Ethical Considerations in Clinical Research

Researchers have an ethical obligation to provide clinical trial participants with a robust explanation of the trial. This ensures that participants can make an informed choice about their participation.

A principal investigator obtaining consent from a couple before a trial
Clinical trial participants are entitled to a complete understanding of their role in the study before it begins

Table of Contents:

  • Informed Consent Challenges
  • Informed Consent in Pediatric Clinical Trials
  • Informed Consent and Cultural Competency

Medical research is a partnership between investigators and study participants. When individuals volunteer for clinical trials, they are entitled to understand the science behind the trial and what their participation means for themselves and their families.

Researchers need to give study participants a complete picture when they agree to enroll in a study. Before a participant commits to the study, the researchers will explain what they will be expected to do and answer all questions. This process is called informed consent and is one of the most important ethical considerations in clinical research.

All potential trial participants need to fully understand what will happen during the trial before they can give consent. Informed consent isn't just signing a waiver. Researchers will need to talk with participants, answer their questions, and address any concerns they may have.

Certain challenges may complicate getting informed consent, but researchers can anticipate them before they become problems.

  • Language Barriers: The staff running a clinical trial may not speak the same language as the prospective participants. Researchers should have translators available to ensure no miscommunications due to language differences.
  • Participant Expectations: Participants may worry they won't get all the information they want during the trial. They may also have unrealistic expectations about the outcomes of the experiment. Researchers and participants should have honest conversations before the trial begins to manage expectations.
  • Religious Practices: Religious beliefs and practices may not align with clinical trial requirements. Study designers should ensure that the trial doesn't conflict with religious holidays, dietary rules, and beliefs regarding the acceptance of blood products and medical procedures. Participants can help researchers accommodate their religious beliefs by being open about them.
  • Vulnerable People and Groups: Researchers should be careful when enrolling vulnerable people in studies. They should ensure that the rights and well-being of individuals with cognitive disabilities or other special needs are considered when they enroll in clinical trials. Study researchers may ask caregivers for proof of power of attorney or guardianship. This ensures that everyone is acting in the participant's best interest.

Research involving children is important for obtaining accurate data and developing the best therapies for them. However, because children are more vulnerable than adults, they need extra protection. When researchers recruit people under 18 for research studies, all ethical issues in clinical research with adults must also be considered. There are also additional concerns that children and families have to consider when enrolling in a clinical trial.

Under FDA regulations, children in clinical trials receive extra protections. These rules limit the potential risks children can be exposed to unless there's a direct benefit to them. Researchers must also get permission from caregivers and, when suitable, assent from the children themselves.

Parents or guardians can give or withhold consent for minors to participate. However, the adult caregiver isn't the final word on informed consent. Children over 7 may need to assent to participate in trials depending on certain factors. Adults also need to make sure the child doesn't have any misconceptions about the possible results of the trial.

Recruiting healthy children for control groups in studies is another complicated matter. Not all families want to commit their children to a trial with no direct benefit to them. Researchers may rely on clinicians with strong doctor-patient relationships to encourage participation.

Sometimes, researchers have to look for trial participants in multiple locations. They may recruit participants from different countries or minority groups. Sometimes, cultural differences may hinder getting informed consent. Ideally, researchers partner with people from the communities where they hope to recruit participants. Ensuring cultural competence gives the researchers and participants a better understanding of one another before beginning a clinical trial.

Clinical trial participants are critical partners in medical research, so researchers must be committed to upholding ethical standards. Connect with Studypages to learn the latest news in medical research.