Researchers will need to consider additional ethics concerns or issues arising from working with potentially vulnerable people. Vulnerability may be defined in different ways and may arise as a result of being in an abusive relationship, vulnerability due to age, potential marginalisation, disability, and due to disadvantageous power relationships within personal and professional roles.
Participants may not be conventionally ‘vulnerable’, but may be in a dependent relationship that means they can feel coerced or pressured into taking part, so extra care is needed to ensure their participation is truly voluntary.
Researchers will need to assess potential vulnerability within the context of the research, in terms of potential consequences from their participation (immediate and long-term) or lack of positive impact where this is immediately needed or expected.
Researchers should make the participants aware of the limits to confidentiality when eliciting consent, and decide whether verbal or written consent will be more appropriate and protective of the participants’ interests.
Researchers should consider the following:
- participants’ vulnerability
- potential negative consequences or lack of personal benefits from their involvement in research where these are expected
- providing appropriate information to elicit freely-given informed consent for participation as well as information regarding data deposit and data re-use (where deposit is possible)
- limits to confidentiality and occasions where this may occur
- legal requirements of working with the specific population (including Disclosure and Barring Service clearance)
- incentives and compensation for participation.
When working with participants who are considered vulnerable, researchers may find themselves in a position of increased responsibilities or expectations (for example, when an interview reveals that a participant is in significant danger and the researcher is obliged to take action), which do not fall within the scope of the research project.
Researchers should endeavour to assess the likelihood of additional ethics issues and develop strategies and a framework of clear responsibilities they can refer to should such issues arise.
They should also use their research ethics committee as a valuable resource for advice and guidance.
Researchers should be able to justify the approach they take in dealing with unforeseen ethics issues (should these arise) and maintain the integrity of the research.
Consent from potentially vulnerable people
In cases where research involves potentially vulnerable groups, for example children, older persons or adults with learning disabilities ), every effort should be made to secure freely given informed consent that participants have actively provided.
Every effort should be made to ensure that they have the time and opportunity to access support in their decision-making, for example by discussing their choice with a trusted adult or relative.
Passive assent, including group assent (with consent given by a gatekeeper) should be avoided wherever possible, and every effort should be made to develop methods of seeking consent that are appropriate to the groups studied, using expert advice, support and training where necessary.
Vulnerability should be considered on a case-by-case basis; many groups or individuals not traditionally considered as vulnerable could be exposed to issues as a result of participating in research that make them vulnerable.
Consent from people lacking capacity to make decisions
Participants should be adequately and appropriately informed of potential risks arising from their participation in research.
When presented with sufficient information individuals will usually be able to use reasoned judgement to decide whether or not to participate. There is therefore a need to ensure that prospective participants have the capacity to understand the consequences and risks of participating in order to give valid consent.
‘Capacity’ is legally defined under the terms of the Mental Capacity Act 2005 and the Adults with Incapacity (Scotland) Act 2000, and any projects that involve participants who fall under these Acts must be reviewed by a recognised research ethics committee (REC) operating under the Governance arrangements for research ethics committees or Scotland ‘A’ REC.
The Mental Capacity Act 2005 applies to 16-17 year olds and adults (18 years and over) who lack capacity to make decisions because of an impairment, mental disorder or ‘disturbance in the functioning of the mind and brain’.
Guidance on the Mental Capacity Act notes that lack of capacity to make a decision may be permanent or temporary. It could be state-related (for example, due to drug or alcohol use, or because of the person’s emotional state at the time).
‘Intrusive’ research involving people without capacity to consent should comply with the specific provisions for research (Sections 30-33 of the Mental Capacity Act 2005) in order to be lawful. Intrusive procedures are defined as the ones requiring consent in law, including the use of personal information.
The Mental Capacity Act states that researchers should assume that a person has capacity to make a decision, unless there is proof that they do not have capacity to make a specific decision, and that a prospective participant must receive support to try to help them make their own decision. The participant has the right to disagree with the decisions that others (such as relatives or carers) might make.
If it is established that an adult does not have the capacity to decide whether to participate, the Mental Capacity Act 2005 requires that the researcher must consult with a specified consultee as set out in the Code of Practice. If possible, this should be a personal consultee.
The researcher should take reasonable steps to identify someone who knows the potential research participant well, but is not a professional or paid care worker; this does not include family members receiving some of the person’s pension or other benefits as a payment towards their share of the household expenses.
The guidance states that it should be someone whom the person who lacks capacity to make a decision would trust with important decisions about their welfare. Thus, a personal consultee could be a family member or close friend of the person.
If no personal consultee can be identified, a nominated consultee should be proposed by the researcher. This is someone who is prepared to be consulted by the researcher, but has no connection with the research project – for example, someone from a relevant organisation (such as a local church or charity); but they could also be a professional care worker (and thus could not be a personal consultee), such as the person’s GP, social worker or carer, providing they have no connection with the research project.
The Code of Practice under the Adults with Incapacity Act clarifies that ‘an adult does not have impaired capacity simply by virtue of having an addiction, psychotic illness or learning difficulties and disabilities’ (p6).
The Scottish Act states that the past and present wishes of the individual should be taken into account and any intervention should benefit the individual and such benefit will not be reasonably achieved without the intervention (Section 51 of the Adults with Incapacity (Scotland) Act 2000).
Consent should be obtained by the closest relative or person with relevant powers (eg welfare attorney).
- Access Northern Ireland
- Adults with Incapacity (Scotland) Act 2000
- Adults with Incapacity Act 2000: Code of practice
- Adults with Incapacity (Ethics Committee) Scotland Regulations 2002
- Mental Capacity Act and consent for research (PDF) (GOV.Wales)
- Disclosure and Barring Service
- Disclosure Scotland
- Health Research Authority: Mental Capacity Act 2005 – Questions and Answers
- Mental Capacity Act 2005
- Mental Capacity Act 2005 Code of practice (GOV.UK website)
- Protecting of Vulnerable Groups (Scotland) Act 2007
- Rehabilitation of Offenders Act 1974
- Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2013
- Safeguarding Vulnerable Groups Act 2006
Relevant case studies
Last updated: 12 October 2021