Informed Consent & Assent

In most research activities, the investigator must obtain informed consent from each subject or the subject's legally authorized representative (e.g., parent, guardian or legal representative).  An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. In situations where full disclosure of the purpose of the research is not possible because it could bias the outcome, the investigator has the responsibility to debrief subjects concerning the purpose of the research.

1. Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
2. Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate.
3. No informed consent may include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

 Basic elements of informed consent: 

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, a description of the procedures to be followed, and identification of any procedures that are experimental; 

2. A description of any reasonably foreseeable risks or discomforts to the subject; 

3. A description of any benefits to the subject or to others that may reasonably be expected from the research; 

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; 

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; 

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; and 

9. One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens: 
   1. A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
   2. A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

One or more of the following elements of information, when appropriate, shall also be provided to each subject or the legally authorized representative: 

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) that are currently unforeseeable; 

2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's or the legally authorized representative'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 that may relate to the subject's willingness to continue participation will be provided to the subject; 

6. The approximate number of subjects involved in the study; 

7. A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit; 

8. A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and 

9. For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen). 

General waiver or alteration of consent: 

An IRB may waive the requirement to obtain informed consent for research and may approve a consent procedure that omits some, or alters some or all, of the elements of informed consent. An investigator must complete the appropriate form and submit it to the IRB for approval, if they wish to alter consent, waive the requirement to obtain consent or waive the requirement for a signed consent.   

In order for an IRB to waive or alter consent as described in this subsection, the IRB must find and document that: 

1. The research involves no more than minimal risk to the subjects; 

2. The research could not practicably be carried out without the requested waiver or alteration; 

3. If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format; 

4. The waiver or alteration will not adversely affect the rights and welfare of the subjects; and 

5. Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation. 

The informed consent form may be either of the following: 

1. A written informed consent form that meets the requirements set forth above. The investigator shall give either the subject or the subject's legally authorized representative adequate opportunity to read the informed consent form before it is signed; alternatively, this form may be read to the subject or the subject's legally authorized representative. 

2. A short form written informed consent form stating that the elements of informed consent set forth above have been presented orally to the subject or the subject's legally authorized representative, and that the key information was presented first to the subject, before other information, if any, was provided. The IRB shall approve a written summary of what is to be said to the subject or the legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Only the short form itself is to be signed by the subject or the subject's legally authorized representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the subject's legally authorized representative, in addition to a copy of the short form. 

An IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if it finds any of the following: 

1. That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; 

2. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or 

3. If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained. 

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research. 

Requirements for permission by parents or guardians and for assent by children: 

1. The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived. 

2. The IRB shall determine, in accordance with and to the extent that consent is required, that adequate provisions are made for soliciting the permission of each child's parents or guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research that not involving greater than minimal risk or research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. Where research involves greater than minimal risk and no direct benefit (but likely to yield generalizable knowledge about a subjects disorder or condition); and research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. 

3. In addition to the provisions for waiver contained in above, if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, state or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition. 

Sample Consent Forms: (files are Word documents)

• Sample Consent Form
• Sample Parental Consent Form

Sample Assent: (Word document)

• Sample Assent Form and Script