ࡱ> { )Ibjbjzz 4~AHH8zLÆZZZZ$gZZZH1J%%%ZZ%%%*>xZ`A$#:{R{HÆ{sv%ss(%%ÆsH h: 91Ƭ Guidelines for Human Research Ethics Clearance Application (non-medical) It is important that research which involves gathering data from people (human participants) treats them fairly and meets ethical standards. Broadly speaking this involves full disclosure (telling them about the research), non-coercion, and privacy issues. Obtaining permission from authorities In certain instances it will be necessary to obtain a formal letter of permission to access premises to conduct the research, or speak to employees or others present on the premises (e.g. from employers, government department, land owner, etc.). In some cases it is a legal matter of obtaining permission to be on the premises, whilst in other cases it is a matter of courtesy. Permission from an institution is not required if individuals are being approached for their professional opinion or views on something for information (e.g. a request to interview someone on their work/research/job at a university would not require permission from the authorities; an interview with a doctor at a clinic would not require permission from the clinic manager). However, if the institution itself is being researched (e.g. an ethnography of the functioning of a supermarket, or the way staff interact with clients in a clinic, or how the HIV Unit in the City of Johannesburg functions) then permission from the institution/department/facility would be required. Depending on the context, the particular individual/facility/department/institution may have their own requirements regarding permission for access, which researchers must abide by (e.g. Dept. of Health requiring local and provincial permission for research with staff in local primary healthcare clinics, some healthcare facilities having their own parallel ethics application processes, etc). In deciding whether permission is required researchers need to consider the methods they intend using, the age / nature of the participant s, where the research will be done, and who owns the premises or is in charge of people working there. When formal permission is required it should be on an official letterhead of the organization and should include the name of the contact person, address, contact details, etc. In summary, permission is required in the following situations: In the case of institutions or support groups where minors will be involved (e.g. schools). When the research involves data collection at the site using methods such as ethnographic observations, interviews, focus groups, recordings, etc. Certain government departments require that permission be obtained. Departments of Education. Any research at a school requires formal permission. In the case of government schools permission is needed from the Education Department and the school principal. For private schools permission is needed from the principal and perhaps the School Board. Find out from the school what their requirements are. Applications for permission to work in Gauteng Department of Education institutions / schools can be obtained from the Gauteng Department of Education. If teachers are involved outside of school hours and off the premises, formal permission is not required. Department of Health. (clinics/hospitals) some provinces have special research committees which would need to approve the application. Researchers must find out from the research site/relevant organisation how to go about obtaining permission, particularly when patients are involved. Tertiary institutions such as universities and technikons. Research involving students and conducted on university premises should be given permission by the Registrar. The Participant Information Sheet The Participant Information Sheet is a short letter (no longer than a page) written in the first person by the researcher, to potential participants. It summarises, in language understandable to the participant, what the research is about, outlines the promises made by the researcher, and explains what will be required from participants. Participants keep this information, which must contain contact details of the researcher(s) and their supervisor (when applicable) Where potential participants are under 18 years of age a separate Participant Information Sheet is required for the parent/guardian. This should be worded appropriately for the person being addressed. The Participant Information Sheet should be short (not more than a page) and should include the following: a polite greeting to the potential participant. an introduction to yourself if they dont know you, and an explanation of your role as a researcher. a brief description of the research, its aims, and potential benefits. an invitation (using a friendly tone) to the participant to become involved in the study (e.g. I am inviting you to be part of the study). a brief explanation of how/ why they were selected. an explanation of what involvement in the study will require potential participants to do (procedures, duration, place, when). if ambiguity or misunderstanding could arise, clarification that the research does not involve treatment and/ or payment. that participation is voluntary, and refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled (e.g. current access to facilities). (If this is not made clear, the researcher risks the accusation that consent was obtained by subtle coercion). promises of anonymity (not identifying the person) and/or confidentiality (what is being done with the information gathered). Alternatively (depending on the research in question) potential participants should be informed if they or their institution/department may be identifiable in a final research report, even if pseudonyms are used. that the participant may refuse to answer questions about which they feel uncomfortable, and may withdraw from the study at any time without penalty or loss of benefits. where applicable, an explanation of any foreseeable risks, discomforts, side effects or benefits. in cases where participation in a research procedure is likely to awaken feelings of past trauma, arrangements must have been made for counselling, and details of a counsellor and their contact information must be provided in the information sheet. how the study will be reported, where it will be available, and to whom (e.g. in a research report / dissertation/ thesis; at seminars/ conferences; in academic papers). [Note: 91Ƭ dissertations and theses are available on the world-wide web]. an invitation to contact the researcher should the potential participant have questions. on offer to make a summary of the research available should the participant request this. contact details of the researcher and the supervisor. The use of on-line data-gathering instruments In the case of on-line questionnaires, participants still need to be told about the research, the relevant promises by the researcher, and that their answers, once submitted, will be used for research purposes. This information is usually put on the first page of the online questionnaire. The formal (signed) Consent Form This is a document that will be signed by participants who agree to become involved in the study. It is NOT the same as the letter of permission. It is written as if by the participant, and includes the following: a statement that the research has been explained to them and that they understand about the research; a brief list summarising what they have been told (the promises/ explanations made to them); a clear statement about what the participant is consenting to, by becoming involved in the research (e.g. agreeing to be interviewed / to complete a questionnaire / to be watched as they go about their work). If audio- or video-taping is involved, a separate sentence allowing the potential participant to agree /disagree to being recorded is required in the consent form. This form should be signed, dated, and returned to the researcher. However, the Ethics Committee needs to see only a copy of the form to be signed, and not all the signed copies. Consent for use of data gathered on-line Participants need to be told that by submitting the completed questionnaire their agreement to participation in the research is assumed. Assent forms for children under the age of 18 If the participants are under the age of 18 the form they sign agreeing to participate in the research is called an Assent Form, while that signed by their parents/ guardian is a Consent Form. The assent form should be phrased in such a way that is comprehensible to the minors. Informal or verbal informed consent This applies in cases where formal signed consent is not possible, perhaps because the research is conducted in community settings (e.g. at a church service, or in the street through informal conversations, or where signed forms might create risks or power differentials that would not otherwise exist). On the Ethics Application Form supply the following: a justification for not obtaining written consent an explanation of your strategy or plan for ensuring that all participants are fully aware of your status as a researcher, that you will be writing up or reporting your findings in some form, and that their consent to participate in the research is assured, for instance, through detailed discussion with informants and participants at the time you first approach them to request their involvement. Common errors in completing the application form The following list includes some common errors that are seen on many ethics clearance application forms, resulting in requests for revisions. On the Participant Information Sheet Researcher does not introduce her/himself; The sheet is not written in the first person. The wording of the information sheet is too long or is unnecessarily technical and/or sophisticated for the target group. The researcher fails to specify the purpose of the study and the auspices under which it is being conducted. No clear up front invitation to participate is given. No explanation is given to the potential respondent of how or why he/she was selected. What will be required from the potential participant is not clearly specified. The time required to complete the research instruments and /or scheduled tasks is not clearly stated or is unrealistic. The information does not state clearly that participation in the study is entirely voluntary; that a choice not to participate will have no adverse consequences; and that should the person choose to participate, he/she may decline to answer certain questions and may withdraw from the study at any time. The wording anticipates or presupposes participation, or could be read as coercive, leading, or prejudicial to free choice. If the respondents are from a workplace or similar institutional setting (e.g. a university) they are not given reassurance (where appropriate) that they will not risk institutional sanctions such as job loss. The specific guarantee of confidentiality/anonymity (where possible, required or desirable) is not provided. Informed Consent While parents of children are asked to agree to their childrens participation in the study, children of an age to comprehend informed consent are not themselves asked. In studies where respondents are audio-taped or video-taped, a statement regarding permission for the recording is not included. Parental consent forms that amount to refusal forms are not acceptable. You may not use a form which says, for instance, If you do not return a written refusal to me in x days I will assume that you grant permission for your child to participate in the study. There is no formal permission from a host organization such as a school or workplace. Where a study is to be carried out on the premises of a host organization such as an NGO, NPO, business, or industrial work-place, a letter is required from the host organization granting the researcher access and expressing support for the study. Research tools and procedures Measures to protect the identity of the respondents are not adequate. Names, addresses, student numbers, ID numbers, etc., should not be recorded on the research instruments together with respondents answers. A coding system should be employed. Insufficient account is taken or potential effects of hidden or implicit coercion. For instance, where lecturers ask students whom they teach and whose work they mark to participate in a research study, implicit coercion may exist and must be dealt with in an appropriate way. It is not acceptable to use what might amount to bribery to promote participation, for instance where students are offered an extra 1% on the assignment mark if they fill in a research questionnaire, or people are paid to participate in the research. NB: It is permissible to pay transport costs in certain situations. In cases where participation in a research procedure is likely to awaken feelings of past trauma, no arrangements have been made for counselling to be available for the respondent. In cases where the questionnaire is not available for submission with the clearance application (for instance, when the questionnaire will be finalized only after a pilot study still to take place), the researcher gives no indication of the type of questions that he/she is likely to use i.e. does not provide some examples. Resources you may wish to consult regarding ethics One of the primary 'foundation' documents for research ethics is the The Belmont Report, Office of the Secretary, US Department of Health and Human Services. The document 'Ethical Principles and Guidelines for the Protection of Human Subjects of Research', produced by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 1979), in the USA, is one of the best guides to general principles. HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm"http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm For questions relating to whether or not your research involves 'human subjects', or is covered by requirement for ethical clearance, you may refer to the 'Decision Chart' of the Office for Human Research Protection (USA). HYPERLINK "http://www.hhs.gov/ohrp"www.hhs.gov/ohrp , especially the decision charts to determine whether proposed research should be examined by the HREC. Go to HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm"http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm Different disciplines vary over their approach to research ethics, and ethical guidelines for your specific discipline should always be consulted. Southern Africa specific resources on research ethics A comprehensive list of electronic resources and guides on research ethics can be found at International Research Ethics Network for Southern Africa (IRENSA) at HYPERLINK "http://www.irensa.org/"http://www.irensa.org/ The Human Sciences Research Council (HSRC), based in Pretoria, is one of South Africa's leading research organisations. The Code of Ethics at HYPERLINK "http://www.hsrc.ac.za/Corporate_Information-6.phtml"http://www.hsrc.ac.za/Corporate_Information-6.phtml is a good guide. Generic consent form The HSRC provides a 'generic consent form' that might be useful as a model. It MUST NOT be used as it stands, but can be adapted to suit your particular project. It is NOT ACCEPTABLE to simply use this form without modification. You can download the form in MS Word format at HYPERLINK "http://www.hsrc.ac.za/Corporate_Information-49.phtmlphtml"http://www.hsrc.ac.za/Corporate_Information-49.phtmlphtml The Medical Research Council The Medical Research Council, South Africa, also has a comprehensive discussion of research ethics on its website. These guidelines relate primarily to medical research, but they may be useful in familiarising researchers with ethical standards, principles and expectations. If your research in the social sciences and humanities involves medical or health aspects, these guidelines will be especially useful. Researchers from the bio-medical, biological or physical sciences who are conduction social science-type research may also find these materials useful. 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