CommentaryClinical Trials

Universal Design of Research: Inclusion of Persons with Disabilities in Mainstream Biomedical Studies

See allHide authors and affiliations

Science Translational Medicine  11 May 2011:
Vol. 3, Issue 82, pp. 82cm12
DOI: 10.1126/scitranslmed.3002133

Figures

  • Fig. 1. Making biomedical studies more inclusive through UDR.

    Providing a magnifier to allow persons with low vision to read a questionnaire is an example of a simple adaption that can promote the participation of disabled individuals in mainstream research studies.

    CREDIT: David Ahntholz

Tables

  • Table 1. Practical UDR guidelines for recruitment, accommodation, and site selection.

     

    Recruit through a variety of media.
    • Make large-print recruitment notices, using nationally recognized standards for large print (20).
    • Use audible recruitment (for example, audible announcements on radio or television or in person at support groups).
    • Recruit through local disability agencies and disability consumer organizations.
    Plan multiple options for response to recruitment notices.
    • Allow for response by telephone.
    • Be prepared to receive responses by video relay service from deaf participants (20–22).
    • If you allow for Internet or Web-based responses to recruitment, provide a site accessible to screen readers and compliant with Section 508 Amendment of the 1973 Rehabilitation Act (23).
    Plan to accommodate special needs of participants during data gathering and other research activities.
    • Do not add disabilities to exclusion criteria unless they would substantively alter the scientific content of the research.
    • Consult with disability experts about facilitating access for your particular project.
    • In all recruitment materials, include contact information for requesting reasonable accommodations.
    • For events lasting two or more hours, have planned breaks or rest periods.
    Plan for accessibility when choosing the location for research activities that involve participants.
    • Whenever feasible, plan for participation from a distance (for example, through online surveys or telephone interviews).
    • When planning a location for face-to-face interaction, consider (i) the needs of nondrivers (such as a need for accessible and reliable public transportation, or inclusion of transportation for nondrivers in the research budget) and (ii) building accessibility standards, especially those pertaining to people in wheelchairs.
    • Before research activities begin, provide an orientation to surroundings for people with visual impairment by (i) explaining the route or guiding each person from the front door to the correct room within a building and (ii) giving a brief orientation to the room layout, the location of a nearby bathroom, and, if meal times are included in research activities, a location for obtaining a meal.
  • Table 2. Practical UDR guidelines for communicating information in research instruments and interventions.

     

    Provide auditory, visual, tactile, and low literacy options for communicating all necessary information.
    • Ensure that all materials needed by research participants are available in multiple formats (for example, the informed consent form, research instruments, and instructions for interventions).
    • Ask each individual to choose his or her preferred format.
    • Create print materials in a format readily transformed into accessible materials, according to the National Instructional Materials Accessibility Standard (24). The simplest way to do this for short documents is to use the “Styles” option in Word.
    • Use plain language (23, 25).
    • In visual formats, use pictures to illustrate major concepts.
    • In audio formats, use conversations and sounds to illustrate major concepts.
    • When creating study Web sites, make sure they are accessible to screen readers and compliant with Section 508 Amendment of the 1973 Rehabilitation Act (26).
    • For surveys with numbered responses, consider using a telephone keypad survey, which is accessible to anyone who uses a telephone.
    Options for communicating with persons with hearing impairment
    • For communicating with persons who are hard of hearing, (i) speak in the middle of your voice range, (ii) pronounce words clearly, (iii) resist the urge to overenunciate, which distorts pronunciation and lip movements, and (iv) consider purchasing and offering the use of a portable personal amplifier.
    • Lip reading, although not sufficient for good communication alone, can provide useful information that helps make speech more understandable. Ask the person if he or she uses lip reading. For lip readers, position yourself with clear sight lines and good lighting on your face. Avoid sitting with a bright window behind you.
    • For communicating with persons who use American Sign Language (ASL), hire an ASL interpreter (27). Because ASL has different grammar, syntax, and vocabulary from English, translation may not be exact (28). Like native speakers of other languages, people with ASL as their first language often have difficulty reading English fluently; they may need an ASL interpreter to understand documents in written English. Plain language in the original document can make accurate translation easier.
    • Use a Video Relay Service (VRS) to communicate with deaf participants by telephone (20–22). [Telecommunication Device for the Deaf (or TDD), an older technology, is being phased out.]
    • When using audiovisual materials for interventions, ensure that all needed information is communicated visually (for example, though closed captioning).
    Options for communicating with persons with visual impairment
    • For participants with low vision, provide materials in large print (18-point, bold, sans-serif font) on nonglare paper; encourage the use of magnifiers and other assistive technology (29, 30).
    • Provide materials in Braille for Braille readers (31).
    • Provide text documents in digital format to participants who use computers with screen readers.
    • Consider (i) providing audio recordings for people who cannot read large print or Braille and (ii) using digital media that allow for personalization (for example, changing the size and colors of fonts and controlling volume).
    • When using audiovisual materials for interventions, ensure that all needed information is communicated audibly though a sound track that describes any necessary visual information or through audio description (32).
  • Table 3. Practical UDR guidelines for providing multiple means of responding to research instruments and interventions.

     

    Provide visual, voiced, and tactile means of response to questionnaires and other research instruments.
    • For visual response, use both written and picture choices.
    • Consider (i) using a VRS to communicate with deaf participants; (ii) allowing Braille responses from Braille writers; (iii) providing an ASL interpreter for deaf participants who use ASL; (iv) using touch screen questionnaires on tablet or pad computers, with visual, tactile, and audio cues; and (v) using telephone interviews, a standard technique that is already accessible to most people.
    Provide accessible options for interventions.
    • For self-management interventions using technology, ensure that options are available with visual, audible, and tactile output (for example, talking blood pressure and blood glucose meters with large print, insulin pumps with vibrating alarms, talking pedometers, and alarm clocks that talk or have flashing lights).
    • For qualitative research that requires participants to keep journals, allow a recorded format for those who keep records as recordings. Consider providing a low-cost digital recorder that can be downloaded into a computer for easy transcription.

Stay Connected to Science Translational Medicine

Navigate This Article