|
STANDARD OPERATIONAL PROCEDURES
University of Pretoria
Faculty of Law
STANDARD OPERATIONAL PROCEDURES (SOP): RESEARCH
ETHICS COMMITTEE
CONTENTS
1.
INTRODUCTION
2.
MEMBERS OF THE RESEARCH ETHICS COMMITTEE
3.
MEETINGS
4.
RESEARCH PROPOSAL SUBMISSION
4.1 Target group (Which proposal should be
reviewed?)
4.2 The Research Proposal
4.3 Obtaining informed/generic consent from research
participants
4.3.1 What should be contained in an
Informed Consent Form
4.4 Practical checklist when drafting research
proposal
5.
REVIEW PROCESS
5.1 Review process for research conducted by
undergraduate
students: LLB
5.2 Review process for research conducted by
postgraduate students: LLM and LLD
5.3 Review process for research referred to the
Research Ethics
Committee by the Postgraduate Committee
5.4 Research conducted by staff members not involved
in graduate
programmes (“contract/sponsored” research)
ANNEXURES:
ANNEXURE “A”: THE ETHICS OF RESEARCH
ANNEXURE “B”: LETTER OF INTENT AND SUBMISSION OF
RESEARCH PROTOCOL WITH SUPPORTING
DOCUMENTATION
ANNEXURE “C”: EXAMPLE OF PARTICIPANT INFORMATION
LEAFLET AND INFORMED CONSENT (WHERE
HUMAN
SUBJECTS ARE INVOLVED)
ANNEXURE “D”: EXAMPLE OF GENERIC INFORMED CONSENT
ANNEXURE “E”: RESEARCHER DECLARATION
1.
INTRODUCTION
The Research Ethics
Committee of the Faculty of Law has been established
as a result of relevant legislation and in line with
the stipulations of the Senate Committee for
Research and Ethics of the University of Pretoria.
The Research Ethics Committee is tasked to monitor
all research activities in the Faculty of Law to
ensure compliance with accepted research principles
that involve human research subjects (participants)
and/or access to information and the protection of
privacy and confidentiality. In this regard the
Research Ethics Committee adheres, amongst others,
to the Constitution of the Republic of South Africa
Act 108 of 1996, applicable legislation such as the
Promotion of Access to Information Act 2 of 2000,
international guidelines such as the Declaration of
Helsinki (where applicable) and other related
guidelines. The underlying rationale of the Research
Ethics Committee is to ensure that the rights of all
research participants are not compromised and that
researchers/investigators adhere to acceptable
research principles to ensure investigator
competence, efficacy, accountability and research
integrity. Ultimately the Research Ethics Committee
also functions to monitor that research conducted
in the Faculty of Law does not legally or ethically
compromise the University of Pretoria.
The Research Ethics
Committee functions independently, but interacts
with other related committees in the Faculty of Law,
such as the Research Committee (managing all
research within the Faculty) and the Postgraduate
Committee (monitoring and approving all graduate
research proposals).
2. MEMBERS OF
THE RESEARCH ETHICS COMMITTEE
DEPARTMENT
|
REPRESENTATIVE
|
|
Mercantile Law
|
Hennie Klopper
|
|
Mercantile Law
|
Daleen van der Nest
|
|
Legal History
|
Annelize Nienaber
|
|
Private Law
|
Trynie Davel
(Chairperson) |
|
Procedural Law
|
Ronel Jordaan
|
|
Public Law
|
Jolandi le Roux
(second Christo Botha)
|
|
Centre for Human
Rights |
Magnus Killander |
3. MEETINGS
The Research Ethics
Committee meets every month (excluding December) on
a date and time determined by the Chairperson with
proper written notification to other members.
Monthly meetings will be scheduled with due regard
to the number of applications received and the
urgency thereof. It is envisaged that applications
might be reviewed by the committee on an ad hoc
basis. Researchers/investigators and his/her
supervisor/promoter may attend the meeting when the
research proposal is reviewed by the committee.
4. RESEARCH PROPOSAL
SUBMISSION
4.1 Target group
(Which research proposals should be reviewed?)
Research by law
students for degree purposes refer to the
undergraduate LLB programme and the postgraduate LLM
and LLD programmes. Research may also be conducted
with regard to diplomas and certificate programmes
offered in the Faculty. It is envisaged, and this
is what past practice and experience have shown,
that it will rarely happen that research generally
conducted (in terms of the mentioned programmes) in
the Faculty will have to be reviewed by the Research
Ethics Committee, as most of the legal research
tends to be descriptive/historical literature/case
studies not involving experimental research with
human subjects and/or access to information/data
usually protected by relevant legislation (such as
the Promotion of Access to Information Act). It is,
however, in recent times abundantly clear that legal
research with regard to vulnerable groups in the
South African society (eg children, the elderly, the
mentally impaired, victims of crime, people
suffering from HIV/AIDS) as well as access to
sensitive information/data (eg access to patients’
medical records; police dockets etc) may now demand
review and ethical scrutiny by the Research Ethics
Committee. It is thus necessary for
researchers/investigators, where applicable, to
apply for ETHICAL CLEARANCE from the Research Ethics
Committee.
In demarcating the
review role of the Research Ethics Committee of the
Faculty of Law, the following legal research
(irrespective of the undergraduate or post graduate
programme followed) MUST be submitted to the
Research Ethics Committee for review:
-
Legal research
involving human subjects [where informed consent
and protection of privacy, anonymity and
confidentiality are paramount];
-
Legal research
(mostly descriptive [whether retrospective or
prospective] involving data collection by way of
questionnaires, observation reports and
checklists) by way of access to information held
by public or private bodies as contemplated by the
Promotion of Access to Information Act 2 of 2000;
-
Any research proposal
which in the opinion of the Postgraduate Committee
of the Faculty of Law should be reviewed;
-
Legal research (not
involving postgraduate programmes) conducted by
staff members of the Faculty of Law [inclusive of
“contract research”] falling within the ambit of
the above categories.
For a detailed
discussion of research methods and types of research
methodology and data collection, researchers are
referred to the following website for
information/guidance:
http://www.petech.ac.za/robert/resmeth.htm
4.2 The Research
Proposal
Before an attempt is
made to start with a research project, a research
proposal should be compiled. For the beginner
researcher, this is usually the most difficult part.
It is, however, the most important aspect of the
research project and should be considered carefully
by the researcher. This does not only require
subject knowledge, but also insight into the
problem that is to be investigated, so as to give a
logical structure to the proposed research. The
research proposal can be envisaged as the
process (step-by-step guidelines) to plan and to give
structure to the prospective research. It is
therefore a written submission to spell out in a
logical format the nature and design and the means
and strategies that are going to be applied.
A research proposal
usually consists of the following elements:
-
A title
-
A problem
statement/question
-
Demarcation of the
terrain of study (assumptions, limitations and
delimitation)
-
Definition of
terminology (where applicable)
-
Indication of
importance/significance of study
-
A careful and
detailed analysis of the proposed research
procedures/methodology (eg
questionnaires/interviews etc)
-
A time schedule
-
A budget (where
applicable)
-
Researcher’s
qualifications
-
A resource list
-
Informed consent
form (where applicable)
-
Where there is a
request for access to information as contemplated
in the Promotion of Access to Information Act,
written authorisation from the designated
information officer to access/use of information
(where applicable)
-
Attach relevant
documentation as annexures.
For a detailed
discussion of research proposals researchers are
referred to the following website for
information/guidance:
http://www.petech.ac.za/robert/resprop.htm
4.3 Obtaining of
informed/generic consent from research participants
(Refer to Annexure “A”: The Ethics of Research)
Section 12(2) of the
Bill of Rights states that everyone has the right to
bodily and psychological integrity, which includes
the right – (b) to security in and control over
their body; and (c) not to be subjected to medical
and scientific experiments without their informed
consent. In terms of section 14 everyone has the
right to privacy. In terms of section 10 everyone
has the right to dignity.
(See also the relevant provisions
in the National Health Act 61 of 2003 and The Mental
Health Care Act 17 of 2000)
Researchers must thus
honour these constitutional/legislative provisions
when conducting research with human subjects. It is
imperative to obtain informed/generic consent
(Adult, Parental, Proxy, Youth, Child), specifically
when dealing with vulnerable research participants
to ensure the research participant’s autonomy and
privacy.
As a general rule it
can be stated that the more invasive the proposed
research will be, the more comprehensive the
informed consent should be. In some instances where
data may be obtained from research participants via
anonymous questionnaires, consent “in general terms”
(so called generic consent) should be obtained. –
For examples of informed consent forms and generic
consent, see Annexure “C and D”.
Specific cognisance
should be taken of the relevant provisions of the
Promotion of Access to Information Act 2 of 2000
when information is requested to gain access to
data/record held by private or public bodies. This
Act states that any person can request information
from a private body if s/he can show that s/he
requires that information for the exercise of their
rights. When requesting information held by a
public body, the requester need not show that s/he
requires the information for the protection of
exercise of their rights. The person or body from
which the information is requested, must refuse such
information if it amounts to an unreasonable
disclosure of information of a third party, UNLESS
THE PERSON HAS CONSENTED to that information about
him/herself being made available to a specified
third party under specified situations.
Note the following
specific terminology and sections in the Promotion
of Access to Information Act:
-
Definitions of
“public body”; “private body”; “personal
information” and “record”;
-
Chapters 2 and 3;
-
Section 15:
“Voluntary disclosure and automatic availability
of certain records”
-
Section 34:
“Mandatory protection of privacy of third party
who is a natural person”
4.3.1
What should be contained in an Informed
Consent Form?
–
see example in Annexure “C”
-
Title of the research
-
Introduction
-
What is the aim of
the study
-
What is expected of
the participant in the study
-
Has the study
received ethical approval
-
What are the
participant’s rights in the study
-
Sources of additional
information (about the researcher/contact
particulars)
-
Informed consent
clause
4.4 Practical
checklist when drafting research proposal
-
Identify different
types, approaches and methodologies of research (eg
Will this be descriptive or qualitative study?);
-
Apply research ethics
(eg avoid plagiarism; have regard for intellectual
property rights, respect informed consent,
confidentiality and anonymity);
-
Identify the
components of your particular research proposal (eg
research topic selected and problem formulated,
literature study conducted, research method
defined, data collection plan drawn up and
processing technique selected)
-
Develop appropriate
research instrument (eg questionnaire or interview
schedule constructed)
5. REVIEW
PROCESS
Only legal research as
stated in paragraph 4.1 (above) should, in
principle, be submitted to the Research Ethics
Committee of the Faculty of Law for review. In
reviewing the submitted research proposals, the
Research Ethics Committee is guided by the following
considerations:
-
Whether the proposed
research is appropriate with reference to the
intended outcomes thereof;
-
If human subjects are
involved, whether the selection and recruitment
will be free of coercion;
-
The
design/structure/methodology of the study is
sound;
-
Any risks (legal or
otherwise) associated with the research project
are minimised to the greatest possible extent;
-
The potential
benefits are maximised to the greatest extent
possible;
-
The risks (if any) to
human subjects are outweighed or balanced by the
potential benefits;
-
The degree to which
confidentiality is maintained is acceptable;
-
Whether the
University of Pretoria will be legally or
ethically compromised by the proposed research;
-
The method used to
obtain informed consent is ethically and legally
acceptable;
-
The researcher has
the appropriate
qualifications/experience/background and
facilities to conduct the research.
5.1
Review process for research conducted by
undergraduate students in the Faculty of Law
(specifically [but not restricted to] the LLB
programme and more in particular the LLB-
dissertation)
-
REFER TO ANNEXURE “B”
The review process is
initiated by an application for ethical clearance
(by way of a letter of intent and supporting
documentation) by the candidate
(researcher/investigator) supported by his/her
supervisor. It is thus the responsibility of the
supervisor (in consultation with the researcher) to
assess whether the intended research (by way of
dissertation and/or otherwise) has ethical and legal
implications as contemplated in paragraph 4.1 above
and should therefore be submitted to the Research
Ethics Committee for review.
Documentation
required: (3 copies)
·
Letter of intent together with supporting
documentation as per
Annexure “B”
·
Declaration by the researcher/investigator
--- as per
Annexure “E”
Review process:
·
On submission and receipt of the full
application by the researcher/investigator, the
matter is reviewed jointly by the Research Ethics
Committee at a meeting as contemplated in paragraph
3 (above);
·
Researchers/investigators and his/her
supervisor/promoter may attend the meeting when the
research proposal is reviewed by the committee and
may address the committee orally and submit
additional documentation in support of the proposal,
if required;
·
If the research proposal is approved by the
committee, application for ethical clearance is
signed by the chairperson of the committee and the
researcher and supervisor are informed in writing of
the decision;
·
An appeal against decisions reached by the
Research Ethics Committee can be lodged with the
Faculty’s Research Committee. An appeal against
decisions reached by the Research Ethics committee
is lodged in writing (stating the reasons for the
appeal) with the Research Ethics Committee who in
turn will submit the appeal to the Research
Committee. On their part, the Research Ethics
Committee will refer problems that cannot be
resolved through negotiations with the parties
involved, to the Research Committee;
·
All research proposals and subsequent
decisions by the Research Ethics Committee relating
thereto are recorded and filed as the activities of
the Research Ethics Committee might be subjected to
external auditing by the Research and Ethics
Committee of Senate.
5.2
Review process for research conducted by
postgraduate students in the Faculty of Law (LLM and
LLD programmes)
-
REFER TO ANNEXURE “B”
The review process is
initiated by an application for ethical clearance
(by way of a letter of intent and supporting
documentation) by the candidate
(researcher/investigator) supported by his/her
supervisor/promoter. It is thus the responsibility
of the supervisor/promoter (in consultation with the
researcher) to assess whether the intended research
(by way of dissertation/thesis and/or otherwise) has
ethical and legal implications as contemplated in
paragraph 4.1 above and should therefore be
submitted to the Research Ethics Committee for
review.
Documentation
required: (3 copies)
·
Letter of intent together with supporting
documentation as per
Annexure “B”
·
Declaration by the researcher/investigator –
as per
Annexure “E”
Review process:
The review process is
the same as stated in paragraph 5.1 above with the
exception that the Research Ethics Committee in
addition notifies the Postgraduate Committee that
ethical clearance was granted for the postgraduate
research (if applicable).
5.3
Review process for research referred to the
Research Ethics Committee by the Postgraduate
Committee
In terms of paragraph
4.1 above, any research proposal which in the
opinion of the Postgraduate Committee of the Faculty
of Law should be reviewed by the Research Ethics
Committee, may be referred as such. The
Postgraduate Committee monitors and approves all
graduate research proposals. In this capacity the
committee, in its discretion and in the absence of
an application for ethical clearance in a graduate
research proposal, may refer the research proposal
to the Research Ethics Committee for guidance.
Documentation required:
(1 copy)
·
A covering referral letter by the Chairperson
of the Postgraduate Committee attached to the
graduate research proposal requesting the Research
Ethics Committee to assess the graduate research
proposal whether ethical clearance is required.
Review process
·
On receipt of the above referral, the
Research Ethics Committee assesses the submitted
research proposal;
·
Should the committee hold the opinion that
the intended graduate research should be subjected
to ethical clearance in terms of paragraph 4.1
above, the committee refers the research proposal
back to the researcher and attending
supervisor/promoter with the instruction to obtain
ethical clearance from the Research Ethics Committee
in the prescribed manner (as per paragraph 5.2
above);
·
The Chairperson of the Research Ethics
Committee notifies the Chairperson of the
Postgraduate Committee accordingly.
5.4
Research conducted by staff members of the
Faculty of Law not involved in graduate programmes
and inclusive of “contract/sponsored research”
Staff members of the
Faculty of Law involved in this capacity in
research (excluding graduate research) as
contemplated in paragraph 4.1 above, should also
apply for ethical clearance.
Documentation required
and review process:
The documentation
required and review process are mutatis mutandis
as prescribed in paragraph 5.2 above. It is
envisaged that staff members who are involved in
contract/sponsored research may be ethically cleared
externally depending on the nature and scope of the
contract/sponsored research. The question to be
posed is whether the staff member’s involvement, as
a employee of the University of Pretoria, in the
research conducted, poses any ethical or legal risks
for the University of Pretoria on the basis of
potential vicarious liability. If the answer to this
question is in the affirmative, ethical clearance
from the Research Ethics Committee should be
obtained in the prescribed manner.
ANNEXURE “A”
– THE ETHICS OF RESEARCH
(Adapted from Proposed Ethical Guidelines, SPMA)
Ethics: principles
Ethical principles should be based on the following:
·
Autonomy: that is the respect for the individual and
the respect for human dignity
·
Beneficence: that is the benefit to the individual
participating in the research
·
Non-maleficence:
that is the absence of harm to the research
participant
·
Justice: that is the equal distribution of risks and
benefits between individuals and communities
Research
Research is the systematic
investigation, including research development,
testing and evaluation designed to develop or
contribute to generalised knowledge. Such
investigation raises ethical issues.
Research ethics
Ethics is the science of
criteria, norms and values for human action and
conduct. It is engaged in reflection and analysis of
morals concerning whether an act is good or bad and
how it influences the quest for meaning. Its
intention is to safeguard human dignity and to
promote justice, equality, truth and trust.
Therefore, ethics is a critical reflection of
morality.
Basic ethics codes of behaviour
The following should
apply to any research programme:
·
Participant as person
Respect for the autonomy of the participant. The
participant must be treated as a unique human being
within the context of his or her community system.
The freedom of choice must be safeguarded.
·
Human
rights
Respect for basic human rights as entrenched in the
Constitution of the Republic of South Africa,
1996 (Act 108 of 1996), must be acknowledged.
·
Justice, fairness and objectivity
The
dignity of people involved in research should be
honoured and should not be exposed to intentions and
motives not directly attached to the research
project, its methodology and objectives.
·
Competence
Researchers must be professionally and personally
qualified and must be accountable for their
research. Professional standards should be
maintained in accordance with academic training.
·
Integrity
Researchers must be honest and fair, be honest about
their own limitations, competence, belief systems,
values and needs.
·
Sensitivity
Scientific research must be balanced with the values
and dignity of the subjects of the research being
held in high regard.
·
Confidentiality
Confidentiality must be respected under all
circumstances. Documentation should be safeguarded
and considered as private within the limits set by
the research project.
·
Demarcation of roles
A
mutual understanding of the roles and interests of
the researchers and the participants should be
established.
·
Communication
Clear and understandable verbal communication is
required with the factual data and cultural values
should be considered.
·
Indirect coercion
Direct or indirect coercion in the name of research
should be avoided under all circumstances. Coercion
may include the exploitation of vulnerable people.
Taking undue advantage of a participant should be
prevented. The misuse of authority and influence
must not be allowed.
Legal and procedural requirements
·
Consent
Subject to the constitutional provisions contained
in the Bill of Rights, a person may not be subjected
to medical or scientific research without their
informed consent. This implies that research must
honour the constitutional provisions.
·
Form
of consent
Written information and consent forms should be the
norm although exceptions could be allowed under
justifiable circumstances.
·
Capacity to consent
Consent should be given by a person legally and
factually competent to give consent. Authorised
consent may be required in the case of mental or
physical disability, or in the case of children or
the elderly.
·
Informed consent
Research participants can only be required to
provide informed consent if they know and appreciate
what they are consenting to. Therefore, adequate
information must be provided. Researchers must
disclose any potential risks or benefits to
potential participants.
·
Free
and voluntary consent
Consent may not be induced by fear, force, coercion,
compulsion, deceit, fraud, undue influence, perverse
incentives or financial gain.
·
Revocable consent
Consent may be withdrawn without prejudice, in any
form, and at any time prior to and during the
proposed research process.
Assessment of
the ethics of research
·
Independent ethical review
All
research must be subject to independent ethical
review and should be conducted by the Research
Ethics Committee.
·
Knowledge of involvement
Participants in research must be made fully aware of
their position and the nature of the research (see
Constitutional provisions).
·
Role
and competence of researcher
The
researcher must be properly qualified and
experienced and command the necessary facilities to
undertake the proposed research and to ensure the
safety of the participants.
·
Research Ethics Committee
The Research Ethics
Committee has a crucial role to play in ensuring
that the research is properly regulated in terms of
research ethics. The Committee should act as judge
of whether the research conforms to generally
accepted and acknowledged ethical codes.
ANNEXURE “B”
LETTER OF INTENT AND SUBMISSION OF RESEARCH PROTOCOL
Date:
To:
The Chairperson
Research Ethics
Committee: Faculty of Law
University of Pretoria
PRETORIA
0002
Dear
____________________________
SUBMISSION OF RESEARCH PROTOCOL FOR EVALUATION
NAME OF
PROTOCOL
______________________________________________________________
______________________________________________________________
______________________________________________________________
______________________________________________________________
NATURE
OF STUDY
______________________________________________________________
______________________________________________________________
______________________________________________________________
______________________________________________________________
ARE SUFFICIENT
FACILITIES/FUNDS/RESOURCES AVAILABLE TO COMPLETE
STUDY? (If applicable)
Yes / No
If no, indicate if
application for outside funding was done:
Yes / No
Name of possible
funding institution:
________________________________
RESEARCH PARTICIPANTS/VOLUNTEERS/FILES/SAMPLES
(Select applicable)
State the type of
samples to be collected and source of research
participants or nature of information/data to be
accessed:
______________________________________________________________
______________________________________________________________
IS THE
PROTOCOL SUPPORTED BY THE SUPERVISOR/PROMOTER?
Yes / No
If no, explain:
___________________________________________________
______________________________________________________________
______________________________________________________________
IS THE
STUDY FOR DEGREE PURPOSES?
Yes / No
If yes, state degree:
_____________________________________________
If no, explain the
nature of research ________________________________
_____________________________________________________________
Please declare all
interests in sponsor company or products e.g.
shareholding, congress sponsorships, etc: (only if
applicable)
______________________________________________________________
______________________________________________________________
______________________________________________________________
______________________________________________________________
Signed on:
________________________ at
__________________________
___________________________
_____________________________
Signature of
researcher Signature
of Supervisor/Promoter
___________________________
_____________________________
Print
name
Print name
Contact
address: ______________________________
______________________________
______________________________
______________________________
Phone:
______________________________
Cell:
______________________________
NB: PLEASE FIND THE ATTACHED DOCUMENTATION (IN
COMPLETED FORM) IN SUPPORT OF THE SUBMTITED RESEARCH
PROPOSAL:
ATTACHED DOCUMENTATION IN
SUPPORT OF RESEARCH PROPOSAL:
PROTOCOL FOR ALL
REVIEWABLE RESEARCH IN THE FACULTY OF LAW AS PER
PARAGRAPH 4.1 OF THE STANDARD OPERATING PROCEDURES:
All applicable research protocols
(undergraduate/postgraduate/others) should be
accompanied by a letter of the
supervisor/promoter/applicant and should contain the
following information:
Student name and
surname:
___________________________________
Student
number:
___________________________________
Contact telephone
number:
___________________________________
Title of the
study:
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
Supervisor/Promoter
name and surname:
___________________________________
The supervisor/promoter
herewith declares that the following documents are
in order:
1.
Protocol contents and methodology
Yes / No
2.
Budget (If applicable)
Yes
/ No
3.
Informed consent
Yes
/ No
4. Clearance in
terms of the Promotion of Access to Information Act
obtained (If applicable)
Yes / No
5. Signed
Commitments and Responsibility Declaration of
Researchers required for research
Yes / No
Signature:
______________________________
Date:
______________________________
Contact tel no:
______________________________
Study title:
State the study title
of the proposed research eg. “A Prospective,
descriptive investigation into research participants
suffering from HIV/AIDS in order to establish a
regulatory legal framework for non-discrimination
and the promotion of equality in the workplace”.
Introduction
Example:
You are invited to volunteer for
a research study. This information leaflet is to
help you decide if you would like to participate.
Before you agree to take part in this study you
should fully understand what is involved. If you
have any questions, which are not fully explained in
this leaflet, do not hesitate to ask the
investigator. You should not agree to take part
unless you are completely happy about all the
procedures involved.
What
is the purpose of the study?
State (in context
of degree purpose)
How will the study be conducted?
State and explain fully. If
questionnaires will be used, attach copy of
questionnaire to the informed consent.
What
is the duration of the study?
State
Has the
study received ethical approval?
This research protocol was
submitted to the Faculty of Law Research Ethics
Committee, University of Pretoria and written
approval has been granted by the Committee. The
study has been structured in accordance with the
Constitution of the Republic of South Africa, Act
108 of 1996, applicable legislation and ethical
considerations such as …
What are
my rights as a research participant in this study?
Example:
Your participation in this trial
is entirely voluntary and you can refuse to
participate or stop at any time without stating any
reason. Your withdrawal will not affect your access
to other medical care. The investigator retains the
right to withdraw you from the study if considered
to be in your best interest.
May
any of the research procedures result in any
discomfort?
State, if applicable
What are the risks/benefits
involved in the study?
State,
if applicable
Are there any restrictions
concerning my participation in this study?
State, if applicable
Insurance and financial
arrangements
State, if applicable
Source of
additional information
Example:
The study will be conducted by
way of interviews/observations by _________________
(State research investigator’s particulars). Should
you have any questions, please do not hesitate to
contact him/her. The telephone number is
____________, through which you can reach him/her or
another authorised person.
Confidentiality
Example:
All information
obtained during the course of this trial is strictly
confidential. Data that may be reported in
scientific journals will not include any information
which identifies you as a participant in this
study. Data/information will be published
anonymously. No information will be disclosed to
any third party without your written permission.
INFORMED CONSENT CLAUSE: (NB: MAKE PROVISION FOR
CONSENT OBTAINED FROM ADULTS/CHILDREN/BY PROXY ETC)
I hereby confirm that I
have been informed by the research investigator
______________________ (state particulars) about the
nature, conduct, benefits and risks of the proposed
research. I have also received, read and understood
the above written information (patient leaflet and
informed consent) regarding the study.
I am aware that the
results of the study, including personal details
regarding my sex, age, marital status etc (state)
will be anonymously processed into the research
report. (See in particular the definition of
“personal information” in the Promotion of Access to
Information Act 2 of 2000.)
I may, at any stage,
without prejudice, withdraw my consent and
participation in the study. I have had sufficient
opportunity to ask questions and (of my own free
will) declare myself prepared to participate in the
study.
Participant’s
name: _______________________________
Participant’s
signature: _______________________________
I,
________________________ herewith confirm that the
above participant has been informed fully about the
nature and scope of the above study.
Investigator’s
name: _______________________________
Investigator’s
signature: _______________________________
Witness’s
name:
_______________________________
Witness’s
signature:
_______________________________
Date:
_______________________________
WHERE
APPLICABLE ATTACH INTENDED QUESTIONNAIRE
Example of
Participant Information Leaflet and Informed Consent
Form (so called generic consent) where the intended
research consists only of a survey by means of
anonymous questionnaires
INFORMED
CONSENT FORM
1.
STATEMENT THAT THE STUDY INVOLVES RESEARCH
I
__________________________________ willingly agree
to participate in this study which has been
explained to me by ____________________
(investigator’s particulars). This study is being
conducted by _______________ (state particulars).
2. PURPOSE OF THE
STUDY
A survey to determine
______________________________________ (state
particulars).
3. DESCRIPTION OF
PROCEDURES
A questionnaire will be
completed by each participant. Participation is
voluntary and anonymous. The proposed questionnaire
is attached hereto in order for a participant to
have access to the intended questions to make an
informed decision whether a participant is willing
to respond to the questions posed in the
questionnaire. Participants have the right not to
respond to any question posed in the questionnaire,
should they elect to do so.
4. RISKS OR DISCOMFORT
Not applicable.
5. CONTACT PERSON
The contact particulars of the
researcher/investigator in the event of enquiries by
participants are as follows ______________________
(provide detail).
6. BENEFITS OF STUDY
After completion of this study a
description of ___________________________ (provide
detail) will be documented.
7. VOLUNTARY
PARTICIPATION
Participation in this
study is voluntary. No compensation will be given.
Please note that as the questionnaires will be
completed anonymously, and as data will be processed
anonymously, it will not be possible to withdraw
your consent once you have completed and submitted
the questionnaires. Completion and submission of the
questionnaires will thus be construed as informed
consent on your part to participate in the study.
8. CONFIDENTIALITY
The filling out of the
questionnaires is anonymous, there is thus no risk
of disclosure of personal information. All
data/information obtained from the questionnaires
will be treated anonymously and should publication
of the results of the questionnaire be effected you
will in no way be identified.
9. CONSENT CLAUSE
I have read all of the
above, had time to ask questions, received answers
to areas of concern and I willingly give my consent
to participate in this study. Upon signing this
form, I will receive a copy.
Participant’s name
__________________
Witness’s name
__________________
Participant’s signature
_____________ Witness’s signature _____________
Date: _________/______
2006 Date: _________/______ 2006
Researcher’s Name:
___________ Signature
_____________________
Date: _________/______
2006
ATTACHED PLEASE FIND
INTENDED QUESTIONNAIRE.
ANNEXURE “E”
(TO ACCOMPANY ALL RESEARCH PROPOSALS)
COMMITMENTS AND RESPONSIBILITIES OF RESEARCHERS/
INVESTIGATORS REQUIRED FOR RESEARCH THROUGH THE
FACULTY OF LAW RESEARCH ETHICS COMMITTEE, UNIVERSITY
OF PRETORIA
DECLARATION BY
RESEARCHER/INVESTIGATOR:
I agree to personally
conduct or supervise the described
investigation/study.
I understand as
investigator that I am totally responsible for
aspects of the study and am legally bound by the
research proposal signed with the research
participant/sponsor.
I have read and
understand the information in the Standard Operating
Procedures of the Research Ethics Committee of the
Faculty of Law.
I agree to ensure that
all associates, colleagues, and employees assisting
in the conduct of the study are informed about their
obligations in meeting the above commitments,
without relinquishing my total responsibility for
the study.
I confirm that I am
suitably qualified and experienced to perform and/or
supervise the study proposed.
I agree to conduct the
study in accordance with the relevant, current
research protocol and will only make changes in the
protocol after approval by the Research Ethics
Committee, except when urgently necessary to protect
the safety, rights, or welfare of subjects and/or
the integrity of the University of Pretoria.
I agree to inform all
research participants as prescribed in the approved
research protocol and I will ensure that all the
ethical guidelines and Research Ethics Committee
requirements relating to obtaining informed consent
are met. I will endeavour at all times to protect
the reputation and integrity of the University of
Pretoria and not to ethically or legally compromise
the institution.
I agree to timeously
report to the Research Ethics Committee adverse
experiences that occur in the course of the study to
alert the committee to possible potential risks to
the University of Pretoria.
I agree to maintain
adequate and accurate records of the study and to
make those records available for inspection/external
auditing by the Research Committee, the Research
Ethics Committee, the Post Graduate Committee, the
Faculty Board or the Research and Ethics Committee
of Senate.
I agree to comply with
all other requirements regarding the obligations of
researchers/investigators and all other pertinent
requirements in the Guidelines of the Research
Ethics Committee and am conversant with these
guidelines.
I understand that the
study may be audited at any time and that deviation
from the principles in this declaration will be put
before the Research Ethics Committee for action,
which may include a recommendation for disciplinary
action in terms of the prescribed rules being taken
against me.
_______________________________
SIGNATURE OF
RESEARCHER/INVESTIGATOR
_______________________________
________________________
NAME
(PRINTED)
DATE
Draft document compiled by Prof PA Carstens (The
Standard Operating Procedures of the Faculties of
Health Sciences and Humanities provided guidance for
drafting the above Standard Operating Procedures,
and are hereby formally acknowledged.)
Document updated by Prof CJ Davel (Chairperson:
Research and Ethics Committee, Faculty of Law),
January 2006
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