As a researcher, it is essential to respect both your participants and colleagues during research by conducting yourself in a manner that does not influence their willingness to participate in your activities. In this blog, we will focus on two ethical concepts: “coercion” and “undue influence.” These concepts are addressed in the informed consent procedure, where investigators are instructed to seek consent only under circumstances that minimize the possibility of coercion and undue influence. They are also applicable to vulnerable populations, where researchers can easily influence them. Therefore, our first concern is to ask ourselves:

What is coercion and undue influence?

Coercion

The Belmont Report defines coercion as ‘occurring when an overt threat of harm is intentionally presented by one person to another to obtain compliance’.

Coercion also involves threats of something bad or unfair or withholding something participants have a right to if they do not act as desired. Therefore, if any research carried out involves even a statement to cause harm or inflict pain on the potential participant for compliance, the researcher or investigator is practicing coercion which must be avoided at all stages of the study.

Example 1: Imagine being a patient suffering from a potentially fatal disease who has been denied a medication that is the confirmed cure for your disease by your attending physician because he wants you to participate in the research study, he is conducting on patients of the same disease he is treating. This is blatantly coercive and should be avoided.

Example 2: A research investigator who threatens to pay a participant less than what was promised at the initial consent unless he continues into a distinct extension study although the participant has adhered to all requirements and stated conditions on receiving the full payment.

Undue Influence

Undue influence is defined as occurring through an offer of an excessive, unwarranted, inappropriate, or improper reward to obtain compliance from a participant. It can also be the offer of something good, such as money, and may have the effect of motivating people to enroll or remain in a study. Undue influence is centered around tempting a participant with something that will make him or her comply with the request of participating in the research. In this case, that participant will not comply with the research in the absence of what has been used to lure him/her to participate.

Example 1: If you are carrying out a study on severely poor individuals, a grocery voucher of 50,000 FCFA may be considered undue influence. This amount is way too enticing to compensate for participation especially because the study is carried out on economically disadvantaged population.

Example 2: If a physician offers special services or benefits to patients which are inappropriate with the intention of tempting the patients to enroll in his study without the patients evaluating the risk/benefit situation to them, it is considered undue influence. These services could include better hospital private wards and treatment, offering to pay the patients’ bills, and taking care of their needs throughout their hospital stay.

Differences between coercion and undue influence  

The table below describes the differences between coercion and undue influence.

How can Coercion and Undue Influence be prevented in Research?

Generally, it is recommended that when recruiting participants in clinical studies, the investigator should seek for consent under any circumstances that provide the prospective subject or the Legally Authorised Representative (LAR) sufficient time, information and opportunity to consider participation thereby, minimizing the possibility of coercion and undue influence. The following precautions are required when recruiting participants into studies;

• Ethical Review: Regular review by an ethical committee should be done. Therefore, the research protocol should be submitted to an IRB for approval before implementation. 
• Transparent Communication: Provide clear, jargon-free information about risks and benefits.
• Appropriate Compensation: Ensure fair compensation that doesn’t overly incentivize participation as it will lead to undue influence.
• Independent Consent Process: An independent party for consent to avoid influence.
• Researcher Training: Educate staff on ethical recruitment and voluntary participation. All staff involved in the study should undergo proper training on GCP and ethics.
• Voluntary Participation: Emphasize the right to refuse or withdraw without penalty. This point is very important because it clearly informs the potential participant of free consent and rights which keeps the study free from coercion and/or undue influence.  
• Careful Recruitment: Avoid targeting vulnerable populations; ensure voluntary participation. According to the International Conference for Harmonisation (ICH), these are a group of people whose willingness to participate may be unduly influenced by the expectation of benefit or fear of reprisal for noncompliance. These groups are; infants and very young children, adults with mental or emotional disorders, patients with dementia, unconscious patients and prisoners. We can also have many others.
• Monitoring and Feedback: Continuously monitor recruitment and consent by providing feedback channels. The researcher needs feedback at all intervals to keep informed of how the study is being done at the site. This helps to identify any research misconduct and malpractices as a whole.  
• Cultural Sensitivity: Tailor consent processes to cultural and social contexts. The investigator needs to be aware that cultural differences and similarities between people exist. Therefore, the consent processes should be made in a manner that will avoid coercion and /or undue influence on the participants.
• Distinguish Care from Research: Clearly differentiate between medical care and research participation. The purpose of clinical research is to generate knowledge which will be useful for patients in the future while medical care aims to promote the wellbeing of individual patients. 

Below are a few examples of vulnerable populations that if research should be conducted on these precautions should be considered:

1. Prisoners: This is a group of people that are considered vulnerable because their freedom has been grounded due to maybe a crime they have committed or something against the law. Therefore, enrolment of this group of people should not provide participants with advantages in terms of living conditions, quality of food, amenities, opportunities etc. because participants’ ability to evaluate the risks is minimal since they hunger for freedom.
2. People living with terminal diseases: They can be easily influenced because of their health situations and they might not clearly evaluate the risks that the study can expose them to. So, the informed consent should clearly state that whether or not they agree to participate, it will not in any way affect their treatment (medication) and routine appointments. It is advised that even if consent is obtained from them, their legal representative should also give his/her consent to ensure that the study has been thoroughly assessed by both parties.
3. Elderly patients in group healthcare settings: elderly patients may have reduced mental capacity which is temporary, progressive or even permanent due to an ongoing disease process, neurological disorders like stroke, or dementia. Therefore, their decision capacity is a big area of concern. A legally authorized representative must consent to such participants.
4. Students: In the case where the professor has to issue his survey to be completed by students, the study team should not include the professor as a member since his presence alone can cause coercion or undue influence. Also, the team can arrange to have someone other than the professor to obtain consent from participants to avoid any words of threat or promises that can tempt the students into compliance. E.g. promises of glowing recommendation letters at course completion.

Conclusion

Summarily, researchers should incorporate in their study designs additional protection for participants, especially the vulnerable ones. Researchers should respect the Belmont’s principles by selecting participants fairly without bias, respecting their autonomy and providing them with a favourable risk-benefit ratio. they should be respected and neither coerced nor unduly influenced. For the vulnerable participants, the consenting process should be obtained with the help of a legally authorized representative.

References

• https://www.advara.com. The Many Faces of “Coercion” and “Undue Influence” by Luke Gelinas, PhD, senior chair director December 2, 2020
• https://ps.psychiatry online.org/doi/abs/10.1176/appi.ps.202000427digital technologies and coercion in psychiatry
• https://www.acrpnet.org/2019/03/paying- subjects- to- take-part-in-research-a-new perspective-on-coercion-and-undue-influence- march 12,2019 (volume 33, issue 3)
•  http://testbook.com /amp/key-differences/difference-between-coercion-and undue-influence
• https://research.uoregon.edu.com/manage/research-integrity-compliance/human-subjects-research/compensation-participation-research
• https://www.statistics.com/compensation-for research-participants-avoiding-undue-influence
• https://testbook.com/key-differences-between-coercion-and-undue-influence-know-all-the-differences-between-coercion-and-undue-influence
• https://www.washington.edu/research/glossary/undue/influence
• https://blog.petrieflom.law.harvard.edu/2015/11/23/vulbnerability-coercion-and-undue-influence-from-themud-into-the-muck