S

S.06-111

For Information

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SIMON FRASER UNIVERSIT

OFFICE OF VICE-PRESIDENT, RESEARCH ?

OFFICE OF RESEARCH ETHICS

TO: Ms. Alison Watt, Director ?

FROM: Bruce Whittlesea, Chair

University Secretariat ?

Research Ethics Board (REB)

RE:

Annual REB Senate Report

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DATE: September 25, 2006

2005/2006

Dear Ms. Watt;

In accordance with Policy R20.01, "Ethics Review of Research Involving Human

Subjects", Section 3.6,1 am submitting, on behalf of the Research Ethics Board, the

Annual Report to Senate. The report spans the time frame September 1, 2005 to August

31, 2006.

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Sincerely,

Bruce ?

ttlesea

Endosure

/ bjr

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lav

Office of Research Ethics

a

Simon Fraser University

Annual Report to Senate ?

September 1, 2005 - August 31, 2006

Regular meetings are held on the third Monday of each month. The REB

Annual Report to Senate 2005/06

Page 2.

2. Minimal Risk Applications Approved by the REB September 1, 2005

to August 31, 2006

Faculty - 158

Graduate Students - 169

Undergraduate Students -44

Post Doctoral -6

Staff -5

Other - 7 (visiting, adjuncts, research assistants)

3.

Non-Minimal Risk Applications Approved by the REB September 1, 2005

to August 31, 2006

Post doctoral -1; graduate students —4

4.

Courses Approved by the REB under Policy R20.01

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The REB approved 31 course applications from September 1, 2005 to August 31,

2006

5.

Internal Policies Adopted by the REB

i)

The DORE will review and approve minimal risk amendments to non-

minimal risk applications. These applications will not have to be brought

back to the REB for ratification.

ii)

Minimal risk retroactive applications are approved by the DORE and

ratified by the REB.

iii)

Once course applications are approved, they are no longer considered

confidential.

iv)

The Office of Research Ethics is directed to send one "warning" email to

the applicant (supervisor and student), one month after initial request for

initiation of the application without progress on its completion. If after

three months there is no response and the application remains

incomplete, the application shall be deleted.

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v) Adverse Events form approved.

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Annual Report to Senate 2005/06

Page 3.

vi)

Protocol is deemed to be active while the data is being gathered.

vii)

The REB considers the student researcher of every thesis conducted at

Simon Fraser University to be the Principal Investigator of the thesis

project, and therefore requires that the P1 for each thesis project request

ethics approval, if the project includes human research. (May 15/06)

viii)

Applications that are considered by the Director of the Office of Research

Ethics to utilize or involve medical procedures, or which may have

medical implications, will be sent to the Director of the Office of Research

Ethics (DORE) with a request that the DORE ask one of the persons

shown below, or others at

his/her discretion who is a licensed MD to:

(a)

Designate the protocol as Minimal Risk, or

(b)

Designate the protocol as Non-Minimal Risk, or

(c)

Designate the protocol as one that needs external or internal

review, and suggest who might be approached to do the review.

It was agreed that the following may be included in the group of MDs

who will assume the responsibility. Dr. David MacLean has confirmed

this policy.

Dr. Elliott Goldner

Dr. David MacLean

Dr. Tim Takaro

Dr. Charlotte Waddell

For Information

The Board of Governors and Senate approved the revised Policy R20.01- Ethics

Review of Research Involving Human Subjects - in July

2006.