IRB Manual
      4.6 Documentation of Informed Consent (All Facilities/Agencies)
   
Research investigators are responsible for ensuring that informed consent is documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative, unless this requirement is specifically waived by the IRB. A copy of the consent form must be given to each person who signs it. It is recommended that IRBs stamp each approved consent form, and include the date that is was approved, or the date on which the approval will expire (one year maximum), to allow monitors to verify that the approved forms are being used.

Documentation of consent may consist of either:
 
(1)   
A written consent form which includes the items listed in Section 4.2 and 4.3. If the form is read to the subject or his/her legally authorized representative, the person signing it must be given an adequate opportunity to read the form before signing it. Note: A statement on the consent form that the risks, benefits and procedures have been explained is not sufficient unless the short form procedure (as described below) is followed.

or
 
(2)   
A "short form" stating that the required elements of informed consent have been presented orally to the subject or his/her legally authorized representative. When a "short form" is used, the following conditions must also be met:
    (a) a witness is present at the oral presentation;
(b) the short form is signed by the subject or his/her representative;
(c) the witness signs the short form and a copy of the written summary of the oral presentation;
(d) the person obtaining the consent signs a copy of the summary;
(e) a copy of the short form and the summary is given to the subject or his/her representative;
(f) the written summary receives the prior approval of the IRB.

   
The "short form" may be used for any research project which requires subject consent. It is particularly useful for subjects who have poor reading skills. Questions have arisen about the length of time that a consent form is valid. The following guidelines should be followed:

 
(1)   
A new consent document should be signed whenever substantive changes, which may affect the subjects' involvement or their willingness to participate, are made to the research. A full explanation of the changes must be provided and the subject must be reminded of his/her right to refuse to participate or to withdraw from the study.

 
(2)   
When significant periods of time elapse between research interventions eg. if an investigator is conducting yearly follow-ups of a group of subjects, the original consent form should be re-signed to indicate continued willingness to participate, or a new consent document should be signed.

 
(3)   
During ongoing studies, a dialogue with the subjects should be maintained and a verbal consent process (i.e.,. supply of information and indication of willingness to continue participation) should continue over the entire study period.


4.6.1 Waivers or Alterations of Informed Consent Components
    (NOTE: This section does not apply to any studies involving FDA regulated articles, i.e. investigational drugs or devices.)
     
    Waiver of Documentation
   
The IRB must record decisions to waive documentation of some or all elements of the consent form in written minutes or in a separate approval. Such decisions are not to be taken lightly. The IRB may waive the requirement that a research investigator obtain a signed consent form, for some, or all subjects, if the IRB determines 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 must be asked whether he/she wants to sign a consent form. The subjects decision must be followed;
    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 documentation requirement is waived, the IRB may require the research investigator to provide subjects with a written statement regarding the research. A waiver of documentation does not waive any of the required elements of consent.

NOTE: The FDA does not provide that an IRB may waive the requirement for signed consent when the principal risk is a breach of confidentiality because FDA does not regulate studies which fall within this category.

    Waiver or Alteration of Consent
    The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent or waives the requirement to obtain informed consent, provided that the IRB finds and documents 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: (i) Programs under the Social Security Act, or other public benefit or service programs; (ii) procedures for obtaining benefits and procedures under those programs: (iii) possible changes in or alternatives to those programs or procedures: or (iv) possible changes in methods or levels of payment for benefits or services under those programs;

And


    and

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

The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent or waive the requirements to obtain informed consent providing the IRB finds and documents 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 will be provided with additional pertinent information after participation.


    A waiver of consent requires the completion and IRB approval of  the form: Request for HIPAA Waiver or Authorization and/or Waiver of Consent under 45 CFR 46.116(d). 

   
4.6.2 Deception and/or Incomplete Disclosure
    NOTE: This section does not apply to studies involving FDA regulated articles, i.e. investigational drugs or devices)

If the investigator cannot fully disclose the purpose, nature, expected outcome, and implications of the research to the subjects before it begins, the investigator must clearly and rigorously justify to the IRB that such disclosure is inadvisable and that failure to give full disclosure is not detrimental to the subjects. Under such conditions, disclosure may be deferred until the subject's participation or the research project is completed. Any incomplete or deferred disclosure must be approved under the regulations regarding waiver of elements of informed consent (see section 4.6.1 of this manual).
         
   


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