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Ethical Principles for conducting Research with Human Participants

The Standing Committee on Ethics in Research with Human Participants has now completed its revision of the Ethical Principles for Research with Human Subjects (British Psychological Society, 1978).The new 'Ethical Principles for Conducting Research with Human Participants' (q.v.) have been approved by the Council.

The Standing Committee wishes to highlight some of the issues that concerned it during the drawing up of the Principles published below. In the forefront of its considerations was the recognition that psychologists owe a debt to those who agree to take part in their studies and that people who are willing to give up their time, even for remuneration, should be able to expect to be treated with the highest standards of consideration and respect. This is reflected in the change from the term 'subjects' to 'participants'. To psychologists brought up on the jargon of their profession the term 'subject' is not derogatory. However, to someone who has not had that experience of psychological research it is a term which can seem impersonal.

Deception

The issue of deception caused the Committee considerable problems.To many outside the psychology profession, and to some within it, the idea of deceiving the participants in one's research is seen as quite inappropriate. At best, the experience of deception in psychological research can make the recipients cynical about the activities and attitudes of psychologists. However, since there are very many psychological processes that are modifiable by individuals if they are aware that they are being studied, the statement of the research hypothesis in advance of the collection of data would make much psychological research impossible. The Committee noted that there is a distinction between withholding some of the details of the hypothesis under test and deliberately falsely informing the participants of the purpose of the research, especially if the information given implied a more benign topic of study than was in fact the case. While the Committee wishes to urge all psychologists to seek to supply as full information as possible to those taking part in their research, it concluded that the central principle was the reaction of participants when deception was revealed. If this led to discomfort, anger or objections from the participants then the deception was inappropriate. The Committee hopes that such a principle protects the dignity of the participants while allowing valuable psychological research to be conducted.

Debriefing

Following the research, especially where any deception or withholding of information had taken place, the Committee wished to emphasise the importance of appropriate debriefing. In some circumstances, the verbal description of the nature of the investigation would not be sufficient to eliminate all possibility of harmful after-effects. For example, an experiment in which negative mood was induced requires the induction of a happy mood state before the participant leaves the experimental setting.

Risk

Another area of concern for the Committee was the protection of participants from undue risk in psychological research. Since this was an area in which the Principles might be looked to during an investigation following a complaint against a researcher, the Committee was concerned to seek a definition that protected the participants in the research without making important research impossible. Risks attend us every moment in life, and to say that research should involve no risks would be inappropriate. However, the important principle seemed to be that when participants entered upon a psychological investigation they should not, in so doing, be increasing the probability that they would come to any form of harm.Thus, the definition of undue risk was based upon the risks that individuals run in their normal lifestyle. This definition makes possible research upon individuals who lead a risk-taking or risk-seeking life (e.g. mountaineers, cave divers), so long as the individuals are not induced to take risks that are greater than those that they would normally encounter in their life outside the research.

Implementation

The Council of the Society approved the Principles at its meeting in February 1990.There followed a two-year period during which the new Principles were provisionally in operation. In Spring 1992 the Council reviewed the Principles, in the light of experience of their operation. During this period researchers were unable to identify problems in the working of the Principles. Following minor amendment the Principles were formally adopted in October 1992.

The Council urges all research psychologists to ensure that they abide by these Principles, which supplement the Society's Code of Conduct (q.v.) and thus violation of them could form the basis of disciplinary action. It is essential that all members of the psychological profession abide by the Principles if psychologists are to continue to retain the privilege of testing human participants in their research. Psychologists have legal as well as moral responsibilities for those who help them in their study, and the long-term reputation of the discipline depends largely upon the experience of those who encounter it first-hand during psychological investigations.

1. Introduction

1. The principles given below are intended to apply to research with human participants. Principles of conduct in professional practice are to be found in the Society's Code of Conduct and in the advisory documents prepared by the Divisions, Sections and Special Groups of the Society.
   
2. Participants in psychological research should have confidence in the investigators. Good psychological research is possible only if there is mutual respect and confidence between investigators and participants. Psychological investigators are potentially interested in all aspects of human behaviour and conscious experience. However, for ethical reasons, some areas of human experience and behaviour may be beyond the reach of experiment, observation or other form of psychological investigation. Ethical guidelines are necessary to clarify the conditions under which psychological research is acceptable.
   
3. The principles given below supplement for researchers with human participants the general ethical principles of members of the Society as stated in The British Psychological Society's Code of Conduct (q.v.). Members of The British Psychological Society are expected to abide by both the Code of Conduct and the fuller principles expressed here. Members should also draw the principles to the attention of research colleagues who are not members of the Society. Members should encourage colleagues to adopt them and ensure that they are followed by all researchers whom they supervise (e.g. research assistants, postgraduate, undergraduate, A-Level and GCSE students).
   
4. In recent years, there has been an increase in legal actions by members of the general public against professionals for alleged misconduct. Researchers must recognise the possibility of such legal action if they infringe the rights and dignity of participants in their research.

2. General

1. In all circumstances, investigators must consider the ethical implications and psychological consequences for the participants in their research.The essential principle is that the investigation should be considered from the standpoint of all participants; foreseeable threats to their psychological well-being, health, values or dignity should be eliminated. Investigators should recognise that, in our multi-cultural and multi-ethnic society and where investigations involve individuals of different ages, gender and social background, the investigators may not have sufficient knowledge of the implications of any investigation for the participants. It should be borne in mind that the best judge of whether an investigation will cause offence may be members of the population from which the participants in the research are to be drawn.

3. Consent

1. Whenever possible, the investigator should inform all participants of the objectives of the investigation.The investigator should inform the participants of all aspects of the research or intervention that might reasonably be expected to influence willingness to participate. The investigator should, normally, explain all other aspects of the research or intervention about which the participants enquire. Failure to make full disclosure prior to obtaining informed consent requires additional safeguards to protect the welfare and dignity of the participants (see Section 4).
   
2. Research with children or with participants who have impairments that will limit understanding and/or communication such that they are unable to give their real consent requires special safe-guarding procedures.
   
3. Where possible, the real consent of children and of adults with impairments in understanding or communication should be obtained. In addition, where research involves any persons under 16 years of age, consent should be obtained from parents or from those in loco parentis. If the nature of the research precludes consent being obtained from parents or permission being obtained from teachers, before proceeding with the research, the investigator must obtain approval from an Ethics Committee.
   
4. Where real consent cannot be obtained from adults with impairments in understanding or communication, wherever possible the investigator should consult a person well-placed to appreciate the participant's reaction, such as a member of the person's family, and must obtain the disinterested approval of the research from independent advisors.
   
5. When research is being conducted with detained persons, particular care should be taken over informed consent, paying attention to the special circumstances which may affect the person's ability to give free informed consent.
   
6. Investigators should realise that they are often in a position of authority or influence over participants who may be their students, employees or clients.This relationship must not be allowed to pressurise the participants to take part in, or remain in, an investigation.
   
7. The payment of participants must not be used to induce them to risk harm beyond that which they risk without payment in their normal lifestyle.
   
8. If harm, unusual discomfort, or other negative consequences for the individual's future life might occur, the investigator must obtain the disinterested approval of independent advisors, inform the participants, and obtain informed, real consent from each of them.
   
9. In longitudinal research, consent may need to be obtained on more than one occasion.

4. Deception

1. The withholding of information or the misleading of participants is unacceptable if the participants are typically likely to object or show unease once debriefed.Where this is in any doubt, appropriate consultation must precede the investigation. Consultation is best carried out with individuals who share the social and cultural background of the participants in the research, but the advice of ethics committees or experienced and disinterested colleagues may be sufficient.
   
2. Intentional deception of the participants over the purpose and general nature of the investigation should be avoided whenever possible. Participants should never be deliberately misled without extremely strong scientific or medical justification. Even then there should be strict controls and the disinterested approval of independent advisors.
   
3. It may be impossible to study some psychological processes without withholding information about the true object of the study or deliberately misleading the participants. Before conducting such a study, the investigator has a special responsibility to

   (a) determine that alternative procedures avoiding concealment or deception are not available;

   (b) ensure that the participants are provided with sufficient information at the earliest stage; and

   (c) consult appropriately upon the way that the withholding of information or deliberate deception will be received.

5. Debriefing

1. In studies where the participants are aware that they have taken part in an investigation, when the data have been collected, the investigator should provide the participants with any necessary information to complete their understanding of the nature of the research.The investigator should discuss with the participants their experience of the research in order to monitor any unforeseen negative effects or misconceptions.
   
2. Debriefing does not provide a justification for unethical aspects of any investigation.
   
3. Some effects which may be produced by an experiment will not be negated by a verbal description following the research. Investigators have a responsibility to ensure that participants receive any necessary debriefing in the form of active intervention before they leave the research setting.

6. Withdrawal from the investigation

1. At the onset of the investigation investigators should make plain to participants their right to withdraw from the research at any time, irrespective of whether or not payment or other inducement has been offered. It is recognised that this may be difficult in certain observational or organisational settings, but nevertheless the investigator must attempt to ensure that participants (including children) know of their right to withdraw. When testing children, avoidance of the testing situation may be taken as evidence of failure to consent to the procedure and should be acknowledged.
   
2. In the light of experience of the investigation, or as a result of debriefing, the participant has the right to withdraw retrospectively any consent given, and to require that their own data, including recordings, be destroyed.

7. Confidentiality

1. Subject to the requirements of legislation, including the Data Protection Act, information obtained about a participant during an investigation is confidential unless otherwise agreed in advance. Investigators who are put under pressure to disclose confidential information should draw this point to the attention of those exerting such pressure. Participants in psychological research have a right to expect that information they provide will be treated confidentially and, if published, will not be identifiable as theirs. In the event that confidentiality and/or anonymity cannot be guaranteed, the participant must be warned of this in advance of agreeing to participate.

8. Protection of participants

1. Investigators have a primary responsibility to protect participants from physical and mental harm during the investigation. Normally, the risk of harm must be no greater than in ordinary life, i.e. participants should not be exposed to risks greater than or additional to those encountered in their normal lifestyles.Where the risk of harm is greater than in ordinary life the provisions of 3.8 should apply. Participants must be asked about any factors in the procedure that might create a risk, such as pre-existing medical conditions, and must be advised of any special action they should take to avoid risk.
   
2. Participants should be informed of procedures for contacting the investigator within a reasonable time period following participation should stress, potential harm, or related questions or concern arise despite the precautions required by the Principles.Where research procedures might result in undesirable consequences for participants, the investigator has the responsibility to detect and remove or correct these consequences.
   
3. Where research may involve behaviour or experiences that participants may regard as personal and private the participants must be protected from stress by all appropriate measures, including the assurance that answers to personal questions need not be given.There should be no concealment or deception when seeking information that might encroach on privacy.
   
4. In research involving children, great caution should be exercised when discussing the results with parents, teachers or others acting in loco parentis, since evaluative statements may carry unintended weight.

9. Observational research

1. Studies based upon observation must respect the privacy and psychological well-being of the individuals studied. Unless those observed give their consent to being observed, observational research is only acceptable in situations where those observed would expect to be observed by strangers. Additionally, particular account should be taken of local cultural values and of the possibility of intruding upon the privacy of individuals who, even while in a normally public space, may believe they are unobserved.

10. Giving advice

1. During research, an investigator may obtain evidence of psychological or physical problems of which a participant is, apparently, unaware. In such a case, the investigator has a responsibility to inform the participant if the investigator believes that by not doing so the participant's future well-being may be endangered.
   
2. If, in the normal course of psychological research, or as a result of problems detected as in 10.1, a participant solicits advice concerning educational, personality, behavioural or health issues, caution should be exercised. If the issue is serious and the investigator is not qualified to offer assistance, the appropriate source of professional advice should be recommended. Further details on the giving of advice will be found in the Society's Code of Conduct.
   
3. In some kinds of investigation the giving of advice is appropriate if this forms an intrinsic part of the research and has been agreed in advance.

11. Colleagues

1. Investigators share responsibility for the ethical treatment of research participants with their collaborators, assistants, students and employees. A psychologist who believes that another psychologist or investigator may be conducting research that is not in accordance with the principles above should encourage that investigator to re-evaluate the research.