, presented at the Health Care Compliance Association (HCCA) Research Compliance Conference in early June. Their presentation received an overwhelmingly positive response from conference attendees.

The Office of Research Compliance has met the challenges of ClinicalTrials.gov compliance with a strong program consisting of all elements of a compliance program - with the addition of program support offered through the CTSI. The partnership between ORC and CTSI mitigates risk to the University while providing support for researcher compliance.

For more information about the IU ClinicalTrials.gov Compliance Program, please visit the Quality Improvement Office website.

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