UNIVERSITY OF THE WITWATERSRAND, JOHANNESBURG FACULTY OF HEALTH SCIENCES DEPARTMENT OF PSYCHIATRY

PSYCHIATRY ASSESSOR GROUP MEETINGS & PROTOCOL SUBMISSION DATES 2015

DEADLINE FOR SUBMISSION ASSESSOR GROUP MEETING

21 January, 16h00 11 February, 12h00 6 copies of your protocol with standard cover sheet You and your supervisor/s attend an & ethics approval must be submitted to the Postgraduate interview with the assessor group to discuss Office to be stamped & submitted to the Neurosciences your protocol on 11 February. Attendance Office by Jan 21 @ 16h00, together with a signed Is Compulsory. Departmental Plagiarism form.

11 March, 16h00 08 April, 12h00 6 copies of your protocol with standard cover sheet You and your supervisor/s attend an & ethics approval must be submitted to the Postgraduate interview with the assessor group to discuss Office to be stamped & submitted to the Neurosciences your protocol on 08 April. Attendance Office by 11 March @16h00, together with a signed Is Compulsory.

Departmental Plagiarism form. 10 June, 16h00 08 July, 12h00 6 copies of your protocol with standard cover sheet You and your supervisor/s attend an & ethics approval must be submitted to the Postgraduate interview with the assessor group to discuss Office to be stamped & submitted to the Neurosciences your protocol on 08 July. Attendance Office by 10 June @ 16h00, together with a signed Is Compulsory. Departmental Plagiarism form.

12 August, 16h00 09 September, 12h00 6 copies of your protocol with standard cover sheet You and your supervisor/s attend an & ethics approval must be submitted to the Postgraduate interview with the assessor group to discuss Office to be stamped & submitted to the Neurosciences your protocol on 09 September. Attendance Office by 12

August @ 16h00, together with a signed Is Compulsory.

Departmental Plagiarism form.

14 October, 16h00 11 November, 12h00 6 copies of your protocol with standard cover sheet You and your supervisor/s attend an & ethics approval must be submitted to the Postgraduate interview with the assessor group to discuss Office to be stamped & submitted to the Neurosciences your protocol on 11 November. Attendance Office by 14 October @ 16h00, together with a signed Is Compulsory. Departmental Plagiarism form.

CANDIDATE’S SURNAME: [Please print]

FIRST NAME/S:

STUDENT NUMBER:

CURRENT QUALIFICATIONS:

TEL: CELL: E-MAIL: FAX:

DEGREE FOR WHICH PROTOCOL IS BEING SUBMITTED:

PART-TIME OR FULL-TIME:

FIRST REGISTERED FOR THIS DEGREE: TERM : YEAR:

DEPARTMENT:

TITLE OF PROPOSED RESEARCH:

CANDIDATE’S SIGNATURE: DATE:

SUPERVISOR’S NAME:

SUPERVISOR’S QUALIFICATIONS:

SUPERVISOR’S DEPARTMENT:

CO-SUPERVISOR’S NAME:

CO-SUPERVISOR’S QUALIFICATIONS:

CO-SUPERVISOR’S DEPARTMENT

CO-SUPERVISOR’S ADDRESS / TEL / E-MAIL: SYNOPSIS OF RESEARCH: [Use reverse side of this page if more space is required]

ETHICS PENDING: ETHICS APPROVED: (circle appropriate symbol)

IF SUPPLY ETHICS CLEARANCE No:

SIGNATURE OF SUPERVISOR/S:

SYNOPSIS OF RESEARCH CONTINUED

UNIVERSITY OF THE WITWATERSRAND

JOHANNESBURG

FACULTY OF HEALTH SCIENCES

Post Graduate Studies

Guidelines for Applicants for Higher Degrees

in the

Faculty of Health Sciences

GUIDELINES FOR APPLICANTS FOR HIGHER DEGREES

1. APPLICATION

Each applicant for a higher degree in the Faculty is required to complete a Higher Degree application form. The degree for which registration is being applied, personal and professional details of the applicant, the provisional title or the field of the intended research work, the names of the intended supervisor/co-supervisors, and the approval and signature of the head of department in which the degree will be registered must be given. All documentation pertaining to previous degrees obtained, must be included with the application and certified.

The Postgraduate Committee will consider the application, and either approve it or request certain amendments, the details of which will be sent to the applicant and the head of department

Work submitted for a previous degree may not contribute in more than a minor way, as research material for the degree for which the application is submitted.

2. PROTOCOL SUBMISSION

The next step is the preparation and submission to the Postgraduate Committee of a research protocol. This must be submitted within 6 months of registration for a PhD, or within 3 months for MSc degrees by dissertation. Submission dates are obtainable from the Faculty Office. For a Masters degree by course work, the protocol must be submitted to the Faculty no later than 31st January of the year immediately following completion of the coursework component. Protocols are assessed by sub-groups of the Postgraduate Committee, whose aim is to guide candidates and prevent methodological problems that could affect the outcome of the study.

3. FACULTY REQUIREMENTS FOR PROTOCOLS

Detailed guidelines are attached, but please note the following:

a) Length: A protocol must not be very long. It is a plan of action, not a dissertation itself. The protocol document in entirety may not exceed 10 typed pages, must be in 12 font, single spaced with 25mm margin.

b) Summary: The protocol document must be accompanied by a

summary of not more than one A4 page. Your name, qualifications, student number, the year you started your degree, the degree for which you are registered, your department, the title of your research, and your supervisor’s name, qualifications and department, the short abstract and the signature of the supervisor must appear on the summary page of the document.

c) Copies: Six copies of the protocol and summary must be submitted

to the Faculty Office, by the dates specified by the Faculty Secretariat. 4. DETAILS OF THE CONTENT OF THE PROTOCOL

You will be required to meet with the sub-group of the Postgraduate Committee, together with your supervisor, on a date specified by the Faculty Secretariat. The objective of the meeting is to facilitate your research and assist you in your higher degree studies. You will be notified after the next meeting of the Postgraduate Committee as to whether your protocol and/ or candidature has been approved. Approval of your protocol cannot be given unless you have provided the Faculty with ethics approval numbers from the Committee for Research on Human Subjects, or the Animal Ethics Committee.

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CONTENTS OF THE RESEARCH PROTOCOL

A protocol is a plan for a research project. It is one of the most important phases of the study. If it is inadequate, misguided, or incomplete, it is unlikely that the research will be successful. Formulating the protocol may, for some research projects, take longer than the collecting of data. A protocol should include the following: 1. A TITLE

A title should be brief, and precise, and should avoid redundancies and unnecessary phrases such as “An investigation into...”. Below the title, state your name, student number and the degree for which you are registered. Also give the name(s), qualifications and position(s) currently held, of your supervisor(s).

2. INTRODUCTION

The introduction should explain, for the non-expert but intelligent reader of your document, what the background is to your proposed study. You should formulate the question being asked, or the hypothesis of the study, in the context of the prevailing scientific knowledge on the subject. Therefore in this section you should also include a brief review of the relevant literature that has led to the idea or conceptualization of your project. Usually about five to ten references will suffice.

3. STUDY OBJECTIVES

This section requires you to be specific about the research questions or problems to be studied, which were raised in the introduction. It is probably the single most important section of a protocol. State exactly what it is you intend to do, and what outcomes you will measure to find answers to the questions you have in mind. You may list the study objectives, or specify them in paragraph form, but the reader must be left in no doubt as to what your objectives are.

4. METHODS

This section should include all the information relating to your plan of action. Specifically, address the following:

i) State who/what subjects are to be studied. If they will be animals, give details such as

their species, body weight, sex and number and the inclusion and exclusion criteria. If human beings are to be studied, specify the population and state which of its characteristics are relevant to your study.

ii) Explain what experimental groups the animals, subjects, or members of the population

will form, which subjects will act as controls and whether when the study will be open, or single/double blind, cross-over or parallel in nature, or a clinical trial.

For each of (i) and (ii), justify your selection of experimental subjects and sample size.

i) If using tissues or tissue samples, x-rays, patient records etc, state the choice(s) of

material for your study and justify your choice(s), in terms of type of study material, size of sample, control material or tissue etc to be used.

ii) What intervention(s) is (are) to be made? Describe what each intervention involves.

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iii) What measurements or observations are to be made? Describe the variables to be controlled and the techniques to be used, and identify and explain which of these are established techniques, and which will require development, or require you to work somewhere other than in your institution or require someone else to perform the measurements. The level of detail in this section should be such that the reader clearly understands how these measurements are designed to enable you to elicit a conclusion from your research questions.

iv) State the endpoints you have in mind for your study, which will allow you to know when

it has reached its completion.

v) Consider such issues as sources of bias, and confounding variables.

vi) If a pilot study will be necessary, explain what aspects of the protocol may change as a result of its outcome.

5. DATA ANALYSIS

Specify the methods to be used in the analysis of the data of each section of the work, statistical tests that will be used and whether expert statistical help will be necessary. If it will, state whose help will be needed.

6. ETHICS

If the study raises ethical issues, explain how you will deal with these issues. State whether clearance has already been obtained from the relevant ethics committee, or when you envisage making a submission to the committee.

7. TIMING

State when the study will commence, and its expected duration. 8. FUNDING

Explain how the project will be funded. There may be a need to specify the sources of funding for specific aspects of the project, or to pre-empt a question as to where funding would come from, possibly for particularly expensive equipment, agents or tests. If a drug company is donating agents to be used, please disclose this information.

9. PROBLEMS

If there are any issues, which you consider may compromise your progress with the project, such as availability of study material or patients, or problems of a technical nature, please raise these issues, so that the Faculty Committee can attempt to help you.

10. REFERENCES

You should list the references in an accepted referencing format.

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WHAT CONSTITUTES AN M MED RESEARCH REPORT?

This report refers particularly to the MMed/MDent Research report, but may also be applied to other Masters Research Reports or Dissertations. 1. NAME

To note that the M Med research component is correctly termed a “Research Report”. 2. TYPE OF RESEARCH THAT IS ACCEPTABLE

a) A Clinical Audit

This would be a review of topics in clinical medicine with prospective or retrospective collection and analysis of data from clinical cases.

b) A Review of the Literature

This would be acceptable provided it is a comprehensive review of the literature with extraction and extrapolation of data or is a meta-analysis using recognised research methods or is a formal systematic literature review along the lines of the Cochrane Collaboration.

c) Research Study

This would be a retrospective or prospective study involving laboratory-based research and would constitute the traditional type of research report.

d) Contract Research

An analysis of cases collected in contract research projects may be suitable for presentation in a research report. These should not normally represent a small sub-analysis of a much larger study. Formal permission would be required from the sponsor to present the data as a research report.

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e) In Exceptional Circumstances: A Case Study

This would be acceptable in certain circumstances, such as in extremely unusual or rare cases, if important contributions have been made to the investigation, understanding or management of the case(s), or if the presentation is accompanied by additional clinical audit.

3. FORMAT OF THE RESEARCH REPORT

The report may be presented in either the standard research report format or on the basis of published papers. With regard to the latter, the research report may be constituted from one or more substantial papers, published in indexed, peer-reviewed journals, within the last two years. In either case the quality and presentation should follow the recognised criteria and the protocols be scrutinised and approved by the postgraduate committee in the usual way.

The research report would vary in length, but the body of the text would not need to be greater than 60 - 80 pages, excluding the preface, dedication, abstract, table of contents and references. This would constitute approximately 10 000 words. The format should follow the recognised style guide of the Faculty of Health Sciences.

NEW DATES FOR ETHICS COMMITTEE MEETINGS, 2007

Please note the new dates for submission of ethics applications, and the number of copies required 23 copies of the application form 23 copies of the consent form, if there is one 23 copies of the patient information sheet, if there is one 23 copies of the questionnaire, if there is one (These should be collated and stapled together) 4 copies of the research proposal

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These documents are to be submitted to Aneesa Keshav in the University Research Office, Senate House 10005, tel. 717-1234

Submission deadlines and the dates scheduled for meetings are attached

Please note: applications that do not adhere to these requirements will be returned with regret

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WITS HUMAN RESEARCH ETHICS COMMITTEE: (MEDICAL): ETHICS SUBMISSION & MEETING DATES

SUBMISSION DATES 2015

HREC MEETING DATES 2015

07 January 2015

WEDNESDAY

30 JANUARY 2015

FRIDAY

06 February 2015

FRIDAY

27 FEBRUARY 2015

FRIDAY

06 March 2015

FRIDAY

27 MARCH 2015

FRIDAY

07 April 2015

TUESDAY

24 APRIL 2015

FRIDAY

07 May 2015 THURSDAY

29 MAY 2015

FRIDAY

08 June 2015

MONDAY

26 JUNE 2015

FRIDAY

07 July 2015

TUESDAY

31 JULY 2015

FRIDAY

07 August 2015

FRIDAY

28 AUGUST 2015

FRIDAY

07 September 2015

MONDAY

02 OCTOBER 2015

FRIDAY

07 October 2015

WEDNESDAY

30 OCTOBER 2015

FRIDAY

06 November 2015

FRIDAY

27 NOVEMBER 2015

FRIDAY

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FORM HREC (2007 - MEDICAL)

UNIVERSITY OF THE WITWATERSRAND, JOHANNESBURG

APPLICATION1 TO THE HUMAN RESEARCH ETHICS COMMITTEE: (MEDICAL) FOR CLEARANCE OF

RESEARCH THIS APPLICATION MUST BE TYPED OR HANDWRITTEN IN CAPITALS Please complete ALL Investigators’ details involved in the Study as requested below (including Item 6.3): SECTION 1 PRINCIPAL INVESTIGATOR PER SITE

NAME: Prof/Dr/Mr/Miss/Ms

PROFESSIONAL STATUS (if student, year of study) UNIVERSITY DEPARTMENT

DETAILS OF SITE WHERE STUDY WILL BE CONDUCTED / (SYNDICATE NAME:)

HOSPITAL/INSTITUTION WHERE EMPLOYED FULL-TIME OR PART-TIME: HPCSA NO:

TELEPHONE NO: FAX NO:

CELL: EMAIL:

GCP TRAINING: Please list all Investigators GCP Training

Please indicate DATE AND NAME of GCP Course attended (dd/mmm/year)

(Investigators meetings do not qualify as GCP training)

Full Name:_____________________________________________________________

GCP Course Name: _____________________________________________________

Date of GCP course: day/month/year: ______________________________________

(the date is important for database process– please insert full date)

(It is a requirement that a GCP course be attended every THREE years)

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SECTION 2 PLEASE SUPPLY CONTACT PERSON; ADDRESS AND CONTACT DETAILS TO WHOM ALL

CORRESPONDENCE SHOULD BE ADDRESSED:

NAME:

COMPANY:

ADDRESS:

TELEPHONE NO: FAX NO:

CELL: EMAIL:

SECTION 3

3. TITLE OF RESEARCH PROJECT: 2 (Use no abbreviations)

WHERE WILL THE RESEARCH BE CARRIED OUT? (Please furnish name of hospital/institution and particular department)

All the following sections must be completed

3. Please tick all relevant boxes.

3.1 PURPOSE OF THE RESEARCH: Postgraduate: degree/diploma (state which)

Undergraduate: degree/diploma (state which)

Not for degree purposes

3.2 OBJECTIVES OF THE RESEARCH (please list):

3.3 SUMMARY OF THE RESEARCH (give a brief outline of the research plan):

SECTION 4

4. REQUIREMENTS 4.1 If this project involves studies with drugs at a teaching hospital associated with this

University, approval must first be obtained from the Protocol Review Committee.

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Has application been made? Yes No (If not, this application cannot be considered)

4.2 If radiation or isotopes are to be used, written approval must be obtained from the Nuclear

Medicine Department, Diagnostic Radiology Department, Radiation Therapy Department or NUCOR representative.

Is this attached? If not, the application cannot be considered. Yes No

4.3 Participant Information Sheet4 is attached. (For written and verbal consent)

Yes No

Informed Consent Form5 is attached. (For written consent). Yes No

Please refer to Wits Informed Consent Form Template

Consent will be verbal Yes No

Informed consent is not necessary. State why not. Yes No

4.4 If a questionnaire or interview is to be used in the research, it must be attached.

Is it attached? If not, the application cannot be considered. Yes No

SECTION 5

5. PARTICIPANTS FOR STUDY 5.1 If patients are being studied, state where and how the participants are selected:

5.2. Where the participants are not patients, They will be invited to volunteer they will be selected State how the participants are selected, or who is invited to volunteer: Are the participants subordinate to the person doing the recruiting? Yes No If yes, justify the selection of subordinate participants:

5.3 Will control participants be used? Yes No

If yes, explain how they will be recruited

5.4 Participants records: state what records will be used and how they will be selected: 5.5 Age range of patients/participants/controls:

If under 18 years, from whom will consent be obtained? If under 18 years, is a Patient Assent Document included? Yes No

5.6 Sex: Male Female

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5.7 Number of patients ________; non-patient participants_____ controls ____

5.8 Benefit to patient or participants: will the research benefit the patient(s) or participant(s) in any direct way. If yes, explain in what way. Yes No

Is the patient being remunerated for participating in the study? Yes No If yes, please state what the remuneration is for and how much will be paid.

5.9 Disadvantages to patients/participants/controls. Will participation or non-participation

disadvantage them in any way? If yes, explain in what way: Yes No SECTION 6

6. PROCEDURES 6.1 Mark research procedure(s) that will be used:

Record review

Interview form (must be attached)

Questionnaire (must be attached)

Examination (state below nature and frequency of examination)

Drug or other substance administration (state below name(s) of drug(s)/substance(s) and dose(s) and frequency of administration)

X-rays

Isotope administration (state below name(s) of isotope(s) and frequency)

Blood sampling; venous; arterial (state below amount to be taken and the frequency of blood sampling)

Biopsy

Other procedures (explain)

Use this space to elaborate procedures marked above:

6.2 Is/are procedure/(s) routine for: diagnosis/management? Specific to research?

6.3 Who will carry out the procedure(s)?

(State name/(s) and position/(s) held per research unit.

All sub-investigators must be listed here, Please attach the study specific CV’s in the required format.)

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GCP TRAINING: Please list all Investigators GCP Training

Please indicate date and name of GCP Course attended

(Investigators meetings do not qualify as GCP training)

Full Name: _______________________________________________________

GCP Course Name: _____________________________________________________

Date of GCP course: day/month/year: ______________________________________

(It is a requirement that a GCP course be attended every THREE years)

6.4 When will the research commence, and over what approximate time period will the research be conducted?

START DATE: _________________________ END DATE: ______________________

RECRUITMENT START:_________________ END DATE: ______________________

6.5 Research on studies being conducted outside the Gauteng Academic Hospitals, please list the number of other studies currently being conducted by the Principal Investigator, the number of patients per study and state where they are being performed.

6.6 For applications outside the Gauteng Academic Hospitals: Is the investigator involved in clinical -Time / Full-Time capacity (delete whichever is not applicable)

SECTION 7

7. RISKS OF THE PROCEDURE(S) participants/controls will suffer:

No risk Discomfort

Pain Possible complications

Side effects from agents used

If you have checked any of the above except "No risk" provide details here:

SECTION 8

8. GENERAL 8.1. Has permission of relevant authority/ies been obtained? eg IBC, MCC, DoA, etc Yes No N/A

State name of authority/ies:

8.2 Has this study been submitted to other Ethics Committees? Yes No N/A

If yes, what is the status of the application?

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8.3 Confidentiality: How will confidentiality be maintained so that patients/ participants/controls are not identifiable to persons not involved in the research?

8.4 Results: to whom will result be made available?

8.5 Finances: There will be financial costs to:

Patient/Participants Yes No

Hospital/institution Yes No

Other Yes No

Explain any box marked "Yes":

8.6 How will the research be funded? Please complete details of Funder / Donor / Sponsor / Pharmaceutical Company - (Full name and address)

8.7 Any other information, which may be of value to the Committee, should be provided here:

Date: Applicant's Signature: _________________________________________________________________________________________ WHO WILL SUPERVISE THE PROJECT? (WHERE APPLICABLE)

Name

Department:

Telephone No: Date Signature: ___________________________________________________________________________________ HEAD / RESEARCH COORDINATOR OF DEPARTMENT / INSTITUTE IN WHICH STUDY WILL BE CONDUCTED (where applicable) or, if not applicable, NAME, CONTACT DETAILS AND SIGNATURE OF COMPANY REPRESENTATIVE: Name: Signature: Date: Tel No:

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Fax No: Email:

Company:

PLEASE NOTE:

1 If not employed by the University or one of the University's teaching hospitals, please indicate clearly,

where correspondence should be sent.

2 This requirement holds even if, to assist the Committee, a protocol detailing the background to the research, the design of the investigation and all procedures, is submitted with the application.

3 NB. If any doubt exists please contact Wits Ethics Regulatory Office Secretariat to the Human

Research Ethics Committee

At 011 274 9278 / 9279 /80 – Fax: 011 274 9281

4 Whether written or verbal consent is to be obtained, the HREC requires a Participant Information Sheet

written in language understandable to the participant (or guardian) detailing what the participant will be told. This should include the following:

(1) Participation is voluntary, and refusal to participate will involve no penalty or loss of benefits to

which the participant is otherwise entitled:

(2) The participant may discontinue participation at any time without penalty or loss of benefits:

(3) A brief description of the research, its duration, procedures and what the participant may expect and/or be expected to do:

(4) Any foreseeable risks, discomforts, side effects or benefits, including those for placebo:

(5) Disclosure of alternatives available to the participant. If risks are involved:

(6) A professional contact name and 24 hour telephone number:

(7) Explanation whether medical treatment will be provided in the case of a complication

developing:

(8) Compensation for trial related injuries will be in accordance with the ABPI guidelines:

(9) A separate Patient Information and Informed Consent sheet for blood / tissue samples taken for future testing. The Participant Information Sheet may be incorporated into the consent form, or the consent form may be submitted separately:

(10) Please ensure to INVITE the participant to take part in the study:

The HREC requests that the participant be invited – (using a friendly tone):

5 The Informed Consent Form should include a clear statement that the participant is consenting to involvement in research, and not to treatment, which will necessarily provide personal benefit. Any personal benefit should be mentioned when this is possible. In a trial containing a placebo, the participant must be made aware that, although the potential risks and benefits of all the substances under trial have been explained, none of the active substances may be administered and it will not be possible for the researcher to reveal whether an active substance or placebo is being administered. An important piece of information is that the participant is free to withdraw from the trial at any time without prejudicing any treatment that is required for existing or future medical conditions. If this is not made clear, the researcher risks the accusation that consent was obtained by subtle coercion (that is, the possibility of prejudice against the participant as a current or future patient).

6 STORAGE OF BLOOD AND/OR TISSUES SAMPLES:

The ethical issues surrounding the storage of blood and/or tissue samples internationally and in South Africa

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"If, blood specimens are to be stored for future analysis and it is planned that such analysis will be done outside Wits then the blood must be stored at Wits with release of sub-samples only once projects have been approved by the local Research Ethics Committee applicable to where the research will be done as well as by the Wits Human Research Ethics Committee: (Medical)."