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Indiana University
Research Compliance Quarterly 1st Edition
May 8th, 2015
Comply with Me - Making it easy to do it right, and hard not to do it right
In this issue:

Welcome to the first edition of Research Compliance Quarterly, the newsletter for researchers and ethics committee members. Published by the Office of Research Compliance, Research Compliance Quarterly invites the research community to Comply With Us and provides updates about research compliance process and procedure, guidance for conducting ethical human and animal research at IU, and research compliance news from around the country. The newsletter will be published at least quarterly; more often if necessary. Sign up to be on the mailing list via the Research News Email Service, or email inforsch@iupui.edu.

Transition of regional IRB activities to HSO

Effective July 1, 2015, review of human subjects research at all eight IU campuses will be facilitated by the IU Human Subjects Office, resulting in a University-wide human research protection program. Investigators at all campuses will make submissions via the Kuali Coeus IRB system and HSO staff will serve all IU investigators regardless of campus location. Transition information is being shared directly with researchers on each campus. Investigators are encouraged to contact Amy Waltz (acthurst@iu.edu) with any questions or concerns.

New electronic stamp for informed consent documents - Coming July 9, 2015

Beginning July 9, 2015, approval stamps on informed consent documents will be automatically applied by KC IRB and will take on a watermark format. The electronic approval stamp will no longer contain approval or expiration dates. This change has been carefully analyzed and, while removing dates will end a long-standing convention, the ability to identify and track approved forms will be maintained.

What you should know:

  • KC IRB will apply one of several different versions of the electronic stamp, depending on the status of the protocol. Electronic stamps will appear as follows:
    • For studies which are Open to Enrollment: Protocol 1501429309 IRB Approved
    • For studies which are Closed to Enrollment: Protocol 1501429309 IRB Approved for re-consenting only
    • For studies in Data Analysis Only: Protocol 1501429309 IRB Approved - Do Not Enroll Subjects
    • For disapproved studies: Protocol 1501429309 Disapproved
    • For expired studies: IRB Approval of Protocol 1501429309 Expired DD-Month-YYYY
    • For closed studies: Protocol 1501429309 Closed
  • The electronic stamp will be applied by KC IRB to any unsecured PDF on the Notes & Attachments tab of the KC Protocol. This means that:
    • PDF versions of informed consent documents must remain unsecured and
    • Other PDF documents which do not require a stamp should be secured.

    Study teams will be encouraged to secure any PDF documents that does not require an electronic stamp prior to uploading to KC IRB. HSO staff will work closely with study teams to ensure that existing documents which do not require electronic stamps (i.e. not informed consent documents) are secured.

  • The electronic stamp is applied by KC IRB when the document is viewed and downloaded. The correct stamp, per protocol status, will be applied to the current informed consent document each time it is viewed or downloaded.

Since the stamp will no longer include approval or expiration dates, it is very important for study teams to utilize version dates and/or version numbers. A few tips to remember:

  • Be consistent. Develop a naming and versioning convention to be used by all members of the study team. Document your naming convention in your study files where all team members, monitors, and auditors can reference it.
  • Abbreviate standard document types to reduce the length of file names (e.g. Protocol = PRO, informed consent statement = ICS; assent = AST)
  • Include version dates/numbers in document footers and document file names.
  • Format dates consistently and choose a clear standard. Always include the year.
  • Be sure to update version dates/numbers in document footers each time the document is revised.

HSO staff will facilitate the transition to the new electronic stamp as much as possible. More specific guidance and instructions will be provided via training sessions and the HSO website.

Additional changes to HSO policies, procedures, and processes - Coming July 9, 2015

On July 9, 2015, the HSO will implement a series of changes to policies, procedures, and processes. These changes will decrease burden on the HSO and the research community, and ensure HRPP processes are aligned with accreditation standards.

In addition to transition of IRB activities from the regional campuses and changes to the informed consent stamping procedure, major changes effective July 9 include:

  • Expanded exempt review. Research which would previously have been reviewed under certain expedited categories and is not subject to federal oversight (not federally funded, or subject to FDA or VA regulations) may be reviewed via exempt procedures beginning July 9. As part of the exempt review, these studies will undergo an abbreviated application process and will not be required to submit annual review. Eligible studies include: research involving materials that have been collected for a purpose other than the specific study being submitted; collection of data from voice, video, digital, or image recordings made for research purposes; and research on individual or group characteristics or behavior, or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. More information will be available in the June edition of Research Compliance Quarterly.
  • Extended approval periods. Minimal risk research which is not subject to federal oversight may be approved for up to three years (extended from two years).
  • CITI education requirements extended. Principal investigators, co-PIs, key personnel, and non-key investigators directly interacting with subjects will be required to complete CITI training every five years (extended from 3 years). Those who have completed the modules previously will be automatically rolled over into the extended 5 years from initial completion requirement, instead of 3 years.
  • Conflicts of Interest disclosure requirements changed. The IRB requirements for conflict of interest disclosures have been harmonized with the Conflict of Interest Office policy such that non-key investigators will no longer be required to submit the annual conflicts of interest disclosure in order to receive IRB approval.
  • Changes for VA research. The recently-released VHA Handbook 1200.05 makes several clarifications for research-related processes and decreases burden on investigators. Revisions to the handbook will be integrated into HSO SOPs and KC IRB questionnaires.
  • Revised SOPs, guidance documents, and KC IRB questionnaires. IU's human research protection program is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), and will be preparing for reaccreditation for the remainder of 2015. As part of the process, SOPs, guidance documents, KC IRB questionnaires, and website are being revised to align with accreditation standards. Revised versions will be published July 9, 2015.
Research with newborn blood spots - new federal law requires IRB approval

In December 2014, Congress passed the Newborn Screening Saves Lives Reauthorization Act of 2014. The law includes important changes impacting the use of newborn dried blood spots (also referred to as Guthrie cards) for research. The law states that all federally-funded research on newborn dried blood spots must comply with the Common Rule, 45 CFR 46, even if no identifiable information will be used or obtained by the researchers. Furthermore, the IRB is not permitted to waive informed consent for the use of newborn blood spots for federally funded research.

Revisions to the Common Rule are forthcoming to incorporate these requirements. Until these revisions are passed, please contact the HSO if you plan to use newborn dried blood spots for research, even if you will only obtain de-identified samples. HSO staff can provide additional guidance regarding how to submit for review and regulatory requirements that may apply to your particular research study. The text of the law can be found at https://www.govtrack.us/congress/bills/113/hr1281/text.

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