THE UNIVERSITY OF WESTERN ONTARIO
RESEARCH ETHICS BOARD FOR NON-MEDICAL RESEARCH INVOLVING HUMAN
SUBJECTS PROTOCOL SUBMISSION
(VERSION - JANUARY 2002)
The protocol submission form is created in MS Word 97. Be patient with the form –
occasionally some of the boxes do not appear to be fully formed however they are there and
saving the form or the addition of a hard return makes the lines reappear. The question and
response boxes are created in Tables. The sections for narrative responses are outlined in red
and will expand as material is added with the exception of Section 3 where, because the
responses can be lengthy, are to be entered after the question box at the red arrow ⇒. X’s or
other symbols may be used in sections requiring a selection e.g. yes or no. Rows may also
be added to tables 1.5, and 7.1 if required. Once completed, please review the document to
ensure that it is complete and layout (e.g. page breaks and other formatting ) is appropriate.
•
•
•
Number all pages: The document will automatically number the pages as text is added
(text may be entered directly or copied and pasted from another electronic document) and
the document expands but if hard copy pages from other sources are inserted in the
package they must be numbered appropriately in conjunction with the protocol submission
form. e.g. page 8 a, page 8 b etc.
Bear in mind that some members of the REB may not be experts in your field so please
strive to make your submission understandable to those outside your area of expertise
Minimum font size is 12 point. Hand written submissions are not acceptable.
It is the investigator’s responsibility to ensure the material is received by the Office of
Research Ethics by the meeting deadline.
Copies: Investigators are expected to provide sufficient copies for the REB review. Submissions
must be collated into packages for each committee member and stapled or clipped with sturdy , well
anchored clips (note – paperclips frequently become dislodged resulting in disordered protocols.)
Instruments –
Fax or email
Protocol
standard,
Instruments –
Recruitment ads or
submissions are
Submission
previously
new or adapted
posters
not accepted.
validated
Full Board
Original
Review
(signed by PI)
4 copies
10 copies
10 copies
+ 9 copies
Incomplete or illegible submissions will be returned to the investigator without review.
Send submissions to: Office of Research Ethics Room 00045 Dental Sciences Building;
The University of Western Ontario London, Ontario N6A 5C1
HAVE ANY
QUESTIONS?
Ethics Officer
Karen Kueneman
Telephone
661-2111 ext. 84588
Email
kueneman@uwo.ca
or
ethics@uwo.ca
UWO NON-MEDICAL RESEARCH REB SUBMISSION FORM (VERSION – JANUARY 2002)
Page 1
SECTION 1 PROJECT REGISTRATION
1.1
Project Title
Aspectual past tense distinctions in French
1.2a
Anticipated Project dates
1.2b
While all protocols are dealt with as quickly as
possible it is helpful to know in advance about
pending agency deadlines. Indicate if there is a
specific funding agency deadline by which REB
approval is required.
1.3
Start Date June 10, 2003
Completion Date November 30, 2003
Pending deadline date
Principal or Lead Investigator at this site. (PI must be a faculty or staff member at UWO or affiliated
institutions. PI for student or resident projects must be the faculty advisor.)
Name
Title & Position
Degrees
Departmental Affiliation
Mailing Address
Telephone
Email
Dr. J. Bruhn de Garavito
Assistant professor
PhD McGill
Modern Languages and Literatures
UC 154
661-2111 ext. 85864
Fax
joycebg@uwo.ca
1.4
Signature of Local Principal Investigator attesting that:
a) all co-investigators have reviewed the protocol contents and are in agreement with the protocol as
submitted;
b) all investigators have read the Tri-Council Guidelines and the UWO Guidelines on Non-Medical Research
Involving Human Subjects and agree to abide by the guidelines therein;
c) the investigator(s) will adhere to the Protocol and Consent Form as approved by the REB; and
d) the Principal Investigator will notify the REB of any changes or adverse events/experiences in a timely
manner;
e) the study, if funded by an external sponsor, will not start until the contract/ agreement has been approved
by the appropriate university, hospital or research institute official.
______________________________________
Signature
______________
Date
UWO NON-MEDICAL RESEARCH REB SUBMISSION FORM (VERSION – JANUARY 2002)
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1.5
List all local co-investigators and collaborators. Include research personnel only if they have a
significant role in the conduct of the study. Expand chart as required.
Name
Title/Position
Degrees
Role
Carol Clemance
MA student
MEd
co-investigator
1.6a
1.6b
Is this a multi-centred study?
YES
NO
X
If YES, who is the Principal Investigator or Project Leader for the entire study? Provide name and
contact information.
1.7a
Is this a student project? i.e. Is completion of this project an academic
YES
X
requirement for a course or degree?
NO
1.7b
If YES, please describe the course or degree. (e.g. name of course, Honours BA paper, Masters or
Ph.D theses etc) and the student’s role in the research (e.g. questionnaire design, data collection,
interviews, data analyses etc).
Masters memoire; The student is involved in the design of the tasks, data collection, data analyses, ethical
application, and, of course, writing of the memoire.
SECTION 2 FUNDING
2.1a
What is the status of the funding or support for this
Funding not required
project? The NMREB strongly recommends
waiting to apply for ethics approval until after a
project submitted for funding has received
notification that the funding has been approved.
It is very wasteful of the researcher’s and the
REB’s time to prepare/review a protocol that may
not proceed or may require significant revision
and re-review as a result of receiving less funding
than anticipated.
2.1b
2.1c
2.1d
2.1e
2.1f
Application Pending
Funded
In-Kind contribution only
If Application Pending; Funded; or In-Kind Contribution fill in chart below.
Name of funding agency(s) or
SSHRC
sponsor(s)
Name of investigator
Joyce Bruhn de Baravito
receiving/applying for funding
2001-2004
Date submitted for funding.
Agency/sponsor reference
410-2001-0131
number if known
Title as submitted to funding
The steady state grammar of early and late bilinguals
agency(s) if different than title of
this ethics submission
X
UWO NON-MEDICAL RESEARCH REB SUBMISSION FORM (VERSION – JANUARY 2002)
Page 3
SECTION 3 PROJECT DESCRIPTION
Complete each section under the appropriate heading. Be succinct and adhere to the page limitations. DO NOT
DIRECT THE COMMITTEE TO ‘SEE ATTACHED’. DO NOT USE TEXT COPIED FROM FUNDING
APPLICATIONS OR STUDY PROTOCOLS UNLESS IT PROVIDES A SUCCINCT SUMMARY OF THE
METHODOLOGY APPROPRIATE FOR ETHICAL REVIEW AND DEALS WITH ETHICAL ISSUES. Copies of
detailed proposals submitted to a funding agency or sponsoring agency protocols will not be reviewed as the
ethical issues are not often adequately addressed in such documents and they frequently do not provide a
succinct summary as noted above. Your protocol will be RETURNED UNREVIEWED if the project description
information is incomplete, illegible or improperly filled out.
3.1a
Is this a sequel to previously approved research?
3.1b
If YES, indicate the previous ethics review number(s):09106S
YES
X
NO
3.1c
If YES, describe differences from the previously approved protocol(s):
Two new tasks added and original tasks modified. The subjects, instead of being advanced learners of French,
will be near-native adult learners and bilingual speakers of French, as well as native French.
3.2
Provide a brief one or two sentence overview of the proposed research describing the population,
intervention and outcome. E.g. Children 5 to 8 years of age will view a video about animal mothers and
their babies then be asked if they think there are any similarities between an animal mother’s
behaviour and a human mother’s behaviour. The research will take place in the children’s classroom.
Francophone adults will indicate whether certain sentences written in the French past tense are logical or not.
They will read brief situations in French and answer true/false questions about them, and also describe a short,
wordless cartoon sketch using French past tense.
3.4
Background & Justification – Address the scholarly and scientific validity of the study and the
appropriateness of using human subjects. (1 page maximum)
⇒Evidence of near-native and bilingual mastery of aspectual differences involved in the use
of the past tense in French can be drawn only from human subjects. Previous research has
not to this date provided ample data. We will, therefore, use adult humans as research
subjects.
3.5
Objectives and Hypotheses: Provide a clear statement of the purpose and objectives of the
project. (1 page maximum)
⇒Knowledge and understanding of past tense aspectual distinctions in French are
complicated and are among the later skills to be attained. A learner of French as a second
language may know how to form the passé composé and the imparfait. Yet, the appropriate
usage of each in a given context varies greatly even among advanced learners, as our
previous study showed, but not among native speakers. Some studies claim that adult
second language learners cannot master some of the more difficult areas, even after many
years of exposure to the target language. We will show that near-native adult learners of
French, as well as bilinguals, however, will use these tenses in the same ways as do native
speakers of French.
UWO NON-MEDICAL RESEARCH REB SUBMISSION FORM (VERSION – JANUARY 2002)
Page 4
3.6
Methodology – Describe the study design and what participants will be asked to do at each stage
of the research. Investigators are encouraged to use flow charts or diagrams in their descriptions.
(2 page maximum)
⇒There will be a standard language competency test administered to the subjects in order
to ascertain their proficiency in the use of French. Three other tasks will test their use of the
passé composé versus the ímparfait and vice versa.
The Sentence Conjunction Judgment Task involves twenty-four pairs of sentences
which consist of two coordinated grammatical phrases in each sentence. Some sentences
are logical and natural, but other combinations are semantically incompatible. Subjects
must indicate on a scale if each sentence is more or less logical or illogical. Six logical and
six illogical distractor sentences are included.
The Truth Value Judgment Task contains 15 pairs of brief situations followed by two
true/false questions to be answered by the participant; one question is written in the
ímparfait and one in the passé composé.
The Story-Telling Task involves a brief cartoon sketch without words. The subject is
asked to describe the scenes orally on cassette tape using the French past tense. Certain
verbs are listed in order to prompt the participant to respond in certain ways. The results
will be evaluated as to the use of the imparfait and the passé composé.
3.7
Address the strengths and weaknesses of the selected design. Specifically indicate why a
particular design was selected. (1 page maximum)
⇒Many tests evaluate whether a person is capable of forming the French past tenses.
However, our tests will indicate whether near-native adult learners and bilingual speakers
make the same linguistic choices as do native speakers in the given situations. These tests
require understanding of complicated aspectual differences.
3.8
References – If possible please restrict the list to ten of the most relevant references. References
must contain the author, title of article, journal and page number(s).
⇒ Andersen, R., & Shirai, Y. (1991). Developmental sequences: the emergence of aspect
marking in second language acquisition. In T. Huebner & C. A. Ferguson (eds.),
Crosscurrents in second language acquisition and linguistic theories (pp. 305324). Amsterdam: John Benjamins.
Andersen, R., & Shirai, Y. (1996). The primacy of aspect in first and second language
acquisition: the pidgin-creole connection. In Handbook of Second Language
Acquisition (pp. 527-570). New York: Academic Press.
Gosselin, L. & François, J. (1991). Les typologies de procès: des verbes aux
prédications. In G. Kleiber et G. Roques (eds.), Travaux de linguistique et de
philologie (pp. 19-83). Strasbourg-Nancy: Centre National de la Recherche
Scientifique.
Montrul, S., & Slabakova, R. (2002). Acquiring morphosyntactic and semantic
properties of aspectual tenses in L2 Spanish. In Perez-Leroux, A. & Liceras, J.
(Eds.), The Acquisition of Spanish Morphosyntax: The L1/L2 Connection
(pp.XX). Dordrecht: Kluwer.
Montrul, S., & Slabakova, R. (2001). Is native-like competence possible in L2
acquisition? In Anna H.-J. Do et al., (eds.), BUCLD 25 Proceedings : 522-33.
Salaberry, R. (1998). The development of aspectual distinctions in L2 French classroom
learning. The Canadian Modern Language Review 54,4: 508-42.
UWO NON-MEDICAL RESEARCH REB SUBMISSION FORM (VERSION – JANUARY 2002)
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3.9
Analysis – Discuss how the data will be analyzed. (1 page maximum)
⇒The use of the past tenses in French by near-natives and bilinguals will be compared
directly to that of native speakers in identical situations.
3.10a
3.1b
Researchers are required to propose a continuing review
process appropriate for this project. At a minimum all protocols
will require the completion of the REB’s Surveillance Report
Form annually. Please indicate your recommendation as to the
frequency of the REB’s continuing review.
ANNUALLY
(default)
EVERY 6 MONTHS
EVERY 3 MONTHS
EVERY MONTH
If the risks associated with this project are such that they warrant more than an annual review please
discuss what type of report you will provide the REB.
SECTION 4 RESEARCH PARTICIPANTS
Sample Size:
4.1a
Number of subjects in entire study
4.1b
Number of subjects at this centre
4.1c
Number of centres participating
60
60
1
4.2
For all study types, justify the sample size. If a formal sample size calculation was not used give
a rationale for the proposed number of subjects. If a formal sample size calculation was
performed, complete 4.3 and 4.4.
⇒ Twenty second language learners of French and twenty bilingual speakers of French will
be compared with twenty native speakers of French. This number should result in a
reasonable outcome.
4.3
⇒
Sample Size Calculation – give the actual calculation
4.4
Sample Size Reference:
Give a reference for the formula used. If, instead of a calculation, a table in a published source
was used, provide the reference(s) and table reference numbers. If a sample size calculator was
used, provide a description of the software package used and/or the URL for internet-based
calculators.
⇒
UWO NON-MEDICAL RESEARCH REB SUBMISSION FORM (VERSION – JANUARY 2002)
4.5
The study will involve: (check all that apply)
Incompetent or unconscious participants
Minors (under 18)
Institutionalized persons (e.g. prison, extended care facility)
UWO Psychology Pool
Participants with language barriers (e.g. illiterate, non-English speaking, dysphasic)
Employees or students of UWO or the institution where the study is being carried out
Patients
Pregnant women
Participants recruited in emergency or life-threatening situations
Other (describe) Francophones in the London area
Page 6
√
X
X
4.6b
X
YES
NO
If NO, explain why only one gender is being selected. (e.g. condition under study is gender specific)
4.7
What is the age range of the participants?
4.8
Participant Inclusion and Exclusion Criteria: List all inclusion/exclusion criteria and indicate with an
asterisk (*) those criteria which will be included in the Letter of Information.
Inclusion Criteria
4.6a
4.8a
Will the study involve males AND females?
LOWER AGE LIMIT
UPPER AGE LIMIT
18
65
Second language learners of French who learned the major portion of their conversational and writing skills after
the age of 16 will be included. Bilingual speakers of French who learned French along with their native
language as children will be included. Native speakers of French who spoke only French until at least the age of
16 will be included.
4.8b
Exclusion Criteria
4.9a
4.9b
YES
NO
UNKNOWN
If YES or UNKNOWN, explain any risks associated with participation in multiple studies
Are these participants also taking part in other research?
SECTION 5 PARTICIPANT RECRUITMENT
5.1
Describe the method of recruiting and sampling participants.
Known students and staff of the university will be personally recruited. Other suitable
persons in the London area will be recruited mainly by word of mouth.
5.2
Identify who will be contacting them .
The investigators will be contacting them.
5.3
Indicate where the research will be conducted.
The research will be conducted at University College.
X
UWO NON-MEDICAL RESEARCH REB SUBMISSION FORM (VERSION – JANUARY 2002)
5.4
Will announcements or advertisements be used?
Page 7
YES
NO
X
If YES (Provide copies of all advertisements /announcements that will be used)
SECTION 6 RESEARCH PROCEDURES
6.1
Indicate which of the following interventions, testing or procedures are to be performed on the human
participants as part of this research study. (Check as many as needed)
Interview/survey/questionnaire X
Evaluation of program or services
Non-invasive physical measurements (e.g. BP,
Cognitive or perceptual experiment
temperature)
Observation of public behaviour
Collection of biological materials
Analysis of existing data
Retrospective chart or file review
Audio or video taping X
Other (specify)
SECTION 7 INSTRUMENTS TO BE USED IN STUDY
Instruments (forms) = questionnaires, assessment forms, scales, interviews, surveys and
diaries etc.
7.1
In the chart below list all instruments that will be used in the study. If you will be using standard,
previously validated or widely accepted instruments provide FOUR copies. If the instruments have
been developed or adapted for this project, provide 10 copies Expand chart as required.
If you are conducting open-ended or unstructured interviews or focus groups provide an outline of the
topics to be discussed.
To assist the REB indicate clearly on this chart, who will be completing the form (E.g. subject – self
administered, subject-interviewed, caregiver, teacher etc)
INSTRUMENT
STATUS
Who will be completing Standard
New
the form?
Adapted
Laval French Placement Test
all subjects
S
Sentence Conjunction Judgment Task
all subjects
A
Truth Value Judgment Task
all subjects
N
Story-Telling Task
all subjects
N
SECTION 8 DECEPTION OR PARTIAL DISCLOSURE TO BE USED IN THE STUDY
8.1a
8.1b
8.1c
Do any of the procedures in this study include the use of deception or partial
disclosure of information to participants?
If YES, provide a rationale for the planned deception or partial disclosure.
YES
NO
If YES, describe the procedures for a) debriefing the participants and b) giving them a second
opportunity to consent to participate after debriefing.
X
UWO NON-MEDICAL RESEARCH REB SUBMISSION FORM (VERSION – JANUARY 2002)
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SECTION 9 RISKS AND BENEFITS OF THE RESEARCH
RISKS & DISCOMFORTS: Discuss the overall risks of the proposed research, and specify the
particular risks and discomforts associated with each aspect of the protocol. Consider physical,
psychological, emotional, social, economic etc. risks and stressors.
No known risks or discomforts
9.1
BENEFITS: Discuss any possible direct benefits to the research participants as a result of their
participation in the study. Please note that monetary compensation is not considered a benefit. If
applicable, discuss possible benefits to society at large or the population being studied.
No known benefits
9.2
SECTION 10 COMPENSATION AND COSTS
YES
X
Will the participants be compensated or reimbursed for their time and
expenses?
NO
10.1b If YES, provide details. Specify the amount, what the compensation or reimbursement is for, and how
payment will be determined for participants who do not complete the study.
$10 per hour
10.1a
10.2a
Are the participants likely to incur any additional expenses or inconveniences as
a result of their participation in this study?
10.2b If YES, describe
Campus parking fees may apply.
YES
NO
X
SECTION 11 PROTECTION OF HEALTH AND SAFETY OF PARTICIPANTS
11.1
Describe facilities and procedures to protect the physical and mental health, comfort and safety of the
participants.
N/A
11.2a
11.2b
Will the study be likely to induce stress, fear, anxiety in some or all participants
YES
or require them to discuss painful memories of past events?
NO
If YES, explain what resources you will make available to subjects to cope with such stress.
SECTION 12 INFORMATION ON THE RESEARCH RECORDS
12.1
Describe the procedures to be used to ensure anonymity of participants and for preserving the
confidentiality of data both during the research and in the release of the findings. Describe any
condition in which confidentiality or anonymity cannot be guaranteed or must be breached.
Participants will be given identification numbers, which will appear on their various tasks
instead of their names.
X
UWO NON-MEDICAL RESEARCH REB SUBMISSION FORM (VERSION – JANUARY 2002)
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12.2
Describe the procedures for securing and storing written records, videotapes, computer discs,
recordings and questionnaires etc. Describe the method of disposal and indicate the length of time the
material will be retained.
All records will be stored on paper and on computer discs, which will be filed in a limited –
access cabinet. The material will be retained for five years.
12.3
Identify all agencies or individuals other than the research team who may have access to confidential
data collected for this study, now or in the future e.g. the Sponsor(s), regulatory agencies such as
Health Canada or the FDA etc.
None
12.4
Briefly describe any plans for provision of feedback to participants.
None
SECTION 13 INFORMED CONSENT DOCUMENTATION
Disclaimer: The REB does not assess the legal validity of the consent form nor does it provide any other legal
advice.
13.1
If written consent cannot be obtained from potential participants prior to intervention or written consent
is not appropriate, provide a justification. (E.g. completion of a questionnaire in a survey study is
evidence of compliance.)
13.2
Attach a copy of the documentation that will be used to inform and obtain consent from the potential
participants about the research. Separate Information/consent documents or a combined
Information/Consent document may be used. Wording regarding the participant’s consent must
comply with the UWO policies and procedures and participants must be given a copy of the Letter of
Information or combined Information/consent document to keep for reference.
Requests for interviews with persons in authority need not follow such a structured
outline. (see Section 10.0 in the Guidelines.)
COMPLETE CHECKLIST ON NEXT PAGE
&
INCLUDE IT WITH YOUR SUBMISSION
UWO NON-MEDICAL RESEARCH REB SUBMISSION FORM (VERSION – JANUARY 2002)
Page 10
13.3
CHECKLIST – INFORMATION & CONSENT DOCUMENTATION
Checklist must be included with the protocol submission.
HAVE YOU INCLUDED OR ADDRESSED THE FOLLOWING ISSUES?
YES
Not
Appl
(see Informed Consent documentation guidelines Appendix 1 NMREB
guidelines for detailed description/requirements of each category)
Title of the research
Identity of researchers & sponsors
Invitation to participate in research
Information/consent documents addressed to research participant
Summary explanation of research
Number of participants – total & local
Participant inclusion & exclusion criteria
Description of the research and any experimental procedures
Explained specific research techniques
Estimate of participant’s time commitment
Location of the research
Described Risks / Harms / Benefits
Explained voluntary participation and freedom to refuse to participate/withdraw at any time.
Participation in concurrent or future studies
Specimens or Human Tissues (separate consent for banking and unspecified future research)
Notification of new findings
Anonymity
Confidentiality
Alternative treatments
Contact person(s) for participants a) regarding the study & b) subject rights
Compensation & Costs to Subjects
No waiver of rights
No indication of institutional or REB approval
Publication of results
Conflict of Interest declared
Measures taken to deal with stress, anxiety, or fear induced by study, if any
Language Level - lay language, grade 8 level
Formatting – pages numbered, type size, page layout, header/footer, headings
Consent Statement as per UWO standard or written consent not required
Signatures – participant, person obtaining consent
Assent form for
what the study is about
children 7+
why the child is eligible to participate for the study
(Optional)
procedures, what will happen
voluntary participation, withdrawal
risks, discomforts
benefits
contacts
an invitation to ask questions
signature
UWO NON-MEDICAL RESEARCH REB SUBMISSION FORM (VERSION – JANUARY 2002) Cross Cultural
Page 1
SECTION 14 CROSS-CULTURAL RESEARCH
INCLUDE THIS SECTION ONLY IF THIS ETHICS SUBMISSION DEALS WITH CROSSCULTURAL RESEARCH.
Submissions dealing with aboriginal peoples, isolated or non-traditional communities, or
work in other countries must include this section.
If the research is cross-cultural, special consideration will be given when reviewing the
ethical standards to ensure that the work is carried out in an ethically sound manner yet
within the norms of the community.
14.2a
Indicate which of the following special considerations should be acknowledged when
reviewing the ethical standards of your research.
Barriers to or other unusual considerations about obtaining access to subjects.
Reduced ability to obtain informed consent.
Reduced ability to ensure privacy.
Different cultural views of the kinds of activities and information to which privacy concerns apply.
Acquisition and use of cultural property, both tangible and intellectual.
14.2b
Address how the work will be dealt with and what approvals have been or will be sought from the
community.
√
UWO NON-MEDICAL RESEARCH REB SUBMISSION FORM (VERSION – JANUARY 2002) Biological Spec
Page 1
SECTION 15 BIOLOGICAL SPECIMENS TO BE COLLECTED FROM SUBJECTS
INCLUDE THIS SECTION ONLY IF THIS ETHICS SUBMISSION REQUIRES BIOLOGICAL
SPECIMENS TO BE COLLECTED FROM THE RESEARCH PARTICIPANTS.
√
15.1a
Indicate which biological specimens will be collected for the purposes of
the research?
If you are collecting specimens other than those listed here,
the protocol must be submitted to the Health Sciences
Research Ethics Board for review. (see the web site
www.uwo.ca/research/ethics for the correct forms)
Blood
Hair
Nail clippings
Saliva/Sputum
Sweat
Urine
Faeces
15.1b
If YES,. describe what samples will be taken and what they will be used for.
15.2b
If YES, indicate how much will be taken and how it will be collected.
15.2c
If YES, explain how and where the samples will be stored.
15.2d
If YES, describe how and when the samples will be destroyed.
15.1c
Discuss any biohazard issues that are relevant.
15.2a
15.2b
Are any tissue or blood samples being taken for possible future genetic or other
studies?
If YES, describe what samples will be taken and what they will be used for.
15.2c
If YES, explain how and where the samples will be stored.
15.2d
If YES, describe how and when the samples will be destroyed.
15.2e
If YES, will there be a code that allows linkage of the samples back to
the original study and/or the subject’s records?
YES
NO
YES LINKAGE
POSSIBLE
NO LINKAGE
UWO NON-MEDICAL RESEARCH REB SUBMISSION FORM (VERSION – JANUARY 2002) Contract & Industry Page 1
SECTION 16 CONTRACTS & INDUSTRY SPONSORED PROTOCOLS ONLY
COMPLETE AND INCLUDE THIS SECTION ONLY IF THE PROJECT IN THIS ETHICS
SUBMISSION IS FUNDED BY A CONTRACT OR AN INDUSTRY SPONSOR.
16.1
Ethics Review Fee
The University requires an administration fee for contract and industry sponsored protocols
submitted for ethical review. Receipt of this fee will be required before the Research Ethics Board
(REB) will permit the study to commence. Please indicate to whom the invoice should be sent and
include any project references e.g. study number that should be included on the invoice. Due to the
fact that most companies require original documentation, the invoices will be mailed rather than faxed.
Company or Institution
Contact Person
Mailing Address
Telephone Number
Fax
Additional invoicing information
If you feel that due to extenuating circumstances, the REB fee should be waived or adjusted, provide a brief
written explanation to the Office of Research Ethics prior to the submission of this protocol. Do not assume that
prior waivers or discounts will also apply to this submission. (Email ethics@uwo.ca or write to Director - Office
of Research Ethics Room DSB 00045 UWO)
16.2a
16.2b
16.2c
16.2d
16.2e
16.2f
Possible Conflict of Interest
YES
Are any of the investigators or their immediate families receiving any direct personal
remuneration (including investigator payments and recruitment incentives) for taking
part in this investigation?
Is there any compensation for this study that is affected by the study outcome?
Do any of the investigators or their immediate families have any proprietary interests
in the product including patents, trademarks, copyrights and licensing agreements?
Do any of the investigators or their immediate families have equity interest in the
sponsoring company?
Do any of the investigators or their immediate families receive significant payments of
other sorts from this sponsor (e.g. grants, compensation in the form of equipment or
supplies, retainers for ongoing consultation and honoraria)?
Are any of the investigators or their immediate families members of the company’s
Board of Directors (or comparable body).
NO
16.3
If YES to any of the above please describe the arrangement and discuss the implications of a potential
conflict of interest. If a conflict of interest cannot be eliminated, what the arrangement is and how that
conflict is being managed should be disclosed in the Letter of Information. The document should
explain what additional protections have been put in place to protect the study subject.
16.4a
Are there any publication restrictions with regard to this project?
16.4b
If YES, please describe.
YES
NO