Informed consent requires that research staff and participants should be given appropriate [a] information about the research [b] in a comprehensible manner [c] without duress or inappropriate inducement.
The information should include: the research procedure, the purposes, risks and anticipated benefits, alternative procedures [where therapy is involved], and a statement offering the participant the opportunity to ask questions and to withdraw at any time from the research. Where a person is not receiving treatment but is a pure volunteer, the standard of disclosure may be expected to be higher. The extent and nature of information should be such that persons, knowing that the procedure is neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate in the furthering of knowledge. Even when some direct benefit to them is anticipated, the participants should understand clearly the range of risk and the voluntary nature of participation.
Comprehension entails that the manner and context in which information is conveyed is as important as the information itself. For example, presenting information too quickly or in a format that is confusing may adversely affect a participant's ability to make an informed choice. Because a participant's ability to understand is a function of intelligence, rationality, maturity and language, it is necessary to adapt the presentation of the information to the participant’s capacities. Investigators are responsible for ascertaining that the participant has comprehended the information.
Special provision may need to be made when comprehension is severely limited – for example, by conditions of immaturity or mental disability [e.g., infants and young children or those with mentally disabilities]. Participants must have the opportunity to choose to the extent they are able, whether or not to participate in research. This situation also requires seeking the permission of other parties in order to protect the participants from harm and represent their best interests.
Voluntariness requires that a participant make their decision without duress or other undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the participant is especially vulnerable. Unjustifiable pressures usually occur when persons in positions of authority or commanding influence – especially where possible sanctions are involved – urge a course of action for a participant.
Decisions about the ethics [acceptability or unacceptability] of research projects involving human participants begin with principles. There are historical reasons for this. When the mistreatment of research participants first came to light, researchers, physicians, lawyers, ethicists and policymakers came together to describe the general principles needed to protect the human participants of research. In doing so, they were trying to avoid mistakes made in the past and to provide guidance for the future. This resulted in a series of international declarations and conventions which underpin all research involving human participants:
- The Nuremberg Code [1947] set out ten key points for responsible research with human participants, including the need to obtain informed consent, the importance of proper planning and conduct, and the need for beneficence towards participants.
- The Council of Europe [CoE] was created in 1949 and established the European Convention on Human Rights in 1953, which is now also embedded in Member States' legislation.
- The Declaration of Helsinki [1964] developed these ethical principles further by looking at issues such as informed consent in more detail.
- A further Convention which specifically addresses human rights and biomedicine was produced in 1997 in the light of new advances in research.
The Nuremberg Code , the European Convention on Human Rights, and the Declaration of Helsinki have shaped the various national regulations on research with human participants; for more information, see the 'Useful links' box to the right. Over the past 50 years or so, additional 'protections' have also been promulgated as new advances in science are made.
General principles
Today, there is significant agreement on the general principles for research with human participants, although there are national and regional variations in how they are expressed. As you work through this section, therefore, keep in mind that you need to start with the specific rules that apply to you. That said, it will be easier to understand these rules if you are aware of the broader context within which they were developed.
In the following section, you will find out more about the different levels at which these key principles are operationalised. We begin with widely accepted general principles – but remember that your primary obligation is to follow your own national and institutional policies, which you will find in the boxes at the end of this section.
Several documents describe the broad principles that should govern the use of humans in research, including the Nuremberg Code, the Declaration of Helsinki and the Belmont Report. All three are internationally accepted – they are routinely cited in international policies for the protection of human participants – but they have no binding or regulatory power.
International guidelines
Guidelines move beyond principles to outline the proper procedures for protecting research participants. The Council for International Organizations of Medical Sciences [CIOMS] has published a set of guidelines for the conduct of international research using human participants – refer to the useful links box at the end of this section for a link.
National regulations
Most countries have their own regulations/guidelines for the protection of human participants. In the UK, for example, there are guidelines issued by the Department of Business, Innovation and Skills, the NHS and RCUK as well as other professional codes [e.g. the BPS Code of Practice]. The box at the bottom of this section contains a link to the International Compilation of Human Research Standards which covers over 100 countries.
Institutional regulations
National regulations must be interpreted by local institutions. Most organisations that sponsor or host research have developed a specific set of guidelines – based on the national relevant regulations – for the proper treatment of human participants. These are the concrete rules that you must follow when doing research with human participants.
Your obligation to the human participants of research
Whenever and wherever you undertake research that involves human beings as participants you have an obligation to protect their welfare and to make sure they are treated fairly.
Taking as its starting point the European Convention on Human Rights, which is accepted elsewhere as a model statement of fundamental rights, the Council of Europe has now developed the Convention further to address the ethical issues which arise from advances in biomedicine and its associated research. It states that the interests of human beings must come before the interests of science or society as a whole. It also sets out rules related to medical research by including detailed and precise conditions, especially for those who cannot give their consent to participate.
The US Belmont Report is possibly the most concise summary of rights and obligations in terms of research and, as such, provides the foundation for research ethics guidance in several places around the globe. The Belmont Report includes three 'basic ethical principles' for judging the ethical treatment of human participants:
- Respect for persons: The personal dignity and autonomy of individuals must be recognised and there must be special protections for persons with 'diminished autonomy' [e.g. children and prisoners]
- Beneficence: Researchers have an obligation to protect persons from harm by maximising the anticipated benefits and minimising the risk of harm
- Justice: The benefits and burdens of research must be distributed fairly.
In the following section, you will be presented with a number of good research practices with human participants. For each statement, decide which of the Belmont principles [respect for persons, beneficence, justice] it reflects and make a note of your answer.
- There must be a favourable balance of risks and benefits: every effort must be made to maximise benefits and minimise risks.
- There must be a fair procedure for selecting research participants.
- Prior to giving their consent to participate, individuals must be given all relevant information about the study in language they can comprehend.
- Individuals must not be coerced into participating in research.
- Research should never use any kind of brutal or inhumane treatment.
Our suggestion:
Obtaining informed consent and avoiding coercion are both examples of respect for persons. Ensuring that there is a reasonable balance of risks and benefits and that all treatment is humane are both examples of beneficence. A fair selection procedure reflects the principle of justice.
Feedback:
The principles in this material are based on a commonly agreed understanding of the worth of persons in their own right, and not just [nor even primarily] in terms of their utility for research. Respecting personhood includes respecting individual autonomy by providing the requisite information and conditions for an individual to make a real and meaningful choice about whether to participate. Beneficence requires that researchers maintain the priority of a participant's wellbeing over the outcome of their research. Justice is concerned with the equitable treatment of individuals.
Applying and balancing principles in practice
Research ethics committees use these or other applicable principles to review particular projects: to be approved, projects usually have to adhere to all the essential principles. However, there can sometimes be tension between different principles, which research ethics committees have to reconcile.
Equitable distribution
One such tension concerns the equitable distribution of risks and benefits. Simply weighing lives saved against lives lost does not work. [If it did, we could justify sacrificing one individual to harvest their organs to save the lives of many others, which of course is not acceptable.] But when the risks and benefits are more subtle, decision-making becomes more difficult.
In the following section, consider each scenario and reflect on the potential for harm to participants in each. Each scenario is followed by a hint to guide your thinking, and then our feedback.
In order to study how social networks operate, a professor asks students to initiate rumours about one another and trace how they move through networks of friends. How might participants be harmed?
Hint: Research exercises done for pedagogical purposes have consequences.
Feedback:
False rumours can cause real harm. The rumours might upset or offend the students concerned. Even though this begins as an assignment, there is a strong possibility that the rumours will take on a life of their own and be believed by some students.
Question 2 of 4:
A clinical researcher prepares a 12-page consent form for participants in a trial of a new drug, detailing its operation, effects and possible side-effects. How might particpants be harmed?
Hint: Information on a consent form must be complete and understandable.
Feedback:
Too much information given in language that is too technical can overwhelm participants; the result is incomplete comprehension and thus ill-informed consent.
Question 3 of 4:
A social scientist employs a PhD student to help analyse qualitative data from a study of anorexic teenagers. He sends transcripts of his interviews with the teenagers to his assistant via email. How might participants be harmed?
Hint: Protection of privacy is a critical aspect of protecting human participants.
Feedback:
When confidential information is sent via email there is no guarantee of privacy. There are several ways the transcripts could become public – a lost or unattended computer, improper forwarding of a message or interception on a public network.
Question 4 of 4:
An American drug company goes to Nepal to set up a clinical trial for a vaccine for Hepatitis E. This disease is common in poor countries, but the vaccine is intended for soldiers from the United States who are to be sent abroad. How might participants be harmed?
Hint: Justice requires that research participants, and the populations they represent, share in the benefits of the research.
Feedback:
This research is exploitative because there is no intention to share the [potential] benefits of this research with the population from which the subjects are drawn. The subjects are asked to bear the risks of the research with no possibility of benefit for their community.
Final feedback:
This short quiz has offered you an opportunity to think about the ways in which researchers may cause harm to participants – even inadvertently. Research ethics committees can help you identify and prevent possibilities of harm to human particpants.
International collaboration
International collaborations also raise difficult questions when it comes to balancing principles. When you work with colleagues from other countries, whose principles should be followed and how should they be applied? For example, everyone agrees that there must be an element of 'approval/consent' for participation in the research, but from whom should it come? In some cultures, a person's participation depends on getting consent from the head of their family. In others, the individual themselves must consent, unless they are under-age.
What do you think?
If you are doing research in a country with different practices for consent, which practices should you follow?
Answers:
- The practices of the country in which the participant resides, even if those practices are not the same as your practices and might be unethical in your country
- The practices of the country originating the project, even if those practices conflict with those of the participant's country [e.g. allowing the head of the family and not the individual to provide consent]
- The practices of a third country in which one of the research team members resides, if those practices are more lenient than any others
Feedback:
There is little agreement on this issue and your peers may have responded differently to this question. If the practices in another country are truly objectionable in your own, it would be difficult to abide by them. It is equally difficult to accept that every country has a right to apply its standards in every other country. You should be aware of differences between national policies before you embark on an international collaboration and reach an agreement on how to proceed. It is inappropriate to choose to follow a set of rules, just because they are the most lenient. You may need to get approval in both countries and you should plan for such an event in terms of the time needed for this.
As might be expected, it can take time to get approval for projects that raise difficult questions about the proper protection of human participants. We now turn to consider this process in more detail.