Generally speaking, academics and clinicians involved in research are so well versed in ethics that the public reviewer is unlikely to come across areas of an application where there are significant concerns, nevertheless,  the public reviewer would be wise to be familiar with the basics to better equip them with a background. 

With that in mind, most public reviewers need not read on unless you are particularly interested, so feel free to leave this page and turn your mind to more important things like making a cup of tea or coffee, or tidying up the cat litter tray.  The public reviewer who would benefit from reading on are those who anticipate running into ethical questions in their line of work reviewing for an ethics committee, or whose membership of a team is for a study involving particularly vulnerable people.  What is a vulnerable person?...read on.

Research Ethics Committees were first set up in the late 1960's early 1970's, partly as a result of the work of Papworth in this country and Beecher in the USA). Each one was independent and based in a hospital.  They proliferated, and by the late 1970s it was very confusing for researchers as each REC did things their own way.  Recognising the problem and potential for chaos and conflict, the NHS was unusually good here.  They established COREC (Central Office of RECs) in 2000 to standardise forms and procedures etc. and the rest, as they so wittingly say, is history.

What follows is a not a snack, not even a meal, but more an opportunity to experience intellectual indigestion, so if you are going to read on I suggest you do so over a period of time with breaks built in between sections otherwise it will all be too much to absorb.

First of all, let me explain the clear distinction between what are ethics and what are morals because the lines between them can sometimes be blurred.   Ethics concerns itself with the rules of conduct in a culture or group that are recognised by an external source or social system, in this case the research community.  Morals, on the other hand, relate to principles or habits relating to right or wrong conduct based upon an individual’s own compass of what is right or wrong.  This compass may be informed by a number of sources, religion being the most obvious, but there are others.

The fundamental document informing the ethical debate is the one called the Helsinki Declaration….

https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

The Declaration of Helsinki was created in 1964 by the World Medical Association (WMA) and was established seventeen years before in 1947.  It was created to handle the growing concerns of unethical medical practice which became more apparent during and after World War II with the aim to avoid the abuses that took place in Nazi Germany ever happening again.

Moving on, I briefly discuss 12 principles that research applications should be measured against ethically.   It could be argued that what follows is slightly repetitious in places, but I would counter that by saying ethics in research is so important that points can sustain being repeated.  These are, in no particular order:

Beneficence

Social and clinical value

Scientific validity

Fair subject selection

Favourable risk benefit ratio

Independent review

Informed consent

Respect for persons

Autonomy

Non-maleficence

Justice

Respecting confidentiality

Beneficence

The definition of beneficence is action that is done for the benefit of others. This principle states that research should:

Do no harm:

The purpose of health research is to discover new information that would be helpful to society. The purpose of research should never be to hurt anyone or find out information at the expense of other people.  However, in some studies, such as studies involving the development of new drugs, Stage 1 of the research is to find the maximum tolerated dose, so you keep increasing the dose until the patient becomes significantly unwell the go back to last tolerated dose and use that for phase 2.

Maximise benefits for participants and minimise risks for participants:

The purpose of much research involving humans is to show whether a drug or an intervention such as a physical, cognitive or digital therapy is safe and effective. This means participants may be exposed to some harms or risks. Researchers are obligated to do their best to minimise those possible risks and to maximise the benefits for participants.

Social and clinical value

Every research study is designed to answer a specific question. The answer should be important enough to justify asking people to accept some risk or inconvenience for others. In other words, answers to the research question should contribute to scientific understanding of health or improve our ways of preventing, treating, or caring for people with a given disease to justify exposing participants to the risk and burden of research.  The key question public reviewers are asked to consider is whether the burden here is acceptable or not.  If it isn’t it should be raised and discussed.

Scientific validity

A study should be designed in a way that will get an understandable answer to the important research question. This includes considering whether the question asked is answerable, whether the research methods are valid and feasible, and whether the study is designed with accepted principles, clear methods, and reliable practices. Invalid research is unethical because it is a waste of resources and exposes people to risk for no purpose

Fair subject selection

The primary basis for recruiting participants should be the scientific goals of the study — not vulnerability, privilege, or other unrelated factors. Participants who accept the risks of research should be in a position to enjoy its benefits, or at least accept that the benefits might not apply to them directly but can understand the outcomes will improve the lives of others who come after them. Specific groups of participants  (for example, women or children, people from ethnic minorities or with other protected characteristics. https://www.equalityhumanrights.com/equality/equality-act-2010/protected-characteristics)  should not be excluded from the research opportunities without a good scientific reason or a particular susceptibility to risk.

Favourable risk-benefit ratio

This relates to the uncertainty about the degree of risks and benefits associated with a clinical research study is inherent. Research risks may be trivial or serious, transient or long-term. Risks can be physical, psychological, economic, or social. Everything should be done to minimise the risks and inconvenience to research participants to maximise the potential benefits, and to determine that the potential benefits are proportionate to, or outweigh, the risks.

Independent review

This means that a study has to minimise potential conflicts of interest and make sure a study is ethically acceptable before it starts, an independent review panel should review the proposal and ask important questions, including: Are those conducting the trial sufficiently free of bias? Is the study doing all it can to protect research participants? Has the trial been ethically designed and is the risk–benefit ratio favourable? The panel also monitors a study while it is ongoing.

Informed consent

Key here is the point that either consent is informed or it is not consent.   Potential participants should make their own decision about whether they want to participate or continue participating in research. This is done through a process of informed consent in which individuals (1) are accurately informed of the purpose, methods, risks, benefits, and alternatives to the research, (2) understand this information and how it relates to their own clinical situation or interests, and (3) make a voluntary decision about whether to participate.

It’s important to stress here that consent is not a one off ‘thing’.  Consent is an enduring process and extends to giving permission to attend a clinic to be given an experimental drug as it is to a nurse changing a dressing or giving personal care.

The difference between consent and assent:

Consent is a legally defined decision given by someone who is competent, who has been adequately informed (and has adequate understanding), and who is free from undue influence enabling them to make a voluntary decision. The person can provide consent themselves (provided they are competent). Otherwise someone else who is empowered by law can provide it (e.g. a parent in the case of children). A child who is not capable of giving consent alone can still be involved in the decision-making process with others who are able in law, to provide consent.

Assent is difficult to define and is used in diverse ways, e.g. compliance by a child as young as three, through to the active agreement of a young teenager etc. Assent is agreement given by a child / young person, or others who are not legally empowered to give consent. It is important to provide children / young people with information that matches their capacity when seeking assent.

Respect for persons

Individuals should be treated with respect from the time they are approached for possible participation — even if they refuse enrolment in a study — throughout their participation and after their participation ends.

This includes:

1 Respecting their privacy and keeping their private information confidential.

2 Respecting their right to change their mind, to decide that the research does not match their interests, and to withdraw without a penalty.

3 Informing them of new information that might emerge in the course of research, which might change their assessment of the risks and benefits of participating.

4 Monitoring their welfare and, if they experience adverse reactions, unexpected effects, or changes in clinical status, ensuring appropriate treatment. 

5  When necessary, removal from the study informing them about what was learned from the research

Autonomy

All participants in research must take part voluntarily, free from any coercion or undue influence, and their rights, dignity and autonomy should be respected and appropriately protected.

Researchers must respect that individuals should make their own informed decisions about whether to participate in research.  The sticky ethical question here is that handing over a patient leaflet and even having a conversation doesn't go far enough when it comes to informing people.  Ethically, information needs to be retained in people's memory for consent to be valid and enduring.

In order to treat people as autonomous, individuals must be provided with complete information about a study and decide on their own whether to enrol.  Some people in society may not have the capacity to make fully informed decisions about what they do or what happens to them. This could include young children, people who are very ill, or those with mental disabilities. In such cases, these people should be protected and only be included in research under specific circumstances, since they cannot make a true informed decision on their own.

By contrast, when a potential research participant may lack capacity to make autonomous decisions, respect for persons requires that they be protected against harm. The capacity for self-determination matures during an individual's life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated. Some persons are in need of extensive protection, even to the point of excluding them from research that has a risk of harm.

Capacity

Capacity refers to whether someone has the mental ability to make autonomous decisions for themselves, and whether they can weigh up the benefits and disadvantages of something before arriving at a considered decision.  It is informed by the Mental Capacity Act 2005 (https://www.legislation.gov.uk/ukpga/2005/9/contents).  It governs decision-making on behalf of adults who may not be able to make particular decisions.

This could be because of, for example a learning disability or an illness such as dementia mental health problems.

It's important to remember these do not in themselves mean that a person lacks the capacity to make a particular decision. The Act and its codes of practice set out:

who can take particular decisions on someone else's behalf, when and how a decision can be taken, when and how people who lack capacity to take decisions about their care and welfare can be deprived of their liberty to get the care they need in a hospital or care home.

Capacity need not always be black or white.  Capacity can under certain circumstances be present or absent.  For example, people lose capacity to consent to have sex if they have had too much to drink or have taken recreational drugs.  See also the section here on the Mental capacity Act 2005

Non-maleficence

Non-maleficence is a core principle of medical ethics stating that a physician has a duty to 'do no harm' to a patient. It directs a medical professional to consider the benefits of all procedures and weigh them against the potential risks and burdens on the patient.

Justice

This principle deals with the concept of fairness. Researchers designing trials should consider what is fair in terms of recruitment of participants and choice of location to conduct a trial. This encompasses issues related to who benefits from research and who bears the risks of research. It provides the framework for thinking about these decisions in ways that are fair and equitable.

People who are included in research should not be included merely because they are a population that is easy to access, available, or perhaps vulnerable and less able to decline participating.

An experimental strategy that is likely to be used by many types of people should be tested in the very populations of people who are likely to use it, to ensure that it is safe, effective, and acceptable for all of the potential users. For example, experimental treatments that are intended for use in the general population must be studied not only on men, but on enough women to ensure that they are also safe and effective for women.

The principle of justice also indicates that questions being asked in trials should be of relevance to the communities participating in the study.

Confidentiality

During the informed consent process, if applicable, people must be informed of the precautions that will be taken to protect the confidentiality of the data and be informed of the parties who will, or may, have access. This will allow people to decide about the adequacy of the protections and the acceptability of the possible release of private information to the interested parties.

Researchers must maintain the confidentiality and security of the data that is collected and used in all research. This is important in both qualitative and quantitative research, as the rich, in-depth nature of the data collected can increase the risk of individual identification. Qualitative methods especially can be used to explore sensitive research topics, and the implications of identification could cause harm to individual participants, or the wider population being studied.  

Researchers should be transparent in their approach to data security and confidentiality to help participants better understand how their data is being protected. This can allow participants to be more trusting of the research, and therefore more honest and open in the answers they give to researchers.  

It can be difficult to anonymise qualitative data as participants can give in-depth personal information about their own experiences but removing personal characteristics, such as names and addresses (called “data washing” or “data scrubbing”) may not be enough to ensure the privacy and confidentiality of the participants.  Data should be reviewed frequently and at the earliest opportunity. Any unnecessary data should be disposed of. It is therefore recommended that data is coded and analysed as an iterative process alongside data collection. This allows for the researcher to sooner determine what data is relevant to the research and what data can be disposed of. Data should be stored in a secure, safe location, with access limited to only the researchers that need it.

There may be occasions when researchers are given information by participants that requires them to report the information to others, and researchers should stay alert to the signs of harm and abuse. If a participant discloses information that makes a research team or individual within that team worried for their safety, or the safety of someone else, they should follow safeguarding procedures or alert the appropriate authorities.  

This may be more likely in some research projects than others, dependent on the topic being studied. However, all researchers should be aware of this risk, and try to identify any safeguarding issues that may occur and strategies to deal with these, during the planning phase. The public reviewer will be expected to highlight any risk here a team may have overlooked. It

3) The conditions are—

(a)  a learning or physical disability;

(b). a physical or mental illness, chronic or otherwise, including an addiction to alcohol or drugs; or

(c). a reduction in physical or mental capacity.

(4) The disabilities are—

(a). a dependency upon others in the performance of, or a requirement for assistance in the performance of, basic physical functions;

(b).  severe impairment in the ability to communicate with others; or

(c)   impairment in a person’s ability to protect himself from assault, abuse or neglect.

(5) In this regulation “care home”, “independent clinic”, “independent hospital”, “independent medical agency” and “National Health Service body” have the same meanings as in the Care Standards Act 2000(1).

Stages of a clinical trial

For the purposes of clarification, here are the stages of a clinical trial of a drug.  

Clinical trials are conducted in a series of steps called “phases.” Each phase has a different purpose and helps researchers answer different questions.

Phase I trials: Researchers test a drug or treatment in a small group of people (20–80) for the first time. The purpose is to study the drug or treatment to learn about safety and identify side effects.

Phase II trials: The new drug or treatment is given to a larger group of people (100–300) to determine its effectiveness and to further study its safety.

Phase III trials: The new drug or treatment is given to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments, and collect information that will allow the new drug or treatment to be used safely.

Phase IV trials: After a drug is approved by the regulatory authorities and made available to the public, researchers track its safety in the general population, seeking more information about a drug or treatment’s benefits, and optimal use.

When it comes to the application process, to most major funders, they come in two stages. 

Stage 1 applications are involved and lengthy and set out a broad outline of a research proposal. 

Stage II applications are very very lengthy and cover absolutely everything.  Public reviewers can be involved in both stages for both the applicant and the funder.

What are the Caldicott principles?

The Caldicott Principles are named after Dame Fiona Caldicott and were first introduced in 1997 then amended in 2013. The latest amendment was in 2021 with the addition of another principle.   Caldicott Guardians are people who support the upholding of the principles at organisational level and who are consulted when a new or difficult decision about the use of data is required.  before the Caldicott Principles were established, personal information relating to health wasn't protected.  This meant that personal information and health status could become public knowledge, be abused and people exposed to stigmatising discrimination.  As technology advanced, these risks rose considerably.  The basis of the review was to ensure that confidentiality in medical and social care records wasn't undermined, therefore the Caldicott Principles set out what, when and how information could be shared.

Principle 1: Justify the purpose(s) for using confidential information

Every proposed use or transfer of confidential information should be clearly defined, scrutinised and documented, with continuing uses regularly reviewed by an appropriate guardian.

Principle 2: Use confidential information only when it is necessary

Confidential information should not be included unless it is necessary for the specified purpose(s) for which the information is used or accessed. The need to identify individuals should be considered at each stage of satisfying the purpose(s) and alternatives used where possible.

Principle 3: Use the minimum necessary confidential information

Where use of confidential information is considered to be necessary, each item of information must be justified so that only the minimum amount of confidential information is included as necessary for a given function.

Principle 4: Access to confidential information should be on a strict need-to-know basis

Only those who need access to confidential information should have access to it, and then only to the items that they need to see. This may mean introducing access controls or splitting information flows where one flow is used for several purposes.

Principle 5: Everyone with access to confidential information should be aware of their responsibilities

Action should be taken to ensure that all those handling confidential information understand their responsibilities and obligations to respect the confidentiality of patient and service users.

Principle 6: Comply with the law

Every use of confidential information must be lawful. All those handling confidential information are responsible for ensuring that their use of and access to that information complies with legal requirements set out in statute and under the common law.

Principle 7: The duty to share information for individual care is as important as the duty to protect patient confidentiality

Health and social care professionals should have the confidence to share confidential information in the best interests of patients and service users within the framework set out by these principles. They should be supported by the policies of their employers, regulators and professional bodies.

HOWEVER: patient information should be shared when they or others are at risk from harm, they are at risk of posing harm to others, a crime could be prevented if information is shared, a serious crime has been committed, a court order or other legal authority has requested the information.

Principle 8: Inform patients and service users about how their confidential information is used

A range of steps should be taken to ensure no surprises for patients and service users, so they can have clear expectations about how and why their confidential information is used, and what choices they have about this. These steps will vary depending on the use: as a minimum, this should include providing accessible, relevant and appropriate information - in some cases, greater engagement will be required.

Many people are squeamish about the thought of animal testing, and make protests when asked about the topic.  What most people don’t know is that every prescribed drug they have ever had, many they buy over the counter, soaps, toothpastes, skin creams, eye drops, etc etc have all been tested on animals at some stage according to the relevant national regulations governing animal testing.  Some commentators suggest that if people have a big problem with animal testing perhaps they should eschew future medications, stop washing and avoid cleaning their teeth. Globally, improvements in hygiene, sanitation and public health have made huge inroads to public health, so have medicines, treatments and vaccines. Diseases like polio, TB are seldom heard of in the western world as a result of advancements in medicine. 

Science is dependent upon an experiment being able to be replicated.   What this means is that for new knowledge to be recognised as having value, it has to be demonstrated as being credible, and that the evidence gathered to underpin that knowledge has to be transparent and gold plated.  What this means is that experiments are conducted in such a way that by using identical methods the results will always be the same regardless of who repeats the experiments, and this is only possible if the elements of an experiment are identical. This is regardless of the fact that the human population is not identical, with regional variations in the human genome and even response differences between sexes in such things as pain. This is recognised in science, and also investigated differently within different hypotheses.

 For an experiment using animals to be replicated and identical, it has through standardisation, to be possible for experiments to be repeated in exactly the same way. 

This requires that when it comes to experiments using animals only the very best, healthiest and correct animals are chosen, and they are supported by only the highest quality products. (Unless of course the experimental design requires something different). Scientist are aware of this, and the poor recording of all the details of the experiment – see arrive guidelines https://arriveguidelines.org/

 What this means in practice is that the animals used in experiments are of such high quality they are quite expensive.   As with anything expensive in one’s personal life, expensive things are protected and cared for so as not to abuse the privilege of owning them.  What this means is that animals used in experiments:

 

1. Get the high quality food, tailored to their individual needs.

2. Get the highest quality bedding. Not the stuff available at the local pet shop but bedding specifically designed for animals used in experiments, analysed for contaminants and quality.

3. Get the highest quality air if they are held in a laboratory with the best equipment and are of the smaller variety.  They don’t breathe the same air as you and I do, but triple filtered air. 

4. Get the highest quality personal healthcare. They don’t have to complain before they get to see a doctor, they are examined routinely once a day by law checked by people trained to assess them to identify health problems. 

5. Get the highest quality water.  They don’t get the muck that comes out of our taps, but the champagne of water. 

 

All this is highly regulated.  There are strict (expensive)  licensing arrangements that cover every single animal and every part of their life and death, and the penalties are significant and have serious implications if any of the rules and regulations involved in keeping and caring for animals are breached.  It is worth reflecting that it might be said that animals used in experiments have more care than are those confined in our prison service.   

 Why people are squeamish about animal experimentation is the belief that they have to suffer.  – they imagine it’s not an experiment unless there is pain, suffering or distress. But in defining what is pain, suffering or distress, we can acknowledge that ¾ of the animals that are used, the most that happens is breeding and an ear biopsy and most pet animal like a dog will need to have more needle stick in the first few month of life. Newborn children have a heel prick test, putting it into perspective.  Animals are not humans.  We project perceptions and stereotypes of suffering onto animals in the same way we would envisage humans suffering, but humans don’t get the best quality of food, water, air, accommodation the way animals do.  In many ways animals used in experiments have a better quality of life than most humans.  Reference should be made at this point to the 1993 set of standards for animals in human care; an animal should have freedom from hunger and thirst, freedom from discomfort, freedom from pain, injury or disease, freedom to express normal behaviour and freedom from fear and distress. All these freedoms are important to scientists when it comes to animal experimentation. ( https://pmc.ncbi.nlm.nih.gov/articles/PMC4810049/ ).  When animals suffer, the data they provide corrupts what we need to know from the purpose of why we experiment on them, so extreme measures are taken to prevent suffering, and what takes place in animal experiments leads to newer and better treatments.  So next time you need a painkiller or an antibiotic or a bath, give thanks for those people who, on your behalf, made it possible you do, and give thanks for those animals who were involved and also to those that that voice concerns, that aim to improve welfare and reduce suffering both external and internal to the industry.

 

To participate in a clinical trial, an individual has to be able to consent, or an advocate acting on their behalf persuaded that if they were able to consent would do so and gives consent for them.

Consent has to be informed.  if it isn't informed, it isn't consent. If it isn't consent then participation in a clinical trial is technically invalid.   I often see patient facing materials of such poor quality that it is unlikely that a patient really understands what they are signing when they consent to participation in a trial.

Consent is not a one off process, but an enduring one.

The following is culled from the Government website covering the Mental Capacity Act, and I refrain from embellishing it.  What is here are the sections I think are most relevant, but I wouldn't discourage anyone from exploring further the complete text. For the complete text, go here.  

The principles of the Mental Capacity Act (MCA) 2005 are:

 (1). The following principles apply for the purposes of this Act.

(2). A person must be assumed to have capacity unless it is established that he lacks capacity.

(3). A person is not to be treated as unable to make a decision unless all practicable steps to help him to do so have been taken without success.

(4). A person is not to be treated as unable to make a decision merely because he makes an unwise decision.

(5). An act done, or decision made, under this Act for or on behalf of a person who lacks capacity must be done, or made, in his best interests.

(6). Before the act is done, or the decision is made, regard must be had to whether the purpose for which it is needed can be as effectively achieved in a way that is less restrictive of the person's rights and freedom of action

People who lack capacity

(1). For the purposes of this Act, a person lacks capacity in relation to a matter if at the material time he is unable to make a decision for himself in relation to the matter because of an impairment of, or a disturbance in the functioning of, the mind or brain.

(2). It does not matter whether the impairment or disturbance is permanent or temporary.

(3). A lack of capacity cannot be established merely by reference to—

    (a) a person's age or appearance, or

    (b) a condition of his, or an aspect of his behaviour, which might lead others to make unjustified assumptions about his capacity.

(4). In proceedings under this Act or any other enactment, any question whether a person lacks capacity within the meaning of this Act must be decided on the balance of probabilities.

(5). No power which a person (“D”) may exercise under this Act—

  (a) in relation to a person who lacks capacity, or

  (b) where D reasonably thinks that a person lacks capacity, is exercisable in relation to a person under 16.

Inability to make decisions

(1). For the purposes of section 2, a person is unable to make a decision for himself if he is unable—

  (a) to understand the information relevant to the decision,

  (b) to retain that information,

  (c) to use or weigh that information as part of the process of making the decision, or

  (d) to communicate his decision (whether by talking, using sign language or any other means).

(2). A person is not to be regarded as unable to understand the information relevant to a decision if he is able to understand an explanation of it given to him in a way that is appropriate to his circumstances (using simple language, visual aids or any other means).

(3). The fact that a person is able to retain the information relevant to a decision for a short period only does not prevent him from being regarded as able to make the decision.

(4). The information relevant to a decision includes information about the reasonably foreseeable consequences of—

 (a) deciding one way or another, or

 (b) failing to make the decision.

Research

(1). Intrusive research carried out on, or in relation to, a person who lacks capacity to consent to it is unlawful unless it is carried out—

  (a) as part of a research project which is for the time being approved by the appropriate body for the purposes of this Act in accordance with section 31, and

  (b) in accordance with sections 32 and 33.

(2). Research is intrusive if it is of a kind that would be unlawful if it was carried out—

  (a) on or in relation to a person who had capacity to consent to it, but

  (b) without his consent.

(3). A clinical trial which is subject to the provisions of clinical trials regulations is not to be treated as research for the purposes of this section.

(3A). Research is not intrusive to the extent that it consists of the use of a person's human cells to bring about the creation in vitro of an embryo or human admixed embryo, or the subsequent storage or use of an embryo or human admixed embryo so created.

(3B). Expressions used in subsection (3A) and in Schedule 3 to the Human Fertilisation and Embryology Act 1990 (consents to use or storage of gametes, embryos or human admixed embryos etc.) have the same meaning in that subsection as in that Schedule.]

(4). “Appropriate body”, in relation to a research project, means the person, committee or other body specified in regulations made by the appropriate authority as the appropriate body in relation to a project of the kind in question.

(5). “Clinical trials regulations” means—

  (a). the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031) and any other regulations replacing those regulations or amending them, and

  (b). any other regulations relating to clinical trials and designated by the Secretary of State as clinical trials regulations for the purposes of this section.

(6). In this section, section 32 and section 34, “appropriate authority” means;

  (a). in relation to the carrying out of research in England, the Secretary of   State, 

  (b). in relation to the carrying out of research in Wales, the National Assembly for Wales.

Requirements for approval

(1). The appropriate body may not approve a research project for the purposes of this Act unless satisfied that the following requirements will be met in relation to research carried out as part of the project on, or in relation to, a person who lacks capacity to consent to taking part in the project (“P”).

(2). The research must be connected with—

  (a)  an impairing condition affecting P, or

  (b). its treatment.

(3). “Impairing condition” means a condition which is (or may be) attributable to, or which causes or contributes to (or may cause or contribute to), the impairment of, or disturbance in the functioning of, the mind or brain.

(4). There must be reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the project has to be confined to, or relate only to, persons who have capacity to consent to taking part in it.

(5). The research must—

  (a)  have the potential to benefit P without imposing on P a burden that is disproportionate to the potential benefit to P, or

  (b)  be intended to provide knowledge of the causes or treatment of, or of the care of persons affected by, the same or a similar condition.

(6). If the research falls within paragraph (b) of subsection (5) but not within paragraph (a), there must be reasonable grounds for believing—

  (a). that the risk to P from taking part in the project is likely to be negligible, and

  (b). that anything done to, or in relation to, P will not—

  (i) interfere with P's freedom of action or privacy in a significant way, or

  (ii) be unduly invasive or restrictive.

(7). There must be reasonable arrangements in place for ensuring that the requirements of sections 32 and 33 will be met.

Consulting carers etc.

(1). This section applies if a person (“R”)—

  (a). is conducting an approved research project, and

  (b). wishes to carry out research, as part of the project, on or in relation to a person (“P”) who lacks capacity to consent to taking part in the project.

(2). R must take reasonable steps to identify a person who—

  (a)  otherwise than in a professional capacity or for remuneration, is engaged in caring for P or is interested in P's welfare, and

  (b). is prepared to be consulted by R under this section.

(3). If R is unable to identify such a person he must, in accordance with guidance issued by the appropriate authority, nominate a person who—

  (a). is prepared to be consulted by R under this section, but

  (b). has no connection with the project.

(4). R must provide the person identified under subsection (2), or nominated under subsection (3), with information about the project and ask him—

  (a)  for advice as to whether P should take part in the project, and

  (b)  what, in his opinion, P's wishes and feelings about taking part in the project would be likely to be if P had capacity in relation to the matter.

(5). If, at any time, the person consulted advises R that in his opinion P's wishes and feelings would be likely to lead him to decline to take part in the project (or to wish to withdraw from it) if he had capacity in relation to the matter, R must ensure—

  (a). if P is not already taking part in the project, that he does not take part in it;

  (b). if P is taking part in the project, that he is withdrawn from it.

(6). But subsection (5)(b) does not require treatment that P has been receiving as part of the project to be discontinued if R has reasonable grounds for believing that there would be a significant risk to P's health if it were discontinued.

(7). The fact that a person is the donee of a lasting power of attorney given by P, or is P's deputy, does not prevent him from being the person consulted under this section.

(8). Subsection (9) applies if treatment is being, or is about to be, provided for P as a matter of urgency and R considers that, having regard to the nature of the research and of the particular circumstances of the case—

  (a)  it is also necessary to take action for the purposes of the research as a matter of urgency, but

  (b)  it is not reasonably practicable to consult under the previous provisions of this section.

(9). R may take the action if—

  (a). he has the agreement of a registered medical practitioner who is not involved in the organisation or conduct of the research project, or

  (b) where it is not reasonably practicable in the time available to obtain that agreement, he acts in accordance with a procedure approved by the appropriate body at the time when the research project was approved under section 31.

(10). But R may not continue to act in reliance on subsection (9) if he has reasonable grounds for believing that it is no longer necessary to take the action as a matter of urgency.

Additional safeguards

(1). This section applies in relation to a person who is taking part in an approved research project even though he lacks capacity to consent to taking part.

(2). Nothing may be done to, or in relation to, him in the course of the research—

  (a). to which he appears to object (whether by showing signs of resistance or otherwise) except where what is being done is intended to protect him from harm or to reduce or prevent pain or discomfort, or

  (b)  which would be contrary to—

          (i). an advance decision of his which has effect, or

          (ii). any other form of statement made by him and not subsequently withdrawn,

of which R is aware.

(3). The interests of the person must be assumed to outweigh those of science and society.

(4). If he indicates (in any way) that he wishes to be withdrawn from the project he must be withdrawn without delay.

(5). P must be withdrawn from the project, without delay, if at any time the person conducting the research has reasonable grounds for believing that one or more of the requirements set out in section 31(2) to (7) is no longer met in relation to research being carried out on, or in relation to, P.

(6). But neither subsection (4) nor subsection (5) requires treatment that P has been receiving as part of the project to be discontinued if R has reasonable grounds for believing that there would be a significant risk to P's health if it were discontinued.

Loss of capacity during research project

(1). This section applies where a person (“P”)—

  (a). has consented to take part in a research project begun before the commencement of section 30, but

  (b). before the conclusion of the project, loses capacity to consent to continue to take part in it.

(2). The appropriate authority may by regulations provide that, despite P's loss of capacity, research of a prescribed kind may be carried out on, or in relation to, P if—

  (a). the project satisfies prescribed requirements,

  (b). any information or material relating to P which is used in the research is of a prescribed description and was obtained before P's loss of capacity, and

  (c). the person conducting the project takes in relation to P such steps as may be prescribed for the purpose of protecting him.

(3). The regulations may, in particular,—

  (a). make provision about when, for the purposes of the regulations, a project is to be treated as having begun;

  (b). include provision similar to any made by section 31, 32 or 33.