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
- Health care representative
- Adult child
- Adult sibling
- Adult grandchild
- The nearest other relative in the next degree of kinship not listed in items 3-7 (except VA research)
- 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.
- 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.
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 email@example.com.
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.