Common Audit Findings: Consent Forms

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Common Audit Findings Consent Forms

• Jessica Randall, M.A.
• Compliance Coordinator
• Institutional Review Board (IRB)

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Barriersfrom a Coordinators Perspective

• Little to no training- thrown into the fire,
  afraid to ask supervisor or Principal
  Investigator (PI) questions
• Few/No meetings, little communication
• Pressure to enroll quickly, may lead to
  skimming over consent form.
• Example A page was reported missing in the
  consent form. This shows whichever
  co-investigator is consenting is not reading the
  consent form thoroughly with subject.

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More Barriers

• At a follow-up point subjects may not remember
  you or the study, little or no connection
  established.
• You may be afraid to go into too much
  detail/explanation for fear the potential subject
  may become disinterested in participating
  (however this may lead to another problem a high
  drop-out rate)
• Things are done differently from one PI to
  another, one institution to another, one country
  to another

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Plus we are all human and make mistakes
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Common Audit Findings in Consent Forms

• Consistency, Consistency, Consistency!
• Several Consents/Assents? Make sure to carry over
  all tests/procedures, definitions, time frames
  from one consent to another and lower the reading
  level as necessary
• Always work off of the first consent form your
  write-
• (the telephone game- things get changed)
• Misspellings/Missing words
• Are you going through the consent process
  thoroughly?
• Font is too small
• Dont SQUEEZE everything onto one page
• Language level is too high above an 8th grade
  reading level

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Common Audit Findings in Consent Forms Solutions

• HIPAA language or vague future research
  language is in the consent form
• i.e. Your samples will be saved for future
  research or talk of your authorization in the
  IRB consent form.
• Seek consult from the HIPAA Privacy Coordinator
  (Tina Calia, HIPAA Privacy Coordinator,
  tmc2002_at_med.cornell.edu OR 212-821-0629)
• Little to no documentation about consenting in
  the file
• i.e. time, date, questions answered, anything
  noteworthy that occurs, was a copy given to the
  subject?
• There is a poor flow to the consent form
• Ask yourself in reading the consent form would
  you yourself sign up for this study?

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Common Audit Findings

• Compensation is not accurate
• Example the consent form says 10 but you are
  giving 20
• Unanticipated travel costs
• Cost of living increases over time
• The words research study must appear in the
  consent form
• Not the words project or study
• Never cross out on a consent form- even in a good
  faith effort.
• Submit a revision

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• Is what the consent form says actually what is
  taking place?
• If the answer is NO it is time to revisit your
  consent and protocol and submit an amendment to
  the IRB
• When do co-investigators need to re-consent
  subjects?
• i.e. major amendments, time between sessions
• How long must you retain a hard copy of the
  consent form?
• In most cases 6 years is sufficient, but 7 years
  will be the standard soon
• Who keeps the original signed consent form?
• You do! The subject gets a copy.

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Where? What? When? Why?

• The IRB has a consent form template on the IRB
  web site at
• http//www.med.cornell.edu/research/for_pol/
  ins_rev_boa.html
• In your packet are 2 excerpts from the reference
  book
• Good Clinical Practice A Question Answer
  Guide May 2006
• Always download the latest template version as
  it is updated on a regular basis.
• As of 2/07, the most recent version to use is
  9/06
• As always, allow enough time for all revisions
  (expedited or full board) to be reviewed and
  approved by the IRB.

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Contact Me!

• Jessica Randall, M.A.
• Compliance Coordinator
• Institutional Review Board
• jar2023_at_med.cornell.edu
• 212-821-0672