FAQs

An intellectual disability is life-long developmental disability involving limitations in intellectual functioning and everyday skills.

Disability-accommodations and experience can improve intellectual functioning and everyday skills.

Yes, in 2023 the National Institute on Minority Health and Health Disparities (NIMHD) designated people with disabilities as a population with health disparities for research supported by the National Institutes of Health. 

Adults with intellectual disability experience premature mortality, higher rates of chronic conditions (e.g., diabetes, heart disease), and poorer preventive healthcare access than others. 

Many adults with intellectual disability value the opportunity to be in research, and the personal and societal benefits of research.

Researchers can include adults with intellectual disability by considering their preferences and providing disability-accommodations.

Inclusion of adults with intellectual disability in research directly affects the generalizability of study findings and efforts to promote health benefits for all.

Historically, people with intellectual disability have been mistreated in research and healthcare, and long assumed incompetent. Initial efforts to address these injustices favored approaches that restricted their inclusion in research, or limited their right to autonomous decision-making in research participation decisions.

While there are concerns about possible challenges in understanding consent information, susceptibility to influence, or differential impacts of research risks, today there are efforts to re-balance approaches to responsibly include adults with intellectual disability, and to use strategies that favor their right to autonomy.

Adults with intellectual disability often want to be in research, and disability-accommodations can promote their understanding of consent information.

The ENGAGE Toolkit can help researchers responsibly include adults with intellectual disability.(opens in new tab)

Adults with intellectual disability have health needs that require scientific knowledge and tailored translation of this knowledge into clinical care. Including people across demographic characteristics in research ensures that the knowledge derived is widely applicable. The inclusion of adults with intellectual disability in research helps to generate new knowledge that can improve their health.

Federal research regulations state that researchers should take extra care when including populations that might experience consent capacity challenges or be more readily harmed by research. The ENGAGE Toolkit provides researchers with information and practical tools for the responsible inclusion of adults with intellectual disability in research.

Exclusion should only be considered when inclusion via surrogate consent is inappropriate, or there are other specific ethical or scientific justifications.

Guardianship requires a court order to appoint another person to make all or some decisions for an adult who cannot make or communicate decisions about their person and/or other significant life decisions (such as property). Guardianship is a last resort.

Not all adults with intellectual disability need or have a guardian.

To learn more about guardianship and research participation, see Federal Laws and Regulations.(opens in new tab)

Adults with intellectual disability subject to guardianship can usually be in research.

State law and the specific guardianship orders determine whether or not guardians have the authority to make a research participation decision on behalf of the adult subject to guardianship.

Even adults with intellectual disability subject to guardianship may retain the right and have the consent capacity to make some research decisions.

When the guardian has the authority, and absent ethical or scientific justifications to exclude the adult with intellectual disability from a research study, the guardian can serve as the legally authorized representative (LAR). In such cases, the adult with intellectual disability can provide assent or dissent.

To learn more about guardianship and research participation, see Federal Laws and Regulations.(opens in new tab)

Federal research regulations state that researchers should take extra care when including populations that might experience consent capacity challenges or be more readily harmed by research. The ENGAGE Toolkit provides researchers with information and practical tools for the responsible inclusion of adults with intellectual disability in research.

For adults determined to lack capacity to consent to a specific research study, state and territory laws have different approaches regarding whether or when legally authorized representatives (LARs) can consent to research participation on behalf of another person.

To learn more, see Federal Laws and Regulations.(opens in new tab)

Adults with intellectual disability, like others in the general public, experience a range of health conditions for which research is needed and can inform future care. Their inclusion in research is thus a necessary step and adults with intellectual disability should have the opportunity to decide whether they want to be in a research study. Many adults with intellectual disability want to be in research and can make their own decisions about being in research.

Similar to actions taken to invite anyone to be in research, researchers must take steps to enhance understanding of consent disclosures and prevent or mitigate potential undue influence or coercion.

Learn more about creating consent protocols and materials and applying for IRB approval.(opens in new tab)

Yes, most adults with intellectual disability can make decisions about being in research.

Having an intellectual disability is not evidence that a person lacks consent capacity to make a specific research participation decision. Categorical, label-based characterization is contrary to NIH guidance.(opens in new tab) Disability-accommodations and support can improve consent capacity.

Consent capacity requirements should be responsive to the complexity of the research participation decision. Given widespread challenges in understanding consent disclosures, there is no consensus on what is “informed enough”.

For some research studies, consent capacity can be assumed for anyone able to communicate a consent choice. Generally, assessment of consent capacity should increase in rigor as:

• The complexity and risks of the participation decision increase; and
• The extent of impairment to potential participants’ functional abilities is higher,

The assessment of consent capacity must be specific to the information in a specific research study.

Learn more about consent to research and adults with intellectual disability.(opens in new tab)

Yes, unless this right was explicitly removed by law or an individual court order.

State and territory law and the specific guardianship orders determine whether or not guardians have the authority to make a research participation decision on behalf of the adult subject to guardianship. When the guardian does have the authority, and unless there are ethical or legal reasons otherwise, the guardian can serve as the LAR and the adult with intellectual disability can provide assent or dissent.

Adults with intellectual disability can almost always say no to research participation.

To learn more about guardianship and research participation, see Federal Laws and Regulations.(opens in new tab)

Consent to research involves making an informed, voluntary decision.

Disability-accommodations like using everyday words, reading things out loud, and, when desired by the adult with intellectual disability, receiving support can improve consent capacity.

Learn more about how to promote the responsible inclusion of adults with intellectual disability.(opens in new tab)

Consent capacity is specific to a research participation decision, and malleable.

Disability-accommodations like using everyday words, reading things out loud, demonstrating research procedures, and using activities like a card sort can enhance understanding.

When desired by the adult with intellectual disability, the potential participant can also use supported decision-making to improve consent capacity.

The ENGAGE Toolkit includes recommendations and materials to enhance consent capacity.(opens in new tab)

A potential participant should be assumed to have consent capacity unless there is reliable, substantial evidence otherwise. Having an intellectual disability is not evidence that a person lacks consent capacity to make a specific research participation decision.

For research that: (1) is not greater than minimal risk and (2) does not have clinical care implications (e.g., non-therapeutic, no return of personal genetic or health results), consent capacity can generally be assumed for anyone able to communicate a consent choice.

Generally, assessment of consent capacity should increase in rigor as:

• The complexity and risks of the participation decision increase; and
• The extent of impairment to potential participants’ functional abilities is higher. The assessment of consent capacity must be specific to the information in a research study.

The ENGAGE Toolkit includes recommendations and materials for consent to research and adults with intellectual disability.(opens in new tab)

There are legal and ethical considerations in determining consent capacity. It is always good practice to pay attention to whether an individual appears to be understanding consent disclosures.

Generally, assessment of consent capacity should increase in rigor as:

• the complexity and risks of the participation decision increase; and
• the extent of likely impairment to potential participants’ functional abilities is higher. The assessment of consent capacity must be specific to the information in a specific research study.

The ENGAGE Toolkit includes recommendations and materials for consent to research and adults with intellectual disability.(opens in new tab)

A determination that an individual lacks consent capacity for a specific research decision can be made because of being

• subject to individual guardianship court orders that include the research participation decision, or
• formally assessed and determined to not meet the required threshold for understanding for a specific research study.

In such cases, determine whether it is legal, ethical, and feasible to include individuals via a legally authorized representative (LAR) in the research study. That is, whether individuals requiring proxy or surrogate consent are eligible for the study.

The ENGAGE Toolkit includes recommendations and materials for consent to research and adults with intellectual disability and LARs.(opens in new tab)

Use The ENGAGE Toolkit to:

• Create customized, editable consent materials for your study. Go to Create Consent Materials(opens in new tab), provide information about your study, and receive editable, customized consent materials to download. Your customized materials will be saved in your account and available for future modification or replication.
• Learn best practices for consent. Review information about consent best practices(opens in new tab) and laws and regulations(opens in new tab) relevant to research participation decisions.
• Download consent tips and editable consent templates
• Access the ENGAGE Toolkit QuickStart Guide (PDF) to learn more

No!

The ENGAGE Toolkit was supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) and National Human Genome Research Institute (NHGRI) of the National Institutes of Health under Award Number R01HD108701 (MPIs McDonald & Sabatello) and is available for use at no cost.

Yes!

See the User Agreement.(opens in new tab)

For citing The ENGAGE Toolkit in grant proposals, IRB applications, publications and presentations:

McDonald, K. & Sabatello, M. (2025). The ENGAGE Toolkit. Syracuse University, Columbia University ENGAGE-Toolkit.org