Guidelines on Communicating Informed Consent for Individuals Who are Deaf or Hard-of-Hearing and Scientists

Overarching Issues

  • There is a great need for clear language and direct, effective communication.
  • Individuals should be encouraged to refrain from signing a consent form until the terms are well understood.
  • While pledging to establish and maintain confidentiality, scientists should inform potential participants of situations where it may be impossible to maintain complete confidentiality or about potential negative outcomes from participation in a study. For example, some insurers have been known to ask if a person has participated in genetic screening; persons responding "yes," or not responding are denied insurance.
  • Some individuals may be unwilling to ask questions because they are concerned that they don't have the background to understand the answer. This may be particularly problematic for some deaf or hard-of-hearing individuals.
  • It is important not to exclude deaf children from school-based research. There are cited examples of "exclusion stigmatization" in school-based research when deaf children are excluded from research on a group or class. Parents and other children are sensitive to the implications of this exclusion.
  • Among individuals who are deaf or hard-of-hearing, there are wide ranges in type and degree of hearing loss, and differences in etiology, age of onset, communication experience, communication preference and language use.

Conceptualizing the Research Project and Informed Consent

  • Consider the inclusion of an anthropologist on the research team when studying different ethnic or cultural groups.
  • Seek scientists who are deaf or hard-of-hearing as members of the research team.
  • Involve a member of the community to be studied in explaining ethnic values to the research team.
  • Be sure that members of the research team, as well as support staff, understand the use of text messaging and voice relay systems for communicating with subjects who are deaf or who are hard-of-hearing.

Considerations for the Research Grant Applicant

  • When using deaf or hard-of-hearing subjects, applicants should address the cost of interpreters and assistive communication devices in their application.
  • Researchers should consider various methods for obtaining informed consent in developing their grant applications.

IRB Considerations

  • Improve Institutional Review Board's (IRB) understanding of informed consent with deaf and hard-of-hearing persons.
  • Encourage researchers to become advocates for including deaf and hard-of-hearing individuals on IRB panels.

Improving Consent Forms

  • Consider visual information such as symbols, pictures or diagrams on the consent form to enhance understanding.
  • Develop consent forms that are readable and understandable aimed, where feasible, at a 5th grade reading level. (A caution was noted about using readability programs, because certain needed concepts and metaphors may not be acceptable to the program and vital information would be lost.)
  • Use the active rather than passive voice to increase understanding.
  • Provide real situations and examples to explain abstract concepts.
  • Develop informed consent materials that are responsive to the variations of language used by deaf and hard-of-hearing people. These materials should also clarify unfamiliar scientific terms.

Considering New Consent Strategies

  • Educate writers for publications and organizations serving individuals who are deaf, or hard-of-hearing, about the nature of research and the nature of informed consent. Heightened awareness will enhance opportunities to recruit individuals who are deaf or hard-of-hearing as research participants.
  • Consider videotapes that show the process or performance of treatment or research.
  • Consider the provision of videotapes for use by interpreters and subjects to explain consent forms. (Remember to protect the confidentiality of subjects if videotapes are used to obtain consent.)
  • Consider developing interactive computer programs to assist in informed consent process.
  • Allow prior research subjects to interact with new subjects.

Facilitating Communication at the Consent Event

  • Consider "cultural brokers" to facilitate communication with deaf and hard-of-hearing individuals.
  • Translate the consent form into American Sign Language for those who prefer to use this language.
  • Assess the subject's comprehension of informed consent by encouraging questions and requesting feedback where appropriate. Emphasize that a decision not to participate will in no way affect the quality of current or future interactions.

Using Interpreters

  • Institutions should maintain a directory of certified, registered interpreters. [For information about interpreting services, qualifications and certification, contact The Registry of Interpreters for the Deaf, Inc. or e-mail them at ridcmp@aol.com.]
  • Use qualified, certified interpreters or deaf researchers to explain the consent form. Interpreters need to be fluent in the language of the subject as well as being fluent in their pertinent scientific terminology. Great priority should be placed on finding the most direct communication.

This page last reviewed on February 16, 2016