Title Slide

1
Research Ethics / IRB Part IV IRB (cont.)
Informed Consent Eric D. Zemper, Ph.D.
Statewide Campus System Michigan State
University College of Osteopathic
Medicine Department of Physical Medicine
Rehabilitation University of Michigan
2
IRB

• How Can I Get My IRB Application Through
  Smoothly?
• Pay attention to details (make sure all
  necessary
• information is contained in the
  application).
• Make sure the application is consistent
  throughout.
• Make sure all elements of the application have
• been included.

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IRB

• Another Hint
• Accurately Assess the Risk Level of Your Project
• No more than minimal risk routine physical or
  
• psychological evaluation
• Minor increase over minimal risk
• Moderate risk
• High risk

4
IRB
A central UM source for information about IRB,
informed consent, HIPAA, form templates, FAQs,
classes/workshops about all of the above,
etc. http//www.med.umich.edu/irbmed The HIPAA
information site is http//www.med.umich.edu/u/hi
paa/ http//www.med.umich.edu/irbmed/hipaa/npp_off
icial.htm (HIPAA Health Insurance Portability
and Accountability Act)
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IRB

• Elements of Informed Consent
• The participant must be given the following info
• Nature of the research project
• Procedures of the study
• Risks and benefits, alternatives to
  participation
• Procedures to maintain confidentiality

6
IRB

• Elements of Informed Consent
• The participant must be given the following info
• Assurances that participation is voluntary
• Compensation, treatment if injured, and contact
  information for injury and for questions
• Written, signed consent form
• (Consent from subjects who lack decision-making
  capacity obtained from legally authorized
  representative)

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IRB

• Elements of Informed Consent
• Helpful Hints
• Put in lay terms (8th grade reading level)
• Make sure all aspects of the research are
  described,
• risk-benefits, direct and indirect
  benefits, etc.
• Use the IRB template, if one is available
• If not, make sure all elements of consent are
  covered
• (see IRB website)
• If requesting an alteration of consent or
  waiver, make
• sure it qualifies

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Research Ethics

• Investigator Responsibilities
• Avoid scientific misconduct (e.g.,
  fabrication/ falsification of data, plagiarism)
• Avoid or minimize conflicts of interest
• Authorship accountability
• Information about the UM Research Responsibility
  Program can be found at
• http//www.research.umich.edu/training/peerrs.htm
  l

9
IRB

• Brief notes on other Research Ethics Issues
• re RCTs - ideally, the treatment arms should be
  in equipoise (i.e., current evidence does not
  indicate that either arm is superior)
• re Control Groups - be aware of Principle of
  Non- maleficence (e.g., should known effective
  therapies be withheld?)
• use a Data Monitoring and Safety Board (an
  independent group that monitors results and can
  determine whether a study should be terminated
  prematurely)
• Payments to participants should be limited to
  compensation for time and effort and
  out-of-pocket expenses (paying more could result
  in payments being coercive)