Transcript Document

Research Administration & Development
WRITING CONSENT FORMS FOR
RESEARCH SUBJECTS
WHO IS THE FH REB?
Meets TCPS & Health Canada quorum requirements
Co-Chairs/Primary Reviewers:
Dr. Allan Belzberg [SMH]
Dr. Marc Foulkes [RCH]
Primary Reviewers:
Dr. Bob Gillies
[Pharmacy]
Dr. Michael Vince [RCH lab]
Dr. Arthur Friesen [RCH Cardiologist]
WHO IS THE FH REB?
Ethicist:
Prof. Lindsay Meredith [SFU]
Statistician: Michael Wasdell
Legal Representation:
Ms. Camille Ciarniello [LLB]
Ms. Mara Stickland
[LLB]
Lay member:
Mrs. Nancy Magnees
OBLIGATIONS OF THE REB
“ The consent form is not meant to
reassure the subject, quite the
contrary, it is meant to raise every
possible concern that might be
relevant to the subject’s
participation.”
Time 2002 April 22
APPLICATION FORM BOX 28
28a. Will the data be completely anonymized (i.e. the data
becomes anonymous because it is completely stripped of all
identifiers such that there is no possibility of relinking data to
the subject’s identity)? Yes
No
28b. If NO, will the data be “de-identified” by using a unique code
ONLY before leaving the FH site? Yes
No
28c. If YES, describe how the data will be “de-identified”.
28d. If NO, describe what identifier(s) will be used.
e.g. DOB
28e. Clarify where the data will reside. Will it be kept at FH or sent
elsewhere. Specify location if sent offsite.
THE CONSENT FORM: A LEGAL
DOCUMENT
Three basic elements:
1.
2.
3.
Complete and Accurate Information
Readable
-well organized
-lay terms
-grade 7 level
Voluntary
-avoid coercion and undue influence
FH REB Consent Form Template @
http://www.fraserhealth.ca/Initiatives/Research/Forms+and+
Templates.htm
Common Consent Form Errors
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First Page
Introduction
Your Participation Is Voluntary
Who Is Conducting The Study?
Background
What is the Study Purpose?
Who Can Participate In the Study?
Who Should Not Participate In The Study?
What Does The Study Involve?
What Are My Responsibilities?
What Are The Possible Harms And Side Effects Of Participating?
What Are The Benefits Of Participating?
What Are The Alternatives To The Study Treatment
Common Consent Form Errors
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What If New Information Becomes Available?
What Happens If I Decide To Withdraw My Consent?
What Happens If Something Goes Wrong?
Can I Be Asked To Leave The Study?
After the Study Is Finished
What Will This Study Cost Me?
Will My Taking Part In This Study Be Kept Confidential?
Contact For Questions About Study Participation
Contact For Questions About Subject's Rights
Subject Consent
Signatures
Other Consent Issues
Format Guidelines
• Titles: for optional studies, always
include “Optional” in the title
• Co-investigators:
• Emergency Contact #: if applicable
• Introduction: “you are being invited to participate”
because you have/are…..
• Your Participation is Voluntary:
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free to participate
free not to participate
free to participate and to withdraw at any time
no explanation required
discuss with others
• Who is Conducting Study?
– Differences between a ‘sponsor’ and a ‘grant’
• Background: Describes:
– extent of the problem, i.e. incidence,
prevalence
– significance of problem
– previous research [animal and human]
– Links to Purpose
• Purpose = Objective
• Who Can Participate: Inclusion criteria
• Who Cannot Participate: Exclusion
criteria that lay person knows of
– pregnancy
– disease
– use of drugs/alcohol
– Age/gender
WHAT DOES THE STUDY INVOLVE?
• When – duration and # visits,
• Where – as inpatient/outpatient/home
• How – type of design:
– RCT, placebo-controlled, standard care
– Experimental intervention - tests
– Data collection only –
questionnaire/interview
Specific Treatment Procedures
• Under MRI scan: State that the subject will
be in a confined space and there could be a
risk of claustrophobia
• Describe ECG, blood tests
• Consistency, e.g.
– This paragraph states that “blood will be collected from
you at one additional time” while page 3, states that
“before each treatment …some blood…will be
taken…”. Reconcile these 2 statements to clarify how
often blood is collected and for what purposes.
Consistency:
Under Lab Tests: Provide an equivalent
measure for the total amount of blood.
Describe how the blood will be taken and
from what location in the body. Delete “part
of the blood sample will be processed….” as
the protocol states that this site is not
participating in these optional exploratory
studies.
• Data Collection: Specify where data
comes from – i.e. medical chart
Subject Responsibilities
• Specific instructions
• Reporting side effects
• Reporting pregnancy
Harms
• Quantify, quantify, quantify the risk of the harm!
• Table format
• Provide a lay equivalent for the exposure to X-rays
Benefits
• Usually benefits other than to knowledge and society
should never be promised – avoid coercion
• Alternatives to Study Treatment?
– Applicable only to therapeutic trials
• New Information
• What Happens if I Withdraw My
Consent?
- “By law, this data cannot be destroyed”
What Happens if Something Goes Wrong
– Delete “No further compensation…available”.
Can I Be Asked to Leave the Study?
– Complete withdrawal without explanation/safety
issues
After the Study is Finished
– Expensive drugs
What will the Study Cost Me?
– Explain how subjects can be reimbursed for
expenses
Confidentiality : Personal = Identifiable Health Information cannot
be retained
– Sponsor ? , Health Canada ? , FDA ? FHREB always
– Data Protection sections should be replaced with standard FHREB wording
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Your confidentiality will be respected. You will be assigned a unique study
number as a subject in this study. Only this number will be used on any
research-related information, including medical records, personal data and
research data, collected about you during the course of this study, so that your
identity [i.e. your name or any other information that could identify you] as a
subject in this study will be kept confidential. [Explain where the researchrelated information will be sent]. Information that directly discloses your
identity will remain only with the Principal Investigator and/or designate. The
list that matches your name to the unique identifier that is used on your
research-related information will not be released without your knowledge and
consent unless required by law or regulation.
Identifiable Data
• “It is unusual to include [name the nonstandard identifiers, e.g. date of birth] on
research records and material forwarded
to others. Most studies submit information
identified by code numbers or letters only.”
• No information that discloses your identity will be released
or published without your specific consent to the
disclosure. However, research records and medical
records identifying you may be inspected in the presence of
the Investigator or his or her designate by representatives
of Amgen Inc., Health Canada, the U.S. Food and Drug
Administration, and the FH Research Ethics Board for the
purpose of monitoring the research. These personnel are
required to keep your identity and personal information
confidential. However, no records which identify you by
name will be allowed to leave the Investigators' offices.
Out of Canada
-disclosure required by FOIPPA
“I understand that as part of the [Name of Study] research study to
which I have consented, identifiable information about me will be
sent to [specify the name and location of the foreign institution or
organization]. I have been informed that the BC Freedom of
Information and Protection of Privacy Act (FOIPPA) prohibits the
disclosure of personal information outside of Canada without my
consent. All the questions I have asked have been answered in a
satisfactory manner and I consent to the disclosure of the
information as described during the study for the [number of
months] period beginning [date of disclosure].”
Questions re Subject Participation
Questions re Subject Rights
“If you have any concerns about your rights as a research
subject and/or your experiences while participating in this
study, contact Dr. Marc Foulkes and/or Dr. Allan Belzberg,
Research Ethics Board [REB] co-Chairs by calling 604587-4681. You may discuss these rights with the cochairmen of the Fraser Health REB.”
Subject Consent Page
-title
- “I”
- Signatures
Required for Health Records
Process Tips
• Full Board Review – meetings held
2nd Tuesday of each month; hard
copy submissions required 2 weeks
in advance
• Expedited Review – conducted
weekly by co-Chairs; submissions
by email
FH RESEARCH REVIEW PROCESS
PI/designate submits appl’n to
FH Research for Expedited
Review
Email
Application completed & submitted
to admin. supervisor for signature
Mail
Appl’n screened for completeness
No
No
1 business day
PI/designate submits
Appl’n to FH Research
for Full Board Review
Appl’n & consent form pre-reviewed
Yes
5 business days
10 business days
FHREB co-Chair conducts review
Yes
Study approved?
FHREB ‘approves’ Expedited
Review
5 business
days
Has all of the required
documentation been submitted?
No
5 business days
Request for
Deferral Notice sent
Modifications sent to PI
to PI
PI responds within 6
months
PI responds within 6
months
FHREB co-Chair conducts review of
response
No
FH Research issues Certificate of Ethical Approval to PI
Full Board Review
Yes
Study Approved?
5 business days
If applicable, PI submits to FH Research:
•Signed DAR Form
Yes
FH Research issues “Letter of
Authorization to Conduct Research”
•Contract for clinical trial research
•Health Canada No Objection Letter
EXPEDITED REVIEW PROCESS
Minimal Risk Applications, Amendments, & Renewals
PI/designate submits appl’n to
FH Research for Expedited
Review
Email
Application completed & submitted
to admin. supervisor for signature
Expedited Renewal Applications:
Appl’n screened for completeness
No
1 business day
Yes
- Notice of Renewal sent to PI 4 weeks prior to due date
- PI to send Renewal Appl’n 2 weeks prior to due date
**NO NEW SUBJECTS CAN BE ENROLLED UNTIL
RENEWAL CERTIFICATE IS ISSUED**
5 business days
FHREB co-Chair conducts review
Yes
Application approved?
No
5 business days
FHREB ‘approves’ Expedited
Review
Request for
Modifications sent to PI
5 business
days
PI responds within 6
months
FHREB co-Chair conducts review of
response
No
FH Research issues Certificate Approval to PI
Yes
Application Approved?
5 business days
For New Applications ONLY:
Has all of the required
documentation been submitted?
If applicable, PI submits to FH Research:
Yes
FH Research issues “Letter of
Authorization to Conduct Research”
•Signed DAR Form