McMaster Student Research Ethics Committees

c/o Office of Research Services, SREC Secretariat, GH-306, x23142, e-mail: ethicsoffice@mcmaster.ca

UNDERGRADUATE STUDENT APPLICATION TO INVOLVE

HUMAN PARTICIPANTS IN RESEARCH

Please complete and submit 5 paper copies or 1 paper copy plus e-mail attachment to:

Chair of appropriate Student Research Ethics Committee (SREC) or MREB Secretariat, as applicable.

Please answer every question. If a question does not apply to your protocol, write "Not Applicable".
 UNDERGRADUATE INVESTIGATOR(S)* ADDRESS PHONE NO. E-MAIL
Janet Jason 981 Main St. W. #101 525-1234 Jason
(co-students would put names here) THIS FORM IS FOR INDEPENDENT STUDY OR HONOURS THESIS FACULTY MUST USE THE COURSE-BASED STUDENT APPLICATION FOR THE WHOLE CLASS
FACULTY INVESTIGATOR(S) COURSE PHONE # /EXT E-MAIL
Dr. Jane Doe Women’s Studies

4D06

23142 doej
(name of other faculty if necessary)

TITLE OF RESEARCH PROJECT:
A Study of Women Public Broadcast Announcers at the CBC (Titles should be short if possible)
Expected starting date: ASAP but research can’t start until approved by a REB, so anticipate 2-3 weeks waiting time! Day Month Year Expected completion date: A student thesis has to finish before the end of term or end of year in general

(Please refer to the Student Research Ethics Committees prior completion of form. Find out the Student Research Ethics Committee to which you must apply)


Is this an amendment to a previously approved protocol? Yes X No

Approval number:_________ Previous Title:__________________________________
If it’s an amendment, the approval number will be like MREB#2000 150 Has this research project been approved by the McMaster University Research Ethics Board, or another Ethics Committee where the research will occur? Yes X No

It is unlikey an undergrad has submitted a protocol for ethics review before, but just in case…

If yes, there is no need to provide further details about the protocol, but please provide the following details:

TITLE OF RESEARCH PROJECT APPROVED ELSEWHERE:

 
Principal Investigator: Name of Ethics Board: 
Address: Phone:  E-mail:
Contact Person: (If not the McMaster Research Ethics Board)

  1. SUMMARY OF PROPOSED RESEARCH:
  1. Briefly state the purpose of the research.
  2. Describe in detail what will happen from the participant's perspective in lay terms. Append a copy of questionnaire(s) or test instrument(s).
These text boxes can be adjusted for size before printing to save paper.

State the purpose of the research here.

Attach any samples of questionnaires or surveys referred to in the purpose.

Here are some sample materials, such as an information letter and consent form from the University of Waterloo Research Ethics Office.

Consent forms are another example of an attachment to this form.

Ethics Reviewers see from the point of view of the participants. They are looking for anything that is more than minimal risk (Check link for Tri-Council Policy on Minimal Risk) to them.
 
 
 
 

 
Does the study involve the administration of any substance? Yes X No
Do any of the procedures involve contact with the body (e.g. touching, attachment to instruments, collection of specimens)? Yes X No
Perhaps this question is more appropriate for psychology or other sciences but reviewers of ethics applications need to know if the research involves any physical risk to participants. These questions might flag an application as being more than minimal risk and not appropriate for an undergraduate ethics committee to review

2. PARTICIPANTS INVOLVED IN THE RESEARCH:

  1. Describe the salient characteristics of participants - age range, sex, institutional affiliation or where located.
  2. Describe how participants are to be recruited and number needed. Attach recruitment notice or letter, if applicable.
  3. Describe the relationship between the investigator(s) and the participant(s) (e.g. student peers, my club group, my relatives, no relationship).
  4. Will participants be compensated for their participation? If so, how?
A recruitment letter needs to clearly identify the researcher and the researcher institution. It needs to outline in easy to understand language the benefits and risks, if any, of the study, as well as the procedures and any remuneration. 

3. ESTIMATE OF THE RISKS OF THE PROPOSED RESEARCH:
 
a) Is there any physical risk? Yes X No

 


 
b) Is there any psychological risk? (Might a participant feel demeaned, embarrassed, worried or upset? (Could participants be fatigues or stressed?) Yes X No
c) Is there any social risk? (Possible loss of status, privacy and/or reputation?) Yes X No
d) Do you see any change that participants might be harmed in any way? Yes X No
e) Is any deception involved? Yes X No
f) Are the risks similar to those encountered by the participants in everyday life? Yes X No

More than minimal risk undergraduate applications will be reviewed by the main McMaster Research Ethics Board. The department student research ethics committee (SREC) will try to work with the student to minimize concerns before forwarding the application to the main Board.

If the answer is YES to any of the questions under section 3, please explain why alternative approaches involving less risk cannot be used. Procedures for reversing reversible harm should be stated.
 

Deception can be a valid research tool, since some research would be nullified if it wasn’t used, and there is no problem if it is of minimal risk.

The key point about risk, according to the Tri-Council, is risk that is "similar to those encountered by the participants in everyday life." 

In a future draft of this application, even if the researcher chooses NO, they must still explain here why they chose NO. There are often unanticipated risks, like shame or embarrassment, which doesn’t take into consideration the dignity or respect of the participants.

If a student researcher checks YES to all of the above it is likely that the application would be considered "more than minimal risk" and would not be reviewed by a department student research ethics board. Instead, it would be forwarded to the McMaster Research Ethics Board.

Reviewers use this form to determine if the application is a case of minimal risk or not. This is the area where the "red flags" usually go up. Even if a researcher marks "No" the reviewers may think otherwise, so it is best to explain why you are saying No as well as Yes. If you are concerned that by saying Yes to Psychological Risk for example, you are placing your research in a more than minimal risk category, explain how this risk can be minimized or controlled. If you can not satisfy to the committee that the research is worth doing in spite of this risk, the committee will try to work with you to modify some aspect of the design until they are satisfied that the risk is justifiable. By justifiable is meant that the human participants are being protected with all due regard to their dignity and well being.

4. ESTIMATE OF THE BENEFITS OF THE PROPOSED RESEARCH:

What are the likely benefits to the student researcher, the participants, the scientific community, and/or society that would justify asking participants to participate? Types of answers that might be appropriate:

Student researcher: increase understanding of research methods and cognition;

Participants: no direct benefit, although I will be available to answer questions about memory;

Scientific community: the study may provide insights into how memory changes with age; none, because I will be replicating a well-known phenomenon;

Society: better understanding of memory may lead to effective memory training programmes; none, because I will be replicating a well-known phenomenon.
 

The above are just "Types of Answers" that a student researcher in Psychology might use. In this box many applicants follow the above suggestion in this format:

STUDENT RESEARCHER: Say here that the student is learning about research methods and procedures and increasing knowledge about a particular field of interest.

PARTICIPANTS: If there are no particular benefits to the participants say so. But if part of the research is some form of output or publication, there may be something of interest to the participants who will want to share in the research results. 

SCIENTIFIC COMMUNITY: Pure research will advance knowledge and lead to new insights to our society. So there is a possibility genuine results can be achieved. However, be honest if the results of the research will only be to satisfy a course requirement, verify previously conducted research, or is just an exercise in research learning.

SOCIETY: It’s not all research that will ultimately be of benefit to society. Research that leads to better understanding is well worth while. Just replicating other research work will not shed any new light, but there could be intangible benefits.

 

5. PLAN FOR OBTAINING INFORMED CONSENT:

a) Attach a description of the verbal explanation to be given to participants before they are asked to consent to participation.
Attach any consent form (see instructions). If there will not be a consent form, explain why not.
 

As the Tri-Council Policy Statement says "free and informed lies at the heart of research involving human subjects."

A consent form must be submitted for each subject population. For example, using a control group will require two consent forms. 

A verbal consent form may suffice out of respect for some culture groups.

A verbal consent and a written consent are often required.

These are necessary attachments if any kind of consent if needed.

There are many elements for a valid consent form. Consult the Ethics in Human Research Website for samples of consent forms.

If no consent form is required, explain why. This could also be an indication that only secondary data is being used so there is no need to submit an ethics application.

b) Are participants minors or for other reasons not competent to consent? Yes No X

If so describe the alternate source of consent.
 

If subjects are mentally not competent, there is more reason for a consent form to be signed by legally recognized authorities or guardians. Research involving minors, (under eighteen years of age) requires the written consent of parents or legally recognized guardians. 

A verbal consent form will also be needed which explains in easy to understand language, the methods, procedures, harms and benefits (if any) of the research. It should at least try to accommodate the level of understanding of the participants.

c) Do participants have the right to withdraw at any time during the research project? If no, explain below. How and when are participants informed of this right?
 

It is very important that participants do not feel coerced into participating in the research. If data is taken during the research and the participant withdraws, they should be told what will happen to the data. They should be allowed to withdraw from the research for whatever reason they wish. They should be told about the risks and benefits of the research in order to make an informed choice as to whether they want to participate. They should be told they have the right to withdraw before the research begins, in verbal and written form, as the case may be.

 d) What procedures will be followed for participants who wish to withdraw at any point during the study? e.g. the procedure will be stopped immediately; participants will be thanked and debriefed; any questions or concerns will be addressed; participants will/will not receive the same compensation as if they had completed the procedure; data collected up to that point will/will not be destroyed.

Given that participants may elect not to complete the research, the study must outline how the data gathered so far will be treated. Participants may have a right to have the data gathered be destroyed or invalidated. Or, they may have the right to complete the study at a later time.

How will the research be stopped and how will the subjects be debriefed? If there is any output of the research, will the subjects be able to access that? Do they contact information from the researchers? What is the form of the debriefing? Who does the debriefing?

6. STEPS TO BE TAKEN TO ENSURE CONFIDENTIALITY OF DATA:
a) Will the data be treated as confidential? X Yes No

 

If yes, explain the steps that will be taken to ensure confidentiality of the data (e.g. participants’ names will not be recorded; participants will be referred to by initials or other code). If no, explain why and how participants’ agreement will be obtained.
 

Data will be locked in a cabinet in the supervisor’s office.

Data will be recorded without identifying the subjects.

After six weeks the data on the diskettes will be erased.

Names will not be used. There will be code numbers instead to perserve anonymity of data.

Participants have consented to being identified but are ensured that all information pertaining to the research will be kept confidential.

Participants will be allowed to examine the results of the study before it is released and may then elect not to have themselves identified.

b) If the data are not anonymous, where will the data be stored, and who will supervise access to the data?

Anonymity and confidentiality are two different things. Anonymous data does not identify the subjects. Data that identifies subjects must be treated as confidential. Subjects have a right to know how the data will be kept confidential. Data on diskettes must be protected. Storage of data in secure filing cabinets protects the confidentiality of the subjects. Who has access to the data? Assure the participants that only the supervisor or other qualified individuals have access to the data. 

7. PARTICIPANT DEBRIEFING:
a) Will participants be debriefed fully at the end of the research project? If yes, explain how this will be done. If no, explain why not. Yes X No

b) If the participants are interested in the results of the study, will these be available? If yes, explain how. X Yes No

On the consent form or information letter, you have given contact information for the participants to reach if you have told them that they have the right to review the results of the study.

Make sure the participants have a copy of the consent form with the contact information.

Some complicated research methods don’t fully explain the purpose of research to the participants and therefore it is necessary to have a clear debriefing procedure to inform the participants of the nature of the study. 

In addition to the completion of this application, what steps will be taken to make the Undergraduate Investigator more sensitive to ethical issues relevant to the proposed research?
 

A supervisor can outline here how much class time was devoted to teaching about research ethics, what materials were consulted, or workshops attended. The supervisor should work with the student on this ethics application.

A student can relate any training or study in the areas of ethics and research they may have received, or previous experience.

Anything relevant to research ethics, especially knowledge of Codes of Ethics like the Tri-Council Policy Statement, is very beneficial.

In submitting this form, I certify that the information provided accurately describes how the research will be conducted.

BOTH FACULTY RESEARCHER AND STUDENT MUST SIGN THIS!

SIGNATURES:

Faculty Supervisor Student Investigator
Jane Doe Janet Jason

Q:\web\ors-web\ethics\undergradethicsguide.htm Revised Feb. 01