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Understanding religious and cultural barriers to clinical trial participation

In this blog post we discuss how you can understand cultural barriers to clinical trial participation.

Human beliefs have played a role in healthcare since the beginning of time, but for many years the modern medicine community preferred to largely ignore these, than to engage with them. That was until Christina Puchalski founded the George Washington Institute for Spirituality and Health in May 2001, with the purpose of bringing attention to the intersectionality of belief and health for both providers and patients.

The same belief systems that prevent people from seeking healthcare also cause cultural barriers to clinical trial participation, which doesn’t help to solve the current lack of diversity experienced in trials.

Here are some of the most common beliefs that present problems for clinical trial prospects:

#1: Religion

It’s easy to discount the power of religion on healthcare, but we’re learning that it doesn’t necessarily fall outside the bailiwick of modern medicine. A number of religious, cultural and ethical beliefs prevent people from taking part in trials. On the religious front, these include (in alphabetical order):

  • Hinduism – products derived from pigs or cows are prohibited.
  • Jehovah’s Witnesses – products derived from or containing blood are prohibited.
  • Judaism – products derived from pigs are prohibited.
  • Sunni and Shiite Islam – products from pigs are prohibited.

How to resolve this:

Don’t try to hide the facts from anyone. There are many potential participants out there who don’t practice their faith daily and don’t care particularly about these issues, and there are others who will participate in spite of them.

State clearly what the ingredients and other associations of the treatments are, and you’ll win trust and confidence from the audience as a whole. You’ll also exclude from the outset those who aren’t able to overcome these cultural barriers to clinical trial participation. That’s far better than having them drop out midway when they discover facts that they were unaware of.

#2: Privacy

Religious barriers may or may not be faith-based, such as Muslim laws regarding privacy. It’s easy for Western-educated personnel to assume confidentiality is inherent in a clinical trial, but this might be less obvious to someone educated elsewhere.

How to resolve this:

Make it clear in your recruitment materials that confidentiality is assured. State openly how and when information is released and to whom, and ensure that participants sign to indicate their understanding.

#3: Culture

Cultural barriers to clinical trial participation often also come in the form of modesty issues, such as for Muslim, Sikh and Hindu women who prefer to be seen by female doctors. Unless a trial clearly addresses this in advance, it risks losing women from these demographics who might have a concern about being examined by a male doctor.

How to resolve this:

Specify under what conditions participants will be examined. Include medical professionals with various gender identities and cultural backgrounds, and provide the option for participants to ask for the type of doctor they prefer.

#4: Ethics

Ethical barriers to participation usually fall into categories such as environmental consciousness, veganism, animal activism, and others. Clinical trials often make use of products that may:

  • Be tested on animals in the laboratory environment or include animal derivatives in medication, such as Premarin HRT, which was originally manufactured from the urine of pregnant mares.
  • Contain ingredients such as palm oil derivatives, which contribute to deforestation and the loss of animal habitats.
  • Be packaged in plastic containers that are not biodegradable or recyclable, thereby contributing to the pollution of the planet and the destruction of the ecosystem.

How to resolve this:

Once again, clarity in communication is everything, and while drawing attention to any of these controversial issues might seem counter-productive, in the long term it will serve companies well to be transparent from the outset.

Many people from a wide range of backgrounds feel strongly about these issues, and as much as this can be a hindrance to finding participants, it can also work in your favour. If a trial treatment is not tested on animals or delivered in controversial packaging, it may be worth stating this in the recruitment materials.

Applying your understanding of cultural barriers to clinical trial participation to gain informed consent

Obtaining informed consent from participants about what they’re getting into is vital for any company that hopes to avoid cultural barriers to clinical trial participation and conduct successful research. We read daily about the risks of signing any types of consent without reading the fine print, and with so much of our lives online these days, it’s no secret many platforms push people into signing away much of their privacy without even realising it.

This is just as much of a risk in clinical trials, where participants seldom have the time or the training to identify clauses that could create difficulties for them. Structure the consent documentation as simply as possible and use images to illustrate and support the copy.

Avoid the jargon typically embraced by the medical community, particularly in the terms and conditions of participation. Having participants who understand precisely what the trial involves is far more ideal than having them fight you every step of the way because they misunderstood what was required.

Be clear about the financial contribution, if any. Make sure your potential participants understand what costs will be covered, and whether they’ll need to pay for anything themselves. In most instances, having expenses covered is not one of the typical religious or cultural barriers to clinical trial participation, but clarity goes a long way towards avoiding misunderstandings. And since it’s difficult enough to attract, recruit and retain participants in your clinical trials, the last thing you need once you find them is a misunderstanding that derails the entire project.

This blog was first published here:

8th June 2020



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