WRITING CONSENT FORMS FOR

RESEARCH SUBJECTS

Research Administration & Development

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. Complete and Accurate Information

2. Readable -well organized -lay terms -grade 7 level

3. 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

• 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

• 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: – 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• 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 research-related 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 non-standard 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 604-587-4681. You may discuss these rights with the co-chairmen 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

Application completed & submitted to admin. supervisor for signature

PI/designate submits appl’n to FH Research for Expedited Review

PI/designate submitsAppl’n to FH Research for Full Board Review

Email Mail

Appl’n screened for completeness

Yes

No No

FHREB co-Chair conducts review

Appl’n & consent form pre-reviewed5 business days

Full Board Review10 business days

1 business day

Study approved? Yes

FH Research issues Certificate of Ethical Approval to PI

No

FHREB ‘approves’ Expedited Review

Request for Modifications sent to PI

Deferral Notice sent to PI

5 bu

sine

ss

days

PI responds within 6 months

PI responds within 6 months

FHREB co-Chair conducts review of response

Study Approved?

Yes

No

5 business days

5 business days

If applicable, PI submits to FH Research:

•Signed DAR Form

•Contract for clinical trial research

•Health Canada No Objection Letter

Has all of the required documentation been submitted?

Yes

FH Research issues “Letter of Authorization to Conduct Research”

EXPEDITED REVIEW PROCESS Minimal Risk Applications, Amendments, & Renewals

Application completed & submitted to admin. supervisor for signature

PI/designate submits appl’n to FH Research for Expedited Review

Email

Appl’n screened for completeness

Yes

No

FHREB co-Chair conducts review

5 business days

1 business day

Application approved? Yes

FH Research issues Certificate Approval to PI

No

FHREB ‘approves’ Expedited Review

Request for Modifications sent to PI

5 bu

sine

ss

days

PI responds within 6 months

FHREB co-Chair conducts review of response

Application Approved?

Yes

No

5 business days

5 business days

If applicable, PI submits to FH Research:

•Signed DAR Form

For New Applications ONLY: Has all of the required

documentation been submitted?

Yes

FH Research issues “Letter of Authorization to Conduct Research”

Expedited Renewal Applications:- 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**