IRB Manual
      4.1 The Informed Consent Process
   

   
The informed consent process is central to the ethical conduct of research involving human subjects and derives from a key ethical principle, "respect for persons". Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.

"An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation. To respect autonomy is to give weight to autonomous persons' considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an autonomous agent is to repudiate that person's considered judgments, to deny an individual the freedom to act on those considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling reasons to do so.

However, not every human being is capable of self-determination. The capacity for self-determination matures during an individual's life, and some individuals lose this capacity wholly or in part because of illness, mental disability or circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated." (see the Belmont Report ).

The person who obtains a prospective subject's consent to participate in a research project must not accept the subject's consent unless it is freely given by an informed subject who has sufficient capacity to consent. This duty remains even when a witness is present or when another person(s) has been authorized to assess the subject's capacity to consent.


  4.1.1 Components of the Informed Consent Process
   
Consideration of the following components of the process should be included in the IRB's initial and ongoing reviews:

 
  (1)   
Who will assess the prospective subject's capacity to consent? Is this person appropriate given the nature of the research and the subject population? For more than minimal risk research it is recommended that a qualified person who is not a member of the research team should conduct an independent assessment of capacity. A member of the participant's treatment team may be the most appropriate person to carry out this function.

 
(2)   
Who will conduct the consent interview and fully explain the research to the prospective subject? Does this person have the appropriate experience and qualifications given the nature of the research and the subject population?

 
(3)   
If the study has been approved for the inclusion of incapable subjects, is the person who will obtain consent aware of the requirements for surrogate consent?

 
(4)   
If a "legally authorized representative" (surrogate) provides consent on behalf of an incapable subject, what provisions have been made to inform the subject about the research and obtain his/her assent and/or lack of objection?

 
(5)   
Does the consent form contain all of the required items? See sections 4.2 and 4.3 below.

 
(6)   
Should a witness or an advocate be present during the consent process?

 
(7)   
Under what conditions will the consent be sought (e.g., where, when, as part of another process such as admission procedure)?

 
(8)   
Does the consent process encourage the consent to be freely given? (Consent is freely given when it is (i) in the absence of coercion or an inappropriate inducement; (ii) the subject is in such a mental, physical and legal state as to be able to fully exercise his power of choice - in the absence of such a state, consent of an authorized representative must be obtained; (iii) with sufficient knowledge and understanding to make an informed decision; (iv) with the knowledge that refusal to participate will in no way influence future health care afforded him; and (v) with the knowledge that he may withdraw from the study at any time without prejudice.)

 
(9)   
Is the consent form written in language that can be understood by the subject? (i.e., the level of comprehension required to understand the form should be compared to the abilities of the subject population.) Consent documents are more understandable if they are written just as the investigator would give an oral presentation to the subject. That is, the subject is addressed as "you" and the investigator as "I/we". This second person writing style also helps to communicate that there is a choice to be made by the prospective subject. Use of the first person (subject is addressed as "I") may be interpreted as a presumption of subject consent and should be avoided.

 
(10)   
Are the subjects going to be paid? How much? Is the amount coercive for the specific subject population? Does the consent form explain how much the subject will be paid if he/she withdraws prior to the completion of the study? In most cases, payment should be pro-rated to ensure that subjects are not coerced into continuing participation.

 
(11)   

The consent process must not include any written or spoken communication whereby the subject (or his/her legally authorized representative) is made to waive or appears to waive any of his/her legal rights or releases or appears to release the Institution (or its agent), the investigator or the sponsor from liability for negligence (exculpatory language).

     
   


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