Sage-Tips

What are some of the risks associated with being a participant in a clinical trial?

Being part of a clinical trial may have risks, but it may also have benefits….What are the Potential Risks of a Clinical Trial?

• The new treatment may cause serious side effects or be uncomfortable.
• The new treatment may not work, or it may not be better than the standard treatment.

Why is informed consent important in clinical trials?

Why Is Informed Consent so Important? Informed consent is a crucial part of enrolling in a clinical trial because it gives the potential participant all the information they need to understand what they are volunteering for. Without informed consent the subjects may not fully understand what they are participating in.

Is it acceptable to obtain informed consent prior to IRB approval?

Yes, in some circumstances. The HHS regulations require that an investigator obtain legally effective informed consent from subjects or a legally authorized representative before the subjects may be involved in research (45 CFR 46.116), unless this requirement has been waived by an IRB.

What requirement must be met to conduct a clinical trial?

All clinical trials have guidelines, called eligibility criteria, about who can participate. The criteria are based on such factors as age, sex, type and stage of disease, previous treatment history, and other medical conditions.

What happens when informed consent is not obtained?

Informed consent is meant to honor your right to decide what’s done with your body. Rules and the law pertaining to this topic have changed over the years, but one thing hasn’t: Failure to obtain informed consent is a crime—medical malpractice, specifically—and the doctor can be charged with negligence and battery.

Why do you think it is important to write a letter of consent when conducting a survey?

It is that important. Informed consent provides participants with sufficiently detailed information on the study so that they can make an informed, voluntary and rational decision to participate.

What type of IRB review does not require approval but does require a determination?

Exempt Research Although the category is called “exempt,” this type of research does require IRB review and the determination of exemption must be made by the IRB. The exempt determination process is much less rigorous than an expedited or full-committee review.

What are the FDA’s informed consent requirements for clinical investigations?

FDA’s informed consent requirements are set forth in FDA’s regulations on Protection of Human Subjects (21 CFR part 50). These regulations apply to clinical investigations regulated by FDA.

What is the consent process for a clinical trial?

The consent process begins with subject recruitment, and it includes advertising used to recruit subjects into the clinical trial. 3 Once a potential subject is identified, a person knowledgeable about the clinical investigation and capable of answering questions raised by the potential subject should conduct a consent interview.

How do I make an informed decision about participating in clinical trials?

To make an informed decision about whether to participate or not in a clinical trial, people need to be informed about: participation being a voluntary decision on their part. This information is provided to potential participants through the informed consent process.

Can a subject be involved in research without informed consent?

21 CFR 50.20 General requirements for informed consent Except as provided in ß50.23, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.