Research: Obtaining Consent and the Collection of Personal and Sensitive Data

This is a summary of the Department of Health’s guidelines on seeking consent. Most of the guidelines available are on seeking consent for medical treatment; it is clear from those guidelines, however, that the same principles apply for research. This summary cannot cover all situations. Further advice can be obtained from the Information Rights Officer at data-protection@bristol.ac.uk or an ethics committee.

Contents

1. Consent - General

2. When is someone competent to agree to take part in research?

3. Adults

4. Children

5. Who can consent on behalf of a child?

6. Older people

7. People with learning difficulties

8. Psychiatric patients

9. Mental Capacity Act 2005

10. Medical research

11. Human Tissue Act 2004

12. Withdrawing consent

13. The media

14. Sources

 

1. Consent - General

To collect sensitive data from a volunteer (the data subject) you are legally obliged to obtain specific written informed consent from the data subject unless you have a legal reason to collect the data. In addition to obtaining specific written consent from the data subject, for consent to be validly given:

  • Individuals must be given sufficient information to ensure that they understand what is involved in the research and what will happen to their personal data. The information must be presented in a form that they can understand; and 
  • Individuals' consent must be given voluntarily, not under any duress or undue influence from health professionals, family or friends.

Obtaining consent should be seen as a process, not a one-off event. Discussing options and coming to a decision should be seen as part of the consent process.

It is strongly recommended that a plain language written description of the project (often referred to as a 'patient information sheet') is given to every volunteer, including information about:

  • the goals, methods and possible benefits of the research;
  • who will collect the personal data and/or sensitive data (including the name of project, department and telephone number);
  • why the data is being collected;
  • who will have access to the data, including any external organisations that might be given the data;
  • the circumstances in which data may be disclosed to those allowed access;
  • whether copies of the data may be made;
  • the arrangements for storing the data;
  • how long the data will be stored;
  • whether the data may be used for similar future research projects;
  • the implications of taking part in the project, including any risks, in as much detail as any 'reasonable person' would require;
  • how the research will be published and whether individuals will be identifiable.

Volunteers must be given sufficient time to read explanatory material and to consider the implications of their decision. Forms and explanatory papers must not imply that consent is expected.

Potential distress is not a sufficient reason to deny individuals access to their personal information arising out of a research project. It is possible that deliberately withholding information from individuals who participate in a project would be more likely to engender feelings of distress when discovered than any distress incurred by individuals learning the truth about their condition.

Similarly, it is essential that all volunteers know whether there are any risks involved in the proposed study. A risk that is acceptable to one individual might not be acceptable to another. Even questionnaires, for example, could have the unwanted side effect of distressing or depressing a volunteer.

Aside from potential distress incurred, incalculable damage could be done to a researcher's reputation should an individual discover that he/she was unknowingly part of a research project. If members of the public become suspicious of research they may choose not to take part in research in future. Keeping individuals in ignorance is therefore against the public interest in medical progress.

2. When is someone competent to agree to take part in research?

A person is competent to agree to take part in research if they can understand and weigh up the information needed to decide whether to take part, including the consequences of taking part in the project. Unexpected decisions do not prove that someone is not competent but may indicate a need for further information or explanation.

3. Adults

Adults are always assumed to be competent unless demonstrated otherwise.

Where doubts exist as to an individual’s capacity, an assessment consistent with the Mental Capacity Act 2005 should be made in conjunction, where appropriate, with specialist colleagues such as speech and language therapists or experts in the field of learning difficulty. This assessment and the conclusions drawn from it should be retained in the individual’s record. When assessing whether an individual understands and is able to use information the following should be considered:

  • whether the person is able to paraphrase what has been said
  • whether the person is able to compare alternatives, or to express any thoughts on possible consequences other than those already disclosed
  • whether the person applies the information to his or her own case

Information given should be appropriate and accessible. This may include using pictures or communication aids, such as boards where people can indicate ‘yes’ or ‘no’. Explain what will happen in simple terms or short sentences and be willing to repeat or reword explanations. Always check that you have been understood. If necessary, interpreters should be used. If you and the subject have difficulty understanding each other those supporting them may be able to help, as may other professionals such as language therapists. It may be appropriate to involve an independent advocate to help people obtain the information they need, for example if someone finds it difficult to ask questions of those perceived to be in authority, or where there are possible conflicts of interest between an individual and his or her carer.

Information should always be communicated in a respectful way and the right to privacy and confidence should be respected.

Do not confuse capacity with your assessment of the reasonableness of the person’s decision. People have the right to make a decision based on their own value system as long as they understand the outcome of their decision, even if others perceive it to be irrational. If a decision seems irrational, discuss it with the person and, where appropriate, those supporting them. In some cases the individual may choose to go ahead after further information and discussion. However, individuals must never be coerced into changing their decision.

In England and Wales, no one (not even a spouse) can give consent on behalf of adults who are not capable of giving consent themselves, UNLESS that person has been designated a Lasting Power of Attorney (LPA) under the Mental Capacity Act 2005. Those close to the research participant should always be included when decisions are being made, however, unless the person has earlier made it clear that they do not want such involvement. The Mental Capacity Act 2005 now regulates research on adults who cannot consent. A principal consideration is that it is not appropriate to carry out research on adults who cannot give or withhold consent to take part if the research can instead be carried out on adults who can. More information on research with people who lack capacity or who have fluctuating capacity can be found in the Mental Capacity Act Code of Practice, Chapter 13. This type of research should be considered with caution and advice must always be sought from the National Research Ethics Service before proceeding (not a University Ethics Committee as these are not recognised by the Secretary of State).

4. Children

Children aged below 16 are not presumed to have competence to consent to participate in research. Consent in young people can be obtained when they have 'sufficient understanding and intelligence to enable him or her to understand fully what is proposed' (sometimes known as 'Gillick competence' or the 'Fraser guidelines').

Young people aged 16 or 17 are presumed competent under legislation. However, the extent of this presumption has been interpreted by the courts as pertaining only to consent to treatment, not refusal, and there have been no cases specific to the context of research.

Therefore, for any research involving young people under the age of 18, it is good practice to obtain consent from a parent or carer with parental responsibility in addition to obtaining assent/consent from the child or young person. If a competent child agrees to take part but specifically asks you not to inform his or her parents and you cannot persuade them otherwise, then this should be respected. Advice should be sought before proceeding with research if a competent child refuses but a parent agrees. Such research, however, should be considered with caution and advice from an ethics committee should be sought.

Once children reach the age of 18 no one else can take decisions on their behalf.

Appropriately designed information should be available for children involved in research and they should be encouraged to be as involved as they are able in any decisions. Even very young children will have opinions on their health and welfare, and children should not feel that decisions are being made over their heads. Also, from an early age, children can be encouraged to countersign the consent form, to show that they agree to what is proposed.

5. Who can consent on behalf of a child?

If a child is not competent to give consent you should seek consent from a person with parental responsibility (usually, but not always, the child’s parent). Legally you only need consent from one person but it is good practice to involve all those close to the child when making a decision.

The Children Act 1989 defines those with parental authority as:

  • the child’s parents if married to each other at the time of conception or birth;
  • the child’s mother but not father if they were not so married unless the father has acquired parental responsibility via a court order or a parental responsibility agreement, or the couple subsequently marry;
  • the child’s legally appointed guardian - appointed either by a court or by a parent with parental responsibility in the event of their own death;
  • a person in whose favour a court has made a residence order concerning a child;
  • a local authority designated in a care order in respect of the child (but not where the child is being looked after under section 20 of the Children Act, also known as being ‘accommodated’ or in ‘voluntary care’);
  • a local authority or authorised person who holds an emergency protection order in respect of the child.

Recent legislation has added another class of parents with parental responsibility:

    For all children born in England and Wales after 1 December 2003, both of a child's parents will have parental responsibility if they are               registered on the child's birth certificate, regardless of whether the parents were married at the time the child was born.

Foster parents, step-parents and grandparents do not automatically have parental responsibility.

If the mother herself is under 16 she will only be able to give valid consent for her child if she is herself ‘Gillick competent’; this may vary depending on the complexity of the proposed research.

If a child is a ward of court the court must first approve all ‘important steps’ in the child’s life. Further advice should be sought to see whether reference to the court would be necessary.

6. Older People

Adults are always assumed to be competent unless demonstrated otherwise. This applies as much to elderly people as to any other adult. It should never be assumed that people are not able to make their own decisions because of their age or perceived frailty. Where any doubt exists of a person’s capacity to take part in research you or an appropriate colleague should assess the capacity of that person following the guidelines above. Some people may have the capacity to consent to take part in some research projects but not others. It should never be assumed that people cannot take decisions for themselves because they have been unable to do so in the past. A person’s capacity can also fluctuate: they may, for example, be able to make a decision one day that they had been unable to make the day before.

Information should be presented in a respectful way, and the person should be addressed in the way that they prefer.

7. People with learning difficulties

Adults are always assumed to be competent unless demonstrated otherwise. This applies as much to people with learning difficulties as to any other adult. It should never be assumed that people are not able to make their own decisions simply because they have a learning difficulty. Neither should it be assumed that people cannot take decisions for themselves just because they have been unable to do so in the past. Individuals may be capable of taking some decisions but not others, depending on the complexity of the information required to make that decision.

If at all possible, people with learning difficulties should be assisted to make their own decision, and should be given the time and support they need to make that decision. Often people with learning difficulties have support from family members, carers or friends who can help them understand the issues and come to their own decisions.

8. Psychiatric patients

The Royal College of Psychiatrists emphasises that ‘the majority of psychiatric patients are as capable of giving consent as other patients’. An individual may be in a position to consent to take part in some studies but not others. If at all possible, such individuals should be assisted to make their own decision when deciding whether to give consent to take part in research, and should be afforded the time and support they need to make their decision.

9. Mental Capacity Act 2005

From 1 October 2007, the Mental Capacity Act 2005 came into force. It is important that anyone proposing to undertake research involving adults who lack the capacity to provide consent ensure they are fully aware of the provisions of this Act. In summary, research covered by the Act cannot include any people who lack capacity to consent to the research unless:

  • the research has the approval of a research ethics committee recognised by either the Secretary of State or the Welsh Assembly Government, (usually a NHS Research Ethics Committee) as appropriate;
  • the researcher considers the views of carers and other relevant people;
  • the research treats the person's interests as more important than those of science and society; and
  • the researcher respects any advance decisions or expressed preferences of a person who lacks capacity and any objections the person makes during the research.

For more detailed guidance on how the Mental Capacity Act 2005 affects research, please consult the Mental Capacity Act Code of Practice.

10. Medical research

For medical research information must be provided covering the following points:

  • There is no pressure to take part and they can withdraw consent at any time without their medical care being affected
  • If the research is a clinical trial, the nature of the trial, and the information so far on the therapy’s effectiveness and side effects
  • If the research is a randomised controlled trial, the fact that they will be randomly assigned to the standard treatment, the new treatment or (if applicable) the placebo

11. Human Tissue Act 2004

It is important to obtain clear and meaningful consent from any individual donating human tissue for the purposes of research.

There is information and advice regarding the Human Tissue Act 2004 on the Research and Enterprise Development website.

12. Withdrawing Consent

If an individual objects to the research and asks to withdraw, it is good practice to stop the research and establish the individual’s concerns. Sometimes an objection may reflect pain, distress or a lack of understanding, and appropriate reassurance may enable you to continue. However, people who have given consent to take part in a research project are entitled to withdraw their personal data from the project at any time. If a patient wishes to withdraw consent during a medical procedure and this would put the patient’s life at risk you may be entitled to continue until the risk no longer applies.

13. The media

Before making arrangements for external individuals or organisations to film research subjects you should inform the Public Relations Office and the organisation where volunteers are being filmed if this is different. Appropriate permission for the recording should be obtained from all bodies as well as the individual. Within the NHS, a contract with the filmmaker will normally be required.

If you are involved in any way with recording volunteers for television and any other public media you should satisfy yourself that permission has been properly obtained from the patient, even if you are not responsible for obtaining that permission or do not have control over the recording process. The BBC and the Independent Television Commission have guidance for programme makers that requires permission to be fairly obtained in such cases.

It should be made clear to subjects that if they agree to the recording they may not be able to withhold consent for future use. If patients wish to restrict the use of material they should get written agreement from the owners of the recording before recording begins.

Particular vigilance is required in recordings of those who cannot give permission themselves. Individuals’ interests, well-being, privacy and dignity must not be compromised by the recording. If you believe the recording is too intrusive or damaging to a patient’s interests you should raise the issue with the programme recorders. If you remain concerned, do your best to stop the recording and withdraw your co-operation.

14. Sources

Information Commissioner's Office - Use and Disclosure of Health Data

Department of Health Consent Guidance Page

British Medical Association

Medical Research Council

Consent information

Personal Information in Medical Research

Executive Summary on Personal Information in Medical Research

For practical help with the legislative and good practice requirements relating to the use of personal data and human tissue samples in healthcare research in the UK: www.dt-toolkit.ac.uk/home.cfm

Useful links for the Mental Capacity Act 2005 are:

www.rdforum.nhs.uk/docs/newsletters/news270607.htm

www.dh.gov.uk/en/socialcare/deliveringadultsocialcare/mentalcapacity/index.htm