Informed Consent

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Informed Consent
Presented by Annette Anderson VA Central IRB
Administrator
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Informed Consent is a Process

• Not a piece of paper or moment in time
• Is an educational process between investigator
  and prospective subject
• Document is only a record of what was suppose to
  have been communicated and is not proof of what
  subjects actually understood
• Reflects basic principle of respect for persons

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Informed Consent Process Requirements

• Process can only take place when
• Sufficient opportunity for subject to consider
  whether or not to participate is provided
• The possibility of coercion or undue influence is
  minimized
• Information is provided in language
  understandable to the subject
• Does not include any exculpatory language
• VA Form 10-1086 is used as consent form and all
  required elements completed

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Basic Required Elements

• Name of study and Principal Investigator
• Statement study involves research and purpose of
  research
• Expected duration of subjects participation
• Description of procedures to be followed
• Identification of experimental procedures
• Description of reasonably foreseeable
  risks/discomforts
• Description of benefits to subject or others that
  may reasonably be expected
• Disclosure of appropriate alternative procedures
  or treatments if any

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Basic Required Elements

• Statement describing the extent to which
  confidentiality of records identifying subject
  will be maintained (statement that other federal
  agencies may have access such as FDA, OHRP, and
  GAO)
• More than minimal risk must include an
  explanation of whether any compensation or
  medical treatments are available if injury
  occurs, what the compensation or treatments
  consist of, where further information is
  available, and whom to contact (VA must provide
  necessary medical treatment in a project approved
  by a VA RD Committee and conducted under
  supervision of VA employees and informed consent
  must contain language explaining VAs authority
  to provide such treatment)

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Basic Required Elements

• Statement that participation is voluntary
  refusal to participate involves no penalty or
  loss of benefits and subject may discontinue at
  any time without penalty or loss of benefits
• Statement that a veteran subject will not be
  required to pay for care received as a subject in
  a VA project except, if normally required to pay
  co-payments, subject will continue to pay them
  for medical care and services provided by VA that
  are not part of the study

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Additional Elements When Appropriate

• Statement that treatment or procedure may involve
  currently unforeseeable risks to subject, embryo,
  or fetus if subject is or may become pregnant
• Anticipated circumstances subjects participation
  may be terminated by investigator without regard
  to subjects consent
• Any additional costs to the subject that may
  result from participation in the research
  (consistent with federal laws concerning
  veterans eligibility for medical care and
  treatment)
• Consequences of subjects decision to withdraw
  from study and procedures for orderly termination
  of participation

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Additional Elements When Appropriate

• Statement that significant new findings developed
  during the course of the research which may
  relate to subjects willingness to continue
  participation will be provided to subject
• Approximate number of subjects involved in the
  study
• Statement regarding any payment subject is to
  receive and how it will be made

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Additional Elements When Appropriate

• Current VA policy and VHA regulations must be
  followed in the event that investigators believe
  human biologic specimens obtained as a part of
  the research project could
• Be part of or lead to the development of a
  commercially valuable product
• Specimens are to be retained at the end of a
  study

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VA Required Elements if Collecting Biologic
Specimens

• Informed consent will contain all required
  elements, additional elements if appropriate and
• Type of specimens to be stored and location of
  biorepository or tissue bank
• Whether specimen will be used for future research
  and allowing participant choice on how specimen
  will be used
• Length of time specimen will be stored
• When and under what conditions research results
  will be conveyed to participant and/or
  participants family and physician
• Whether participant will be re-contacted after
  original project is completed
• If feasible, provision allowing participant to
  request specimen and all links to the clinical
  data to be destroyed

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Waiver or Alteration of Informed Consent Process

• Waiver or alteration may be requested if
• Study does not utilize an FDA-regulated product
  or device and is
• Conducted by or subject to approval by state or
  local government and is designed to study,
  evaluate or examine on or more of the following
• Public benefit or service programs
• Procedures for obtaining benefits or services
• Possible changes or alternatives to those
  programs or procedures
• possible changes in methods or levels of payment
  for benefits or services Or
• Research could not be practicably carried out
  without the waiver or alteration

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Waiver or Alteration of Informed Consent Process

• An IRB may approve a request for waiver or
  alteration if it finds and documents that
• Research involves no more than minimal tangible
  or intangible risk
• Waiver or alteration will not adversely affect
  the rights and welfare of the subjects
• Research could not be practicably be carried out
  without the waiver or alteration
• Whenever appropriate, subjects must be provided
  with additional pertinent information after
  participation
• Waiver request required if investigator plans to
  access PHI for recruitment

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Documentation of Written Informed Consent

• Written consent form approved by the IRB and
  signed and dated by
• Subject or subjects Legally Authorized
  Representative (LAR)
• A witness whose role is to witness the signature
• Person obtaining the informed consent
• Original form filed in subjects case history
• Copy provided to subject or LAR
• IRB approval by stamp or pre-printed box on form
  and maintains copy of approved form

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Waiver of Requirement for Documentation of
Informed Consent

• IRB may waive requirement for documentation of
  the informed consent if
• Only record linking subject and research would be
  consent document and the principal risk is
  potential harm resulting from breach of
  confidentiality each subject must be asked
  whether the subject wants documentation and the
  subjects wishes govern
• Research no more than minimal risk and involves
  no procedures for which written consent is not
  normally required outside of the research context
• IRB must document reason for granting waiver and
  may require investigator to provide subjects a
  written statement regarding the research

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Surrogate (Legally-Authorized Representative)
Consent

• May be requested and accepted only when the
  prospective participant is incompetent or has an
  impaired decisionmaking capacity as determined
  and documented in the persons medical record in
  a signed and dated progress note
• If feasible, research must also be explained to
  prospective subject even when surrogate gives
  consent
• Under no circumstances may a subject be forced or
  coerced to participate

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Additional VA Requirements

• Progress note documenting informed consent
  process must be placed in subjects medical
  record including
• Name of study and person obtaining consent
• Statement that subject or LAR was capable of
  understanding consent process
• Statement that study was explained to subject and
  subject was given opportunity to ask questions
• Entry placed in progress note when subject
  entered into study and when subjects
  participation is terminated (can be combined)

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Additional VA Requirements

• Informed consent must include information on
  where and how the subject can verify the validity
  of the study
• The informed consent process must include
  provisions for advising subjects to review the
  risks of usual care with their health care
  providers

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Resources

• OHRP Website Guidance Topics Informed Consent
• OHRP IRB Guidebook, Chapter III, Section B
• VHA Handbook 1200.5, particularly appendix C
• 38 CFR 16 and 21 CFR 50.25
• Development of Written Informed Consent Templates
• Reviewer checklists
• Forms for requesting waiver or alteration of
  informed consent process

http//www.hhs.gov/ohrp/policy
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QUESTIONS