15th Edition - July 2, 2018

A revision to Indiana law, effective July 1, 2018, changes the list of individuals who can consent for those incapable of consenting for themselves. For research purposes, the law defines which individuals may serve as a legally authorized representative (LAR) for adults lacking consent capacity. The IU HRPP Policy on Adult Individuals Lacking Consent Capacity in Research has been updated to reflect the change in law and investigators are responsible for complying with the new policy beginning July 1.

What You Need To Know: Definition of legally authorized representative (LAR)

Under Indiana Law IC 16-36-1-5, the following individuals may serve as LAR in order of priority, as of July 1, 2018

1. Health care representative
2. Spouse
3. Adult child
4. Parent
5. Adult sibling
6. Grandparent
7. Adult grandchild
8. The nearest other relative in the next degree of kinship not listed in items 3-7 (except VA research)
9. The individual’s religious superior, if the individual is a member of a religious order (except VA research)

If none of the above are reasonably available, the IRB may approve, on a case-by-case basis, that a friend may serve as LAR if the friend is an adult, has maintained regular contact with the individual, and is familiar with the individual’s activities, health, and religious or moral beliefs.

Important impacts

• Priority: The revised law and HRPP policy introduce the concept of priority into the LAR process. When the IRB has approved consent via LAR, study teams must identify the individual with the highest priority who is reasonably available to serve as the LAR. More information regarding determining when an individual is “reasonably available” is described in the policy and additional guidance will be available shortly.
• Additional LAR: If individuals listed in priorities 1-8 are not reasonably available, the nearest other relative in the next degree of kinship may serve as LAR. Individuals listed in priorities 1-9 may serve as LAR for any research study without specific IRB approval beginning July 1, 2018. Study teams do not need to submit amendments to the IRB to implement the policy, unless they wish to utilize a friend as LAR.
• Friend as LAR: The law allows consent from a friend, if the three criteria listed above are met. While the law allows consent via friend as long as priorities 1-8 are not reasonably available, the IU HRPP has decided that specific IRB approval must be requested and granted before a study team may use friends to enroll a subject. The study team should provide specific justification for why allowing a friend to provide consent appropriately protects the specific subject.

Resources

Please see the revised IU HRPP Policy on Adult Individuals Lacking Consent Capacity in Research, as well as the revised HSO guidance on Adults Lacking Consent Capacity, published July 1, 2018. These two documents provide specific detail on assessing consent capacity, identifying LARs, and documenting the consent process with LARs. If you have questions regarding the new policy, or would like specific department training, please contact HSO at irb@iu.edu.

Important Note

The actual Indiana law differs slightly from how the HRPP has decided to interpret and implement it for research purposes. Clinicians should defer to their hospital/provider policies for how the law affects clinical practice, as the above information and the revised IU HRPP Policy is specific to research.

Final revisions to the Federal Policy for the Protection of Human Subjects (Common Rule) were expected to go into effect on July 19, 2018; however, a recent final rule from DHHS has delayed the implementation. The revised Common Rule will now be effective January 21, 2019. Education regarding the revised Common Rule will continue towards the end of 2018.

In order to allow institutions to take advantage of the revisions more immediately, the final rule allows implementation of three burden-reducing provisions beginning July 19, 2018. Institutions may implement the provisions at their discretion; however, any study which utilizes any of the three provisions must comply with all elements of the revised Common Rule beginning January 21, 2019.

The three provisions include:

• Clarification to the definition of human subjects research: The revised Common Rule adds language which clarifies that some activities are not considered to be human subjects research and are not subject to the Common Rule. IU already interprets the regulation in this way, so this provision has no practical impact on research at IU or its affiliates.
• Elimination of requirement that the IRB review the grant application or proposal for federally-funded research: The revised Common Rule no longer requires that the IRB take this action so, beginning July 19, study teams no longer need to submit their grant application or proposal with their initial IRB submission.
• Elimination of continuing review requirements: The revised Common Rule also eliminates the continuing review requirement for expedited research and full Board research which is now in long-term follow-up only or data analysis only. Research regulated by FDA and VA regulations will continue to receive annual renewal until those agencies are able to harmonize their regulations and policy to the revised Common Rule.

The HSO will revise relevant IU HRPP policies to allow implementation of these provisions on July 19, 2018. We are still finalizing implementation details and which research will be affected by these changes. Please stay tuned for more information.

In preparation for implementation of the revised Common Rule, HRPP will publish a new set of IU HRPP policies on July 19, which replaces the previous IU SOPs for Research Involving Human Subjects.

The revised policies have been:

• Reformatted and revised to increase clarity and understanding.
• Condensed to include only those requirements which are mandated by regulation, policy, or accreditation standards. Suggestions and/or best practices have been removed to the various HSO guidance documents.
• Standardized to increase consistency of language and definitions.

Please carefully review the revised IU HRPP Policies which are relevant to your research upon their release on July 19th.

When study teams wish to use an external IRB, including independent IRBs, a Reliance Request must be submitted in KC IRB for HSO review and acceptance. Once the Reliance Request has been accepted, all IRB further communication takes place between the study team and the external IRB, with a few exceptions. Study teams must report the following information to the IU HSO after acceptance of a Reliance Request:

• PI and personnel changes
• Changes that require revisions to the HIPAA authorization
• Potential protocol-specific conflicts of interest, including institutional and potential financial interests, that could affect or be affected by the research
• Study closure

KC RB now has the functionality to accept Amendments to Reliance Requests. To submit an amendment to a Reliance Request:

1. On the Protocol Actions tab, click Create Amendment.
2. Enter a Summary of the purpose of the amendment and detail any changes being made, including names of added/removed personnel.  There is no Amendment Questionnaire for amendments to Reliance Requests.
3. Update tabs as appropriate (e.g. Personnel tab, Notes & Attachments tab).
4. On the Protocol Actions tab, click Show next to Request an Action, click show on Submit for Review, then click Submit.

HSO staff will review the changes and accept them.

For more information, see the Quick Guide on Reliance on External IRBs.

Promptly reportable events must be submitted to the IRB within 5 business days of the study team becoming aware of the event. KC IRB allows you to still take the action of ‘Notify IRB of a Reportable Event’ even if your Protocol has a renewal or amendment submission pending approval.

The Office of Vice Provost for Graduate Education and Health Sciences, in collaboration with the Office of Research Compliance within the Office of the Vice President for Research, is pleased to continue offering the IU Bloomington, Responsible Conduct of Research (RCR) Series. This series is designed to satisfy the in person requirements for RCR Education and is open to all members of the IU research community.

Location: IU Bloomington Campus
Sessions Held: 4:00 – 6:00 pm
Facilitators: Expert faculty researchers, faculty members of compliance committees, representatives from the Office of Research Compliance.

Content Areas, Sessions Dates, and Locations:

Threats to Research Integrity - September 13th, 2018: Indiana Memorial Union (IMU), Oak Room 

• Research Misconduct
• Conflicts of Interest/Commitment

Protection of Research Subjects and Participants - October 11th, 2018: Indiana Memorial Union (IMU), Dogwood Room

• Human Subjects Research
• Research with Animals

Reporting/Reviewing Research - February 14th, 2019: Indiana Memorial Union (IMU), location TBD

• Peer Review
• Publications practices and responsible authorship

The Practice of Research - March 21st, 2019: Indiana Memorial Union (IMU), location TBD

• Data acquisition, management sharing and ownership
• Collaborative science
• Mentor/trainee responsibilities