It is generally accepted that people with intellectual disabilities are not considered in clinical research if the type of the disease could be studied with people without disabilities. The reasons are different: to protect that vulnerable population but also the ethical principles in clinical trials which require patients to be aware of the research and give informed consent.
However, this has its disadvantages because it limits the research and treatment options in diseases which are specific for people with intellectual disabilities.
In order to improve participation in clinical trials some countries have created requirements for research involving people with disabilities. The criteria in US, Canada, Australia, UK and EU include the following:
- Recommendations for IRBs:
- All IRBs considering proposals that involve people with disabilities should have at least 2 members who are familiar with this patient population and at least one of them should be member of the population, family member or representative of this population.
- Creation of a specific standing panel (SSP): to review individual protocols that cannot be approved by individual IRBs and to set guidelines that would permit local IRBs to approve protocols that cannot otherwise be approved.
- Recommendations regarding research design:
- Appropriate subject selection: An IRB should not approve clinical studies targeting persons with mental disorders if such research can be done with other subjects.
- Thorough justification of research design and description of procedures to minimize risks to IRBs
- Thorough evaluation of risks and benefits to the recruited patients.
- Recommendations regarding informed consent:
- No person who has the capacity for consent can be enrolled without informed consent
- For research protocols that present greater than minimal risk, an IRB should require that an independent qualified professional assess the subject’s capacity to consent.
- A person who has been determined to lack capacity to consent must be notified about that determination before permission is sought from his legally authorized representative.
- Recommendations regarding categories of research:
- Different recommendations are in place for clinical research involving minimal risk, greater than minimal risk with direct benefit to the subjects and greater than minimal risk that don’t offer the prospect of direct benefit to subjects with the latest category often requiring approval by a SSP.
- Recommendations regarding surrogate decision making
- Prospective authorization can be given while a patient still maintains capacity to make decisions
- A legal authorized representative needs to provide consent for patients who lack the capacity to consent by themselves
- Special recommendations are in place regarding educational materials and the public of ethical issues related to the involvement of such persons as research subjects, and increased funding will be required to ensure compliance with these recommendations.
One of the main challenges in research with patients with intellectual disabilities is that it is difficult to standardize the outcome. Treatment responses could vary significantly between individual patients, groups and types of diseases.
Regardless of all challenges people with intellectual disability should be included in research where appropriate and possible because it could have very beneficial therapeutic effect.
Author: Olga Peycheva
Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe.
Originally published on 2 Mar 2017