Clayton State University IRB

Section 7.3 Informed Consent

Proposals for research on human subjects must demonstrate that prospective participants will be apprised fully and in advance of the nature of the research in which they are being asked to participate as subjects. Prospective subjects are considered to be autonomous agents and are assured that they may choose voluntarily to participate or not to participate in research and, further, that they have the right to terminate participation in a study at any time without penalty of any type.

Proposals for research on human subjects must include a copy of the Informed Consent Form to be used in the research. Such a form must be worded at a level of understanding appropriate to the prospective subject. Furthermore, the form may not include a statement or statements which waive or which appear to waive a prospective subject’s legal rights, including release of the University or its agents from liability for negligence. An Informed Consent form must contain the following:

  1. the heading Informed Consent Form;
  2. an explanation of the duration of the project, procedures to be followed and their purposes, including identification of any procedures which are experimental;
  3. evidence that the subject will be able to exercise free power of choice to participate or not to participate as well as to withdraw consent and to discontinue participation in research at any time without prejudice and that no element of coercion or constraint will be used in obtaining consent to participate;
  4. a description of any attendant discomforts and risks that may be reasonably expected as a result of participation in the research;
  5. a description of any benefits that may be reasonably expected to accrue from participation in the research;
  6. a statement pertaining to the security and, hence, the confidentiality of information associated with the research, especially as it relates to specific individuals;
  7. a statement on the availability of compensation in the event of physical injury and how to obtain more information;
  8. an offer to answer any inquiries concerning the research procedures, including a telephone number and address of a contact person;
  9. a place for the subject (or guardian, in the case of minor) to sign and date the form.