Table 6 Implications of vulnerability, grouped by theme
From: The concept of ‘vulnerability’ in research ethics: an in-depth analysis of policies and guidelines
Restrictions for research with vulnerable groups or individuals | Policy/Guideline |
|---|---|
When research is carried out with vulnerable participants it should be responsive to the needs, conditions, or priorities of the vulnerable group involved | Declaration of Helsinki; CIOMS |
Vulnerable subjects should be involved in research only when it cannot be carried out with less vulnerable subjects | CIOMS |
Special justification is required for involving vulnerable groups in research and appropriateness ought to be demonstrated | CIOMS; Belmont Report |
Children should not be included in early-phase research until therapeutic effects have been shown in adults | CIOMS |
Opportunities to participate in and influence research affecting their welfare should not be withheld from vulnerable groups | TCPS2 |
Members of vulnerable groups are entitled to access the benefits of research | CIOMS |
Children must be involved in studies of medicinal products likely to be of value to them | EU Clinical Trials Directive |
People with a cognitive impairment, intellectual disability, or mental illness are entitled to participate in research, which need not be limited to their particular impairment, disability, or illness | Australian National Statement |
Research with communities vulnerable to exploitation should strive to enhance capacity for participation | TCPS2 |
Patients receiving high-risk clinical care should not be inappropriately included in or excluded from research | TCPS2 |
Risk to vulnerable subjects is justified when it arises from interventions that will provide a direct health benefit, or when it will benefit the subject’s population group | CIOMS |
Special protections and obligations | |
Individuals and groups of special vulnerability should be protected | UNESCO Declaration |
Special ethical obligations exist towards vulnerable subjects | TCPS2 |
Vulnerable subjects should receive special/specific protections | Declaration of Helsinki |
Groups or individuals in vulnerable circumstances may need or desire special measures to ensure their safety in a specific research project | TCPS2 |
Vulnerable subjects should be afforded security against harm or abuse | CIOMS |
Special (or additional) protections for the rights and welfare of vulnerable subjects should be applied | CIOMS; Common Rule |
Attention and consideration | |
Special attention should be paid to trials involving vulnerable subjects | ICH GCP |
Special attention or regard should be paid to vulnerable communities, groups, or persons | UNESCO Declaration; TCPS2 |
Researchers and REBs should recognise and address changes in participants’ circumstances that may impact their vulnerability | TCPS2 |
Research ethics board composition | |
REBs reviewing research with vulnerable subjects should include members with expertise on these populations | Common Rule; EU Clinical Trials Regulation |
Community members on REBs ought to reflect participant’s perspectives, particularly important when participants are vulnerable and/or risks are high | TCPS2 |
Assessing harms, risks and benefits | |
For those gauging the severity of harm in research, the vulnerability of a population will be relevant | Australian National Statement |
The existence of vulnerable circumstances may require greater effort to minimise risks/maximise benefits to participants | TCPS2 |
Care must be taken to ensure the risks and burdens of proposed research with persons with a cognitive impairment, intellectual disability, or mental illness are justified by potential benefits | Australian National Statement |
Recruitment practices | |
The vulnerability of persons in unequal, dependent relationships must be taken into account when considering recruiting these persons | National Statement |
Process of informed consent | |
Consent may need to be re-confirmed in research where participants are vulnerable | National Statement |
The method of consent in qualitative research depends, in part, on the vulnerability of the research participant; the method must be tailored for their protection | National Statement; TCPS2 |
When requirements of free, informed, ongoing consent cannot be met, vulnerable participants ought to be involved in decision-making, i.e. obtaining assent, asking about their feelings regarding participation | TCPS2 |
Clinician-researchers must take care not to overplay the benefits of research participation to vulnerable patients, who may be misled to enter research with false hope | TCPS2 |
Inducements that may not be excessive or inappropriate for other participants may be undue influences if the subject is especially vulnerable | Belmont Report |
Care should be taken in the informed consent process to ensure that women vulnerable to coercion have adequate time and a proper environment in which to take decisions | CIOMS |
Care should be taken in the informed consent process for adults with mental health problems or learning difficulties to ensure that information is provided in the appropriate format and that the roles and responsibilities of those involved are clearly explained and understood | UK Research Governance Framework |
Additional consent from a parent or guardian may be required for young people who are vulnerable through immaturity in ways that warrant this | National Statement |
Researchers should invite participants in dependent or unequal relationships to discuss their participation with someone who can support them in making their decision; especially vulnerable participants in these circumstances should be offered participant advocates | National Statement |
Debriefing | |
REBs must assess risks and benefits of debriefing participants and whether debriefing plan is appropriate for participants, especially when they are vulnerable | TCPS2 |