Working Group on Communicating Informed Consent to Individuals Who Are Deaf or Hard-of-Hearing

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.

II. Meeting Summary

Welcome and Background

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.

III. Background

Amy Donahue, Ph.D., Chief, Hearing, Balance/Vestibular Sciences Branch, NIDCD, provided background from the December 8, 1998, report on genetic testing (http://www.nidcd.nih.gov/funding/hb/genetic.htm). 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 Report and Application, http://www.nih.gov/grants/guide/rfa-files/RFA-HG-99-002.html). [Although the deadline is Aug. 31, 1999, the text is helpful in referencing some of the issues of this meeting and the archived link has been provided.]

IV. Gary B. Ellis, Ph.D.

Gary B. Ellis, Ph.D., Director, Office for Protection from Research Risks, NIH, discussed the issues of informed consent in all research conducted under the Department of Health and Human Services (DHHS). The Federal Regulations of June 18, 1991 were approved by 17 departments and agencies and are also used by other research institutions. Dr. Ellis reviewed the 8 required elements of informed consent in Section 46.116 of the regulations (http://grants.nih.gov/grants/oprr/oprr.htm), which include a description of the research, risks and benefits, alternative treatments, confidentiality, compensation and treatment available for injuries, contact persons, voluntary participation and rights of refusal. Six more elements are included, when appropriate: risks to fetus, project termination, costs to subject, withdrawal of subject, new findings, and number of persons in the study. General requirements for informed consent are that coercion should be minimized and language used should be understandable to the subjects or their legally authorized representatives. Ellis reviewed the 8 part "chain of judgements" on the research process that are designed to protect human subjects from harm.

V. Benjamin Wilfond, M.D.

Benjamin Wilfond, M.D., Co-Director, Office of Bioethics and Special Populations Research, National Human Genome Research Institute (NHGRI), discussed the issues involved in informed consent for NHGRI genetic research. Dr. Wilfond focused on the challenges of genetic research related to informing subjects of medical, legal and social risks, and the projects's efforts to minimize risk. Some of the potential risks are misunderstanding of information, confusion about information, anxiety, implications for related family members, stigmatization, discrimination, vulnerable populations, and group harm from labeling or reinforcing stereotypes.

Dr. Wilfond felt strongly that informed consent is not a form but a process that includes a variety of ways to communicate. He discussed several of these elements: (1) assessing decisional capacity; (2) reasonable disclosure; (3) comprehension: and, (4) the voluntary nature of participation. Dr. Wilfond also emphasized that for research involving children, the major concerns should be: (1) the benefits to the child, not the parents; (2) minimizing harm; and, (3) protecting the child's autonomy and future rights.

Dr. Wilfond proposed the following ways to minimize harm to subjects: (1) disclose results to minimize stigma or do not disclose results to subjects; (2) remove linkage of samples to research findings; (3) Encrypt database; (4) disguise family pedigrees; (5) involve the patient community in research design; (6) obtain informed consent after IRB Review of informed consent process; and, (7) provide and assess genetic counseling, if results are disclosed; and (8) assess real or potential harms.

VI. Marin P. Allen, Ph.D.

Marin Allen, Ph.D., Chief, Office of Health Communication and Public Liaison, NIDCD, described the communication recommendation from the "NIDCD Working Group on Considerations for Developing and Implementing Genetic Diagnostic Tests for Hereditary Hearing Impairment and Other Communication Disorders" that preceded this meeting. The related recommendation was to evaluate methods for providing education and counseling to scientists, the deaf and hard-of-hearing communities, and the public to facilitate informed consent. Allen gave the charge to the group to develop guidelines and recommend materials to be used to educate a broad variety of scientists in all fields, clinical practitioners, deaf and hard-of- hearing individuals and the general public, about the need for improving informed consent for individuals who are deaf or hard-of-hearing. She asked that, in addition to guidelines, the group provide recommended materials or identify areas where materials are needed to help facilitate this communication.

VII. Robert E. Johnson, Ph.D.

Robert E. Johnson, Ph.D., Professor, Department of ASL, Linguistics, and Interpretation, Gallaudet University, described issues surrounding Miranda warnings for individuals who are deaf. This provided a model for issues in communication across cultures and languages. He outlined and provided examples illustrating three issues: comprehension, capacity, and voluntarism. He provided information about both literacy level and language use differences among differing groups of deaf individuals. Additionally, he described problems with the varying quality, experience and knowledge of interpreters in these critical settings. He noted that a standardized sign language hasn't worked to equalize the information provided to the deaf individuals noting that the variation in the experience of the deaf individual and limited exposure to some of the concepts exacerbates these problems. Additionally, words like "right" or "silent" have contextual meanings, are abstract, and when signed by different interpreters, result in completely different meanings. Regardless of educational level, many deaf persons are not exposed to mainstream culture through mass media based on sound. Media exposure is the source for the general public for its information about courts, legal processes, and the Miranda warning itself. It is also the way that many people are introduced to concepts related to research and clinical trials. He also noted another concern about determining that the individual has truly understood the consent process, stating that deaf people tend to comply with authority figures (uniforms, lab coats), so they may sign a consent form even if they don't understand it.

VIII. Evelyn McClave, Ph.D.

Evelyn McClave, Ph.D., Department of English and Linguistics, California State University at Northridge, discussed the role of gesture and ways in which misunderstandings occur in face-to-face communication. Gestures such as head nodding (up and down) can mean that the deaf person is indicating they are trying to be cooperative conversational participants, not that they are understanding what is being said, nor that they are, necessarily, agreeing with it. Speakers also do "back-channeling" (head-nodding) to indicate they want feedback. Head-shaking (from side to side, generally understood as "no" in American culture) can mean agreement in some cultures and actually often means "I am assessing what you are saying," not disagreeing, in many contexts within American culture. Gestural nods cannot be taken to be assurance of comprehension or of agreement without additional information, according to McClave.

IX. Patricia A. Kvochak, JD

Patricia A. Kvochak, JD, Deputy Director, NIH Legal Advisor, advises the National Institutes of Health on their clinical research protocols, which include the legal issues of informed consent. The basic elements that need to be included in informed consent are: (1) understanding of the problem; (2) nature of proposed treatment or intervention; (3) risks and benefits; (4) likelihood of success; (5) feasible alternatives; and, (6) disease prognosis, if research or intervention is not undertaken. She raised a concern about the length and complexity of consent forms and the ability to obtain true informed consent. She also noted that a qualified interpreter is essential to maintain confidentiality, to assure accurate translation, and to avoid undue cultural influence or coercion that may come from use of family members as interpreters.

She reported that it is important to inform the patient of all information related to the decision to participate in a study and of any reasonable foreseeable medical and psychosocial risks. She emphasized that consent is an ongoing process. She noted that if any person lacks the mental capacity to understand, then a legally appointed representative or a durable power of attorney for health care is usually needed to give consent.

X. John P. Madison, Ed.D.

John P. Madison, Ed.D., Department of English, National Technical Institute for the Deaf, stated that low literacy is a problem for the general population as well as for persons who are deaf or hard-of-hearing. He emphasized that low literacy does not mean low understanding, if appropriate communication processes are used. Using sign language to interpret oral language is different from reading an informed consent form and having someone sign. Even if forms are simplified and sign language is used, there still may be semantic and syntactic problems that are barriers to communication. The ability to read and understand abstract language may be compromised for those whose hearing loss occurs early in life. If hearing loss occurs in later life, the subject's understanding of the English language has already been established and fewer misunderstandings may occur.

XI. Nancy J. Bloch

Nancy J. Bloch, Executive Director, National Association of the Deaf, stated that there are a wide range of communication styles among deaf and hard-of-hearing persons, ranging from American Sign Language to spoken English. When arranging for interpretation, she urged that scientists ensure that the interpreter's language skills closely match the language needs of the deaf person. This is best done in advance by asking the deaf person his or her specific communication preferences i.e. American Sign Language or signed English. Often for the general public, including deaf and hard of hearing persons, complex medical terms require time for explanation and require that concepts are broken down into simpler terms. In the same sense, effective two-way dialogue between medical personnel and deaf and hard of hearing people is of critical importance, especially when dealing with consent forms. Working with deaf persons from a cultural perspective would enable medical personnel to appreciate and be more sensitive to language nuances and the need for accurate third-party interpretation. Medical personnel who interface on a regular basis with deaf individuals would also benefit from in-depth training on culture and language issues.

XII. Karen Emmorey, Ph.D.

The next three presentations related to issues for scientists working with families who have members who are deaf or hard-of-hearing.

Karen Emmorey, Ph.D., The Salk Institute for Biological Studies, Dr. Emmorey described a successful approach to obtaining informed consent used by the Laboratory for Cognitive Neuroscience. An important component of this approach is to involve deaf researchers in the studies. This allows deaf subjects to communicate directly with deaf researchers who can also serve as "cultural brokers" between hearing scientists and the deaf community. Dr. Emmorey also described a study with more complex procedures in which the written consent form was translated into American Sign Language and presented to potential deaf subjects on videotape. For this study, deaf subjects had to interact with hearing, non-signing doctors and technicians, and thus independent ASL interpreters were employed so that deaf researchers were available to answer questions, but not act as interpreters. The critical components for obtaining informed consent for the Salk Institute studies were identified as a) the involvement of deaf research assistants and scientists in the studies, b) the use of consent forms which are easy to read and understand, c) where necessary, the additional use of ASL translations of consent forms on videotape, and d) the use of certified ASL interpreters when deaf subjects must interact with non-signing researchers.

XIII. Thomas B. Friedman, Ph.D.

Thomas B. Freidman, Ph.D., Chief, Laboratory of Molecular Genetics, NIDCD, provided two examples of difficult experiences he had in obtaining informed consent in studies of hereditary deafness in ethnic groups outside the USA that had caused him to better define future strategies. In one international project the subjects had congenital deafness, used a unique sign language, and were not literate. A special consent form was developed through a long process, and was delivered in their sign language. The process utilized a native interpreter as a witness to obtain oral consent from subjects. After consent had been obtained in this way, Friedman reported that OPRR had rejected the approach, because the regulations require a signature. A second consent was then obtained using a witness and a thumbprint. Friedman described a second experience where he felt that it was a mistake not to have had advice from an anthropologist. He felt that in small, more identifiable populations it is extremely important to carefully disguise family pedigree so as to not disclose carrier status. Dr. Friedman proposed a two-form strategy that would include a clear, direct consent form with large print for deaf persons to sign, which states that the person was informed of the necessary information, paired with a longer written form for reference.

[Note: In the discussion that followed, Pat Kvochak stated that the simple form met the regulations provided it was signed by the subject. She further stated there are three ways to get informed consent: (1) a written document that subjects read and sign; (2) a written document that is orally presented and signed by subject; or (3) a short-form written consent document including the required elements of consent that is presented orally and signed by the subject, as long as a written summary of what was said was approved by an IRB and there is a witness to the oral presentation. [See 45 CFR 46.117(b)(2).]

XIV. General Concerns from Summary Discussion

Several concerns were highlighted by the working group for consideration:

(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.

XV. Brenda Schick, Ph.D.

Brenda Schick, Ph.D., University of Colorado, utilized a straightforward brochure to explain her research on "How ASL Skills Affect a Child's Theory of Mind," in order to recruit children in families who are deaf. The brochure outlined the need for the research and how it was being conducted. It used pictures to help clarify the text. The brochure included information about the researchers, who were connected to deaf culture. In her experience, this approach increased ease of communication with parents. Dr. Schick emphasized the importance of involving deaf people from the outside to review her research forms and processes. Role-playing was used to train deaf people who worked directly with the deaf participants in the required aspects of a properly informed consent.

XVI. Carolyn Stern, M.D.

Carolyn Stern, M.D., Marion B. Folsom Center, Rochester, New York, suggested that scientists and medical investigators use visual models, pictures, and observations of actual procedures to communicate with deaf patients. She recommended that scientists (1) write consent forms in simpler language, (2) compare the time physicians spend with deaf and hearing persons, (3) involve deaf researchers, interpreters, and lay persons in research projects; (4) include deaf persons in research studies to avoid biased results; and (5) recognize the individual differences of deaf persons who are being studied.

XVII. John Niparko, M.D.

John Niparko, M.D., Professor in The Johns Hopkins School of Medicine and Director of The Listening Center, The Johns Hopkins Cochlear Implant Program, noted that cochlear implant programs attract individuals with a range of hearing histories and levels of hearing loss. These individual differences need to be kept in mind when communicating procedures and obtaining consent as the preferred method of communicating can vary markedly. Due to the relatively low level of open-set speech recognition sometimes achieved by adult recipients of implants deafened prior to the age of 5, expectations and predicted benefits should be examined carefully in this population. Thus, the mode of communication that is most informative to the candidate must be adopted in such discussions. Discussions with a peer-group recipient of an implant are generally viewed as extremely valuable. Quality-of-life studies on this adult population indicates that, on average, persons who became deaf early in life do not view deafness as a severe disability when compared to persons who lose hearing later in life. Such beliefs should be carefully examined as they can greatly aid discussions of whether an implant is truly indicated and likely to be of benefit. The Listening Center Program is able to use hospital-based interpreters and also recommends the use of peers to explain procedures and to maintain compliance after the implant.

In response to a query about how the project recruits children, obtains informed consent for their participation, and explains to the parents the expected results, Dr. Niparko described the use of parents as proxy for the child. To Dr. Niparko's knowledge, no program advocates that children be actively recruited for evaluation of their cochlear implant candidacy. Such an approach would be immediately self-defeating, as the family's commitment to a prolonged period of rehabilitation should be strong and sincere. Since the Hopkins program has found better results for implants in congenitally deaf infants who receive an implant by 24 months of age, the parents must serve as proxies for the decision to pursue implantation for a child. Niparko noted that prospective client families can benefit immensely from meeting with other families whose children have received an implant. This is a procedure that is widely used in his program. Referrals for alternative approaches to facilitating communication can be made within the Hopkins environment. In the past year several children have been judged as poor candidates for a cochlear implant and have been referred to the Maryland School for the Deaf to pursue language acquisition through visual modalities. This example illustrates that service providers must be cognizant of a region's resources. Appropriate referrals for alternative services should be made when a child's best interest can be served elsewhere.

XVIII. 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. (http://www.rid.org) 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.

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.

XIX. Resources

This section will continue to be updated as materials become available.

Most recent update 8/31/99

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". (http://www.aai.org/genetics/ashg/policy/pol-13.htm)

ASHG Report "Statement on Informed Consent for Genetic Research," Am. J. Hum Genet., Vol. 59, 1996, pp. 471-474. (http://www.aai.org/genetics/ashg/policy/pol-25.htm)

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 (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11062052&dopt=Abstract).

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. (http://www.gallaudet.edu/~nicd/pub1.html)

"Deafness: A Fact Sheet" (#085) Washington DC: Gallaudet University. (http://www.gallaudet.edu/~nicd/pub1.html)

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. (http://www.nidcd.nih.gov/funding/hb/genetic.htm)

OHRS Information Sheet #5 "Guidelines for Writing Research Protocols" (rev 5/5/97). (http://helix.nih.gov:8001/ohsr/info/einfo_5.php3)

OHRS Information Sheet #6 "Guidelines for Writing Informed Consent Documents" (rev "5/5/97). (http://helix.nih.gov:8001/ohsr/info/finfo_6.php3)

OPRR Reports "Protection of Human Subjects: Title 45 Code of Federal Regulations Part 46", Revised June1991. (http://grants.nih.gov/grants/oprr/oprr.htm)

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". (http://www-psy.ucsd.edu:80/~kemmorey)

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 by e-mail: 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). (http://www.rid.org/bizprac.html)

"Code of Ethics." (Doc. #103). (http://www.rid.org/code.html)

"Interpreters and Interpreter Services." (Doc. #107). (http://www.rid.org/terp.html)

"Interpreting in Medical Settings." (Doc.#119). (http://www.rid.org/med.html)

"Professional Sign Language Interpreting." (Doc #120). (http://www.rid.org/prof.html)

"Use of a Certified Deaf Interpreter." (Doc #121). (http://www.rid.org/cdi.html)

[Document numbers are supplied for Fax-on-demand 1-800-711-3691. Other titles are available. The homepage for RID is www.rid.org]

The two national organizations that certify interpreters are the National Association of the Deaf (NAD) at nadinfo@nad.org and the Registry of Interpreters for the Deaf (RID) at ridcmp@aol.com

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. (http://www.nih.gov/grants/guide/rfa-files/RFA-HG-99-002.html)

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.

Working Group Members

Nancy J. Bloch, Executive Director, National Association of the Deaf

Karen Emmorey, Ph.D., The Salk Institute of Biological Studies

Stephen Epstein, M.D., A.G. Bell Association of the Deaf **

Thomas B. Friedman, Ph.D., NIDCD, Laboratory of Molecular Genetics, NIDCD

Robert E. Johnson, Ph.D., Professor, Department of ASL, Linguistics, and Interpretation, Gallaudet University

John P. Madison, Ed.D. (co-chair), Department of English, National Technical Institute for the Deaf

Evelyn McClave, Ph.D., Department of English and Linguistics, California State University-Northridge

John Niparko, M.D., Professor in the Johns Hopkins School of Medicine and Director of The Listening Center, The Johns Hopkins Cochlear Implant Program

Brenda Schick, Ph.D., University of Colorado

Carolyn Stern, M.D., (co-chair) Marion B. Folsom Center/ Lifetime Health, Rochester, NY.

NIH Presenters/ Participants

Marin P. Allen, Ph.D., Chief, Office of Health Communication and Public Liaison, NIDCD

James F. Battey, Jr., M.D., Ph.D., Director, NIDCD

Amy Donahue, Ph.D., Chief, Hearing, Balance/Vestibular Sciences Branch, NIDCD

Gary B. Ellis, Ph.D., Director, Office for Protection from Research Risks, NIH

Benjamin Wilfond, M.D., Co-Director, Office of Bioethics and Special Populations Research, National Human Genome Research Institute

Patricia A. Kvochak, JD., Deputy Director, NIH Legal Advisor

Observers

Jamie-Lynne Huffman, Partnership Program Intern from Gallaudet University

Kelby N. Brick, Legal Counsel for Government Affairs, National Association of the Deaf

(Additional NIH and NIDCD Staff observed)

**Dr. Epstein was called away on an emergency and could not participate.