Ethics, consent and safety
Consent that is real, and a plan for when something goes wrong
Informed consent, capacity and communication, confidentiality, safeguarding, data protection and escalation.
Ethics is not a form. It is the set of decisions that protect people who did not design the study. You will make those decisions in the room, without the team beside you.
Consent that is real
Consent has four parts. All four must be present. If one is missing, the consent is not valid.
Four parts of valid consent
- Information. The person understands what the study is, what they will do, how long it takes, what happens to their data, and what the risks and benefits are.
- Capacity. The person can understand the information and weigh the decision, with support if needed.
- Voluntariness. The choice is free. No pressure from a professional, a family member, or you.
- Record. The consent is written down, signed or witnessed, dated, and stored.
Capacity is not a yes or no
Capacity depends on the decision and the moment. A person may be unable to weigh a complex trial and fully able to decide about a short conversation. Support the decision rather than testing the person. Speak more slowly. Use short sentences. Offer written or picture support. Ask the person to say the decision back in their own words, and treat a muddled answer as a signal to explain again, not to give up.
The Mental Capacity Act 2005 applies in England and Wales. Where a person lacks capacity for a research decision, only a consultee process set out in the approved protocol may be used, and only if the ethics approval covers it. You do not improvise this. You stop and call the study lead.
Involvement work and ethical approval
Patient and public involvement activity, where people advise on the research, is not research on those people, and it usually needs no ethical approval. Research activity, where people give data that will be analysed, does. The distinction matters for you because your tasks may include both.
The practical split
- Involvement: a priority-setting meeting, a co-design workshop, a discussion about wording. Consent is still good practice, and you still protect privacy.
- Research: an interview, a focus group, a questionnaire, a photograph that will be analysed. Written consent is required, and the approved procedure applies.
The IBISES case studies made exactly this split: two of the four were involvement activities with no ethics approval, and two were research studies with University of Sheffield approvals and written informed consent.
Confidentiality, and its limits
You will hear things that are personal. Confidentiality means you do not repeat them outside the team, and you do not discuss individuals at home or in the community, even when the story is flattering.
Confidentiality has limits, and you should state them before you begin, not after something is said.
When you must pass information on
- A person discloses a risk of serious harm to themselves or another person.
- A person discloses the abuse or neglect of a child or an adult at risk.
- A court order or a legal duty requires disclosure.
- The protocol names a specific safeguarding route that applies.
Say this at the start of a session, in plain words: "If you tell me someone is being hurt, or that you plan to hurt yourself or someone else, I have to tell the person responsible for safety. I would tell you first."
Safeguarding in practice
- Know the route before you need it. Name, role, phone number, and what happens out of hours.
- Do not investigate. Record what was said, in the person's words, and pass it on the same day.
- Do not promise secrecy. You cannot keep that promise, and breaking it later does more harm.
- Do not act alone. If a person is in immediate danger, call the emergency services, then tell the study lead.
- Record the referral. Date, time, what you did, who you told, and what they said.
Data protection in five rules
UK GDPR for link workers
- Collect only what the study needs. Do not add questions because they are interesting.
- Use only the devices and systems the study provides. No personal phone for study photographs unless the study says so in writing.
- Keep consent forms and data separately, and in the places the study names.
- Do not send participant details by ordinary message or email. Use the approved route.
- If a device is lost, or data goes to the wrong person, tell the study lead the same day. A delay makes a small incident into a reportable breach.
The study holds the legal responsibility. You hold the practice. Ask for the one-page data note that tells you which systems to use. If it does not exist, ask why.
Working alone and staying safe
- Tell someone where you are going, with whom, and when you expect to finish.
- Meet in a public or shared place for a first contact, unless the study says otherwise.
- Keep your own phone charged and the supervisor's number to hand.
- You may end a session at any time if you feel unsafe. The study does not require you to continue.
- Record any incident, however small, in the study log.
When something goes wrong
The escalation card
Carry these five facts. Fill them in before your first session.
- Study lead: name and number.
- Safeguarding contact: name and number.
- Data or information governance contact: name and number.
- Out of hours route: number or instruction.
- What to do if you cannot reach anyone: the default, stated in writing by the study.
The line you do not cross
You do not give clinical advice, diagnose, interpret test results, or tell a person whether a treatment is right for them. You may explain the study, help a person find the right service, and pass a concern to the team. Where a person asks for advice, the answer is: "I am not the right person for that. I can help you find who is."
The test of understanding
During a focus group, a participant says her neighbour is being neglected by a carer. She asks you not to tell anyone. What do you do?
You tell her, at the time, that you cannot keep that promise: a concern about the safety of an adult at risk must go to the person responsible for safeguarding. You record what she said in her words, tell the study lead or safeguarding contact the same day, and record what you did. You do not investigate, and you do not raise it with the neighbour.