Q. What kinds of research proposal require ethical approval?
A. Any research proposal which:
• Involves experimentation on humans or animals;
• Involves collection of human tissue or samples; affect individuals’ personal information, rights and freedoms;
• Requires ethical approval if such interaction presents possible risks beyond those of everyday life.
Q. What research procedures or circumstances might take ethical approval necessary?
A. If your research involves any of the following, you probably will have to submit an application for ethics review:
• A vulnerable or dependent population (e.g. children, mentally disabled, ethnic groups);
• A situation where participants may feel obligated to take part , or where participation may not be voluntary (e.g. students in a class, employees in their workplace, prisoners, patients in a hospital);
• Access to records that include personal information;
• Observing people;
• Risk of creating psychological stress;
• Risk of identifying distressed or disturbed individuals;
• Risk to participants reputation;
• Risk that the participants might suffer any economic loss by participating in the study;
• Risk that participants might be stigmatized by participating in the study;
• Political or physical risk to a subject/researcher in an international setting (e.g. unauthorized contact with a foreigner);
• Risk that participants’ personal information may not be kept confidential;
• Risk the participants may suffer through loss of anonymity.
For further advice, please contact the Ethics Review Committee Office about the specifics of your research.
Q. Whose research requires ethical approval?
A. All Research conducted by any undergraduate or postgraduate student, employee, or other interested researchers including surveys or questionnaires undertaken by the administration or student services concerning organizational practices.
Q. What issues need to be considered in relation to human participants?
A. Researchers should adopt the following guidelines:
• Research should aim to benefit society and/or increase knowledge
• Research should preferably benefit the direct participants
• Research should not cause harm to participants
• Research should be carried out to the highest possible standards, giving sue respect to participants commitment of time, and to the commitment of resources, in projects
• Potential participants should be free from coercion of any kind and should not be pressured to participate in a study
• Potential participants have the right to receive clear information about the research in advance from the researcher
• Participants in research study have the right to give their informed consent participating, and to withdraw that consent at anytime
• The consent and/ or assent of vulnerable participants or their representatives should be actively sought by researchers
• Honesty should be central to the relationship between researcher, participant and institutional representatives
• Participants confidentiality and anonymity should be respected
• The collection and storage of research data by researchers must comply with the Data Protection Act
• Researchers have a duty to disseminate their research findings to all appropriate parties
Q. Whose responsibility is ethical approval of a research studies?
A. It is the researcher’s responsibility to seek and to ensure that the hospital gives approval to relevant research studies before contact is made with human participants.
Q. When should I seek ethical review?
A. You should seek an ethical review before you make contact with human participants as part of your research.
Q. How can I ensure that I won’t have problems with my research ethics review?
Talk to the Chair of the REC informally about any problems you may have with the form before you officially submit the application. Read and follow the instructions at the end of the form. Often the pro forma responses to be found here will guide you. Ensure that you answer all the questions on the form.
Q. Why am I asked to allow up to three months for the review of my research ethics application?
All applications submitted must be assessed by members of the Research Ethics Committee, who will then report to the Chair. The information is collated then writes to the applicant indicating the outcome of the review, listing alterations requested and indicating a final date for resubmission of the revised application. Committee members need time to review each application and/or prepare a considered response. Furthermore, the volume of applications can be considerable. A member may review more than one application in any given period. Furthermore, applicants should allow time to revise their applications and resubmit them. Contact with research participants should not begin until a final letter of clearance has been received.
Q. What kind of revisions are the ERC likely requests?
The most likely reason for returning an application is that not all the questions have been answered.
What other reasons?
Care needs to be taken Plain Language Statements (PLSs) and Informed Consent Forms (ICFs). They should be formulated in language appropriate to the cohort they are intended for. Jargon should be avoided and technical terms explained. A level of literacy should not be assumed. This means that several different PLSs/ICFs may be necessary, depending on whether they address e.g. teachers, parents, or children. PLSs and ICFs should contain ALL relevant information, including the title of the project. The signed ICF should be retained by the researcher, while the PLS should be retained by the participant.
Q. Will every adaptation of my instruments require a further review process?
A. All relevant instruments and elements of the research which differ from those outlined at the stage at which clearance has been given in a way that relates to ethical issues, should be ethically reviewed by ERC at every stage in their evolution and before any contact is made with human participants.
Some Thoughts on How to Survive the Research Ethics Review Process
The research ethical review process can be a daunting experience, but it is an inherent part of research in contemporary times. It is not going to go away so how can we survive this experience with our sanity intact. And, how can we get through the process in a timely fashion so our research funds or candidatures do not rum out before we get ethics approval and, at the same time, have a project that is ethically and methodologically sound. This paper provides a preliminary guide on developing an application and managing the ethical review process. It is based on research on anthropological, ethnographic research on the ethical review process as culture and cultural process.
Put your ego aside
This process can be an assault on your ego, but it does not have to be. During the process you may receive enquiries and responses from the ethics review committee that will (or at least seem to) challenge your perceptions of yourself as an intelligent, responsible, knowledgeable person. Try not to take this things personally. Sometimes your response will not be to the question or comment, but to the way it is presented to you. Some committees have better communication skills and mechanism than others.
Know your research and methodology
You need to be the expert in your research area and have a firm grasp of the methodology and data collection methods you intend to use. Your research questions/ topic must be clear in your mind before you can communicate it to others, particularly those who have no knowledge or experience in this area or only think they do.
Support your argument for why this research is important, but do not over-reference. Select your references with great care, but you can let the committee know through your writing that you know these are only a few examples of relevant references. The same goes for presenting your methodology and data collection methods. It is up to you to make a case that how you propose to do this research is not only the best way to do it in this instance, but that what you proposed to do is within the guidelines for best practice or, if the approach is new or innovative, that you can support this approach. Again, use the literature to support your argument, but do not over reference. Use your references for the greatest effect.
Unless there is a compelling reason to do so (like your audience will expect it to be named), do not label your methodology, particularly if your research involves an alternative paradigm or the kind of research many refer to as qualitative research. It is safer to describe and support what you propose to do that to name it. There is too much variation in understandings of many research terms, particularly in what is called qualitative research. The result may be that the same term can result in you and your reader thinking about different things. People will respond to the label. If you do not provide a description or your description does not match with the reader’s understanding of the term, then you will have problems.
Know the potential ethical issues associated with your research topic and the methods you plan to use.
The ethical review process can be used to your advantage and thus to the advantage of the potential participants. Use it as an opportunity to think through all the potential ethical implications of your research from the research questions to situations that might occur when you are collecting data to writing the research from the research and disseminating it. Be your own most critical audience. Use your mentors, supervisors, friends and colleagues to help you think through the potential ethical issues. In most fields there are now texts that outline common ethical issues in relation to particular methodologies and data collection methods. Use them to help you think about potential ethical issues for your research and then try to think about them from the perspective of someone who does not know anything about this type of research. This is where your colleagues can be very helpful. You might also want to ask some people who know nothing about your research to get their perspective. Ask them how they would react if someone came to them and asked them to participate in a project like this. What kinds of concerns might they have? What questions do they have? Then be sure you consider them when you write your application.
You should also be familiar with the guiding documents for research in the places where you intend to do it. For example, in Australia you should be aware of the National Statement and the expectations it sets for ethically responsible research and the review of research. Use these documents to your advantage to not only identify potential ethical issues and concerns, but how they are addressed in the guidelines and any relevant legal documents, like the privacy legislation
And last, but by no means least, review your professional code of ethics and any others that are potentially relevant to your work. Nearly all professional codes of practice today give some guidance in relation to research in that discipline.
Know your review committee
This is not always an easy task. Committees vary in the amount of information they provide on the members of the committees and the processes they use in the review of applications. They also vary in terms of the issues and concerns upon which they focus.
Although you may not be able to identify particular member of the committee, all committees are made up of group of experts that includes researchers and lay people. The membership of the committee is guided by a set of national guidelines. The kind of expertise available on a committee is not always easy to identify, but most committees, even those devoted to the review of behavioral and social science research, usually have a clinician and all have lay men and women. In some countries the committee may also be required to include a lawyer and a religious or cultural leader. Even when a committee is not required to include people from these categories, people from these categories may still be members.
Obviously, if you know who the actual people on the committee you have the opportunity to identify whether or not a member has expertise in your specific area. You may also be able to identify their particular peccadillos. If you know that a member has particular concerns about certain issues, then you know better what kinds of things you need to take care to address in your applications. However, as we often do not know who the members of the committee are, write for the more general audience.
Write to your audience
Assume that the people reading your application are intelligent people who know little or nothing about your topic or the methodology you plan to use, but do so being aware that these people have often reviewed many applications. Even if they have not been on your particular topic, they have probably read applications on related topics. They may or may not be familiar with the methodology or data collection methods you plan to use. Even if some members are knowledgeable about these things, many member are not. Write to the person who is not knowledgeable, but do not write “down” to them. Again, just as you want to be treated as a reasonably intelligent person, so too do members of the committee. Considering how much power they have over your research, you want to communicate with them in a respectful way.
Use the proper form
Ethics committees are pedantic about forms and how they are filled out. One quick way to get on the bad side of the ethics committee is to use the wrong form or to not fill it in the way they expect.
Ethics committee often change their forms. You need to be sure you use the most recent version of the application form. Even if you just submitted your last application a month ago, check to be sure you are using the most recent version of the form. Submission on the wrong form (or version of the form) irritate committee members to the point that it actually influences how some will review your current application, even whether or not they will review the application.
Most committees provide downloadable versions of the most current ethics form on the committee’s website. If the committee does not have a website or you cannot download a form, then contact the ethics officer.
Many of the questions on a form may seem inappropriate or not applicable to your research, particularly if you are not doing a medical research. Most committees’ forms are designed for medical and behavioral research, with the clinical trial the core model. You must deal with each question, even if is to note that it is not applicable. However, do not assume that you and the committee will agree on what questions are applicable. When in doubt, contact ethics officer or other designated member of the committee. Do this before you submit the form or it might be sent back to you unreviewed.
As you work through an application form it is easy to lose track of what you have already written, particularly when several questions seem to address the same issue. Working through the form may also encourage you to think about how you will do the research and you may actually make changes to your methods as you fill out the form. Before you submit the application, be sure that the responses are consistent across all sections of the form. Ethics committee members will almost certainly pick up any inconsistencies in your application. So check your application to be sure there are none for them to find.
Proof the final form
The quality of the writing on you application form can influence the committee’s impression of the quality of your work- not just this application, but the general quality of your work. There is no way to overemphasize the impact of the quality of the writing on the response of the ethics committee members. One of the pet peeves of committees is poorly written forms. They become easily irritated by spelling and grammatical errors. This does their reviews.
You must proof the final copy, and then do it again. Use the spelling and grammar checking program on your computer and ask several people to read the application. If possible, use the services of a professional editor, particular for information sheets and consent forms.
Ethics committees often spend an inordinate amount of time reviewing and critiquing informational sheets and consent forms. Get this part right. It needs to be in a clear and concise language and it needs to be grammatically correct and with the appropriate punctuation. You should write these forms in language understood by someone with a Grade 6 education. Some committees suggest a higher level, but at the grade 6 level the information should be understandable to most people, including highly educated people who tend to read such materials very quickly.
Translations and Verbal Consent
If the population or populations you will be working with are more fluent in another language, be sure the forms are appropriately translated. These are standard procedures for obtaining high quality conceptual translations that are appropriate to the population. When possible use the skills of a professional translator. Consider providing a form that includes English and the other language/s on the same sheet. Many people are bilingual and many find it useful to be able to read the information in more than one language to be sure they understand the material.
In some cases it may be more appropriate to provide the information that would commonly appear on an information sheet in another medium, for example verbally or on a video or audiotape. Committees will expect you to provide the basic information that will be included in the consent process no matter what media will be used. In some cases it will not be possible to provide a script, but you do need to let the committee know basically what kinds of information the person will receive before making a decision to participate in the research.
Ethnographic research and things like participatory research present particular challenges for the consent process and convincing committee of the appropriateness of the process to be use. Obtaining consent is one of the most contentious issues in the review process. This means that methods other than a written consent form are often more appropriate, but it is your responsibility to convince the committee of this.
The time it takes to get through the review process varies from country to country and committee to committee. For example, minimum times can vary from a few days to two months. Some projects can take up to a year to get through the process. If the committee has questions or concerns about the research or the application this will expand the time required. If this project requires review by more than one committee then the time required often increases exponentially. If you can, find out how long it normally takes and application to go through the review process with the committee or committees involved and then use that information to help you plan when you have to submit your application. Sooner is better than later. It is safe to assume that you will not get through in the minimum time reported. So plan ahead.
Planning ahead also means thinking about the kinds of questions the committee is likely to ask. If you can deal with them in the initial application, all the better. Assume that no matter how good your application, the committee will have questions or will demand some changes. This is not a personal attack; it is just a way they do things.
In the meantime
Do not just sit and wait for the ethics committee’s response. Get on will all the related work for the project so you are ready to begin when the approval finally comes through. Do not let the waiting time be wasted time.