Guidelines for completing the proposal

Your application should be filed in accordance with the TCPS 2 and the information for researchers that is included here. Careful attention to these documents will help you 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 both straightforward, and successful.

It is important that you inform the ICEHR of research ethics review for your project that is being/has been undertaken elsewhere in the province, the country or internationally. If your project has been reviewed elsewhere, please provide the Committee with a copy of your documentation stating the outcome of that review. Note that while ethics approval from another research ethics board does not preclude or guarantee ethics approval from the ICEHR, it will be considered as part of the ethics review by the ICEHR.

Please submit an electronic copy of your proposal to the ICEHR Coordinator at icehr@mun.ca , Office of Research Services. Ensure that you include: your completed electronic application form, a summary of the research, a summary of the relevant ethical issues, and all related documents. Please not that "Section D Signature page must be submitted with original signatures

These guidelines discuss the following topics:

Summary of the Research
Statement of Ethical Issues [Revised Clearance Statement]
A Note on Participant Observation
Related Documents

Summary of the Research

Please provide the Committee with enough information about the proposed research so that the ethical issues can be considered in appropriate context. The following information is especially helpful to the Committee (not necessarily in this order).

Scope and objectives of the proposed research.
Scholarly significance including potential contribution to knowledge and relation to existing research and literature along with appropriate referencing.
If applicable, its social relevance or practical importance.
Research question and/or expected outcome of the study.
Theoretical approach or conceptual framework, as appropriate.
Research plans and methods, including target population and/or sample; estimated sample size; sampling method; type of research design; data analysis plan.

The onus is on the researcher to explain the proposed research so that it may be understood by members of the ICEHR who are from varied disciplinary backgrounds, and who include community representatives. Assume that you are communicating with persons outside your field who may be unfamiliar with discipline- or profession-specific practices and jargon.

Please keep in mind that the ICEHR reviews many proposals each year. For this reason, the summary of research should be brief (about 1000 words in length). 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.

Statement of Ethical Issues

Each of the following topics (indicated in boldface) must be addressed. They are inter-connected with one another and none should be taken or applied in isolation. Some are also addressed in Memorial University’s Policy on Ethics Involving Human Participants. Even if a topic is not relevant to the proposed research, please include it in your Summary of Ethical Issues, but indicate that it is not applicable.

Scholarly Review (TCPS 2 Section 1.C 2)

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 will normally avoid duplicating previous scholarly review; however, it 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 concerned. Information on this subject is requested on p.2 of the application form, but additional information may be included in the description of the project of this seems necessary.

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.

Harms and Benefits (TCPS 2 Section 1.C 1)

Harms: Researchers should bear in mind that harms come in a variety of forms, including physical, psychological, social and financial. Care should be taken to neither underestimate nor overestimate a study’s potential for harm. In particular, researchers should be aware of the tendency to understate the risks posed by a project due to a belief that the project is ultimately safe and worthwhile. What is most important in explaining the risks involved in participating in a project is to provide potential participants in research with a clear understanding of the potential for harm. Without such information, a legitimately informed consent to participate in research cannot be achieved.

Researchers should, in particular, remember that an assessment of potential harm cannot be based only on the information one hopes or intends to derive from interview subjects. Participants may provide unexpected information and questions may sometimes be upsetting to them despite the researchers best intentions. Please note that the committee considers carefully the experience and expertise of any researcher or research staff person involved in face-to-face interviews where questions may elicit strong emotional reactions. If the interviewer does not have counselling expertise, or is unable to provide the necessary support it is expected that the researcher will put in place a process for immediate referral to such a person and that this will be noted in the ethics review proposal.

It is also important that researchers take a long view when considering a project’s potential for harm. For example, if the research is to be used in making a decision that will affect the participants in a negative way (or in what they may perceive as a negative way), it is appropriate to let potential participants know this. This is so even if there is no guarantee that the research will lead to this negative result.

Of course, it will not always be practical for researchers to reveal literally all the logically possible harms posed by a project. Some may be so remote and minor as to not be worth mentioning. Nonetheless, when in doubt about whether to mention a particular harm during the consent process, researchers should err on the side of revealing too much. What is most important is that potential participants not be under-informed about possible harms.

Benefits: As with harms, the most important consideration is that the benefits of participating in a study should be presented accurately. If, for example, participation in the research is generally enjoyable for the subjects, this should be mentioned, but not oversold. Researchers should, when in doubt, err on the side of revealing too little about a project's benefits. What is most important is that the benefits of participating in a study should not be over-represented. Any such inappropriate inducement to participate will interfere with the legitimacy of a participant’s informed consent to take part in the study.

Free and Informed Consent (TCPS 2 Section 2)

The basic principle here is relatively simple: that anyone who is a subject of research 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.

Competence (TCPS 2 Section 2.E): Determining competence to provide consent can be a particularly challenging issue. Competence to provide informed consent may be a concern where participants are drawn from potentially vulnerable populations such as people who are very young or elderly and/or who have significant impairment of their mental health. For further discussion of this issue, refer to the relevant section of Memorial University’s Policy on Ethics of Research Involving Human Participants. Researchers would also be well advised to read this section of the TCPS 2 carefully, and make use of it in preparing their submission to the ICEHR.

Parental or third-party consent: 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 is in question, you must discuss your proposed treatment of this issue.

Age of consent:Unlike some other Canadian provinces, the age of legal consent in this province is 19 years of age. There is not a different age for consent to participate in research. However, there is room in law to argue the case of "mature minors" having the ability to provide consent. There are situations where parental consent may be dispensed with for "mature minors" or "emancipated minors" (i.e., those who have withdrawn from parental care). 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 Section 2.B, and Section 2.E): 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 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 is not to say, of course, that no research may be undertaken in such circumstances. However, if your research involves circumstances where there is the possibility of coercion or inducement, or the perception of this, you should consider it in the discussion of ethical issues and describe steps that will be taken to minimize or eliminate the effect.

In order that the ICEHR be able to ensure that consent is, indeed, free, please include a full description of the recruitment process, including advertisements, letters, and scripts/guides of personal communications.

Classroom Administration of Questionnaires: Given the fact 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 for data collection. The researcher (or a substitute, if the researcher is actually the class instructor) should take only a few minutes, preferably at the end of the class, to explain the study, hand out the 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.

Informed Consent (TCPS 2 Section 2.D): Researchers should, as a matter of course, let participants know that they (the researchers) will provide all the information they can about the research. A participant must know what he or she is consenting to. This means that, at a minimum, the participant must be provided with a description of what the research is about, and his or her part in it.

Deception: 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 read the TCPS 2 Section 2 carefully and provide the ICEHR with a full explanation of how they intend to proceed.

Documentation of Informed Consent: 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.

The process of obtaining consent: 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 reach the conclusion 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 coercion (actual or perceived by the potential participants). Moreover, the way in which information about the study is provided influences the opportunity for consent to be informed.

Outcome of the consent process: Proof of the participant's free and informed consent: Researchers are held accountable for the provision of opportunity for meaningful informed consent. They must, therefore, document the fact that participants give informed consent to participate in a research project.

Some practices regarded as standard by the authors of the TCPS 2 may be regarded by some researchers as incompatible with some methods of research, such as "participant observation". The TCPS 2 states that "for most people in our society, a signed statement is the normal evidence of consent" (TCPS 2 Section 2.A). Some researchers may feel that this statement does not sufficiently acknowledge the variety of cultural attitudes in "our society" based on ethnicity and class, but they should note that the TCPS 2 does allow for other ways in which participants can signify their consent. For example, when an anonymous survey questionnaire is used, the fact that respondents return it may in itself be regarded as an expression of consent to participate in the study (although the covering letter or oral contact script should include all the information necessary for an informed consent).

There are various ways to document active consent (e.g., audiotape, oral, written 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 part of the ethics review process, except that there will not be an assumption by the ICEHR that written consent is the norm for all research involving human participants. While there can be situations in which it would be problematic even to tape record the consent process, you must always provide clear and compelling justification if your project proposes not to document the consent process. The ICEHR's primary concern is that there is documentation that provides for researcher accountability concerning informed consent.

Researchers should employ the most verifiable process of documenting consent that is suitable for the research proposed. Researchers are expected 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.

Reference to third parties to whom the participant may go for further information: In most cases, it is advisable to include here, and/or in the consent form (if one is to be used), a reference to a third party to whom the participant may go for further information if necessary. In addition to the name, contact information for this person should be provided to participants. 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 statements of information/consent forms must contain the following 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 icehr@mun.ca or by telephone at 709-864-2861”.

Consent for various aspects of the study: In some cases, participants are asked to consent to several different things: for example, 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.

Participants should be provided with as much choice as possible, and generally should have the option of participating in the study without necessarily needing to agree with options such as the electronic recording of the interview or storage of the data in an archive. In some cases, for example, the items may be listed on the consent form, with a place for the participant to indicate agreement or otherwise 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 or participation in a focus group.

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, as a model may do when signing a form for a photographer. 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.

Privacy and Confidentiality

Respect for research participants’ rights 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 discussion of ethical issues for the ICEHR, explain the extent to which you intend to offer participants anonymity and confidentiality, and the means by which you intend to fulfill the promise, including matters such as the storage of data, access to personal information by such people as transcribers, the potential use of data by others, and so on. The TCPS 2 does not require that all participants in research be offered confidentiality or anonymity, but is concerned that no one should 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 to even the researcher, and research where the participant’s anonymity will be protected from those outside the research project. This becomes significant in those cases where the participant is 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, 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 statement to the Committee.

A significant issue in the protection of privacy is the destruction of research data once it has served its purpose. Participants should not normally be asked for a 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.

Limits to confidentiality:

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 policy document 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. The ICEHR recommends that researchers read Section 3 of the TCPS 2 with particular care and that they explain in their submissions how they propose to deal with the issues involved.

Researchers should take special note that they cannot assure participants of complete confidentiality. As the TCPS 2 points out (p.3.2), "In the free and informed consent process, researchers should indicate to research participants the extent of the confidentiality that can be promised, and hence should be aware of the relevant law." 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 supposedly confidential. Where relevant, potential participants should be so advised during the informed consent process.

Barriers to anonymity:

Careful attention should be paid to the informed consent process, to special circumstances in which anonymity may be difficult or impossible to achieve, as, for example, in focus groups or in small communities.

Conflict of Interest (TCPS 2 Section 4)

If your proposed research involves real or apparent conflict of interest, you should inform the ICEHR and explain how you will inform research participants.

If you believe that any member of the ICEHR is ineligible to review your application because of conflict of interest, you should inform the Committee Chair when you submit your application for ethics review.

Inclusiveness (TCPS 2 Section 5)

Some research is necessarily focused on an identifiable group (for example, women or 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 Section 6)

If your research involves Aboriginal peoples, you should familiarize yourself with the relevant section of the TCPS 2 and indicate in your proposal how you plan to comply with its guidelines. Research relations that are respectful of Aboriginal peoples normally emphasize collaboration, where possible providing for consultation with the community before the research is undertaken, and opportunities for continued involvement and information-sharing.

Research involving Aboriginal communities may raise difficult ethical issues, including over-studying. The investigator must describe in detail for the ICEHR any ethical issues relevant to the particular project proposed. Research begins in consultation with the community or band, often before the design of the research has been finalized. 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.

A Note on Participant Observation

Note: This segment of the guidelines was authored by Dr. Gordon Inglis, a former Chair of the ICEHR. Dr. Inglis is a researcher experienced with participant observation and the ICEHR is appreciative of his many contributions to its work.

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.

Many people who have made use of this method have criticized the TCPS 2 for a lack of attention to their way of conducting fieldwork. They argue that the document contains implicit assumptions that research may be readily defined into discrete ‘projects’, with a clear beginning and end; that research subjects (or participants) are in that role for finite and clearly-demarcated periods; and that the relationship between researchers and subjects is defined by the researcher and may be described and bounded by the conventions of a generalized middle-class Canadian society.

None of these statements can be applied to participant observation. While researchers using this method may - indeed, must - apply for funding on a "project" basis, they typically 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. (In fact, in these days of rapid travel, people whom the TCPS 2 would define as "human subjects" may well come to visit the researcher in his or her own home, and would be hurt and offended if the relationship were to be defined differently simply because a "project" had ended.) Practitioners of participant observation have traditionally made much of the concept of rapport between themselves and their informants/teachers/hosts. In practice, this means that the relationship is defined as much by the conventions and standards of the host as it is by those of the researcher, and perhaps more so. At its best, it is a relationship of trust, respect and affection.

All this does not, of course, mean that practitioners of participant observation should be exempt from the general ethical principles enunciated by the three Councils: indeed, when the sensibilities of hosts from different class and ethnic backgrounds are taken into account, the person practicing participant observation may be bound by rather more principles than are stated in the TCPS 2. However, it may mean that researchers making use of participant observation will fulfill those general principles in ways somewhat different from those envisaged by the framers of the policy statement.

The section on ‘naturalistic observation’ will be of some assistance, but it is not sufficient by itself. In the matter of ‘free and informed consent’, it would be simply impossible for a fieldworker to explain his or her research and gain the consent of all members of even a small community 1 before research could begin; research has already begun when the fieldworker arrives. 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 an experiment - and, if the researcher is to gain the trust of the host community, he or she will be required to do so. Similarly, informants and mentors among the host community will have many opportunities to withdraw cooperation and participation if they are not satisfied with the researcher’s performance. Matters of privacy and confidentiality may be the subject of a number of discussions between the researcher and his or her informants.

In general, it is incumbent on persons proposing research based on participant observation to explain their procedures clearly, to note where these may depart from the procedures mandated by the TCPS 2, and to demonstrate that they are nonetheless fully consistent with the general ethical principles mentioned in the document.

1 It should be noted that seeking permissions from the formal institutions of a community may be advisable for reasons of courtesy or legality, but ethical responsibilities apply mainly to individuals.