Research Ethics for DOCH Students

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Research Ethics for DOCH Students

• How do you submit your protocol consent
  Guidelines Cautionary Tales from the
  Community
• Heather Sampson
• RN, BA, CCRP, MHSc
• Nov 7th 2006

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Objectives

• Develop/increase knowledge/ability to submit your
  protocol informed consent in 2006 within the
  following framework of 7 tenets of good research
  research
• Background to various REBs in GTA
• Discuss some issues controversies with
  preventative Rx potential

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Background

• Evidence Based Medicine is dependent on the
  results of good clinical research.
• Clinical research is an established, credible and
  essential component of improving patient
  outcomes.
• Clinical research is frequently regarded as the
  foundation of systematic reviews and guidelines
  to direct changes in medical practice

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Background

• In Canada our medical system seeks to conduct
  safe effective clinical research
• Challenge is to find a balance between not
  repeating the tragic history of thalidomide while
  searching for the next insulin or penicillin
• Present structure assigns primary responsibility
  to Research Ethics Board members as gatekeepers
  approving or rejecting all proposed clinical
  research in Canada.

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Problem

• In Canada, there is neither national REB
  accreditation, nor central governance in place
  although there is strong recommendation to
  institute such a system, it will not answer all
  the present challenges

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Problem

• Therefore in the GTA there are the same
  problems/challenges
• REB membership mostly volunteer
• Lay people, scientists, legal ethical expertise

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REB membership

• two members who have broad expertise in the
  methods or areas of research that are covered by
  the REB
• one member who is knowledgeable in ethics
• one member who has no affiliation with the
  institution but is recruited from the community
  served by the institution and
• for biomedical research, one member who is
  knowledgeable in the relevant law (this is
  advisable but not mandatory for other areas of
  research).

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• Advertiser Links
• Research study patients Novartis medical studies
  for many health areas seeking US patients
• www.novartisclinicaltrials.com

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Clinical Trial Informationfor patients and
caregivers

• Clinical trials are scientific research studies
  designed to find better ways to treat or prevent
  diseases. Our goal is to help you make an
  educated decision about participating in a
  clinical trial and to help you understand the
  clinical trial process. Novartis recommends that
  you consult your doctor before participating in a
  
• clinical trial
• http//www.novartisclinicaltrials.com

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Ethical Exercise

• The Study - What is it about?
• Patient Care/Student enrollment - How Will it be
  done?
• Patient-participant personal Issues
• Evidence based medicine?
• Ethical validity
• 1. What is/are studys ethical issue(s)?
• 2. How are they being addressed?
• (in the protocol /- the consent)
• 3. Any problems, queries?

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(For Your Patients/Participants)Taking Part in
ResearchIs It For You?

• The decision is always up to you
• You should consider the study, your care and
  personal issues in your decision
• Ask questions!

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Three Step Process(to be completed in ANY order)
1) Review the PROTOCOL 2) Review the
INVESTIGATORS BROCHURE (IB) 3) Review the
CONSENT FORM
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1) REVIEW THE PROTOCOL

• BUT FIRSTWhat is a Protocol?
• A PLAN explaining what will be done in the study,
  when it will be done and why
• The protocol also gives background, methods,
  materials etc. about the experimental treatment
  such as how it was developed and previous results

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2) REVIEW THE INVESTIGATORS BROCHURE (IB)

• BUT FIRSTWhat is the IB?
• A compilation of clinical and non-clinical data
  about the product(s) being investigated in the
  study
• Should be in a non-promotional, objective,
  balanced, simple and concise form
• Provides investigators with information pertinent
  to the rationale for the study and the compliance
  with key features of the protocol (e.g. dosing,
  safety monitoring, etc.)
• Also provides insight into the clinical
  management of study participants

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3) REVIEW THE CONSENT FORM

• BUT FIRSTWhat is a Consent Form?
• Provides information about the trial and the
  experimental treatment or test under study
• Confidentiality - who will have access to the
  information and how the patient privacy will be
  protected
• If the patient decides to participate, he/she
  must sign the consent form
• The signature does NOT mean that the patient must
  stay in the study -free to quit at any point-

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3) REVIEW THE CONSENT FORM

• What is Informed Consent (IC)?
• Getting all the facts before a patient makes a
  decision about participating in the trial
• The process continues throughout the trial - the
  patient should be told promptly of any new
  findings about the trial, such as changes in
  accepted therapies
• Presently done at the beginning, there is a move
  to re-consenting
• Important to inform participants of issues such
  as voluntariness, withdrawal, blinding, risks and
  benefits, compensation, etc.

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3) REVIEW THE CONSENT FORM

• Consent Process
• Describe the process of obtaining consent
• Access to participants?
• Methods of recruitment?
• Who is recruiting?
• Pre-existing relationship?
• Time allowed for participants to review
  information before providing consent?

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3) REVIEW THE CONSENT FORM

• Required Elements Does the consent form
  include?
• A clear statement that the study involves
  research
• Explicitly states that the treatment is
  experimental and that participation is voluntary
• A clear explanation of the purpose of the
  research study
• Why is this study being done? What do the
  researchers hope to achieve?

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3) REVIEW THE CONSENT FORM

• A clear description of what is involved
• Are all procedures, tests, drugs, questionnaires,
  etc. that will be used adequately described?
• Are all procedures that are experimental,
  placebo, and/or beyond standard procedure clearly
  identified?

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3) REVIEW THE CONSENT FORM

• The expected duration of participation
• Includes an estimate of the amount of time
  required for each visit, the overall number of
  visits, and the length of time that the
  participant will be required to participate,
  including follow-up, to complete the research
  study.
• The approximate number of human subjects involved
  in the study how many at your institution

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3) REVIEW THE CONSENT FORM

• A description of the reasonably foreseeable risks
  and discomforts that the participant may
  experience
• Quantification of risks wherever possible (e.g.
  less than 2 rather than rare)
• Includes possible risks to an embryo, fetus or
  nursing infant
• Includes a statement that the treatment may
  involve risks which are currently unforeseeable

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3) REVIEW THE CONSENT FORM

• A description of the expected benefits to the
  subjects or to others
• If applicable, a statement that there is no
  intended benefit
• e.g. For non-therapeutic studies

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3) REVIEW THE CONSENT FORM

• Alternative options
• A description of any appropriate alternative
  procedures or courses of treatment available
• Includes a statement that the participant may
  elect to receive standard treatment instead of
  participating in research.

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3) REVIEW THE CONSENT FORM

• A description of any additional costs to the
  participant resulting from participation...
• Information regarding compensation
• Describes any methods and amounts of payment or
  reimbursement
• Ensure that such payments are not undue
  incentives or excessive to the point of being
  considered coercive
• Will compensation and/or medical treatment be
  available if a research related injury occurs?

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3) REVIEW THE CONSENT FORM

• Rights as a Participant
• Explicitly states that participation is
  voluntary, that the participant may refuse to
  participate, and that participation can be
  terminated by the participant at any time without
  prejudice
• States that withdrawal from study will not
  involve penalty or loss of benefits
• Explains that the participant may be removed from
  the study by the Investigator at any time

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3) REVIEW THE CONSENT FORM

• Indication of any potential conflicts of
  interest, financial or otherwise, of the
  investigator and institution.
• Contact information
• For a person not involved in the study, to whom
  the subject can speak regarding patient rights
  and ethical issues.

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3) REVIEW THE CONSENT FORM

• Privacy and Confidentiality
• Respond to questions regarding confidentiality of
  data and the protection of participant privacy
  rights, noting
• Description of the extent to which
  confidentiality of records identifying the
  subject will be maintained
• Identification of organizations that may receive
  information regarding the subjects medical/study
  records

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Ethical Exercise

• The Study - What is it about?
• Patient Care/Student enrollment - How Will it be
  done?
• Patient-participant personal Issues
• Evidence based medicine?
• Ethical validity
• 1. What is/are studys ethical issue(s)?
• 2. How are they being addressed?
• (in the protocol /- the consent)
• 3. Any problems, queries?

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(For Your Patients/Participants)Taking Part in
ResearchIs It For You?

• The decision is always up to you
• You should consider the study, your care and
  personal issues in your decision
• Ask questions!

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Take Home Message?

• Take to your family
• It is your baby no one else's
• Leave your ownership at the door
• Employ KISS principle..euphemism for keep it
  simple, s..
• It just might work out?!
• (TEGH DOCH-2 present to REB members)

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Objectives

• Develop/increase knowledge/ability to submit your
  protocol informed consent in 2006 within the
  following framework of 7 tenets of good research
  research
• Background to various REBs in GTA
• Discuss some issues controversies with
  preventative Rx potential

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