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IMPORTANT INFORMATION: 4/4 Please can you hand in your ethical approval forms in the next 10 days for agreement to continue with your project. Anybody who has not got a project please email me as I have several supervisors looking for students. h To see information on projects click on the link: Topics Ethical Approval guidelines Ethical Approval Form If you are planning to start your project in the coming year (current 3rd year students) please take note of the following:
Ethical
Guidelines for Student Research Projects AS WELL AS GAINING ETHICAL APPROVAL FROM THE SCHOOL, INSTITUTION, FAMILY ETC WHERE YOUR PROJECT TAKES PLACE YOU NEED TO LET THE DEPT RESEARCH COMMITTEE SEE AND APPROVAL YOUR PROJECT OUTLINE. PLEASE FILL OUT AND RETURN THE FORM BELOW AS SOON AS POSSIBLE Obtaining Consent from Subjects with Cognitive and/or
Communication Impairments Ethical
Approval for Projects
Some relevant definitions are: Invasive
- where the researcher interacts with the subject including physical Non-Invasive
- where the researcher interacts with the subject but does not carry out any
invasive procedures e.g language assessment or interview.
Observational
- where the researcher has no interaction with the subject e.g. Therapeutic - where procedures are intended to benefit the subject directly e.g. a
project evaluating the efficacy of an intervention. Non-therapeutic
- where the procedures are not intended to directly benefit the subject e.g. a
project investigating the nature of a language impairment. Subjects'
Capacity to Consent I.
The researcher should make every effort to establish the capacity of the
subject to give consent, in terms of their abilities to understand information,
use information to enable them to make a decision, and clearly communicate their
decision to others. II.
Capacity to consent should be established in relation to the particular
decision required at that time. A
subject’s capacity may vary across time, or may depend on the nature of the
decision required. III.
4th year students should not recruit subjects if there is uncertainty
about their capacity to give consent, unless the Project is observational only. Provision of Information Information relevant to the decision whether to give consent must be
presented in a format/formats which will best enable that individual to
understand it. The researcher
should seek to establish which format/s are most accessible to each potential
subject. information provided should normally include the nature of what is
proposed, the purpose of what is proposed, the expected outcome for the
individual subject (where known) and any potential risks involved. Advocacy When appropriate the researcher should obtain the assistance of an
advocate to assist the potential subject to understand relevant information and
express their decision. However, the advocate cannot resolve the situation "when a legally
effective decision is needed and the person concerned does not have the capacity
to make that decision (Law Commission 1995 para 2.44). This means that the
advocate/relative cannot actually make the decision to give or withhold consent
on behalf of another person. The
advocate's role in consent procedures should normally be to assist the Evidence
of Consent I.
Evidence of consent should be obtained in a format which is reliable for
the individual subject. The researcher should seek to establish which format/s are
most accessible to each potential subject. II.
Where a consent form is used the structure, format and content should be
adapted to meet the communication needs of the subject. III. Where
consent is not by signature on a written consent form a video recording AS WELL AS GAINING ETHICAL APPROVAL FROM THE SCHOOL, INSTITUTION, FAMILY ETC WHERE YOUR PROJECT TAKES PLACE YOU NEED TO LET THE DEPT RESEARCH COMMITTEE SEE AND APPROVAL YOUR PROJECT OUTLINE. PLEASE FILL OUT AND RETURN THE FORM BELOW AS SOON AS POSSIBLE Research
Ethics Committee Application
for Ethical Approval for a Student Project 1.
Title of project:
2.
Start date: 3. Anticipated completion date: 4. Name of student investigator: Contact address and telephone:
5.
Name of supervisor: 6. Brief description of project: Background
Aims of study
Design of study
7.
Where will the research be done? (please tick as appropriate)
Schools
Nurseries
Hospitals
Nursing homes/residential care facilities
Day centres
Subjects' own homes
Other (please specify)
.......................................................... 8.
Subjects:
How many subjects will be involved?
How will you recruit your subjects?
What are your recruitment criteria? 9.
What will be required of each subject? (e.g. time commitment,
tasks/activities which subjects will carry out &c) 10. Will subjects benefit from being
involved in your research? If so,
how? 11.
Will your research disrupt subjects' regular care, education or
rehabilitation, and if so to what extent? If
the research is disruptive, how can this be justified? 12.
Informed consent: How
will your subjects and/or their parents give their consent? Attach
a copy of your information sheet and consent form. These should be written
in terms which are accessible to your subjects and/or their parents. 13.
Confidentiality / Record keeping What records will you keep of your subjects? (e.g. research notes,
computer records, tape and video recordings) How will you ensure the confidentiality of these records? What will happen to the records at the end of the project? 14.
Information to others: Who will you inform about subjects' involvement in your research? (please
GPs
Teachers
Care staff
Others (please specify)
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