The Concept and Process of Informed Consent Federal code states that any research project using human subjects as participants requires the informed consent of those participants. Informed consent is about people’s understanding and willingness to participate in studies. The concept of informed consent is a cornerstone of ethical decision making in clinical and health services research. Informed consent means that potential study participants must understand the nature of the study, as well as the risks and benefits involved, before they make a decision to participate. The details of the study must be presented in simple language by someone who is knowledgeable about both the study and informed consent.
It is important to remember that obtaining study participant consent is a process. This process requires a "consent document" that explains the research and any risks and benefits. Because informed consent is an ongoing process, it starts before any forms are signed and it continues through the completion of the participant’s involvement in the study. The consent document is only the confirmation of the consent process.
Federal Informed Consent Guidelines The federal government has developed a set of guidelines that define some key steps that must be followed in obtaining informed consent from study participants.
Here are some components of those guidelines:
- If consent is to be informed, participants must genuinely understand the study’s purposes and procedures.
- For people to make truly informed decisions about participating in research, they must also have a clear understanding of the possible risks and benefits of study involvement.
- Having the opportunity to discuss any questions or concerns with a knowledgeable research team member is a necessary component of informed consent.
- Prospective participants should be granted the necessary time to think about their decision to participate and, if necessary, to discuss it with family, friends or other advisers before making their decision.
- Consent is an ongoing process; study participants always retain the right to withdraw at any time, for any reason.
Assurances to Study Participants The Health Measurement Research Group offers the following assurances to all those who agree to participate in any of the individual studies covered by this program of research:
- All studies are conducted with the approval and ongoing oversight of the IRBs of the participating academic health centers.
- All of the individual researchers have completed, and been certified in, training in Human Subjects and Health Information Protection, as required by their IRBs.
- Each study has a data security and management plan in place, designed to protect the confidentially, privacy and anonymity of all data related to individual participants.
- All guidelines for obtaining informed consent of study participants will be closely followed.
- All participants will be provided with the names and contact information of people they can call, if they have any questions about the study or about their rights as participants, at any time during or after their involvement in the study.
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