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GUIDELINES FOR COMPLETING APPLICATION TO UNDERTAKE RESEARCH

By Andrew Cole,2014-11-29 16:34
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GUIDELINES FOR COMPLETING APPLICATION TO UNDERTAKE RESEARCH

    Monash University Human Research Ethics Committee (MUHREC)

    Guidelines to MUHREC application forms

    All researchers undertaking projects involving human subjects are required to comply with the National Statement on the Ethical Conduct of Research involving Humans 2007.

    Recruitment of participants or collection of data must not start without written approval from MUHREC.

Instructions to applicants

    ; Use the current appropriate application form.

    ; Hand written application forms are not accepted.

    ; Complete all the relevant sections.

    ; Ensure all the signatures are obtained.

    ; Ensure that all relevant documents (Explanatory Statements, consent forms, questionnaires)

    are included with your application.

    ; Include permission letters from relevant organisations if available. If these are still pending,

    please forward to MUHREC for approval as soon as they become available.

    Section 1 Project details

    ; List the Chief Investigator and include all researchers (staff/students) who will be involved

    in the project. Provide staff/student ID numbers, affiliation, and contact details.

    ; Provide details of current qualifications of all researchers to enable MUHREC to assess

    their suitability to carry out the research.

    ; In accordance with Monash policy, student researchers must provide a Monash email

    address.

    ; Clearly state in lay terms the aims of the research and the research questions.

    ; Define all terminology and acronyms in full the first time they are used.

    ; Clearly state the research objectives, hypotheses or key questions guiding your research.

    ; State whether the project is staff or student research. If it is a student project, state the title

    of the degree and the current year of study.

    ; Include any source of funding to enable the Committee to consider whether there is a

    conflict of interest. The Committee will, in some circumstances, request that the information

    be included on the Explanatory Statement. If for some reason you cannot include it on the

    Explanatory Statement, please explain why not.

    ; Provide the details of the other HRECs if relevant. If your research project is conducted at

    more than one location, you may need to obtain approval from other ethics committees.

    Section 2 Details about the participants of the proposed research project

    Information collected in this section allows the Committee to assess whether the recruitment is fair across all proposed groups. The ethical value of justice requires that there is a fair distribution of the benefits and burdens of participation in research and, for any research participant, a balance of burdens and benefits.

    ; Indicate whether the project involves direct interaction with human participants and/or uses

    previously collected data.

    ; If the project involves vulnerable people as potential research participants, or those unable

    to make independent and informed decisions, ensure that the research design provides

    protection of these people from potential harm.

    ; Provide details of the selection and recruitment of potential participants. E.g:

    o How and where participants will be sought (organisation X, phone book).

    o How will you recruit the subjects of your research?

    o How will you inform participants about this research?

    o How will they be approached and asked if they are willing to participate?

    o If you are mailing something to or phoning people, how did you get their names and

    contact details? This is important for consideration of privacy related issues.

    ; Please note, if the contact details for potential participants are obtained from

    a public domain source (e.g., white pages, public domain website), there are

    no privacy related issues.

    ; Obtaining names and contact details of potential participants from a third

    party (whether an individual or an organisation) without the consent of the

    individual constitutes a breach of privacy legislation.

    o How will you ensure that the privacy of potential participants is respected, and their

    right to refuse to participate is acknowledged?

    o The time required to participate in the project and whether any payment or incentive

    will be offered to potential participants.

    o You can provide extra information such as flow diagrams to describe the recruitment

    procedures and/or samples of each form of recruitment material to be used (e.g.,

    advertisements, transcripts of radio or television advertisements and telephone calls,

    copies of photographs or other images to be used, posters and letters of invitation). ; Indicate if your project involves other organisations e.g., schools, universities, companies.

    Please note that permission is required prior to obtaining access to the participant

    population, for example:

    o The Department of Education and School principals

    o Senior officers of proposed organisations within commercial or government entities

    o Elders of an Aboriginal community

    o Representative of the Body representing the collective

    ; Address issues of coerciveness and provide enough details to assure the Committee that

    participation will be voluntary. For example, it is a concern to MUHREC if University

    students are participating in research that is part of their assessment or is being done by an

    assessor of the student.

    Section 3 Collection of data: risks and procedures

    ; All research proposals must be so designed as to ensure that any risks of discomfort or

    harm to participants are balanced by the likely benefits to be gained. ; Clearly indicate what the benefits of the research will be both to the participants and to

    humanity in general.

    ; Consider any possible risks and outline a management plan that will either prevent or

    minimise the likelihood of the event of a risk occurring.

    ; Potential risks should be outlined in the Explanatory Statement, and contact details of an

    appropriately qualified person, such as a counsellor or psychologist, should be included for

    reference for participants in case of distress.

    ; Outline how you will manage information that may reveal a serious condition affecting a

    research participant (e.g., domestic abuse, drug use, illegal activities, and vulnerability to

    suicide). If you are mandated by law as a member of your profession, for example, teachers,

    to report certain information you must inform your participants of this fact.

    Section 4a Procedures for explanation and gaining informed consent

    ; Complete this section if the project includes direct involvement of human participants. ; A plain language Explanatory Statement must be attached to each application. This usually

    takes the form of a letter written to potential participants and should contain enough

    information about the project to allow potential participants to give informed consent to

    participate. It must be free from coercive language and promises that cannot be kept or

    unjustified claims of benefits.

    ; The Explanatory Statement should:

    o be written at the level of comprehension of potential participants

    o include information about the investigators, purpose, methods, demands, risks,

    inconveniences, discomforts, and possible outcomes and publication of the

    research, researcher contact details and complaints clause

    o be on Monash letterhead.

    ; In accordance with the National Statement (Chapter 2.2), before research is undertaken,

    the consent of the participants must be obtained, except in specific circumstances. ; If consent is not to be obtained, a written explanation must be provided to the Committee. ; If using an anonymous questionnaire, a consent form is not required as the return of the

    questionnaires is implied consent but an information letter should be provided to

    participants.

    ; If any potential participants are under 18 years of age or are people over 18 who are unable

    to reach an informed decision about participation, additional, separate consent forms are

    needed for parents/guardians.

Please refer to the Human Ethics website for templates and examples.

    Section 4b Use of existing data

; Complete this section if the project involves use of existing data.

    ; Describe what form of data is to be used, where, how and by whom the data was originally

    collected.

    ; Clarify the original purpose for collection of this data set and provide as much details as you

    can about what information was provided to the participants at the time. ; Address issues of consent, how this was obtained and provide a copy of the consent form if

    available and how consent will be obtained for this study, if relevant.

    Section 5 Collection of data materials and procedures

; Indicate how, where and by whom the data will be collected.

    ; For safety reasons the Committee usually suggests that researchers do not conduct

    research in a participant's home. If necessary, a risk assessment must be completed.

    Please contact your OHS consultant for further advice.

    ; Indicate whether data will be collected outside Australia.

    ; Clarify if there is a dependant or unequal relationship between any person collecting the

    data and the participant and how the situation will be managed.

    ; Clarify if the research involves the administration of any tests/procedures that can only be

    used by people with particular qualifications (e.g. certain psychological tests, medical tests,

    interviews in a language other than English).

    ; Clarify how you will deal with your duty of care to the participants in your research identified

    as „at risk‟ (e.g., if you discover some information which has a bearing on the life and well-

    being of another person).

Section 6 Compliance with privacy legislation Research involving collection, use and

    disclosure of information

    Information collected in this section will be used to determine whether the research complies with

    privacy legislation. The Privacy Act covers the:

    1. Collection (consent forms, interviews, identifiable questionnaires)

    2. Use (accessing files/records, contacting participants)

    3. Disclosure (releasing information to other organisations or individuals)

    of personal or health information.

    ; Ensure that information you have collected is used only for the purposes that it was

    collected for (Information Privacy Principle 2).

    ; If information is being collected from a “third party” without the consent of the potential

    participants, the Committee will discuss the risks and the benefits of the research and may

    grant a privacy exemption.

    ; Indicate how the participants‟ identity and issues of confidentiality will be maintained during

    the project, when the results are published and when the data is stored.

    ; Storage of the data should be in a locked storage area at the University. Indicate the

    building and the room. If it is proposed to use alternative arrangements, provide details and

    a justification why this is necessary.

    ; Transborder Data Flow (Q6.11c): Commonwealth and Victoria privacy legislation imposes

    transborder dataflow restrictions to ensure that personal information receives equivalent

    protection if it is transferred (whether physically or electronically) to a place where the

    legislation does not apply.

    o You must answer "yes" to this question if your research involves the transfer of any

    personal information, including sensitive information and health information, outside

    of Victoria (whether to another Australian state or another country). Information

    transfers include the transfer of information for processing, including processing by

    websites such as Survey Monkey.

    o You do not need to answer yes if your research involves the transfer of personal

    information into Victoria from somewhere else. However, you should be aware that

    some other Australian states and overseas countries have their own privacy laws

    and that you need to ensure compliance with these if you are collecting personal

    information outside of Victoria.

    Please refer to Chapter 2 of the Australian Code for the Responsible Conduct of Research for further information on data storage and management.

    Section 7 Feedback and debriefing procedures

    ; Provide details of how, where and in what format the results will be published. ; Such information should be outlined in the Explanatory Statement.

    ; Describe how information about results of any tests will be communicated to participants

    and what arrangements will be in place to deal with participants‟ distress in the case of

    adverse test results?

    Section 8 Other ethical issues

    ; The ethical responsibilities towards potential participants in research include the ethical

    principles of integrity, respect for persons, beneficence and justice. ; Indicate any other ethical issues if relevant.

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