All research, funded or not, involving the use of human subjects must be reviewed and certified as acceptable by the appropriate University Research Ethics Board.
It is the researcher's responsibility to ensure that there is adequate lead-time available for ethical review in relation to other deadlines.
Note: Retroactive certification will not be granted.
All data collected without certification is invalid and cannot be used by the researcher.
ABOUT THE APPLICATION FORM
The General Research Ethics Board (GREB) Application Form is intended as a guideline for the information required by the GREB for its ethics review and to reduce the amount of photocopying and paperwork submitted.
Please put enough information on this form to provide the reviewers with a synopsis of your intended research proposal/project so that your application can be reviewed effectively and expeditiously. The form is meant to replace a fully developed proposal (e.g., a grant application completed for a particular funding agency).
GUIDE TO COMPLETING AN APPLICATION (Information regarding consent procedures, follows)
The total length of your application should not exceed the space provided on the form plus the required attachments. However, if your proposal contains controversial elements, you may wish to attach a complete copy of the actual research proposal as an appendix or additional pages.
Answer every question. If a question does not apply to your protocol, indicate "not applicable". The numbering of the instructions corresponds to the numbering on the form.
The GREB Ethics Certification extends only to those individuals who have a current Queen's University affiliation (for example: student, faculty, staff)
Co-Applicants whether at Queen's or other institution. If persons other than those who are members of Queen's University are involved in the research, please provide, their names, organization/employer, affiliation and other details that may be necessary to identify them.
It is possible for all applicants and co-applicants on any given research project to receive certification on one joint application. However, any related individual not covered in the original certification must be identified for reporting purposes in the regular application process. Changes that affect the work described in the original application may be addressed by an amendment.
If you are a student applicant, be sure to include the name and email address for your supervisor as well as his or her signature in Section 9.
2.0 PROJECT TITLE: Provide the exact title of your project.
3.0 PROJECT DETAILS
3.1 Abstract: Summarize the purpose, objectives and aims of the research and the study methodology. Maximum length 300 words.
3.2 Method: Two additional pages can be appended.
Remember: Include a copy of your questionnaire(s) or test instrument(s).
If you are doing preliminary research in order to develop such research instruments, please contact the GREB for advice on how to proceed.
3.3 Location(s) of the research: Indicate where the data will be collected.
Particular care should be taken when your data are collected in another country. Some examples of information that is helpful to the REB when considering work conducted outside its jurisdiction are:
• Confirmation of collaboration, official sponsorship or active involvement with an international agency such as the United Nations, CIDA, IDRC and so forth.
• Confirmation of collaborative linkages with a scholar or institution in the host country.
• Authorization at an appropriate local level, if applicable.
3.4 Other permissions/approvals: Queen's University ethics clearance does not replace or grant these permissions. If the research is being undertaken at another site, it is the researcher's responsibility to ascertain what is required, and to secure these necessary approvals / permissions, as well. Specify the approvals sought.
Some examples include, but are not limited to: other REBs or a less formally structured process at another university, permission from a First Nations Band Council, a school board, daycare center, a private company, and so forth.
Expect that obtaining these additional permissions could have an impact on the timeline, and plan accordingly.
Research involving a school system:
Permission to access subjects in a school system must have the approval of the respective Board or Boards before the research may commence.
Researchers whose project involves the Limestone public and/or Catholic school system may wish to contact the respective Boards for information and advice in this regard. Separate application forms and deadlines apply.
4.0 RECRUITMENT OF PARTICIPANTS
4.1 - 4.3 Describe who your recruits are, what "type" of participant will be involved (e.g. minors [under 18 years], students in classes, employees examined in their workplace, prisoners, experts, professionals or managers in a given field, and so forth). Are they participating as expert informants? Are these individuals vulnerable for any reason?
If a specific group is to be chosen, your selection criteria should be clearly identified (e.g. age, gender, race, education, religion, specific status such as fellow students, learning disabled, etc.).
Describe your method / steps / procedures that you will use to obtain your participants.
4.4 Number of participants anticipated.
4.5 Source of participants: e.g.Queen's Psychology subject pools, faculty/staff, community, schools, daycares etc.
4.6 Copy of recruitment method: notice, ad, information sheet.
4.7 Remuneration / Compensation: Will there be any remuneration or compensation? If yes, specify how much or what form will it take. How will payment/compensation be determined for individuals who do not complete the study? Comment on how you have mitigated any coercion or influence that this could exert on an individual.
The researcher must state what resources are available to meet these financial obligations.
Remember: Include a copy of your recruitment notice, advertisement, covering letter, or information sheet as well as that used by a sponsor or supportive organization, if applicable. Describe any special provisions that have to be made to accommodate the participant's language requirements.
4.8 What procedures will be followed for people who wish to withdraw at any point during the study? What happens to the data they have contributed to this point?
Example: the procedure will be stopped immediately; data collected up to that point, will/will not be destroyed; people will be thanked and debriefed; any questions or concerns will be addressed; participants will/will not receive the same compensation as those completing the procedure.
4.9 Do you plan follow-up procedures with people? If yes, what are they? Does your field of study require formal debriefing? If yes, describe the procedures you will use.
5.0 ASSESSMENT OF RISKS
Risk can occur in a number of ways:
As per the Tri-Council Policy, minimal risk occurs when the potential subjects can reasonably expect that by participating in the research, the probability and magnitude of possible harms will be no greater than those encountered by the subject in his or her everyday life. See also Section 9, the University's Ethics Review of Research Involving Human Subjects Policy Statement for more detail.
When responding to this question, you should ask yourself, are the risks reasonable in relation to the benefits? Consider the following:
• Is there a physical risk to the participant?
If one or more elements is/are identified as more than minimal risk, the proposal must be reviewed in a face-to-face meeting of the GREB members.
If a more-than-minimal-risk application is submitted by the researcher to Research Services by the first week of a given the month, the applicant can expect to receive notification at or before the end of the same month.
Provisions for Support
What precautions have been taken to manage/minimize the risk: Are the risks reasonable in relation to the benefits?
If the protocol has the potential to upset, distress or disturb individuals, arrangements to mitigate such effects and the provision for support must be described.
The researcher must, at the outset, advise the participant what support services are available (e.g. University Counselling and Student Development Center, referral to an appropriate agency) and whether there is a cost that will be incurred by the participant.
Whenever possible, the researcher is urged to determine optional services that may be voluntary (e.g. the family physician, other appropriate government/community based agencies) versus fee-for-service options.
If your study has the potential to identify upset, distressed or disturb individuals, you must describe the arrangements you have made (if any) to assist these individuals. Have participants been informed of any cost to be borne by them? If you have not made any arrangements, explain why.
What are the likely benefits to the researcher, the subjects and the research community and society, generally, that justifies asking people to participate?
Types of responses 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;
• Society: a better understanding of memory may lead to effective memory training programs.
7.0 PRIVACY: Confidentiality and Anonymity
The researcher will be held to the highest standards in terms confidentiality and anonymity. The researcher should familiarize him/herself with the best practices in this area.
• Is a focus group being conducted?
• Are you audio or video-taping?
• How large is the sample size?
• Is there an identifiable group?
• Are there unique and recognizable circumstances?
• Is there an obligation to inform (e.g. child abuse)?
If anonymity is optional, be sure to include provision in the consent form to have the subject initial the use of his/her name.
7.1 - 7.8 What steps will be undertaken to respect a person's privacy? Outline the precautions to be taken not only in terms of the raw data, but also in terms of the write-up of the results.
For example, a small sample size could, under some conditions, jeopardize participant privacy even if confidentiality procedures are in place.
7.8 Provide specific details about the security procedures for the data. Who will have access to the data, what are the plans for the storage and ultimate disposal of the records / data? Specify where, how, and for how long the data will be stored.
Note: Each Faculty has guidelines for the retention of original data and materials relating to scholarly activity. In the event your Faculty has no formalized policy, the minimum period for data retention accepted by the GREB is 2 years.
In some circumstances, it may be appropriate to deposit your data with an archive. This cannot be done without the permission of the subjects. Take this into consideration when seeking their consent to participate in your research.
8.0 INFORMED CONSENT
The objective of obtaining informed consent is to ensure adherence to the ethical principle of respect for persons. Please note, informed consent does not necessarily take the form of written consent, only.
ABOUT LETTERS OF INFORMATION AND CONSENT FORMS
The purpose of a written Letter of Information and Consent Form (or alternative information procedure) is to provide adequate information of the sort to enable a person to make a rational, informed decision as to whether he/she wishes to participate in the research study, or not.
In certain circumstances, written evidence of informed consent is not appropriate. Please check with the GREB if you think yours may be such a case. Some examples when it may not be appropriate to use written consent are: (a) when it is culturally inappropriate, (b) when the participant is illiterate, (c) there is a potential risk to the participant.
If written consent is not used, the alternative method that will be used must be described.
Whether written or an alternative approach is taken, informed consent must provide the kind of information that a reasonable person volunteering to participate would want to know in this situation.
Queen's University has mandatory components to a consent letter. When justified, the GREB may allow for alternative wording to be used.
• A copy of the consent form, covering letter, information sheets and so forth that you plan to use must accompany your application.
• You must work with two copies of the consent form - one for you and one for the participant to keep.
• If you plan to use minors (persons under the age of 18 years), or dependent populations as subjects, provisions must be made for a person with the authority to sign the consent (e.g. parent, guardian, trustee, principal care-giver and so forth).
• The researcher will, as appropriate, explain to a child the research and his or her involvement. It is recommended that researchers include provision for the child to provide his or her assent to take part in the research as part of the consent procedures.
• Consent forms must be written in simple, direct language and use terms that the subject understands.
• Be sure that what is described in the consent form is consistent with the ethics application.
You may use any combination of the items on the consent form that might be relevant to your situation in order to create a consent form that is appropriate to the design and methodology of your research project.
Be sure to use active voice when creating your consent document(s), and be sure to check it over for grammar, spelling and typing errors.
What to include:
• The two mandatory sections indicated in the sample:
• Names of the researcher(s), institutional affiliations, and how to reach them for questions/clarification regarding the research and participation in the study (e.g. telephone numbers, email addresses).
Some form of identification clearly linking the research and the researcher to Queen's University must be used on consent forms, recruitment notices and/or other forms of documentation created for use in a research protocol. Normally, such identification is accommodated by the use of the University's letterhead, but researchers are not limited by or restricted to this means of identification. However, the REBs reserve the right to specify the form and nature of the identification, if necessary.
• The University's administrative contact and how to reach this person if the participant has concerns or a complaint about his or her treatment as a subject/participant/volunteer.
• The purpose of the study, described in layperson's terms.
• A precise description of what is expected of the participant. Include the time commitment and the frequency of contact. In other words, describe exactly what the researcher expects the participant to do. Sometimes incorporating a series of "check boxes" into the consent form is another way of explaining the choices for participation. (both the positive and negative option should be given)
• I agree to be video taped.
• I do not agree to be video-taped
• I grant permission to be quoted.
• I do not grant permission to be quoted
When using "check boxes" pay careful attention to the choice of language so as not to "lead" the subject.
• Describe any risks the participant may encounter.
For example: distress, inconvenience, psychological, social discomforts, fatigue, or physical safety issues that might be attendant upon participation.
Special attention must be taken in certain circumstances:
o If your study has the potential to upset, distress or disturb the participant, you must make arrangements to mitigate such effects. For example: referral to the University's Counseling & Student Development Centre, a social services agency and so forth. Describe the arrangements you have made in this regard. A letter from the agency, confirming their agreement to provide this assistance, is required before clearance is issued. You must indicate, up-front, whether a cost or not will be incurred by the participant.
• If your study has the potential to identify upset, distressed or disturbed individuals, you must describe the arrangements you have made (if any) to assist these individuals. If you are, in fact, not making any arrangements, please explain.
• If there are no known harms, this should be explicitly stated. For example, "there is no known risk associated with your participation in this research".
• Describe any recording devices (video, tape recorder) to be used. Do you have permission to use these devices? Will you transcribe the information or work from notes? Unless integral to the methodology, what is your rationale for using transcription?
• Describe the extent to which privacy and confidentiality will be protected. Will information be kept confidential? Will it be anonymous? If the researcher promises neither, this must be explicitly stated, and the potential ramifications for the participant described.
• Describe any benefits of the study. If there are no potential benefits to the participant, this should be explicitly stated. Wording such as "You will not benefit directly from participation in this research" is suggested.
If there are anticipated societal benefits or specific groups within society that might benefit, these potential benefits should be briefly explained, separately, so as not to confuse potential benefits to others with potential benefits to the participant.
• Detail any remuneration / compensation. Specify how much, or what form, it will it take. Also explain what payment/compensation will be given if the participant does not complete the study.
• People have the right to refuse to participate, and to withdraw from the study at any time and/or refrain from answering whatever question(s) he/she prefers to omit. This information must be explicitly stated. You may, in addition, wish to extend them the right to withdraw any information already provided. If appropriate to your methodology, reassure the subject that such withdrawal does not have an impact on their welfare or the services he/she may be receiving.
• Explain what happens to the information the participant has provided to that point.
• Do you plan follow-up procedures with subjects? Explain these plans.
• You must indicate to participants instances when you, as a researcher, may be obligated by law to report information revealed as a result of your research to law enforcement or another agency (e.g. child abuse, criminal activity).
CONSENT USING TELEPHONE AND MAILOUT QUESTIONNAIRES
There are two situations in which written consent forms are clearly counter-productive, namely, telephone surveys and mail-out questionnaires.
We recommend that comparable information be used in each of these survey situations, but without the requirement of signed consent. For example:
If an investigator is conducting a telephone survey, informed consent should take the form of a verbal explanation of the same points covered by written consent. The researcher's University affiliation, the purpose of the study, the fact that participation is voluntary, the time commitment being requested, and the manner in which confidentiality or anonymity will be guaranteed should be described.
Any combination of the other items on the consent form that might be relevant should also be included. All of this information can be provided briefly over the telephone, and respondents can give verbal indication of their consent to participate.
For telephone surveys of this type, we request that the "script" that provides the above information be submitted along with the research protocol.
When a totally anonymous questionnaire is planned, the situation is similar in that a signed consent form is not necessary. Instead, a covering letter should be provided that includes all the information ordinarily provided in a consent form.
It might also be useful to include a statement such as the following; "Your decision to complete and return this questionnaire will be interpreted as an indication of your consent to participate."
For questionnaires of this type, we request that the covering letter or alternative form be submitted along with the research protocol.
See samples on our webpage:
Projects of minimal risk and low ethical concern can be submitted for anytime for an expedited review. Normally, the initial review of an ethics application takes two weeks to complete; under ideal circumstances approval is possible in 3 weeks. Cases involving significant revision may take substantially longer.
Projects of higher risk and ethical concern and some international projects may be subject to full board review. Full reviews are conducted at the GREB monthly meeting. See the GREB schedule for dates.
It is in the best interests of researchers to inform the GREB about any significant delays in the start date of the research. In some circumstances, it may be possible to delay requests for extensions and final reports.
The GREB Ethics Certification is issued for twelve months, after which, if the research is on-going, it must be renewed annually. A renewal form will be sent from the GREB office prior to the anniversary date.