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Indiana University
Research Compliance Quarterly 2nd Edition
June 12th, 2015
Comply with Me - Making it easy to do it right, and hard not to do it right
In this issue:
HSO Updates: Understanding the new exempt categories

In recent years, HSO has sought ways to reduce regulatory burden while maintaining a high level of protection of human subjects. Collectively, these efforts are referred to as "flexibility". In 2012, the IRBs took a first step toward flexibility by allowing two year approvals to be granted certain minimal risk research.

On July 9th, 2015, HSO will take another step by granting exemptions under two new exempt categories, Exempt Category 6 Flex and Exempt Category 7 Flex. Research is eligible to be reviewed and approved under the flex categories if:

  • All research procedures are minimal risk,
  • The research is not directly or indirectly funded by any federal agency,
  • The research is not subject to FDA regulations,
  • The research is not subject to VA research regulations, and
  • The research is not subject to HIPAA.

Research that does not qualify as exempt under the traditional exempt categories may be reviewed and approved under the flex categories if it meets the above criteria and falls into one or both of the following categories, which mirror the traditional expedited categories 6 and 7:

  • Category 6 Flex: Research involving collection of data from voice, video, digital, or image recordings made for research purposes.
  • Category 7 Flex: 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.

Research involving interaction with children under the age of 14 will not be eligible for exempt flex approval. Additional exclusions and considerations apply that are fully outlined in the Exemptions SOP and Exempt Research Guidance, available on the HSO website July 9th. Targeted training will also be conducted in the coming weeks with departments and researchers likely to utilize the exempt flex categories.

If you believe your research may qualify for exempt review under the flex categories, create an Exempt submission in KC IRB. The Exempt questionnaire has been revised to elicit information to allow HSO staff reviewers to determine whether the research qualifies for exempt flex review. If you are unsure whether your research should be submitted for exempt review, consult the Level of Review page on the HSO website and/or contact an HSO staff member for assistance.

HIPAA & exempt human subjects research

As part of HSO's ongoing benchmarking and compliance efforts, HSO evaluated the applicability of HIPAA to exempt research. As a result of this assessment, beginning July 9th, the HIPAA requirement for authorization or waiver of authorization for use of research data will be extended to apply to all human subjects research, including exempt research. The exempt questionnaire in KC IRB has been revised with questions that will determine whether each exempt submission is subject to HIPAA. If your research is subject to HIPAA, you will be prompted to indicate whether you will obtain authorization or are requesting a waiver of authorization. There is no need to assess whether your research is subject to HIPAA prior to creating the KC IRB submission. The "smart form" functionality of the questionnaire will ensure that you receive the proper questions and will guide you in determining whether HIPAA applies and if a waiver of authorization might be appropriate.

Exempt studies approved prior to July 9th do not need to be resubmitted, and HIPAA authorization does not need to be obtained for any previously approved exempt study. However, if you submit an Amendment to a previously approved exempt study, you will be required to update to the new Exempt questionnaire. If in responding to the new questionnaire you are prompted to obtain HIPAA authorization, you will be required to obtain HIPAA authorization after approval of the Amendment. If you have questions regarding whether a change to an Exempt study requires an Amendment or how to update to the new questionnaires after July 9th, contact HSO staff for assistance.

Enhanced quality monitoring program for HSO

The Human Subjects Office is enhancing its current quality monitoring efforts with additional monitoring and more formalized documentation beginning July 9, 2015. The HSO's quality monitoring initiatives improve protection of human subjects by ensuring compliance with federal regulations, as well as service to the research community by identifying protocols that have been created but not submitted in the KC IRB system. Since the implementation of KC IRB, better data mining of HSO and IRB documentation is available, making increased quality monitoring efforts possible.

In addition to the already existing efforts, which include identification of protocols that have expired or will expire soon and review of non-key personnel updates, HSO's additional quality monitoring efforts will identify new protocols, amendments and renewals that have been created but not yet submitted for review. It will also involve regular reviews of KC IRB records for protocols that are not appropriately listed as FDA regulated or receiving federal funding. We will work to identify protocols that have had exemptions granted when expedited review may be more appropriate, or which were approved as expedited when an exemption could have been granted. Finally, our quality monitoring program will include the regular review of the average time needed to approve submissions.

HSO staff members will contact researchers when pending submissions or necessary changes to approved protocols are identified. HSO staff are excited for the opportunity to improve our office's operations and look forward to working closely with the research community on this effort.

Harmonizing Training Requirements for IACUC and IBC

Some of the training requirements for investigators working with the Institutional Biosafety Committees (IBCs) and Institutional Animal Care and Use Committees (IACUCs) have recently been harmonized across all campuses of Indiana University. Previously, variation from campus to campus caused confusion among collaborators working on campuses with different requirements because different campus programs required courses and refresher trainings at varying frequencies. The Office of Research Compliance has worked with the campus compliance committees and other stakeholders to standardize the training curriculum for IBCs. IBC and IACUC training, which was previously valid for either 3 or 5 years depending on the home campus, has been standardized to be valid for 5 years for all IBCs and all ORC-administered IACUCs.

Approvals will not be granted if personnel are not up-to-date on training requirements. Incomplete training for one or more persons on a protocol frequently causes a delay in the protocol approval process. ORC hopes to investigate other ways that standardizing compliance committee requirements across campuses can facilitate research.

IACUC Training (IU School of Medicine and IU Bloomington IACUCs):

Both committees use online CITI Training systems, and both programs require refresher training every 5 years.

IBC Training (system-wide):

Training in the NIH Guidelines can be completed online through e-Train. More information about this and laboratory biosafety technique training, bloodborne pathogen training, N95 respirator fit testing, and biological shipping packaging training is available at http://researchcompliance.iu.edu/ibc/biotrain.html.

Research Integrity at IU

The Research Integrity Office (RIO) staff would like to familiarize you with our new role in ORC and remind you that if you have questions, please contact us!

Indiana University is committed to the mission to search for truth and to foster a spirit of creativity and honesty throughout the research process. Research Misconduct is defined as FFP - fabrication, falsification, and plagiarism. For more information, please go here. You may also review the Research Misconduct Policy.

If you suspect that you have witnessed research misconduct, you have an obligation to report the behavior. You can utilize the Indiana University Anonymous Reporting Hotline at 1-888-236-7542, contact the Research Integrity Officer, Shelley Bizila, at sbizila@iu.edu, or call 317-274-5524 for an informal meeting to ask questions. As always, protections for whistleblowers against retaliation always exist.

Please visit the RIO website for more information on educational opportunities, informational materials, and research misconduct information and policies.

New Indiana legislation: Indiana's Right to Try law

In March 2015, Governor Mike Pence signed HB 1065, commonly referred to Indiana's "Right-to-Try" bill, into law. The law is the latest in a string of similar legislation adopted by states which attempts to give terminally ill patients access to experimental drugs not yet been approved by the FDA. The law allows (but does not require) drug manufacturers to offer experimental drugs, biologics, or devices to qualified patients if a physician determines that the patient has a terminal illness and does not have comparable approved therapies available to him/her, among other things.

Under federal law, patients who seek access to experimental drugs and devices have limited options: enrollment in clinical trials, or access via the FDA's compassionate use program. HB 1065 attempts to provide additional options to patients; however, it is unclear how the law will be interpreted in light of current FDA regulations, or whether pharmaceutical manufacturers will be willing to provide drugs and devices under HB 1065 without FDA comment. Until more information is available, the HSO and IU IRBs will continue to follow FDA regulations and IU research policies and guidance.

Investigators are encouraged to contact the HSO directly with any questions regarding compassionate use or access to investigational drugs and devices.

Next month in Research Compliance Quarterly

Join us next month for more information about upcoming HSO changes and our first quarterly Investigator Spotlight. If you know an investigator whose research should be highlighted, or if you'd like to share about your own research, please contact Amy Waltz at acthurst@iu.edu.

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