Is informed consent required even if the data/specimens will be collected from my friends and colleagues?
Who can consent on behalf of a subject for participation in a research study?
Does "Waiver of Informed Consent" or "Waiver of Documentation of Consent" mean that I don't have to get consent from the participant?
Yes. All research involving interaction with human subjects (including collection of specimens) requires informed consent regardless of who the subjects are. In some cases, written informed consent may be waived.
If an adult subject is unable to consent on his/her own behalf due to medical incapacity, the subject's legally authorized representative (a court appointed conservator or guardian, an attorney-in-fact pursuant to a durable power of attorney) may consent on his/her behalf. Family members (also called "next-of-kin") who do not meet the definition of legally authorized representative may not provide consent for a related adult to be enrolled in research. If there is no legally authorized representative, and the adult subject cannot consent, the subject may not become a human subject in an experiment unless the federal requirements for waiver of consent have been met. If a minor is unable to consent on his/her own behalf due to medical incapacity, a parent or legal guardian may provide consent for research. (Note: under normal circumstances, enrollment of minors as subjects requires consent by the parent or legal guardian as well as assent by the minor.)
A waiver of documentation of consent means that a subject's physical signature on the informed consent form is not required. However, you must always get consent from your participants and you must always provide them with enough information about your study so that they can make an informed decision as to whether or not they wish to participate. You can get verbal consent from your participants, but you have to mention this in your research proposal. In cases where a waiver of documentation of informed consent is granted cover letters are typically used to inform subjects. The cover letter is given to the subject (either physically, displayed on a website in HTML, or sent in the mail) but is not signed. A waiver of informed consent means that
- the research involves no more than minimal risk to subjects;
- the waiver will not adversely affect the rights or welfare of subjects;
- the research could not practically be carried out without the waiver;
- whenever appropriate the subjects will be provided with additional pertinent information after participation. Waivers of informed consent are usually granted for retrospective data analysis. For more information on how you may qualify for either of these waivers, please see 45 CFR 46.116 and 45 CFR 46.117.
We prefer that you do not use students from your own class because it is difficult to avoid giving the perception to your students that they have an obligation to participate. In other words, there is a potential for a conflict of interest. However, it can be done if recruitment is done in such a way that there is no hint of undue influence. The students shouldn't be made to feel pressured to participate, and if they refuse, their refusal shouldn't influence their grades for the course. Alternatives to research participation should be used in the consent form.
I want to amend my study to compensate subjects. Do I need to reimburse subjects which have already participated?
The choice is yours. You may go back and "retrospectively" compensate subjects for their participation or you may begin to once the amendment is approved.