Download Ethical clearance form

NORTH-WEST UNIVERSITY
YUNIBESITI YA BOKONE-BOPHIRIMA
NOORDWES-UNIVERSITEIT
MAFIKENG CAMPUS
HUMAN RESEARCH ETHICS COMMITTEE
APPLICATION FOR RESEARCH ETHICS CLEARANCE: 2016
Instructions and recommended path for the completion of your ethics application:
1.
The completed Ethics Application Form must be submitted to the relevant School/ Faculty
Representative of the Human Ethics Committee who will then submit it to the Chair of the research
ethics committee.
2.
All applications must be signed by the relevant parties and submitted in Electronic Format.
3.
Incomplete applications will not be reviewed.
4.
Proof of Research Proposal Acceptance must be submitted with the application (Please refer to your
departmental research committee for relevant documentation).
Please complete all information below:
SECTION A:
Title, initials, surname:
Student or staff no.:
Department:
Telephone:
Cell phone:
Fax:
E-mail:
Application:
First application
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Resubmission
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Title of research:
Supervisor:
Co-supervisor:
Purpose of research:
Estimated duration of research:
Honours
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Masters
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(Including mini –dissertations)
Doctoral
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Non-degree
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Funding (if applicable):
SECTION B:
Student Statement on Research Ethics
(to be completed as part of the Proposal Colloquium)
Please answer each question by ticking the appropriate box1:
Yes
1.
Does the study involve participants who are particularly vulnerable2 or unable
to give informed consent? (e.g. children, people with learning or other mental
or physical disabilities, people who are incarcerated, unemployed or otherwise
compromised in responding to your questions)
2.
Will it be necessary for participants to take part in the study without their
knowledge and consent at the time? (e.g. covert observation of people)
3.
Will the study involve discussion of, or questions about, a sensitive topic? (e.g.
sexual activity, drug use, crime, harassment, violence)
4.
Are drugs, placebos or other substances (e.g. food substances, vitamins) to be
administered to the study participants or will the study involve invasive,
intrusive or potentially harmful procedures of any kind or any physical,
psychological or socio-economic intervention?
5.
Will blood or tissue samples be obtained from participants?
6.
Could the study induce physical, psychological or social stress or anxiety or
cause harm or negative consequences beyond the risks3 encountered in
normal life?
7.
Will the study require the personal identification of individuals for follow-up
evaluation? (i.e. through names and surnames, identification or staff numbers)
8.
Will financial inducements (other than reasonable expenses and compensation
for time) or inducements of any other kind be offered to participants?
9.
Could the image of the NWU, the relevant academic department, your
employer, or any other institution however affected by/involved in the project
be negatively affected by this research or put in a bad light?
No
In answering the following 2 questions; consider the classification of the
research also as being of no, low, medium or high risk, according to NWU
guidelines. Attach documentation in which you outline/describe your
motivation for this classification.
1
Adapted from Economic and Social Research Council (2005). Research Ethics Framework (REF). www.esrcsocietytoday.ac.uk
Vulnerable groups raise special issues of informed consent and potential risk. “Vulnerable” participants are not clearly described, but have been noted to include “…children, prisoners,
pregnant women, mentally disabled persons, economically or educationally disadvantaged persons” (Common Federal Policy, 1991). Weijer and Emanuel (2000) consider participants to
be vulnerable if they are not in a position to provide informed consent, due to their position (such as being in prison), or not possessing adequate intellectual faculty (such as children or
the mentally ill).”Children” here are defined as participants younger than 18 years of age.
3
Risk: These possible risks are described as an “…invasion of privacy, loss of confidentiality, psychological trauma, indirect physical harm, embarrassment, stigma, and group
stereotyping” (Oakes, 2002: 449), and also risks posed to . “…a subject’s personal standing, privacy, personal values and beliefs, their links to family and the wider community, and their
position within occupational settings, as well as the adverse effects of revealing information that relates to illegal, sexual or deviant behaviour” (Economic and Social Research Council
(ESRC), 2005: 21). Minimal risk may be defined as where “…the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of
themselves, than those ordinarily encountered in daily life” (Code of Federal Regulations, 2005).
2
10.
Are you planning on making use of NWU students and/or direct and/or
secondary/contracted staff members as research subjects in this research?
Also please indicate anticipated level of risk:
No risk
11.
Low risk
Medium risk
High risk
Will the study require the co-operation of a gatekeeper for initial access to the
groups or individuals to be recruited? (e.g. students at school, members of selfhelp groups, residents of a nursing home, the Minister of Education, a tribal
chief or village elder). Also please indicate anticipated level of risk:
No risk
Low risk
Medium risk
High risk
If you answered yes to any of the above questions, you will need to describe more fully how you
plan to deal with the ethical issues raised by your proposal. This does not mean that you cannot do
the research, only that your proposal will need to be approved by the Faculty Research Ethics
Committee. Attach a full description of the specific issues to this declaration, for discussion by the
panel at the Proposal Colloquium. Also, outline/describe your motivation for the classification of
the research as being of low, medium or high risk (Please refer to the attached NWU Ethical risk
level descriptors).
Please note that it is your responsibility to follow NWU’s Guidelines for Ethical Research as set out in
the Manual for Postgraduate studies and any other relevant academic or professional guidelines in
the conduct of your study. This includes providing appropriate information sheets and consent
forms, and ensuring the confidentiality in the storage and use of data, and anonymity of
participants. Any significant change in the question, design or conduct over the course of the
research should be notified to the Study Leader and may require a new application for ethics
approval.
Candidate
Students should retain a copy of this form and submit it with their dissertation/thesis.
I have read the NWU’s Manual for Postgraduate Studies and am familiar with the
Guidelines for Research Ethics contained therein4.
Y
N
I have familiarised myself with the NWU Policy on Plagiarism and Academic Misconduct,
and submit myself thereto.
Y
N
4
http://www.nwu.ac.za/sites/www.nwu.ac.za/files/files/i-research-support/ResearchLinkdocs/EnglishPDFs/PGManual.pdf
Student:
Name and Surname:
Signature:
Supervisor
Name and Surname:
Signature:
School/ Faculty Representative
Name and Surname:
Signature:
Chair/ Vice-Chair: Research Proposal Committee:
Name and Surname:
Signature:
Date:
RISK LEVELS OF ETHICAL APPLICATIONS
HIGH RISK
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Research with human participants involving drugs/drug interventions.
Research involving more than blood and sputum, or human tissue samples.
Research involving biological samples more invasive than blood, urine, sputum, and/or hair.
Any Clinical research/research with children.
Research with people suffering from psychological conditions that affect their cognitive, behavioural, or
social functioning so that they cannot take informed decisions.
Research involving interventions more invasive than sampling of human blood.
Any research done that is outside of the researcher's field of expertise can be seen as high risk. The
competence of the researcher within this specific field will be a determining factor for the risk assessment
of the research.
Clinical research involving human participants with research-related medical or psychopathology.
Clinical research involving vulnerable human participants, including foetuses, children, pregnant women
and mentally impaired persons.
Research involving sensitive ethical dilemmas in society.
Research on vertebrate animals involving surgical procedures, excessive pain or excessive stress.
Research involving primates or domesticated animals.
Research involving any pathogen.
Research that may affect public or environmental safety or sensitive ecosystems.
Research budget higher than R1 million per annum.
Any research deemed to present potential high risk for whatever reason by any applicant or
committee.
MEDIUM RISK
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Research with people suffering from psychological conditions that affect their cognitive, behavioural, or
social functioning so that they cannot take informed decisions.
Research involving sensitive ethical dilemmas in society.
Collaborative health research involving people/animals.
Multi-centre health studies involving people/animals.
Long-term health studies exceeding one year in duration.
Umbrella health projects involving human participants.
Research involving face-to-face psycho-social contact with participants e.g. interviews, focus groups.
Any psycho-social intervention studies individually or in communities.
Non-clinical research/research with vulnerable communities/people (older persons and their caregivers,
patients and health-care professionals, students and teachers, persons with life-threatening diseases
and their care givers, people living with HIV, wards of the state and guardians or care-givers, employees
and employers, prisoners and the relevant prison authorities, members of the SA Defence Force and their
supervisors, children, mentally ill persons, special care with women – no clinical research with pregnant
women or foetuses, own direct students).
Umbrella bio-physical projects with humans using no drugs.
Research involving blood, hair, sputum and/or urine human samples.
Research involving tissue samples collected for diagnostic/cosmetic surgery purposes now wanting to be
used for research.
Research budget not higher than R999 999 per annum and not lower that R250 000.00 per annum.
Interventions based on professional, scientific base protocols.
All research not described under high risk, but where the following criteria apply:
Human health projects involving:
 Collaborative research in Multi-centre studies.
 Long-term studies exceeding one year in duration.
 Umbrella projects.
LOW RISK
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Face-to-face surveys by means of validated interview schedules.
Documented data or analyses with identifiable human participants.
Simple questionnaire or instrument development.
Simple bio-physical research with humans.
Questionnaire or instrument development.
Bio-physical research with no drugs involved.
Bio-physical research not involving human tissues or drugs.
Research involving retrospective medicine usage and other clinical data.
Health system research using structured survey forms.
Interventions based on professional, scientific base protocols.
Document/artefact analyses without identifiable human participants.
Research budget under R250 000 but higher than R100 000.
NO RISK
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Systematic reviews/Literature reviews.
Postal / surveys with validated questionnaires.
Document/artefact analyses without identifiable human participants.
Unidentifiable electronic surveys.
Public observation without interaction or intervention.