J. Informed Consent

Unless specifically authorized by the IRB as stated below, no investigator may involve a human being as a subject in research covered by the HHS regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative (46.116). Investigators are responsible for making sure that informed consent is documented by using a written consent form approved by the IRB.

1. Criteria for Informed Consent

   Informed consent refers to the voluntary choice of an individual to participate in research based on an accurate and complete understanding of, among other things, its purposes, procedures, risks, benefits, alternatives, and any other factors that may affect a person's decision to participate. Legally effective informed consent shall (46.116):

   1. Be obtained from the subject or the subject’s legally authorized representative.
   2. Be in language understandable to the subject or representative and written at a level appropriate to the understanding of the subjects to be enrolled; technical language and "first person" statements that ask subjects to make statements that they are not in a position to verify should be avoided.
   3. Be obtained under circumstances that offer the subject or the representative sufficient opportunity to consider whether the subject should participate
   4. Not include exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the research investigator, the sponsor, the institution or its agents from liability for negligence

   At a minimum, informed consent shall provide the following information (46.116a):

   1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of participation, and a description of the procedures to be followed
   2. Any reasonably foreseeable risks or discomforts to the subject
   3. Any benefits to the subject or to others which may be reasonably expected from the research
   4. A disclosure of appropriate alternate procedures of courses of treatment, if any, that might be beneficial to the subject
   5. The means by which confidentiality of records identifying the subject will be maintained
   6. A statement explaining how and with whom the results of the study will be shared
   7. For research involving more than minimal risk, an explanation of any compensation and an explanation as to whether any medical treatments are available if injury occurs and if so what they consist of, or where further information may be obtained
   8. Contact information for the investigator and for the IRB chair should subjects have questions regarding their rights as participants, and contact information in the event of a research related injury.
   9. A statement explaining that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled

   Certain projects, if requested to do so by the IRB, can and may require additional statements of informed consent (46.116b), including

   1. A statement that the treatment or procedure may involve risk to the subject (or to an embryo or fetus, if the subject is or may become pregnant) which is currently unforeseeable
   2. Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent
   3. Any additional costs to the subject that may result from participation in the research
   4. The consequences of a subject’s decision to withdraw from the research and procedures for termination of participation
   5. A statement that new findings obtained during the research may relate to the subject’s willingness to continue participation and
   6. The number of subjects involved in the study

   Documentation of informed consent may be either (46.117b):

   1. Written: a written consent document that contains all elements of informed consent as described above. This form may be read by or to the subject or the subject’s legally authorized representative, and the investigator should give either the subject or the representative adequate opportunity to read it before it is signed, OR
   2. Oral Short form: a short form document, acknowledging that the elements of informed consent as described above were presented orally to the subject or the subject’s legally authorized representative. When this method is used, there shall be a witness to the IRB‐approved oral presentation of the informed consent (need form for oral summary of informed consent), who will sign both the short form, which will be signed by the subject or the representative, and a copy of the oral presentation. A copy of the oral presentation and a copy of the short form shall be given to the subject or representative.
2. Waivers of Informed Consent

   The IRB may waive or alter the requirement for a signed consent form for some or all subjects if it finds either (46.117c):

   1. The consent document is the only record linking the subject with the research and the principal risk would be potential harm resulting from a breach of confidentiality (e.g. studies on potentially sensitive topics such as illegal drug use, other illegal conduct or sexual behavior). In this case, each subject will be asked if they want documentation to remain with them or with the research records, and the subject's wishes will govern OR
   2. The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research setting

   The IRB may approve a consent procedure that does not include or alters some or all of the elements above, or waive or alter the requirement for the investigator to obtain informed consent if (46.116c)

   1. The research or demonstration project is to be conducted by, or is subject to the approval of state or local government officials and is designed to study, evaluate or otherwise examine a) public benefit or service programs, b) procedures for obtaining benefits or services under those programs, c) possible changes in or alternatives to those programs or procedures, or d) possible changes in methods or levels of services under those programs AND
   2. The research could not practicably be carried out without the waiver

   OR (46.116d; all four conditions must be met)

   1. The research involves no more than minimal risk
   2. The waiver or alteration will not adversely affect the rights and welfare of the subjects
   3. The research could not practicably be carried out without the waiver or alteration AND
   4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation