Informed Consent

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Informed Consent describes a process whereby the potential research volunteer is made aware of the nature and purpose of the research study, the risks and benefits inherent to the study, and the volunteers rights before, during and after participation in the research study. The Informed Consent process consists of conversations, the answering of questions, and the signing of an Informed Consent Form specific to the research study. The purpose of the form is to provide much of the information in written form, and to document that the volunteer has indeed received the information. It is not intended to bind the volunteer to the study.

The Informed Consent process, and consent form, as well as the protocol design and conduct are reviewed by the Institutional Review Board (IRB) whose charge is to protect the rights and safety of research subjects. The Informed Consent process is described in the IRB Policies and Procedures as below:

The Committee will evaluate proposed informed consent/assent documents with regard to the following elements as required by law (21CFR 50.25 and 45 CFR 46.116):

  1. a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, subjects' responsibilities, a description of the procedures to be followed, and identification of any procedures which are experimental;
  2. a description of any reasonably foreseeable risks or discomforts to the subject and the likelihood of those risks, and reversibility of anticipated adverse effects ;
  3. a description of any benefits to the subject or to others which may reasonably be expected from the research. If there is no direct benefit to the subject, this should be stated;
  4. a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  5. a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and the conditions under which other agencies (FDA, auditors, sponsors) may review records;
  6. for research involving more than minimal risk, an explanation as to whether 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;
  7. an explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research related injury to the subject; and
  8. a statement 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.

When appropriate, one or more of the following elements of information shall also be provided to each subject:

  1. a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are 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 orderly termination of participation by the subject;
  5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
  6. the approximate number of subjects involved in the study.

In addition, federal guidelines (GCP Guidelines 4.8.10.e) recommend that there also be a section outlining the Subject's responsibilities.

In obtaining informed consent, the investigators shall [1] give the subject (or representative) sufficient information about the study and how the study may affect the subject, [2] deliver the information in a comprehensible manner, using a language readily understandable by the subject, and [3] assure voluntariness of the participation, by providing sufficient opportunity to consider whether or not to participate, and minimizing the possibility of undue influence or coercion.

In virtually all circumstances, informed consent should be obtained prior to any screening procedures; persons should not be subjected to any risk without having agreed to the ultimate purpose (full protocol consent) of the screening procedures.

The process of obtaining informed consent has two components: [1] Providing the person, who is being recruited to become a subject of research, or that person's legally authorized representative, with the information necessary to give informed consent, and obtaining the consent to participate in the research as a subject. [2] Documentation that informed consent has been obtained. Generally, documentation should include, in addition to the signatures, an enrollment note in the source document as to who obtained consent, how, when, were questions asked and answered, and specifically that a copy of the informed consent was given to the subject. The basic rule of human subject research is that both components of the informed consent process shall be completed. However, in accordance with Federal guidelines, under certain circumstances, the IRB-RU has the authority to waive the requirement for obtaining informed consent (Section ), or for documenting that the consent has been obtained (Section ).

In obtaining the consent, the investigators may not request from the subject any exculpatory statements to suggest that any legal rights are being waived, or the investigator, sponsor or the Rockefeller University is being released from liability for negligence.

The Rockefeller University Institutional Review Board has the authority to observe, or have a third party observe the consent process.