Investigators’ Role in Obtaining Informed Consent

As an investigator of a clinical trial, you must share with the participants the purpose, procedures, and risks and benefits of the trial and obtain their consent before involving them in the trial. Watch this video to understand your role in obtaining informed consent.

The Proposed Clinical Trial

An HIV drug trial has been proposed in two large cities in the Philippines. Know more about the trial and understand your role in this trial.

  • BFV Pharmaceuticals has proposed an HIV drug trial for brothel-based sex workers in two large cities in the Philippines.

  • The company's R&D team has taken permission to conduct the trial from the brothel managers. Many women working in their brothels will be a part of the proposed trial.

  • During the trial, the R&D team at BFV Pharmaceuticals will collect blood samples from the trial participants.

  • The team will also assign a unique personal identification number to each participant's blood sample.

  • The participants who are HIV positive per the results of the blood tests will receive free treatment as well as a gift from BFV Pharmaceuticals for contributing to the clinical trial.

  • Assume that you are the principal investigator of this trial. As the investigator, you need to make some important decisions.

  • Each decision may carry a certain level of risk such as low, medium, or high.

  • Remember, you need to make decisions that pose no risk. To do so, you need to apply the knowledge you have gained so far and address some issues. Good luck!

Issues in the Proposed Trial

You have to deal with critical issues. Understand the issues in this video and make decisions on the next screens to address them.

Addressing the Issues: Make a Decision

You learned about the issues in your clinical trial. What is the first step you will take to address the issues?

Select the correct answer.

Rely on the due diligence of your team and their knowledge of the participants since the situation is complex and continue the trial process per your original plan.

Retrain the team on the informed consent process and revise the consent forms to make them easier to understand.

Document the issue that the supervisor has informed you about and continue the trial process per your original plan.

Provide limited information on the informed consent form so that your team won't paraphrase it and ask them to obtain participant signatures on the forms.

The team has been retrained and the consent form has been revised. What will you do next to carry out the informed consent process ethically?

Select the correct answer.

Provide a copy of the updated informed consent form to the participants and proceed with the trial.

Request the participants to read and sign the new informed consent form before the trial begins.

Share detailed information about the trial with the participants and obtain signed informed consent again.

Persuade the participants to sign the new informed consent form since it has detailed information now.

 
NO
LOW
MEDIUM
HIGH
RISK

Feedback

That's not right! This decision involves MEDIUM RISK.

You are responsible for ensuring that the trial participants have a complete understanding of the purpose, procedures, and benefits and risks of the trial, regardless of the complexity of the trial or the competency of the participants. Relying on your team's knowledge and continuing the trial will be unethical.

You got it! This decision involves NO RISK.

You are responsible for ensuring that the trial participants have a complete understanding of the purpose, procedures, and benefits and risks of the trial. Therefore, you must retrain your team to ensure that they understand the correct and ethical way of obtaining informed consent. You must also revise the informed consent form to ensure that the participants understand the information.

That's not right! This decision involves HIGH RISK.

You are responsible for ensuring that the trial participants have a complete understanding of the purpose, procedures, and benefits and risks of the trial. Simply documenting the issue that the supervisor has reported and ignoring the problem would be unethical, unprofessional, and detrimental.

That's not right! This decision involves LOW RISK.

You are responsible for ensuring that the trial participants have a complete understanding of the purpose, procedures, and benefits and risks of the trial. Providing limited information on the form is unethical and illegal.

Feedback

That's not right! This decision involves MEDIUM RISK.

Simply handing over the updated informed consent form to the participants would not be enough. Investigators must share detailed information about the trial. The participants must read, understand, and then sign the updated form. Further, proceeding with the trial without obtaining informed consent will be unethical.

You got it! This decision involves NO RISK.

To carry out the informed consent process ethically, the R&D team should first share detailed information about the trial with the participants and ensure that the participants have a complete understanding of the purpose, procedures, and benefits and risks of the trial. Then the team should obtain the signed informed consent from the participants.

That's not right! This decision involves HIGH RISK.

The participants should have a complete understanding of the purpose, procedures, and benefits and risks of the trial and clarify any doubts they may have before signing the updated informed consent form. Convincing the participants to sign the updated form without explaining the changes is unethical.

That's not right! This decision involves LOW RISK.

It is a fair decision to encourage the participants to read and sign the updated informed consent form before the trial begins. However, this approach is incomplete. Before getting the updated form signed, the R&D team should share the details about the trial with the participants.

Points to Remember

Share information about the trial with participants.

Ensure that the participants have a complete understanding of the purpose, procedures, and benefits and risks of the trial.

Obtain signed informed consent from the participants.