McMaster University Research Ethics Board (MREB)

McMaster University Research Ethics Board (MREB)

FACULTY AND GRADUATE

Application to Involve Human Participants in Research

[Behavioural / Non- Medical]

SAMPLE APPLICATION FOR TIPS AND TRAPS TUTORIAL

Please refer to the McMaster University Research Ethics Guidelines and Researcher’s Handbook, found at http://www.mcmaster.ca/ors/ethics/faculty_guidelines.htm prior to completion and submission of this application. If you have questions about or require assistance respecting completion of this form, please contact the Ethics Secretariat at ext. 23142, or ethicsoffice@mcmaster.ca

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Send this form and all accompanying material in quadruplicate if being submitted in hard-copy. If submitting by e-mail, send the application plus attachments, and forward the original signed signature page to the Ethics Secretariat, Office of Research Services, Room 306 Gilmour Hall, ext. 23142, ethicsoffice@mcmaster.ca.
If you want to change a previously approved protocol, please complete the “Change Request” form http://www.mcmaster.ca/ors/ethics/faculty_forms.htm.

Date:

Application Status: New Change Renewal

Protocol#:

SECTION A – GENERAL INFORMATION

1. Title of the Research Project:

2. Investigator Information

	Name	Dept./Address	Phone No.	E-Mail
Faculty Investigator
Faculty Co-Investigator(s)

Student Investigator(s)
Student Faculty Supervisor

3. Proposed Date (a) of commencement: (b) of completion:

4. Indicate the location(s) where the research will be conducted:

McMaster University

Hospital Specify Site

Community Specify Site

Other Specify Site

5. Other Research Ethics Board Approval

(a) Is this a multi-centred study? Yes No

(b) Has any other institutional Ethics Board approved this project ? Yes No

(c) If Yes, there is no need to provide further details about the protocol at this time, provided that all of the following information is provided:

Title of the project approved elsewhere:

Name of the Other Institution:

Name of the Other Board: Date of the Decision:

A contact name and phone number for the other Board:

A copy of the application to the other institution together with all accompanying materials

A copy of the clearance certificate / approval

If all of the above information cannot be provided, please complete the balance of

this application.

(d) Will any other Research Ethics Board be asked for approval? Yes No

If yes, please specify

6. Level of the Project

Faculty Research Post-Doctoral PhD.

Masters Faculty/Hospital Research

Other (specify)

7. Funding of the Project

(a) Is this project currently being funded Yes No

(b) If No, is funding being sought Yes No

(d) Agency or Sponsor (funded or applied for)

CIHR NSERC SSHRC ARB

NIH Other (specify):

8. Conflict of Interest

(a) Will the researcher(s), members of the research team, and/or their partners or

immediate family members:

(i) receive any personal benefits (for example a financial benefit such as

remuneration, intellectual property rights, rights of employment, consultancies,

board membership, share ownership, stock options etc.) as a result of or

connected to this study? Yes No

(ii) if Yes, please describe the benefits below. (Do not include conference and

travel expense coverage, possible academic promotion, or other benefits which

are integral to the conduct of research generally).

(b) Describe any restrictions regarding access to or disclosure of information (during

or at the end of the study) that the sponsor has placed on the investigator(s).

SECTION B – SUMMARY OF THE PROPOSED RESEARCH

9. Rationale

Describe the purpose and background rationale for the proposed project, as well as the hypotheses(is)/research questions to be examined.

10. Methodology

Describe sequentially, and in detail, all procedures in which the research participants will be involved (e.g. paper and pencil tasks, interviews, surveys, questionnaires, physical assessments, physiological tests, time requirements etc.)

N.B. Attach a copy of all questionnaire(s), interview guides or other test instruments.

11. Experience

What is your experience with this kind of research?

12. Participants

Describe the number of participants and any salient characteristics (such as age, gender, location, affiliation, etc.)

13. Recruitment

Describe how and from what sources the participants will be recruited, including any relationship between the investigator(s) and participant(s) (e.g. instructor-student; manager-employee).

N.B. Attach a copy of any poster(s), advertisement(s) or letter(s) to be used for recruitment.

14. Compensation Yes No

(a) Will participants receive compensation for participation?

Financial

In-Kind

Other (specify)

(b) If yes, please provide details.

SECTION C – DESCRIPTION OF THE RISKS AND BENEFITS OF THE PROPOSED RESEARCH

15. Possible Risks

1. Indicate if the participants might experience any of the following risks:

a) Physical risk (including any bodily contact or administration of any

substance)? Yes No

b) Psychological risks (including feeling demeaned, embarrassed

worried or upset)? Yes No

c) Social risks (including possible loss of status, privacy and / or

reputation)? Yes No

d) Is there any deception involved? Yes No

e) Are any possible risks to participants greater than those the

participants might encounter in their everyday life? Yes No

2. If you answered Yes to any of a – e above, please explain the risk.

3. Describe how the risks will be managed (including an explanation as to why alternative approaches could not be used).

16. Possible Benefits

Discuss any potential direct benefits to the participants from their involvement in the project. Comment on the (potential) benefits to (the scientific community) / society that would justify involvement of participants in this study.

SECTION D – THE INFORMED CONSENT PROCESS

17. The Consent Process

Describe the process that the investigator(s) will be using to obtain informed consent, including a description of who will be obtaining informed consent and a script of what they will say, if anything.

Indicate how consent will be documented. Attach a copy of the Letter of Information if applicable and the consent form if applicable. If there will be no written consent, explain why not and describe the alternative means that will be used to document consent. Attach the content of any telephone script that will be used in the consent process (if applicable)

For information about the required elements in the letter of information and the consent form, please refer to “Instructions for the Preparation of an Information Letter/Consent Form”: http://www.mcmaster.ca/ors/ethics/faculty_checklists_instruct.htm

18. Consent by an authorized party

If the participants are minors or for other reasons are not competent to consent, describe the proposed alternate source of consent, including any permission / information letter to be provided to the person(s) providing the alternate consent.

19. Alternatives to prior individual consent

If obtaining individual participant consent prior to commencement of the research project is not appropriate for this research, please explain and provide details for a proposed alternative consent process.

20. Debriefing (Participant feedback)

Explain what feedback/ information will be provided to the participants after participation in the project. (For example, a more complete description of the purpose of the research, access to the results of the research).

N.B. Please provide a copy of the written debriefing form, if applicable.

21. Participant withdrawal

a) Describe how the participants will be informed of their right to withdraw from the project. Outline the procedures which will be followed to allow the participants to exercise this right.

b) Indicate what will be done with the participant’s data and any consequences which withdrawal might have on the participant, including any effect that withdrawal may have respecting participant compensation.

c) If the participants will not have the right to withdraw from the project, please explain.

SECTION E – CONFIDENTIALITY

22. a) Will the data be treated as confidential? Yes No

b) Describe the procedures to be used to ensure anonymity of participants or confidentiality of data both during the conduct of the research and in the release of its findings.

c) Explain how written records, video/audio tapes and questionnaires will be secured, and provide details of their final disposal or storage.

d) If participant anonymity/confidentiality is not appropriate to this research project, explain, including providing details of how all participants will be advised of the fact that data will not be anonymous or confidential.

SECTION F -- MONITORING ONGOING RESEARCH

23. Annual Review and Adverse Events

a) Minimum review requires the completion of a “Renewal/Project Completed” form at least annually. Indicate whether any additional monitoring or review would be appropriate for this project.

It is the investigator’s responsibility to notify the REB using the “Renewal/Project Completed” form, when the project is completed, or if it is cancelled. http://www.mcmaster.ca/ors/ethics/faculty_forms.htm

b) Adverse events (unanticipated negative consequences or results affecting participants) must

be reported to the REB Secretariat and the MREB Chair, as soon as possible and in any event,

no more than 3 days subsequent to their occurrence.

24. ADDITIONAL INFORMATION

(Use an additional page if more space is required to complete any sections of the form, or if there is any other information relevant to the project which you wish to provide to the Research Ethics Board.)

SECTION G – SIGNATURES

Faculty Investigator Assurance:

“I confirm that I have read the McMaster Research Ethics Board Guidelines for Research with Human Participants and I agree to comply with the conditions outlined in the Guidelines”.

Signature of Faculty Investigator Date

Faculty Supervisor Assurance: For undergraduate students and graduate students where the supervisor is the primary supervisor for a thesis:

“I confirm that I have read the McMaster Research Ethics Board Guidelines for Research with Human Participants, and I agree to comply with the conditions outlined in the Guidelines. I have read the application and proposal and deem the project to be valid and worthwhile, and I agree to provide the necessary supervision of the student(s) and to make myself available should problems arise during the course of the research.”

Signature of Faculty Supervisor Date

Signature of Graduate Student Date

Faculty Supervisor Assurance: For graduate students where the supervisor is not the primary supervisor, and where the research is not for a graduate thesis:

“I confirm that I have read the McMaster Research Ethics Board Guidelines for Research with Human Participants, and I agree to comply with the conditions outlined in the Guidelines. I have read the application and proposal and deem the project to be valid and worthwhile, and I agree to make myself available for consultation should problems arise during the course of the research.”

Signature of Faculty Supervisor Date

Signature of Graduate Student Date