May 25, 1999
Bethesda, Maryland
Workshop Summary
On this page:
- Introduction
- Meeting Summary
- Background
- General Concerns from Summary Discussion
- Guidelines on Communicating Informed Consent for Individuals Who Are Deaf or Hard-of-Hearing and Scientists
- Resources
Introduction
Obtaining informed consent for participation in research has become an increasingly complex issue. Due to issues of language and cultural difference and interpretation, it can be additionally complicated for people who are deaf or hard-of-hearing.*
On May 25, 1999, the National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH), convened a day-long working group on "Communicating Informed Consent to Individuals Who Are Deaf or Hard-of-Hearing," in Bethesda, Maryland. The purposes of the meeting were: (1) to clarify issues of informed consent; (2) to develop guidelines for use by scientists who are recruiting deaf or hard of hearing individuals to participate in clinical research; (3) to highlight materials for the scientific community to use in facilitating clear communication between deaf or hard-of-hearing research volunteers and scientific investigators in clinical research; and, to propose new, needed materials for improving communication about informed consent.
Dr. Carolyn Stern and Dr. John Madison served as co-chairs. Dr. Stern participated through an ISDN video transmission from Rochester, New York. Other members of the working group consisted of scientists, linguists, and other experts in the fields of deafness and hearing impairment from governmental and private institutions, and private organizations representing the deaf and hard-of-hearing communities. Other experts presenting and participating in the meeting were from several NIH institutes or centers, the National Human Genome Research Institute (NHGRI), Warren Grant Magnuson Clinical Center, the NIH Office of Protection from Research Risks, as well as observers from the deaf community and other NIDCD staff. The members and their institutional affiliations are shown at the end of the document. Two teams of interpreters served the two meeting sites. After each series of presentations, there was considerable discussion. That discussion is summarized in the final recommended guidelines.
*It is the stated preference of the National Association of the Deaf (NAD), Self Help for Hard of Hearing People, Inc. (SHHH) and other disability community organizations and advocates to use "people who are deaf or hard-of-hearing." Throughout the report differing terms including "hearing impairment" are used by differing organizations and individuals in some cases reflecting historical use on documents or from organization or meeting titles.
Meeting Summary
James F. Battey, Jr., M.D., Ph.D., Director, NIDCD, in his welcome to the working group, noted the problem of providing informed consent for persons who use different means of communication. NIDCD thought it was important that scientists learn more about how to deliver informed consent to persons who are deaf or hard-of-hearing and how to assess whether or not the message has been received and understood. In the meeting, NIDCD was seeking the advice of the working group and others present to provide guidance to the research and clinical community on how best to communicate informed consent to people who are deaf or hard-of-hearing. The working group recommendations will be widely disseminated using the NIDCD Web Page and other channels.
Background
Amy Donahue, Ph.D., Chief, Hearing, Balance/Vestibular Sciences Branch, NIDCD, provided background from the December 8, 1998, report on genetic testing. The December meeting consisted of experts including molecular biologists, molecular geneticists, ethicists, legal and community activists, clinicians, otolaryngologists, and others to look at the issues from the perspectives of the researcher and physician. Some of the issues of genetic testing for hearing disorders raised include informed consent, appropriate accommodations, understanding of the risks and benefits, individual differences in communication, and future uses of genetic findings. Several recommendations were made by the group: (1) genetic screening for hearing impairment is premature except as part of an appropriately designed clinical trial; (2) many issues must be addressed prior to implementation of genetic testing; and (3) individuals with hearing impairment and individuals who are deaf as well as related organizations representing the spectrum of involved communities of deaf or hearing impaired people should be included in the formulation and establishment of guidelines and future recommendations regarding genetic testing. As follow up, NIDCD and NHGRI are now requesting applications for research on the ethical, legal, social, and cultural issues of studies of genetic variation. [See https://www.genome.gov/10001017.]
General Concerns from Summary Discussion
(1) It is important to consider the implications of signing a form that indicates that consent is obtained but that doesn't reveal all of the consent information within the signature document. (2) It is important to consider how to ensure understanding by the potential subject of the concept of utilizing current samples for future genetic studies. (3) Would a videotaped consent be legal and how could one assure confidentiality of the consent if it exists in videotape linking the person's image to the consent? (4) How can one ensure that interpreters would not be used as witnesses? (5) Group members expressed a concern about the effect of uses of genetic study data on attitudes and behaviors of groups. (6) It was emphasized that the consent form needs to clarify abstract ideas. (7) In response to concern about understanding future use of samples, it was suggested that the form should contain two clear statements that people could sign saying they either are willing to allow future use of their samples or they are not willing. If they are not willing, it was noted that the samples should be destroyed.
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 TTY 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.]
- 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.
Additional Recommended Activity
- Recommend Revision of the 1991 Federal Policy for the Protection of Research on Human Subjects regulations to include the use of videotapes, interactive computer programs, and other oral and electronic means to obtain informed consent. The use of videotape as an option is especially important for two groups of people. The first group is of potential participants who do not read or write, but who could give consent orally on videotape. The second group of potential participants would be deaf people who do not vocalize, but who could give consent by sign language on videotape.
Resources
American Society of Human Genetics (ASHG) Board of Directors and the American College of Medical Genetics (ACMG) Board of Directors Report: "Points to Consider: Ethical Legal, and Psychosocial Implications of Genetic Testing in Children and Adolescents".
ASHG Report "Statement on Informed Consent for Genetic Research," Am. J. Hum Genet., Vol. 59, 1996, pp. 471-474.
Brunger, JW, Murray, GS, O'Riordan M, et al. "Parental Attitudes Toward Genetic Testing for Pediatric Deafness. Am. J. Hum Genet., Vol 76:(6) 1621-1625, Dec. 2000.
Brusky, AL."Making Decisions for Deaf Children Regarding Cochlear Implants: The Legal Ramifications of Recognizing Deafness as a Culture Rather than a Disability." 1995 Wis. L. Rev. 235.
Clayton EW, et. al, "Informed Consent for Genetic Research on Stored Tissue Samples," JAMA Vol. 274, No 22, Dec. 1995, pp. 1786-1792.
Davis DS., "Genetic Dilemmas and the Child's Right to an Open Future" Hastings Center Rep., vol. 27, No.2, Mar-Apr 1997, pp.7-15.
"Deaf Culture: Selected Readings" (#547). Washington DC: Gallaudet University.
"Deafness: A Fact Sheet" (#085) Washington DC: Gallaudet University.
Geller G, et. al., "Genetic Testing for Susceptibility to Adult-Onset Cancer: The Process and Content of Informed Consent, " JAMA Vol. 277, No. 18, May 1997, pp. 1467-1474.
Johnson R E. "Beliefs and Practices in Deaf Education: Magical and Logical." (El Biling"smo de los Sordos), Vol. I, Number 3. 1998(in press). [To be published in translation in Spanish.]
Kelly LP, "Using Silent Motion Pictures to Teach Complex Syntax to Adult Deaf Readers," Journal of Deaf Studies and Deaf Education Vol. 3, No. 3., 1998, pp. 217-230.
Lane H., Hoffmeister R, (contributor), Behan B, Corona M (editor). A Journey into the Deaf- World. San Diego: DawnSign Press, 1996.
McEwen EM and Anoton-Culver H, "The Medical Communication of Deaf Patients" Journal of Family Practice, Vol. 26, No.3, March 1988, pp. 289-291. 1988: 26: 3: 289-291.
National Institute on Deafness and Other Communication Disorders. Americans With Disabilities Act: Combined Health Information Database Resources. Bethesda MD: 1998.
National Institute on Deafness and Other Communication Disorders. Facts About Telecommunications Relay Services. Bethesda MD: 1999. (annual)
"NIDCD Working Group Considerations for Developing and Implementing Genetic Diagnostic Tests for Hereditary Hearing Impairment and Other Communication Disorders". Rockville, Maryland December 8, 1998.
OHRS Information Sheet #5 "Guidelines for Writing Research Protocols" (rev 5/5/97).
OHRS Information Sheet #6 "Guidelines for Writing Informed Consent Documents" (rev "5/5/97).
OPRR Reports "Protection of Human Subjects: Title 45 Code of Federal Regulations Part 46", Revised June 1991.
Padden C, Humphries T (contributor). Deaf in America: Voices from a Culture. Cambridge MA: Harvard University Press, 1996.
Salk Institute "Information regarding the Salk Institute Studies and the Use of Informed Consent With Deaf Subjects".
Schick B, Hoffmeister B, deVilliers P and deVilliers J. "How do ASL skills affect a child's Theory of Mind?: A research study at the California School for the Deaf." [brochure for parents to explain a research study] available from Dr. Schick: Brenda.Schick@colorado.edu
Zazove P and Doukas DJ., "The Silent Health Care Crisis: Ethical Reflections of Health Care for Deaf and Hard-of-Hearing Persons," J of Family Medicine, Vol. 26, June 1994, pp.387-390.
Additional Resources Available from the Registry of Interpreters for the Deaf, Inc.(RID) on Interpreting, Ethics, Interpreting in Medical Settings, Business Practices and Billing Considerations include:
"Business Practices: Billing Considerations." (Doc.#113).
"Code of Ethics." (Doc. #103).
"Interpreters and Interpreter Services." (Doc. #107).
"Interpreting in Medical Settings." (Doc.#119).
"Professional Sign Language Interpreting." (Doc #120).
"Use of a Certified Deaf Interpreter." (Doc #121).
[Document numbers are supplied for Fax-on-demand 1-800-711-3691. Other titles are available. The homepage for RID is www.rid.org.]
Recent Funding Opportunity:
"Studies of the Ethical, Legal and Social Implications for Research Into Human Genetics." Release date: April 29, 1999. Application Receipt Date: August 31,1999. Information about funding of this RFA will be posted here upon award.
Participating Institutes: National Human Genome Research Institute, National Institute on Deafness and Other Communication Disorders, National Institute of Environmental Health Sciences, National Institute of General Medical Sciences.