Build the support plan before the first visit

Map support activity by activity

List prescreening calls, consent, travel, check-in, procedures, recovery, diaries, telehealth, home visits, specimen shipping, payment administration, and safety follow-up. For each activity, identify the access need, requested support, responsible person, approval contact, backup, and cost.

Use exact requirements. “Accessible visit” does not explain whether you need step-free entry, an adjustable examination surface, transfer assistance, a quiet waiting area, extra processing time, large print, captioning, a qualified interpreter, accessible electronic documents, or permission for a support person.

Keep four support roles distinct

A companion is not automatically an interpreter or legally authorized representative. OHRP explains (opens in a new tab) that applicable law determines who may act as a legally authorized representative. Ask the site and IRB which rule governs the study.

Request effective communication before the consent appointment

Tell the site the format and method you use: accessible electronic text, large print, Braille, audio, real-time captioning, sign-language interpretation, speech-to-speech support, relay calling, plain-language explanation, or additional time. Ask for a date when the materials and service will be ready. Request a way to test electronic documents and meeting links in advance.

U.S. Department of Justice guidance (opens in a new tab) explains effective-communication duties for covered entities and lists aids and services for vision, hearing, and speech disabilities. Whether a particular study site is covered and which aid is required depends on the entity, communication, and circumstances. Use the site’s accessibility office or ADA coordinator when available; use the participant-rights contact when an unresolved access barrier affects informed consent or continued participation.

Do not default to a child, relative, or caregiver as the interpreter for complex consent or safety information. DOJ guidance limits when covered entities may rely on an accompanying person and emphasizes accuracy, impartiality, privacy, and independence.

Ask for consent information in a language you understand

Language access and disability access can require different services. Tell the site your preferred spoken and written language and whether you also need an accessible format. Ask which translated consent document, interpreter, witness, and IRB-approved process the study will use.

OHRP guidance (opens in a new tab) states that consent information for HHS-regulated research must be presented in language understandable to the participant. It describes full translated consent and a regulated short-form process with an oral presentation and witness. A bilingual family member may provide support, but the study remains responsible for an approved consent process.

Measure caregiver and companion workload

Record every activity that requires another person: driving after sedation, overnight observation, transfer help, medication or device assistance, child or dependent care, hotel stay, sample shipping, diary support, or emergency communication. Ask whether the same person must attend each time and how late discharge or rescheduling affects them.

Protect the participant’s voice. Agree on what the companion may hear, answer, record, or share. Ask for private time with the research team when needed. The participant should supply self-report answers; a permitted caregiver or accessibility aid may help read or record them. A proxy answers only when the protocol or instrument authorizes proxy reporting.

Build an accessible travel and recovery chain

Confirm step-free routes, accessible parking or drop-off, transportation vendor capability, mobility-equipment storage, service-animal procedures, restroom access, examination equipment, overnight room features, and the route to urgent care. Ask how long a companion must remain onsite and who approves a replacement if that person becomes unavailable.

For sedation, anesthesia, dosing, vision testing, or another procedure that can affect driving or self-care, follow the study’s written discharge instructions. Confirm whether public transit or rideshare is allowed, whether a responsible adult must receive you, and what happens if discharge occurs later than planned.

Test remote technology with the accessibility tools you use

Open the consent platform, portal, diary, video visit, and device instructions with your actual screen reader, magnifier, captions, keyboard, switch device, voice control, hearing technology, or other setup. Test authentication, timeout, error recovery, signature, file download, reminders, and support contact.

Federal eConsent guidance (opens in a new tab) requires an opportunity to ask questions and receive a copy, and FDA decentralized-trial guidance (opens in a new tab) tells sponsors to consider whether remote activities fit participant needs. Ask for a paper, phone, in-person, or accessible digital alternative when the approved protocol provides one. Record what happens to deadlines and payment after a documented technology failure.

Confirm approval and reimbursement for access-related costs

Separate accessibility duties from optional reimbursement. Where ADA Title II or Title III applies, DOJ’s Title II regulation (opens in a new tab) and Title III regulation (opens in a new tab) prohibit covered public entities and public accommodations from imposing disability-related surcharges for measures required to provide nondiscriminatory access, including required auxiliary aids. Whether the ADA applies and which measure is required depends on the entity and circumstances.

Ask whether the study reimburses accessible transportation, companion travel, lodging, meals, parking, childcare, home internet, data use, device accessories, shipping, or added caregiver time. Obtain written preapproval, receipt rules, mileage or fare limits, cancellation terms, and payment timing. HHS advisory guidance on participant payment (opens in a new tab) distinguishes reimbursement from compensation. The protocol’s IRB-approved payment materials govern what the study promises to reimburse; they do not replace independent accessibility duties.

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Escalate a broken support plan before it changes consent or safety

Contact the coordinator with the specific barrier and requested correction. Copy the investigator, accessibility office, interpreter service, or travel vendor when their role is clear. Use the participant-rights or IRB contact when the barrier prevents understanding, creates pressure, changes voluntary participation, or remains unresolved.

For an urgent medical problem, use the study’s safety instructions and local emergency services. An accessibility complaint process does not replace emergency care. This guide identifies planning questions; it does not determine whether a particular organization violated disability, language-access, or research law.