People usually become aware of the opportunity to participate in a clinical study through a variety of means, including:
You don’t have to be sick to join a clinical research study—Many studies include people who have and who don’t have a certain condition.
People volunteer to enroll in clinical research. Those who volunteer have the opportunity to have the potential risks, benefits, alternatives, and responsibilities of the clinical research explained to them before they agree to participate, except in rare circumstances involving emergency procedures in immediate life-threatening situations.
A clinical research volunteer may receive some form of compensation for time and expenses, but not all clinical research offers compensation. Clinical research volunteers are sometimes referred to as study or research participants or study subjects.
When potential participants decide that they are interested in taking part in a study, they begin discussions with various members of the scientific community who are also involved in the study. Once potential participants understand what it means to be in the study and what the possible risks and benefits are, they indicate their willingness to participate by communicating their agreement and signing a document saying they agree to take part. This process is called giving consent.
For children or others who are not legally able to provide consent, a parent or legal guardian provides permission for the person to participate. Even though a person may not be legally able to provide consent, they are still informed about the clinical research to the degree that they are able to understand. They may also have the opportunity to provide their agreement to participate in an alternative way that includes the process of assent.
Federally funded clinical research has many safeguards in place to protect those who volunteer to take part.
For study participants, especially those with complex illnesses, “protected” does not mean “risk-free”—all studies carry some risk. Some of the principles that protect study participants include the following: study organizers identify risks, they inform potential study participants of the risks, and they formalize a risk-management plan.
Some of the protections for study participants include (but are not limited to):
Please note that:
When a study ends, the data collected are then reviewed for completeness. When the dataset is considered “complete,” it is then electronically stored or archived. Any papers and documents related to the study are also archived. The archive is locked, and no one can change the data or accompanying information. Access to the archive is restricted. The specific details of the archive (such as who has access, how long it is maintained, etc.) depends on the policies of the study sponsor.
Researchers who manage NICHD-funded clinical trials analyze results and publish the findings in a timely manner so that scientists, health care providers, policy makers, and others can discuss the public health impact of any study and can consider these impacts in future scientific or policy efforts.
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