9. Informed Consent

9 Informed Consent

9.1 Informed Consent Process

9.2 Basic Elements of Informed Consent

9.3 Waiver of Informed Consent

9.4 Documentation of Informed Consent (Signed Consent)

9.5 Waiver of Documentation of Informed Consent (Waiver of Signed Consent)

9.6 Review and Approval of the Informed Consent Form

9.7 Consent and Language Barriers

9.8 Parental Permission and Assent

9.9 Surrogate Consent

9 Informed Consent 

9.1 Informed Consent Process 

No investigator may involve a human being as a subject in research without obtaining the legally effective informed consent of the subject or the subject’s legally authorized representative unless a waiver of consent has been approved by the CUHS in accordance with Section 9.3 of this policy. In general, the CUHS considers individuals who are unable to give consent for their own clinical care to be unable to give consent for research participation. Tools or instruments such as the Mini Mental Exam also may be used to determine capability to consent. 

The consent process must always: 

• provide relevant information in language comprehensible to the prospective subject or representative; 

• provide the prospective subject or representative sufficient opportunity to consider whether or not to participate; and 

• minimize the possibility of coercion or undue influence. 

The CUHS will consider where the consent process will take place and the individual who will be obtaining consent (e.g., the investigator, collaborator, or qualified designee) in determining the appropriateness of the consent process. When the timing, location, or status of the individuals participating in the proposed consent process may impair the potential participant’s understanding of the research, the CUHS will require an alternative process. 

No informed consent, whether oral or written, may 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. 

A person knowledgeable about the consent process and the research to be conducted (i.e., a member of the project’s research team) must obtain the informed consent. 

If someone other than the investigator conducts the interview and obtains consent, the investigator needs to formally delegate this responsibility and the person so delegated must have received appropriate training to perform this activity. 

9.2 Basic Elements of Informed Consent 

Informed consent must be sought from each potential subject or the subject's legally authorized representative, in accordance with, and to the extent required by 45 CFR 46.116. 

The basic elements of informed consent are: 

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 which are experimental; a description of any reasonably foreseeable risks or discomforts to the subject; 

2. a description of any benefits to the subject or to others which may reasonably be expected from the research; 

3. a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; 

4. a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; 

5. for research involving more than minimal risk, an explanation as to the availability of medical treatment in the case of research-related injury, including who will pay for the treatment and whether other financial compensation is available; 

6. 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; 

7. 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; 

8. for FDA-regulated studies, the possibility that the Food and Drug Administration may inspect the records needs to be included in the statement regarding subject confidentiality. 

Additional elements of informed consent to be applied, as appropriate: 

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 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 must be provided to the subject; 

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

9.3 Waiver of Informed Consent 

There are two sets of circumstances in which the CUHS may either approve a consent procedure that does not include, or that alters, some or all of the elements of informed consent set forth above, or may waive the requirement for informed consent entirely. 

In the first circumstance, the CUHS must find and document that: 

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

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 must be provided with additional pertinent information after participation. 

In the second circumstance, the CUHS must find and document that: 

1. the research or demonstration project is to be conducted by or 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 payment for benefits or services under those programs; 

and 

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

9.4 Documentation of Informed Consent (Signed Consent) 

Informed consent must be appropriately documented in accordance with, and to the extent required by, 45 CFR 46.117. 

1. Informed consent is documented by the use of a written consent form approved by the CUHS and signed and dated by the subject and/or the subject's legally authorized representative at the time of consent. 

2. A copy of the signed and dated consent form must be given to the person signing the form. 

3. The consent form may be either of the following: 

a. a written consent document that embodies the elements of informed consent, and that may be read to the subject and/or the subject's legally authorized representative, in which case the subject or representative must be given adequate opportunity to read it before it is signed; or 

b. a short form written consent document stating that the elements of informed consent have been presented orally to the subject and/or the subject's legally authorized representative. 

When this method is used, all of the following must be true: 

1) there must be a witness to the oral presentation; 

2) the CUHS must approve a written summary of what is to be signed by the subject or representative; 

3) the witness must sign both the short form and a copy of the summary; 

4) the person actually obtaining consent must sign a copy of the summary; and 

5) copies of both the short form and the summary must be given to the subject or representative. 

9.5 Waiver of Documentation of Informed Consent (Waiver of Signed Consent) 

The CUHS may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either that: 

1) the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, 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 of the research context. 

When the CUHS considers waiving the requirement to obtain written documentation of the consent process, the CUHS must review a written description of the information that will be provided to subjects. 

In cases in which the documentation requirement is waived, the CUHS will consider whether to require the investigator to provide subjects with a written statement regarding the research. 

9.6 Review and Approval of the Informed Consent Form 

The CUHS is responsible for the review and approval of the informed consent form submitted by the investigator. The wording on the informed consent form must contain all required elements and must meet all other requirements as described in this section. CUHS approval of the wording of the consent must be documented through the use of a certification stamp on each page that indicates the date of the most recent CUHS approval of the document and the expiration date. If the consent form is amended during the protocol approval period, the form must bear the approval date of the amendment rather than the date of the approved protocol. 

When applicable, the CUHS needs to ensure that the required language for a valid authorization to release health information is included in separate HIPAA (Health Insurance Portability and Accountability Act) Authorization form. The CUHS may waive the requirement for an authorization or may alter the form or content of the authorization only in accordance with and as permitted by the HIPAA Privacy Rule (45 CFR 164.508). Such actions and the justification for them must be fully documented in the minutes of the CUHS meeting where the action was taken or reported (if approved by expedited review). 

9.7 Consent and Language Barriers 

Researchers should prepare both English language and translated consent forms for proposals that include non-English-speaking subjects. The CUHS may consult with language experts or require a "back-translation" into English. In such cases, the investigator may be asked to provide documentation to verify the accuracy of the translation and back-translation. 

If a non-English-speaking subject is enrolled unexpectedly, the subject cannot be enrolled until the CUHS has reviewed and approved the consent process and the process for documentation of consent. 

In studies where written consent is indicated, and a potential subject understands English but does not read or write English, an impartial witness should document that the subject understands the research and the consent process and has consented to participate. 

9.8 Parental Permission and Assent 

See Section 10.1 for policies on parental permission and assent in research involving children. 

9.9 Surrogate Consent 

See Section 10.4 for policies on permission and assent in research involving adults with impaired decision-making capacity.