Ethical Reasons for Inclusion
Ethical Reasons to Include People with Disabilities in Research
Barbara Daly, PhD, RN, FAAN
1. Back to the basics of research ethics:
- Research: necessarily involves “trade-offs” (i.e. burdens are borne by some for the benefit of others)
- “Trade-offs” always require ethical justification.
- Justification can be:
- The “good” of knowledge (scientific validity).
- Adherence to ethical principles.
2. Justice: An obviously applicable ethical principle (Belmont Report)
- Justice: a fair and equitable distribution of benefits and burdens. (emphasis added)
- Injustice: when some benefit to which a person is entitled is denied without good reason, or when the burden is imposed unduly
3. What counts as a BENEFIT? Potential benefits of research participation:
- Access to investigational agents, devices, or interventions
- Altruism, an opportunity to contribute to the greater good
- Helpful aspects of research protocols (e.g. frequent medical monitoring, opportunity to talk, etc)
- Payment for participation
4. These potential benefits can be just as important for persons who have disabilities as for persons who do not have them.
5. Does this mean we ALWAYS have a duty to include persons with disabilities in our research? The question may be better re-phrased: What constitutes fair selection of research subjects?
6. Scientific goals are the primary factor in establishing eligibility, recruiting, and selecting subjects.
- Planned exclusion of categories of disability requires a scientific reason. Examples:
- Deafness may be a legitimate exclusion criterion for a study of the effects of music therapy.
- Persons with double amputations may be excluded from participation in a study of foot care.
- Persons with severe visual impairment may be excluded from a study of the effects of paintings hung in hospital rooms.
- Groups and individuals are not excluded without a sound scientific basis. Examples:
- A study that requires keeping of written records can accommodate persons with visual impairment by accepting audio recordings or tactile records.
- A study involving a questionnaire presented in written English can accommodate Deaf persons whose first language is American Sign Language (ASL) by involving an ASL interpreter.
- A study of the effects of a walking program for exercise can include persons in wheelchairs who are able to “go for a walk” in their chairs.
7. What do the regulations say?
46.107: “If an IRB regularly reviews research that involves vulnerable subjects, e.g. children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals knowledgeable and experienced in working with these subjects. (emphasis added)
46.111: “Selection of subjects is equitable…cognizant of special problems of research involving vulnerable populations, such as mentally disabled persons or economically disadvantaged.” (emphasis added)
Medical research involving a disadvantaged or vulnerable population is only justified if the research is responsive to health needs and priorities of this population and if there is a reasonable likelihood population stands to benefit…” (emphasis added)
- Predominant focus of these regulations is preventing exploitation of persons with limited capacity for informed consent (e.g., cognitively impaired), those vulnerable to coercion (e.g., living in institutions), or those unlikely to derive benefit themselves.
8. What does U.S. law say? Law concerning employment of persons with disabilities is not directly applicable, but is relevant.
From Title I of the Americans with Disabilities Act of 1990:
- An individual with a disability is a person who has a physical or mental impairment that substantially limits one or more major life activities.
- A qualified employee or applicant with a disability is an individual who, with or without reasonable accommodation, can perform the essential functions of the job in question. Reasonable accommodation may include, but is not limited to:
- Making existing facilities readily accessible to and usable by persons with disabilities
- Acquiring or modifying equipment or devices, adjusting or modifying examinations, training materials, or policies, and providing qualified readers or interpreters
- An employer is required to make a reasonable accommodation to the known disability of a qualified applicant or employee if it would not impose an “undue hardship” on the operation of the employer’s business. Reasonable accommodations are adjustments or modifications… to enable people with disabilities to enjoy equal employment opportunities. Accommodations vary depending upon the needs of the individual. (emphasis added)
- An employer does not have to provide a reasonable accommodation if it imposes an “undue hardship.” (emphasis added) Undue hardship is defined as an action requiring significant difficulty or expense when considered in light of factors such as an employer’s size, financial resources, and the nature and structure of its operation.
9. What would constitute an “undue hardship” in the research context? Considerations:
- Size of the study
- How many subjects will be involved?
- What is the likelihood of persons with disabilities in the sampling pool?
- Financial resources
- What would it take to modify the instruments & procedures? (e.g., large print questionnaires may be financially feasible, computerized text readers not so much)
- Opportunity to obtain modifications? (Can specialized equipment be borrowed?)
- Time constraints. Some alternative formats must be arranged ahead of time (e.g., printing a document in Braille, or having a sign language interpreter present).
- Nature and structure of the operation. Are there steps to take to ensure that persons with disabilities have the opportunity to participate?
- A Word to the Wise: Injustice need not be intentional. It is still injustice.
Letter of Resolution. DJ. No. 202-57-146 Case Western Reserve University, regarding Kindle pilot project with 6 other universities (12/22/09)
Alleging that Case Western Reserve University has violated Title III of the Americans with Disabilities Act of 1990 ("ADA") 42 U.S.C. § 12182, and Section 504 of the Rehabilitation Act of 1973, 29 U.S.C. § 947(a), by using the Kindle DX, an innovative, hand-held electronic book reader that is not accessible to students with visual impairments, in a classroom setting. According to the complaints, Case Western Reserve University is participating in a pilot program with six other universities under contract with Amazon.com, Inc., that began in the fall 2009 semester. The object of this IRB-approved pilot is to test the utility of the Kindle DX in a classroom setting.
10. Are any international agreements relevant?
Yes – like U.S. law, not directly addressing research, but still relevant (UN Enable: The United Nations Convention on the Rights and Dignity of Persons with Disabilities):
- Article 25:
- Recognizes “that persons with disabilities have the right to the enjoyment of the highest attainable standard of health without discrimination on the basis of disability.”
- Requires that ratifying countries “Provide persons with disabilities with the same range, quality and standard of free or affordable health care and programmes as provided to other persons…”
- Requires “health professionals to provide care of the same quality to persons with disabilities as to others…”
- The United States became a signatory to this agreement on July 30, 2009.
- As a practical matter, if we are expected to fulfill these requirements, it will be necessary to have high quality research that includes persons with disabilities and addresses a full range of health conditions, from acute and chronic illnesses through health promotion for healthy individuals.
11. Take-home messages:
- Justice demands that we address inadvertent exclusion of people with disabilities from accessing the benefits of research.
- Exclusions (both individual and categorical) require justification on the basis of either scientific or specific practical considerations (time, finances, etc).