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    Standard Operational Procedures: Research Ethical Committee
 

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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:                            ______________________________

E-mail:                        ______________________________

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:    ______________________________

Contact fax no:   ______________________________

 

DECISION OF RESEARCH ETHICS COMMITTEE:

After perusal/review of the submitted research proposal and supporting documentation ETHICAL CLEARANCE for the proposed research is hereby APPROVED/REJECTED/REFERRED BACK (Select applicable).

Signed:    __________________________ (Chairperson of the committee)

Date:       ___________________________

In the case of undergraduate research relevant supervisor notified.

In the case of postgraduate research relevant supervisor/promoter notified as well as the Chairperson of the Postgraduate Committee.


 

ANNEXURE “C”
EXAMPLE OF PARTICIPANT INFORMATION LEAFLET AND INFORMED CONSENT (WHERE HUMAN SUBJECTS ARE INVOLVED):

 

PARTICIPANT INFORMATION LEAFLET AND INFORMED CONSENT:

(NB!! Adapt according to research protocol):

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

 

ANNEXURE “D”

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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