Facilitating Consent through the Provision of Culturally Sensitive Information

Sue ECKSTEIN

There is widespread agreement that consent to research is a crucial prerequisite to research, and that consent can take many forms. In the context in which most of you work, consent is often bound up in the written word. Bobbie has spoken about the complexities that occur once the ideas of culture and consent are brought together. I want to look at a particular problem that can occur when the requirements of research and perceptions of acceptable practice do not necessarily meld. A sponsoring body, for example, may require that written information and consent are clearly incorporated into the research process, regardless of the extent to which the participant group encounters, or relies on, written information.

Balancing Ethics and Cultural Sensitivity

As was suggested in an article by Susan Bull on the SciDev website, "the challenge for researchers is to establish procedures that are ethically sound and culturally sensitive." Although these two requirements may sometimes conflict, I would like to suggest that culturally sensitive information can take the form of appropriately and well-written documentation. In order to achieve consent, prospective participants must:

Be appropriately informed about the nature of the research
Adequately understand the information
Voluntarily participate
Explicitly consent to participate

Since we have already looked at consent in detail, I will concentrate on the first two points. There is some consensus about conditions that should be met on the way to achieving informed consent, but less so on how this can be achieved in different cultural settings. Many of the processes are non-negotiable, but the means of conveying information and what counts as sufficient or necessary might vary greatly depending on the context. This is especially true in situations where many cultures are represented, in multi-centre trials that take place in several regions or countries or in resource-poor communities. But these problems are also applicable to the UK and the US. For example, in Brighton, where I sit on the Ethics Committee, the population is largely homogenous and white. However, there are significant issues related to class, income and education, which affect how information is, or should be, disseminated to participants.

Conveying Information Effectively

The type of information expected to be provided to research participants is fairly uniform, but most of it assumes a high level of literacy, a shared belief system about health, medicine and the role of researchers, a shared understanding of ideas such as privacy and ownership and an understanding of complex research language and tools, such as randomisation, placebo, double blinding, and so on. It is fair to say that anthropologists and linguists tend to show more concern about how research is carried out, especially in relation to the giving of information, than many researchers and sponsors.

Risks and Benefits

Are benefits listed before risks, and in greater detail? Do researchers understand that the degree of risk participants are likely to assume depends on their current situation? Are researchers clear about short-term and longer-term benefits? Will there be problems in communities which have a high regard for authority and medical knowledge? Will they understand that a doctor or researcher may genuinely not know something?

Available Alternatives

Do researchers make it clear that there may not be realistic alternatives for a particular community?

Confidentiality

Do researchers take this seriously? For example, in the UK, it is normal to receive several pieces of post a day. In communities where mail is rare, is it appropriate to use this system to recruit people into a trial or give test results? Can a woman consent without discussing the research with her husband, father or another authority figure?

Compensation

Are researchers aware of the potential for inducement? What might be a negligible amount of money in one community might be an unreasonable inducement in another. And inducement can occur in non-monetary forms. School children, for example, might participate in research if it means they can skip a math class.

Contacts

Who is available to answer questions? Is this a culture where questioning an authority figure is permissible?

Voluntary participation

Does the information make it clear that participation is voluntary? Could someone be forced to participate by a family member? What are the mechanisms in place to prevent this? Who has been approached about research in the first place?

Documentation

Does the signature on a consent form always have meaning or relevance?

Using Language Effectively

I sit on a number of ethics committees in the UK and have seen that the vast majority of protocols are back for revisions due to poor provision of information for participants.

Simplification of Complex Terminology

Doctors and scientists are reluctant not to use the technical terms they are familiar with and reluctant to write short, simple sentences. Researchers must think about the suitability of wording, especially in developing countries, as information will be translated in written or oral forms into the participants' language and back again. In English, there are many everyday words that have sophisticated alternatives: give/administer, test/analyse and the Pill/oral contraceptive, for example. If technical words are necessary, researchers must give a simple definition. For example, "Left ventricular failure is a kind of heart failure. In heart failure, the heart does not pump enough blood around the body."

In addition, we should attempt to remain positive and direct, using active rather than passive forms of language. Clear writing explains people doing things, not having things done to them. UK protocols often employ the passive. For example, "When your blood has been tested, a decision will be taken with respect to your continued participation in the trial." Instead, we should say, "We will test your blood and decide if you should stay in the trial." ('Writing information for potential research participants', Mellor, E., Raynor, D.K., Silcock, J., in Eckstein, S., ed. The Manual for Research Ethics Committees, CUP, 2003.)

Dwain Chambers, the fastest man in Europe, and one of Britain's main hopes for an Olympic gold medal next year, has tested positive for a new banned designer anabolic steroid and could face a life ban from the sport. Britain also faces being stripped of the 4x100m silver medal it won at the world athletics championships in Paris in August as Chambers was part of the team.

This is a recent excerpt of an article in The Guardian, a British broadsheet newspaper with an educated middle-class readership. There are ways of testing readability. The most commonly used method is the Flesch reading ease formula, according to which a higher score, of up to 100, represents easier reading. The Flesch-Kincaid grade level indicates the reading age according to US grade levels. A Flesch-Kincaid grade level of ten indicates a reading age of about 15. This article has a reading age of 17. However, the same story told in The Sun, (see below) a tabloid newspaper, is easier to read, with a reading age of 15. The average Sun article has a reading age of seven.

Top British sprinter Dwain Chambers was last night reported to have tested positive for a new designer steroid.
Chambers,26 - the fastest man in Europe and one of our top Olympic hopes - could face a life ban from the sport.
Traces of the drug tetrahydrogestrinone (THG) were reportedly found in a urine sample he gave at a training camp in Germany in August.

Testing on real people is the only foolproof way of knowing if your information can be read and understood. Most information provided to research participants is unnecessarily complex.

This very commonly used sentence demands a reading age of 15:

"Random allocation into control and treatment groups will be performed by a computer."

The following is a simpler, easier, albeit longer, version that demands a reading age of about nine:

"We will split you into two groups. In the first group you take a new medicine we are testing. In the second group you take the most commonly used medicine. We need to compare the old and new medicines fairly. We do this by randomly choosing the group you go into. We could toss a coin to do this, but we use a computer because it is quicker."

The following sentence demands a reading age of about 16:

"You are being invited to participate in a research project. Participation in this trial is entirely voluntary and you are free to decline entry into the study."

Here is a version of this sentence, which has greater readability, demanding a reading age of eight:

"We invite you take part in a research project. You don't have to accept our invitation. If you decide not to take part, then you don't need to give us a reason."

It may seem childlike, but it is more ethical to write this way.

Unfortunately, I do not have any examples in French. But imagine the complexities of having to translate a sentence from formal English into formal French and then into simple French before translating it into the native language of trial participants.

Being Aware of Problems with Written Information

In developing countries, women and girls may have higher illiteracy rates. The poor and disadvantaged in every culture may have a lower reading ability. If resources are limited, a researcher might ask a family member to interpret information. What about issues of confidentiality and coercion?

There are limitations to interpretation. If a study counsellor is involved, they may make their own decisions about which bits of information are important. They may be able to judge this well, but they may also be influenced by their own preoccupations or prejudice. They might be embarrassed by information or reluctant to talk about certain subjects, such as death or menstruation.

It is also important to avoid making assumptions about prior knowledge. For example, if someone has never witnessed a blood test before, he or she may not understand that the blood removed will be replaced. Conversely, participants may be very able to understand complex data. In Brighton, for example, the HIV-positive community is highly researched and well-informed about the disease and treatment and research options.

Supplementing Written Materials

An article in The Lancet in October 2002 concluded that small investments in better communication can significantly improve participants' understanding of what it means to take part in clinical research. It suggests that formal assessment of participants' understanding of the consent process should be routine. "Research participants in less developed countries can comprehend a complex consent form if sufficient care is taken to provide them with information."

There is an increasing use of role play, drama, village meetings and so on. This may improve the appropriate dissemination of information, but it does not always lead to adequate understanding. For example, in a Family Health International case study on condom use, all adult males and females were exposed to the trials by an entertainment event. It included music, dance, puppetry and people explaining the trial. Researchers had not anticipated the possibility of women suffering trauma as a result of abuse by their sexual partners. Perhaps researchers had been thinking so much about the dissemination of information that they had not thought through some of the non-clinical risks.

Simple props can be useful. A test tube filled with coloured liquid can demonstrate the volume of blood taken in a blood sample, for example. One can also use pictures, but one has to remember that pictures are not culturally neutral, as anthropologists and communications experts testify.

Conclusion

In conclusion, it is important that people who are knowledgeable about the area carry out adequate background research. This is as relevant in developed as in developing countries. We cannot assume that a community has a certain level of literacy or understanding of procedures; people may understand or read much better or worse than expected. We need to think very carefully about the readability and comprehensibility of written information, as it is the basis for translations and alternative means of conveying information, such as role play or video. And the next time you write a scientific paper, you might want to test its readability!