Guidelines for Completing the Application Form
Your application should be completed in accordance with the core principles of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2): Respect for Persons, Concern for welfare, and Justice.
Please submit an electronic copy of your completed application form to the ICEHR at email@example.com, and include all related documents (recruitment and/or information scripts, consent forms, etc). Please do not submit a paper copy of your application. Only the Section D Signature page must be submitted with original signatures.
If your project has already been reviewed and approved by another research ethics board (REB), please provide the Committee with a copy of the application which was reviewed, and the documentation stating the outcome of that review. It is not necessary to submit another application using the ICEHR application form.
The guidelines below are to be used to inform and assist you in preparing your application form. Do not attach an additional text proposal.
Summary of the Proposed Research [application form, section B, #s 1, 2, 4]
Please provide the Committee with enough information about the proposed research so that the ethical issues can be considered in context.
- Rationale and Purpose / Research Questions / Expected outcome of the study.
- Research plans and methods, including target population and/or sample; estimated sample size; sampling method; type of research design; data analysis plan.
Clearly explain the proposed research so that it may be understood by members of the ICEHR who are from varied disciplinary backgrounds, including community representatives. Assume that you are communicating with readers who may be unfamiliar with discipline- or profession-specific practices and jargon.
Please keep in mind that the ICEHR reviews hundreds of proposals each year. Do not submit a full research proposal (e.g., a grant proposal, a thesis proposal) such as might be used for in-depth academic assessment of a research project, unless you are specifically requested to do so by the Committee.
Scholarly Review (TCPS 2, Article 2.7) [application form, section A, #10]
The ethics review process for research that is beyond minimal risk will incorporate a determination of the project’s scholarly merit. Normally the ICEHR will not require minimal risk research projects to be peer-reviewed. The ICEHR does not duplicate previous scholarly review, but may request the researcher to provide full documentation of such review.
The ICEHR will assume that research proposals prepared for presentation to the three national granting councils (CIHR, NSERC and SSHRC), as well as to other funding agencies, will be subjected to scholarly review before funding is granted. For theses, honours essays, and internship research proposed by students, the ICEHR will accept the signature of the academic supervisor as evidence that the proposed research has been given scholarly approval by the academic unit.
In some circumstances, the ICEHR may require that scholarly review be carried out on research that would not otherwise be subject to such review. The ICEHR may establish an ad hoc independent external peer review committee for the assessment of scholarly or academic merit.
Each of the topics indicated in boldface must be addressed in your application. They are interconnected and none should be taken or applied in isolation. Some are also addressed in Memorial University’s Policy on Ethics Involving Human Participants. Careful attention to these issues will help you to provide the ICEHR with the information needed to assess your proposal and its compliance with the TCPS 2. This should increase the likelihood that your review will be straightforward and successful.
Harms and Benefits (TCPS 2, Chapter 2, Section B, pages 22-25)
- Harms [application form, section C, #2 and section B, #5]
Harms come in a variety of forms, including physical, psychological, social and financial. Care should be taken not to underestimate or overestimate a study’s potential for harm. In explaining the risks involved in participating in a project, it is important to provide potential participants with a clear explanation of the potential for harm, and not to understate the risks. For example, if the research could be used in making a decision that may affect the participants in a negative way (actual or perceived), it is important to inform potential participants of this possible negative outcome. It will not always be practical for researchers to specify all the possible harms posed by a project, and some may be remote and minor. During the consent process, potential participants should be fully informed about possible harms.
An assessment of potential harm cannot be based only on the information that researchers intend to collect. Participants may provide unexpected information, and questions may sometimes be upsetting to them. The Committee carefully considers the experience and expertise of researchers or research staff involved in data collection which may elicit strong emotional reactions. If the researcher does not have counselling expertise, or is unable to provide the necessary support, it is expected that you will put in place a process for immediate referral to such a person. This should be explained in your application for ethics review and in the information given to participants, such as recruitment and consent documents.
- Benefits [application form, section C, #1]
As with harms, the most important consideration is that the benefits of participating in a study are presented accurately. If, for example, participation in the research is expected to be enjoyable, this should be mentioned, but not oversold; the benefits of participating in a study should not be over-represented. Any inappropriate inducement to participate will interfere with the legitimacy of a participant’s voluntary and informed consent to take part in the study.
Free and Informed Consent (TCPS 2, Article 3.1) [application form, section C, #3]
The basic principle of ethical research is that everyone in the target study group should participate in the research voluntarily and with full information about what the research involves. The application of this principle, however, can be extremely complex and sometimes contentious, and requires careful consideration of the following:
- Competence (TCPS 2, Articles 3.9 and 4.7) [application form, section C, #3c]
Determining competence to provide consent can be particularly challenging, especially if participants are drawn from potentially vulnerable populations such as the very young, elderly, and/or poor, and/or those who have impairment of their mental health.
- Parental or third-party consent (TCPS 2, Article 3.10)
Participation in research by anyone who is not competent by reason of age or mental ability to provide free and informed consent is subject to the consent of a competent parent or legal guardian. In such cases, if the participant is capable of understanding the objectives and consequences of the research, his or her assent should be obtained, in addition to the consent of the guardian. If your research involves children or others whose competence to consent to participate may be questioned, you must discuss your proposed treatment of this issue in your application.
- Age of consent [application form, section B, #3f]
Unlike some other Canadian provinces, the age of legal consent in Newfoundland and Labrador is 19 years of age, and 19 is therefore the age for consent to participate in research. However, in the case of "mature minors" or "emancipated minors" (i.e., those who have withdrawn from parental care) the law allows that they have the ability to provide consent. The courts have also respected the wish of minors to withhold consent, even where a parent (or a person acting in loco parentis) has consented. Researchers are responsible for ensuring that they adhere to the relevant legislation in the jurisdiction where they are collecting data. They should normally provide children and youth with as much opportunity for consent as is appropriate to their level of competence, along with parental consent.
- Free Consent (TCPS 2, Article 3.1.a ) [application form, section B, #s 4 and 6]
Participants must agree to take part in the research freely and without coercion or special inducement. In some circumstances, for example, very poor people might be induced by money to participate in activity that they would otherwise reject. In other cases, the request to participate might come from a person in a position of authority over the potential participants, or the researcher might be in a position to withhold or provide rewards or services. This does not mean that the research cannot be undertaken. However, if your research involves the possibility of coercion or inducement, or the perception of this, you should discuss it and describe steps that you will take to minimize or eliminate the effect.
In order for the ICEHR to assess free consent, please include a full description of the recruitment process, including advertisements, letters, and scripts/guides of personal communications with your application.
- Informed Consent (TCPS 2, Article 3.2) [application form, section C, #3a]
Researchers should assure participants that they are free to ask questions and that the researchers will provide all the information that they can about the research. Participants must be provided with a description of what the research is about, and their part in it, so that they know what they are consenting to.
- Deception (TCPS 2, Article 3.7) [application form, section C, #9 a-d]
The TCPS 2 recognizes that some research requires the provision of deceptive or incomplete information to participants. Researchers contemplating the use of such techniques should provide the ICEHR with a full explanation of how they intend to proceed.
- Obtaining and Documenting Informed Consent (TCPS 2, Article 3.12) [application form, section C, #3b]
Researchers must provide clear evidence that they have put in place a process whereby potential research participants have an opportunity to provide meaningful and informed consent, and document the fact that participants give informed consent to participate in a research project. It is important that such evidence of informed consent discuss the process by which consent will be sought, as well as the outcome of that process (i.e., a signed consent form or other proof that a participant has provided consent that is informed and voluntary). For instance, the ICEHR can only assess that consent is free and voluntary if we know how participants will be recruited. This is because the recruitment process could be a source of inducement or of actual or perceived coercion by the potential participants. Moreover, the way in which information about the study is provided influences the opportunity for consent to be informed.
The TCPS 2 outlines various ways to document active consent (e.g., audiotaped, oral, written). Researchers should employ the most verifiable process of documenting consent that is suitable for the research proposed. Researchers are required to provide the ICEHR with a copy of the consent form(s) and/or a copy of the informed consent script that will be used to inform potential participants of the research project and seek their agreement to participate. For example, when an anonymous survey questionnaire is used, the fact that respondents return it is usually regarded as an expression of consent to participate in the study. The covering letter or oral contact script should include all the information necessary for seeking informed consent. Research that relies on oral consent is subject to the same TCPS 2 expectations, documentation of the process and the outcome of consent, as with written consent. You must always provide clear and compelling justification of how you will document the consent process, and that it provides for researcher accountability concerning informed consent. For example:
“I read and explained this consent form to the participant before receiving the participant’s consent, and the participant had knowledge of its contents and appeared to understand it.” (Include name of participant, date, and signature of researcher. If possible and practical, include signature of participant.)
For further information on documenting consent see Guidelines for completing the consent form and Documenting consent for telephone interviews.
Consent for various aspects of the study: In some cases, participants are asked to consent to several different things: to be interviewed, for the interview to be electronically recorded, for the electronic recording to be transcribed, for the transcription or the recording or both to be stored in an archive and so on. Adequate information regarding each option should be provided so that the decision to consent or decline is informed, and can be selected by participants.
Participants should be provided with as much choice as possible, and generally should have the option of participating in the study without necessarily having to agree with options such as the electronic recording of the interview or storage of the data in an archive. It is advisable to list the items on the consent form, with a place for the participant to indicate agreement, or not, where choices are offered. Alternatively, a separate consent form may be used for distinct aspects related to the study, such as the storage of the research data in an archive.
Consent vs Release: Although some researchers tend to use these terms as though they were synonymous, they involve the distinction between ethics and legality. Briefly stated, a participant who signs a consent form or who otherwise signifies consent is agreeing to participate in research, and one who signs a release form is absolving the researcher of certain responsibilities. In general, the ICEHR is concerned with informed and voluntary consent. Whether or not a researcher also requires some form of legal release from participants is a matter for him or her to decide.
Right to Withdraw [application form, section C, #8a-c]
Participants should be informed and assured of their right to end their participation in the research and to withdraw their data from the study, including any limits to these rights. Researchers should indicate:
- How participants can stop and/or end their involvement
- Ehat will be done with the data collected up to the point of a participant’s withdrawal, and any related options
- An end date after which data cannot be removed
- Any consequences that withdrawal may have on the participant.
For example, ehen participants can review a transcript of their interview: “After your interview, and before the data are included in the final report, you will be able to review the transcript of your interview, and to add, change, or delete information from the transcripts as you see fit.”
Privacy and Confidentiality (TCPS 2, Article 5.1) [application form, section C, #4 a and b]
Research participants’ right to privacy is a component of ethical research that treats participants with dignity and respect. Therefore, measures to protect privacy are carefully reviewed by the ICEHR. In your application, explain the extent to and the means by which you intend to offer participants anonymity and confidentiality, including matters such as the storage of data, access to personal information by transcribers, the potential use of data by others, and so on. The TCPS 2 is concerned that participants not be led to expect a level of confidentiality or anonymity that cannot be provided. Moreover, researchers should clearly distinguish between research where the participant will be anonymous even to the researcher, and research where participants’ anonymity will be protected from those outside the research project. This is significant in cases where the participants may be known to the researcher.
As a general principle, the ICEHR expects that the minimum number of people possible will have access to identifiable information about participants. Researchers are responsible for ensuring that research assistants, students, transcribers, secretaries, data entry personnel, interpreters, volunteers, or other persons involved with the research know of and comply with the TCPS 2 guidelines for ethical research. Include a discussion of these matters in your application to the Committee and in your consent forms.
A significant issue in the protection of privacy is the retention and destruction of research data. Participants should not normally be asked for blanket consent to use the data for "future research." However, Memorial University requires the retention of data for a minimum of five years in case of challenges to the results of the study. It is important that research participants be aware of how long and under what conditions the researcher intends to maintain the data from the study. This needs to be indicated in the consent form. The ICEHR advises that you state that “data will be kept for a minimum of five years, as per Memorial University policy on Integrity in Scholarly Research.”
Confidentiality when data are aggregated: “Although the data from this research project will be published and presented at conferences, the data will be reported in aggregate form, so that it will not be possible to identify individuals. Moreover, the consent forms will be stored separately from the (materials used), so that it will not be possible to associate a name with any given set of responses. Please do not put your name or other identifying information on the (materials used).”
Confidentiality when quotations will be used: “The data from this research project will be published and presented at conferences; however, your identity will be kept confidential. Although we will report direct quotations from the interview, you will be given a pseudonym, and all identifying information (list relevant possibilities such as the name of the institution, the participant’s position, etc.) will be removed from our report.”
Limits to confidentiality: (TCPS 2, Article 5.2) [application form, section C, #4c]
The TCPS 2 describes privacy as a "fundamental value," and speaks of the duty of researchers to "treat private information in a respectful and confidential manner." At the same time, the TCPS 2 acknowledges that values relating to privacy and confidentiality are by no means absolute and that, in certain circumstances, the public good may outweigh individual rights. Researchers should indicate to participants the extent of the confidentiality that can be promised, and conditions in which confidentiality may be compromised. For instance, researchers should be aware that Section 15 of the Child Youth and Family Services Act of Newfoundland and Labrador provides that anyone who becomes aware that a person actually or apparently under the age of sixteen years is or may be in need of protective intervention, as defined by the Child Youth and Family Services Act, must report this to a peace officer or social worker. This applies even if the information is confidential. If applicable, potential participants should be so advised during the informed consent process. Researchers should explain in their applications how they propose to deal with the issues involved.
Barriers to anonymity: [application form, section C, #4c]
The informed consent process should indicate circumstances in which participants’ anonymity may be difficult or impossible to achieve. For instance, in focus groups or in small communities, participants should be given information similar to that in the examples below.
Limits to confidentiality in focus group research: “The researcher will undertake to safeguard the confidentiality of the discussion, but cannot guarantee that other members of the group will do so. Please respect the confidentiality of the other members of the group by not disclosing the contents of this discussion outside the group, and be aware that others may not respect your confidentiality.”
Confidentiality when there is a chance that a participant might be identified on the basis of what he or she has said: “Because the participants for this research project have been selected from a small group of people, all of whom are known to each other, it is possible that you may be identifiable to other people on the basis of what you have said.”
Reference to third parties to whom the participant may go for further information:
In most cases, it is advisable to include in the consent form (if one is to be used), the name and contact information of a third party to whom participants may go for further information if necessary. The person named should have agreed to provide this service and to keep inquiries confidential. For student researchers, this would ordinarily be the faculty supervisor.
All letters of information/consent forms must contain the following ethics approval statement:
The proposal for this research has been reviewed by the Interdisciplinary Committee on Ethics in Human Research and found to be in compliance with Memorial University’s ethics policy. If you have ethical concerns about the research (such as the way you have been treated or your rights as a participant), you may contact the Chairperson of the ICEHR at firstname.lastname@example.org or by telephone at 709-864-2861.
Classroom Recruitment and/or Administration of Questionnaires: [application form, section B, #3 c, d, e]
All research conducted with students should include an assurance that the decision of whether or not to participate will in no way affect their grades, student status, or access to student services or programs, as in the sample text below:
“Your instructor will not know until after the grades have been submitted who has decided to participate and who has not, so that your decision to participate or withdraw cannot have any impact on your standing in the class or on your final grade.”
Given that the classroom is meant for teaching and learning, not data collection, and the potentially coercive nature of the group setting, the ICEHR requires that special attention be given to this method and setting for recruitment and/or data collection. The researcher (or a substitute, if the researcher is the class instructor) should take only a few minutes, preferably at the end of the class, to explain the study, hand out information sheets and/or questionnaires, and leave. Participants should be instructed to drop off completed questionnaires later in the day (or some other subsequent time) at a secure and neutral location (e.g., a departmental office, with the departmental secretary, a secure internal mailbox). Alternatively, a sealed box can be left with the classroom instructor who can then collect completed or uncompleted questionnaires during upcoming classroom sessions. In this way, responses can be made in full privacy and are independent of the perceptions of the classroom setting. It is possible that more honest and accurate data may also result. The researcher should also emphasize that students who are not interested in participating, or who later become uncomfortable with the process, should either not take a questionnaire or drop off a blank questionnaire at the designated location.
The complexity and ethical issues noted above can be minimized by using online questionnaires.
Conflict of Interest (TCPS 2, Chapter 7) [application form, section B, #3 c, d, e and section C, #5]
If your proposed research involves real or apparent conflict of interest, you should indicate it on the application form and explain how you will inform research participants.
If any member of the ICEHR may be ineligible to review your application because of conflict of interest, you should inform the Committee when you submit your application for ethics review at email@example.com
Inclusiveness (TCPS 2, Chapter 4) [application form, section B, #3b]
Some research is necessarily focused on an identifiable group (for example, members of a specific organization). However, research in general should not be arbitrarily exclusive. Please provide justification if participation is dependent on attributes such as culture, language, religion, race, mental or physical disability, sexual orientation, ethnicity, gender or age.
Aboriginal Peoples (TCPS 2, Chapter 9) [application form, section C, #s 6 and 7, and section B, #7]
If your research involves Aboriginal peoples, you should describe in detail any ethical issues relevant to the particular project proposed and indicate in your application how you plan to comply with the relevant section of the TCPS 2. Research involving Aboriginal communities may raise difficult ethical issues, including over-studying. Research that is respectful of Aboriginal peoples is based on collaboration, where possible, providing for consultation with the community and/or band council before the research is undertaken, and opportunities for continued involvement and information-sharing. As well, the community must be given opportunity to learn of, and to respond to, the research findings before publication. Disagreements in interpretation among community members, and between the community and the research team must be included in any published report.
Qualitative Research (TCPS2, Chapter 10)
Participant observation was once the main method of fieldwork-based disciplines like sociocultural anthropology and folklore, but in recent years similar methods have become more common in other disciplines as well. The TCPS 2 recognizes that some research cannot be readily defined into discrete ‘projects’ with a clear beginning and end. Researchers may return to the same field situations over and over, sometimes for their entire careers. What they learn from their hosts in the field cannot be limited to specific periods, and their hosts do not become or stop being informants, teachers and mentors according to the timetables of research. The rapport between researchers and their participants/teachers/hosts means that the relationship is often defined as much by the conventions and standards of the host as it is by those of the researcher, and it is a relationship of trust, respect and affection. This may mean that researchers making use of participant observation will fulfill ethical principles in somewhat different ways, when the sensibilities of hosts from different class and ethnic backgrounds are taken into account. For example, it may be impossible for a fieldworker to explain his or her research and gain the consent of all members of even a small community before research could begin. On the other hand, the fieldworker may have time to explain his or her intentions and activities much more completely, through a number of conversations, than would be possible in the sort of short statement typically given to participants in a written consent form.
Researchers proposing participant observation should explain their procedures clearly. Seeking permissions from the formal institutions of a community may be advisable for reasons of courtesy or legality, but ethical responsibilities apply mainly to individual participants.
Please provide the Committee with copies of any material which you plan to distribute to potential participants, in addition to any other documentation necessitated by the particular nature of your study. Ensure that all information that participants should know, as outlined in your application form, is also included in the related documents. These may include any or all of the following:
Recruiting materials. The ICEHR reviews recruitment documents to ensure that recruitment measures are not coercive, and that potential participants are provided with enough information about the study to make an informed decision to participate.
- Advertisement(s) (e.g, poster, flyer, radio/television script, newspaper ad, Internet message).
- Letter of initial contact.
- Recruiting phone call script/guide.
Consent form. Informed consent is often documented by means of a written, signed, and dated informed consent form, in which the participant voluntarily confirms his or her willingness to participate in the study, having been informed of::
- Study purpose
- General procedure and time commitment
- Foreseeable risks and benefits
- Measures to ensure confidentiality (identities of individuals with access to data; security measures for data; storage and/or destruction of data, secondary use of data, etc.)
- Limits to confidentiality, if applicable
- Rights to withdraw from the study, and to have data withdrawn
The consent form should also give the participant options concerning how the data may be recorded (e.g., notes, audio taping, videotaping of interviews) and whether or not the raw data may be saved for use by other researchers (e.g., in the Centre for Newfoundland Studies). Please follow the ICEHR Template Consent Form and Consent Form Checklist for this purpose.
For many, but not all, disciplines and professions, a written consent form has become the standard way of documenting consent. Be sure to provide a justification if you do not think written consent is needed or feasible (TCPS 2, Section 2.A).
Cover letter for questionnaire. If the study requires only that the participant complete a questionnaire, a cover letter may be used in lieu of a consent form, provided it includes essentially the same information, as consent is assumed if the questionnaire is completed and returned.
Parent/guardian consent form. Parental consent is required for participants who have not reached the age of legal consent. In the province of Newfoundland and Labrador the age of legal consent is 19 years of age. However, this varies in other jurisdictions, and researchers are responsible for ensuring that they adhere to the relevant law in the jurisdiction where they are collecting data. Children able to sufficiently understand should be given an opportunity to either assent or decline to participate in the research.
Assent Form. Assent of a participant is required when free and informed consent has been obtained from an authorized third party, and where a legally incompetent individual substantially understands the nature and consequences of the research. (TCPS 2, Section 2) [application form, section B, #3f]
Other consent forms (e.g., translated versions). If documents are to be provided to participants in more than one language, please include copies with your application.
Questionnaires, tests, interview scripts/guides, etc. Provide copies of instruments or other measures to be used for data collection. In the case of unstructured interviews or focus groups, a list of the content issues and/or question probes to be explored should be provided (e.g., age, gender, sexual orientation, reproductive history, attitudes toward adoption).
Debriefing letter or script. If the research depends on a temporary exception to the general requirement of full disclosure, written or oral debriefing must occur. (TCPS 2, Section 2) [application form, section D, #9d]
Approval from data holder for use of secondary data. If your study involves use of data initially collected for other purposes, provide copies of your request to the data holder and of the approval given to the researcher. [application form, section A, #7]