IRB Considerations
Definitions of Older Adults in Research
- The exact age range for older adults can vary by organization, but adults over the age of 65 are typically considered to be older adults.1
- Researchers work with two populations of older adults when it comes to Institutional Review Board (IRB) considerations:
- 1) Older adults in the general population who are cognitively intact, community dwelling, and capable of making choices and providing their consent. The majority of older adults are cognitively intact, and as such, general IRB procedures for all adults apply to them, with the additional factor of elder abuse reporting (detailed below).
- 2) Special population older adults are those who may be decisionally impaired and are unable to provide consent, such as individuals with dementia or medical frailty individuals. For special population older adults, additional IRB issues must be addressed. See Consenting Individuals with Dementia.
Informed Consent for Older Adults
- Consent is an ongoing process.
- Some older adults require special protections. The protocol must protect their ability to withdraw or choose not to participate at any time. Individuals suffering from cognitive impairment or are who institutionalized in nursing homes may be susceptible to coercion. 2
- Third Party/ Surrogate Consent with special populations of older adults (e.g., dementia, institutionalized):
- Researchers need to specify a plan to determine competency to consent in special populations (see Consenting Individuals with Dementia for an example of assessments). Determine whether a verbal assent form that the interviewer can sign is appropriate. While participants may be unable to provide informed consent, they are able to assent, indicating affirmative agreement to participate either verbally or in writing. In these circumstances, their legal authorized representative must provide signed consent on their behalf.
- Researchers should explain the study to individuals with cognitive impairment.
- Prior to using 3rd party consent, ensure that a qualified individual administers cognitive assessments. Specify the qualifications of this individual in your IRB proposal.
- The IRB will conduct full board reviews of projects involving individuals whose age, physical impairment, or mental impairment may not enable them to execute legally effective informed consent. Projects will be reviewed on the basis of risks and benefits.
- For researchers at UT Austin, see the IRB Policies and Procedures Manual Sections 6 and 12 for more information.
General Study Considerations for Older Adults
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Inclusion or exclusion of any specific age or age range of individuals must be scientifically justified. See the National Institute of Health guidelines on this topic. 3
- Have a consultant or collaborator who has experience working with older adults involved in the study.
- Consider whether participation exposes older adults to greater risks than those present in ordinary life. Consider the toll participation can take on older adults physically, mentally, and in terms of time and transportation burdens. 4
- If recruiting from a health clinic, senior center that provides services, skilled nursing facility or hospital, outline in the consent form that their choice to participate will not affect their care, their relationship with their facility/hospital, or any of their privileges.
Reporting Elder Abuse
- Researchers have a duty to protect participants from harm and respect their autonomy.
- For healthy older adults, one of the most important distinctions in IRB protections is that researchers may have a duty to report elder abuse.
- Mandatory reporting laws for elder abuse vary by state.
- Texas law requires researchers to report any suspicion of abuse to an individual over the age of 65. See Texas Adult Protective Services for more information.
- Other states may have different reporting laws that you can find here.
- Consider providing all study participants with contact information for the Area Agency on Aging and Adult Protective Services.
- The consent form must specify mandatory reporting conditions for elder abuse. In these cases confidentiality will be broken.