Ethics is described as being the “moral principles that govern a person’s behaviour or the conducting of an activity.”
Clinical trials can evoke many feelings and opinions in people, and although the practice of experimentation has evolved throughout the years, there are still quite a few ethical issues that must be addressed during every clinical trial.
In Australia, a clinical trial can only be approved after evaluation by multiple regulatory bodies, including the HREC (Human Research Ethics Committee) which follows the guidelines set out by the National Statement on Ethical Conduct in Human Research (written in 2007; updated in 2015), which is governed by the NHMRC (The National Health and Medical Research Council).
Every participant must have a thorough understanding of what is expected of them before they give their consent, and the potential risks and benefits involved in the trial have to be clearly defined.
Some of the most common ethical issues related to clinical trials include:
Participation and Consent
Every participant of a clinical trial needs to give informed consent (permission granted in full knowledge of the possible consequences, typically that which is given by a patient to a doctor for treatment with knowledge of the possible risks and benefits) and will need to sign a PICF (Participant Information and Consent Form) which acknowledges that the participant knows what they have agreed to.
For consent to be considered valid, it needs to consist of these 3 factors:
- People need to volunteer to participate on their own terms (not under any coercion).
- The participant should be of sound mind.
- All participants should be informed of every possible risk or benefit before signing consent forms.
There needs to be a mutual understanding between all participants, researchers and medical professionals with respect at the forefront. Participants must understand that they are participating on a voluntary basis and that they can pull out at any time. They also need to know why the clinical trial is being held and who stands to benefit most from it, if it is successful.
Most important of all, participants should always be treated with respect.
Vulnerable or High Risk Participants
Some participants are at a higher risk than others due to ongoing physical or mental health conditions. The researchers and medical professionals need to understand the different needs of each high risk participant and need to look at the clinical trial with an ‘ethical’ viewpoint, rather than a ‘beneficial’ one.
Vulnerable participants include
Pregnant women: The wellbeing of a pregnant woman and her fetus take precedence. The woman also needs to understand all the potential risks to her and her unborn child before even thinking about participating.
Children: Their capacity to understand the process of the clinical trial and all it entails and whether they can give consent. A child’s refusal to participate should always be respected.
People with an Intellectual Disability or Mental Illness: Researchers and medical professionals should be aware that their ability to comprehend all the information and consent to the trial will differ from person-to-person.
Indigenous and Torres Strait Islander Peoples: Researchers must show respect to Indigenous and Torres Strait Islander people by acknowledging relevant issues of research design, ethics, culture and language.
Some participants will be paid for taking part in a clinical trial, however payment is only ethically acceptable if:
- It does not influence a person’s decision to participate in the clinical trial.
- It does not pressure a person to accept the potential risk that is greater than they would normally accept.
- It does not cause a person to conceal information or lie about their eligibility for the research, their contribution to the research or the potential risks linked to participation.
As with every other aspect of the clinical trial, the participants must be informed and kept in the loop when it comes to being reimbursed for their participation. Payment should be overlooked by the HREC (Human Research Ethics Committee) and there should be a clear payment plan put in place so everyone is on the same page and so there are no discrepancies.
Placebos play an important role in the clinical trial process as a control or ‘dummy’ (a sugar pill) that looks and is used in the same way as the medication being tested in the clinical trial. Although there are no known health effects, the use of placebos can still cause some ethical issues:
- Feelings of Deception: Although participants are warned that there will be placebos used in a clinical trial, they aren’t told whether they are taking the placebo or the actual medication so they can get the most effective results. This can cause feelings of deception, distrust and uneasiness in a participant.
- Harmful: More seriously, participants could be harmed by taking placebos instead of the active treatment, which can aggravate their illness or cause them further pain.
It goes without saying that the personal details of every participant must be kept confidential at all times. The NHMRC (The National Health and Medical Research Council) is subject to the Privacy Act, 1988 which sets out privacy guidelines (Information Privacy Principles) that dictate how Australian agencies can collect, use and disclose personal information.
All participants have to be made aware of these privacy guidelines before they can give their consent to take part in the clinical trial.
Clinical trials are always going to be the subject of much debate, however, as long as all the ethical issues are taken into consideration and the researchers and medical professionals work closely with the HREC (Human Research Ethics Committee) and the NHMRC (The National Health and Medical Research Council), they can do a lot more good than harm and are a valuable part of the health and research industry.
“For more information about clinical trials, please visit us at novotech-cro.com