Informed Consent Process
What's Involved
Informed consent is a continual process not a document or piece of paper titled consent form. As a researcher you must understand the concept of respect for persons and the obligation to obtain legally effective informed consent of participants or their legally authorized representatives. It is important that you understand research is voluntary.
Remember that unless informed consent is waived or altered by the IRB you must not involve a human being as a participant in research covered by this policy unless you have obtained the legally effective informed of the participant or the participant legally authorized representative; LAR .
Definition
Legally effective informed consent is defined as informed consent that meets the regulatory criteria for informed consent as well as other criteria required by local jurisdiction.
When
After the prospective participant or the LAR have had sufficient opportunity to consider whether or not to participate and when you have minimized the possibility of coercion or undue influence the researcher may request consent. You must consider the needs of the prospective participant giving them enough time and privacy to read and consider the research and time to discuss it with family or friends.
As a researcher you are responsible for ensuring that informed consent is obtained from each research participant before that participant participates in the research study. In addition, you are ultimately responsible, even when delegating the task of obtaining informed consent to another individual knowledgeable about the research, i.e. co-investigator or coordinator.
You must obtain informed consent prior to all data collection and, unless waived or altered by the IRB, parental consent must be secured before obtaining assent from minors. You must maintain the application and consent documents as instructed by the IRB.
Requirements
The informed consent document must include the following, according to Federal Regulations:
- An explanation of whom to contact for answers to questions about the research and participants rights
- Whom to contact in the event of a research-related injury or other problem to the participant
Unless waived or altered by the IRB the informed consent document should be:
- Documented by the use of a written consent form approved by the IRB
- Signed by the participant or the participants LAR
- A copy should be given to the person signing the form. Note: the federal regulations do not require the copy of the form be given to the subject to be a copy of the document with the participant’s signature, although this is en encouraged. It must; however be a copy of the IRB approved informed consent documents that were given to the subject to obtain consent.
Additional Information
IRB Web site information and sample forms
University Informed Consent Tutorial
Appendix I
Appendix W
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