CREATING AN INFORMED CONSENT DOCUMENT

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CREATING AN INFORMED CONSENT DOCUMENT

• Prepared by the CCNY IRB Administrator for
  Researchers and Students

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Components of the Consent Form

• This presentation outlines step by step, the
  basic components for creating a consent form,
  what pitfalls to avoid, as well as other
  considerations.
• Because research projects can be fundamentally
  unique, the information in this presentation
  should serve as a guide on the basic elements of
  the consent form.

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Informed Consent-Title and Name

• A title line beginning the word consent
  followed by to participate in project
  title--example consent to participate in A
  study on the effects of sleep on memory
• Name--project director, investigator or faculty
  advisor and/or
• Research investigator who may be a student
  working under a project director

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Introduction--Voluntary Participation

• Introductory paragraph
• You are being asked to participate in a research
  projectparticipation is voluntary
• Voluntary participation
• Make clear that participation in the study is
  voluntary, and that refusal to participate in the
  study shall not result in any penalty or loss of
  benefits to which the participant is otherwise
  entitled

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Nature and Purpose

• Nature and purpose of the project
• Include relevant information on similar studies
  previously conducted
• Should be described in lay terms
• Eighth grade reading level
• Brief
• Break down complicated jargon or acronyms like
  randomization , control group or EEG

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Research ProceduresConcise Yet Informative

• Explanation of procedures
• Give enough information but do not include
  technical confusing details that may confuse
  subject
• Identify and explain any procedures which are
  experimental
• Estimated length of time that subject will be
  involved
• Approximate number of subjects who will be
  involved in the study

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RisksFrom the Volunteers Point of View Not
Yours!

• Risks
• Provide a description of any foreseeable risks or
  discomforts to the subject, including financial
  risks and the likelihood of fairly low
  probability risk
• If risks are more than minimal, then provide an
  explanation as to whether any compensation and an
  explanation as to whether any medical treatments
  are available if injury occurs
• Coercion or undue influence
• Ensure that that the possibility of coercion or
  undue influence is minimized

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Benefits and Confidentiality

• Benefits
• Provide a description of any benefits. These are
  not limited to individual benefits but may
  include benefits to the particular group or
  community that the individual is related to
• Payment is not a benefit
• Confidentiality describe how the confidentiality
  of the subjects will be protected
• Include an explanation of where records with
  identifying information, if any, will be stored,
  and who will have access to them, ensuring that
  confidentiality will be safeguarded

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Confidentiality

• More on confidentiality
• If the study is anonymous, describe how data
  from questionnaires or surveys, or other data
  collection instrument, will not link to subjects
  identifying information. Discuss keeping the
  consent form independent from anonymous data so
  as to ensure no linkage.
• If the data collected includes personal and
  sensitive information, explain how data will be
  stripped of names, coded, and who will have
  access to the codes linking the data.
• What will happen to the data once the study has
  been completed?

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Other Considerations Posing Risks

• Costs/reimbursements
• Costs can and do pose risks
• Reimbursements are not to be confused with
  benefits
• Alternatives to participation
• If research provides subjects with medical or
  mental health treatment, provide alternatives in
  case the subject decides to withdraw, or make
  clear that alternatives will be provided

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Wrapping It UpNot So Fast!

• Termination of participation
• Describe the circumstances under which the
  subjects participation may be terminated
• Withdrawal from project
• Describe consequences resulting from a subjects
  withdrawal from research
• Who to call if you have questionsinclude the IRB
  administrator

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Final and Critical Elements

• What signing the consent form means
• There must be no exculpatory language
• Subjects must be given a reasonable amount of
  time to read and sign the consent form
• Signature blocks and dates
• Participant (printed and signed name) --for
  children, parent or legal guardian instead of
  participant
• Research/study investigator (printed and signed
  name)

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Children in Research

• Willingness to participate
• Children must indicate willingness to participate
  by assenting to the study 
• Assent
• A child's affirmative agreement to participate in
  research 
• Failure to object may not be construed as
  assentthis is a legal constraint 

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Common Errors and Oversights

• Enhance the readability and clarity of the
  introduction section in your consent form
• Do not use first person voice but write the
  entire document in the second person
• Information reflects protocol accurately
• The protocol is your blueprint
• Do not include information that has no direct
  bearing on the study. For example, information
  such as directions on how to get to the location
  where the participant should go, should be on a
  separate sheet

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Common Errors and Oversights

• Remember to disclose information about the
  agency funding the study
• The title of the document should only say consent
  with the title of your study and not the word
  "informed