ࡱ>  bjbj ?xikxikT 1"  =#j#X###k0:00 up2.k022## 9992##9299&#KT3jdr0(&7&6<0h-1J9w1<1?00080002222000000000 [: PLEASE READ AND DOUBLE CHECK ALL ITEMS LISTED FOR YOUR CONVENIENCE AND TO ASSIST WITH THE EFFICIENT PROCESS OF YOUR SUBMISSION REMINDER: PATIENT / SUBJECT IS NOT AN ACCEPTABLE FORM OF REFERENCE, AND THAT PARTICIPANT IS THE PREFERRED REFERENCE. YOUR ATTENTION TO THIS IS APPRECIATED. reference to the participant does not in any way imply that theindividual has agreed to join the study, prior to completion of the Informed consent form. Refer to checklist items: 24. ABPI Research study insurance does not substitute malpractice insurance ABPI guidelines on compensation (latest version 2014) contains two distinct sections: Phase I Clinical Trials Compensation Guidelines Phase II, III and IV Clinical Trials Compensation Guidelines Reference to ABPI compensation should not be a standard paragraph in all consent documents, only when appropriate 26. Please note the name and contact details of the chairperson 34. Assent Form (If Applicable) Assent Form for Children 7-11 years AND 12-17 years 36. A separate Information and Informed Consent is required when Controls are used 37. A separate Information & Informed Consent is required for Pre-screening & Screening 38. A separate Information and Informed Consent is required for DNA sampling or any other specimen storage, detailing how much blood/tissue will be taken, how long it will be stored for, where it will be stored, the purpose it will be used for and how the participants anonymity will be ensured A separate Informed Consent / Signature is required when video/audio taping will occur A new Information and Informed Consent is required for an extension to a study Simple, clear language for information sheets to ensure that a potential participant understands what he and/or may be involved, therefore - In a complex study, it may be necessary to add such a simplified information sheet (e.g. <1 page). This does not replace the full information document. For studies involving minors, include a simplified information sheet suitable for children to read before signing assent. A witness to informed consent is only required when a potential participant is illiterate. The participant should consent to participate by making a mark (either a cross or a finger print) obtained in the presence of and countersigned by an impartial witness. Reference to POPIA Your data will be collected, processed and stored according to the South African Protection of Personal Information (POPI) Act of 2013. WHC Secretariat to the 91Ƭ Human Research Ethics Committee: Reference number: 011.Informed Consent Template Contact: Jennifer Palmer / Kim Govender-Mothiba / Thashin Reddy / Yvonne Petersen Telephone: 011 274 9278/ 79/ 80 / 55 Template for 91Ƭ human research ethics committee Informed Consent INFORMATION LEAFLET AND INFORMED CONSENT Each participant must receive, read and understand this document before any study-related procedure STUDY NUMBER:  STUDY TITLE: SPONSOR: INVESTIGATOR INSTITUTION:  DAYTIME AND AFTER HOURS TELEPHONE NUMBER(S):  4. INTRODUCTION:  Good day, my name is . (Insert name of study doctor), I am a (Insert designation) at . (Insert name of Syndicate/Institution/Department). I would like to invite you to consider participating in a research study, entitled Before agreeing to participate, it is important that you read and understand the following explanation of the purpose of the study, the study procedures, benefits, risks, discomforts, and precautions as well as the alternative procedures that are available to you, and your right to withdraw from the study at any time. This information leaflet is to help you to decide if you would like to participate. You need to understand what is involved before you agree to take part in this study. If you have any questions, do not hesitate to ask me. You should not agree to take part unless you are satisfied about all the procedures involved. You may not participate in another investigational medicine research study, nor take any other investigational medicine during your participation in this study. You should not have participated in an investigational medicine research study within the past days. Please be open with me regarding your health history, since you may otherwise harm yourself by participating in this study. If you decide to take part in this study, you will be asked to sign this document to confirm that you understand the study. You will be given a copy to keep. If you have a personal doctor, please discuss with or inform him/her of your possible participation in this study. If you wish, I can also notify your personal doctor in this regard. 7. PURPOSE OF THE STUDY: You have been diagnosed as suffering from ................. and I would like you to consider taking part in the research of a new medicine, called ....................... The purpose of this study is to determine This study will compare . (study medicine) with and ... (Where possible, include the South African trade name and/or examples of the medicine in brackets after the word) 8. PLACEBO A placebo is an inactive substance and it does not contain any medicine. (Delete if not placebo controlled) You will be randomly allocated to one or other treatment (i.e. like spinning a coin). Neither you nor I will know which treatment you are receiving during your participation in the study. This procedure helps to ensure that the information gathered during the study is accurate. In case of an emergency, it will however be possible to determine which treatment you have been receiving. 9. LENGTH OF THE STUDY AND NUMBER OF PARTICIPANTS: The study will be performed in countries Approximately participants will participate in this study around the world. In South Africa .. Participants will be enrolled at each study site The participants will be between the ages of .. and .. The total amount of time required for your participation in this study will be a maximum of hours/days/months/years You will be asked to visit me ......... times during the study. 10. PROCEDURES: If you agree to take part in this study, you will first be asked questions and examined to see if you qualify for this study. Before receiving your first dose of study medicine, you will have. (Explain study procedures in plain language) At each following visit you will undergo: Visit 1 (week aa): Visit 2 (week bb): Etc. Note that: The number of times that blood will be drawn must be stated The amount of blood withdrawn at each visit must be stated in tubes, ml, and teaspoons Where blood and urine samples are taken from participants, the tests to be done must be specified The exact reasons for the blood and urine tests, ECG, and all other tests must be stated The necessity for keeping a study diary and/or other study related requirements must be included 11. WILL ANY OF THESE STUDY PROCEDURES RESULT IN DISCOMFORT OR INCONVENIENCE? (Examples): Venipunctures (i.e. drawing blood) are normally done as part of routine medical care and present a slight risk of discomfort. Drawing blood may result in faintness, inflammation of the vein, pain, bruising or bleeding at the puncture site. There is also a slight possibility of infection. Your protection is that experienced personnel perform the procedures under sterile conditions. A total of ...... ml of blood (i.e. teaspoons) will be collected over the course of the entire study. A chest x-ray is a commonly used diagnostic procedure that exposes you to a small amount of radiation. Although all radiation is cumulative over your lifetime, small doses from x-rays should not create a significant risk to your health. 12. RISKS OF THE STUDY MEDICINE: In previous studies some participants have reported experiencing side effects, which included ................... (Include likelihood, significance etc.) 13. UNFORSEEN RISKS: The study medicine is investigational and there may be other risks or side effects which are unforeseen or unknown. You should immediately contact me if any side effects occur throughout your participation in this study. 14. BENEFITS: The potential benefit from your participation in this study may be control of your... However, you may not benefit from this study. Your participation in this study will contribute to medical knowledge that may help other patients that, like you, have .. 15. ALTERNATIVE TREATMENT: Alternative treatment in the form of............................. is often used to treat (this condition) If you decide not to take part in this study you will still receive the best current care, from your usual doctor; this may or may not include the study medicine. 15.1 BENEFITS AND RISKS OF STANDARD ALTERNATIVE TREATMENT: (Add relevant details) ARE THERE ANY WARNINGS OR RESTRICTIONS CONCERNING MY PARTICIPATION IN THIS STUDY? (Examples) If you are pregnant or breastfeeding or planning to become pregnant during the study period, you may not take part in the study If you are a woman who can become pregnant you must use suitable contraceptive measures during the study and for . Months after you stop taking the study medicine, as the safety of this medicine during pregnancy has not been established. You must also read and sign the Supplementary Informed Consent for Women of Childbearing Potential (14 Years and Older) If you are a man who can father a child, suitable contraceptive measures should be used during the study and for months after you stop taking the study medicine . May affect reaction time. Care should be exercised when driving or operating machinery (Other relevant warnings) INTERACTIONS: It is important that you let me know of any medicines (both prescriptions and over-the-counter medicines), alcohol or other substances that you are currently taking. During this study, you should not take ; if you have to, please inform me immediately. RIGHTS AS A PARTICIPANT IN THIS STUDY: 16 and 17 - VOLUNTARY: Your participation in this study is entirely voluntary and you can decline to participate, or stop at any time, without stating any reason. Your withdrawal will not affect your access to other medical care. Discontinuation of study treatment. You must inform me if you wish to stop taking your study medicine. I will supervise any discontinuation with your health as first priority. New findings: I will provide you with any additional information that becomes available during the study, which may affect your willingness to continue on the study Withdrawal: Your withdrawal will not affect your access to other medical care. I retain the right to withdraw you from the study if it is considered to be in your best interest. If your participation is ended early, you may be asked to return for study-ending tests and procedures for your safety If you did not give an accurate history or did not follow the guidelines of the study and the regulations of the study facility, you may be withdrawn from the study at any time. Pregnancy: Because the safety during pregnancy of the medicine used in this study has not been established, you will be immediately withdrawn from the study, if you become pregnant during your participation in the study. All aspects of healthcare related to your pregnancy and infant will be your responsibility. . (The Sponsor) will require access to your medical records and those of your child, from the time you became pregnant and for a minimum of . Weeks after the baby is born. 20. EMERGENCY CARE AND HOSPITALISATION: If you seek emergency care or if hospitalisation is required at any time during the study or up to month/s after taking the last dose of study medicine, please tell the treating doctor that you are/were enrolled in this research study and that I must be informed. 21. FINANCIAL ARRANGEMENTS: (The Sponsor) will provide payment for all study procedures and reasonable medical expenses that you may incur as a direct result of this study as determined by (the Sponsor) and me. (To prevent misunderstandings, provide a separate list of exactly what will or will not be paid). Neither you nor your medical scheme will be expected to pay for any study medication, study related visit or study procedures. (For Study doctor initiated studies or studies where the participants medical scheme may be paying for certain costs:) Your medical scheme should receive pre-notification on the costs to be borne by them and you should, preferably, obtain clarification as well. Kindly note that a sentence to the effect that, in the event of the participant who is not a member of any medical scheme be participating in this study, or where the participant's medical scheme refuses to pay for the study procedures, then the costs of all study-related procedures would be paid by the sponsor company, should also be included. 22. REIMBURSEMENT FOR STUDY PARTICIPATION: (Except for phase one studies) You will not be paid to participate in this study but your transport and, when necessary, refreshment costs will be reimbursed adequately, according to SAHPRA requirements. 23. INSURANCE: (The Sponsor) has obtained insurance for you and me in the event of study related injury or illness. A study-related injury or illness is one that occurs as a direct result of the administration of the study medicine or of study-specific procedures. ABPI STATEMENT ON COMPENSATION: . (The Sponsor) will provide compensation for reasonable medical expenses incurred as a result of study-related injury or illness, or death determined according to the guidelines laid down by the Association of the British Pharmaceutical Industry (ABPI Compensation Guidelines Version 2014), and Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in South Africa. You must notify me immediately of any complications, side effects and/or injuries during the study and the nature of the expenses to be covered. If a research related injury occurs, you have not waived any of the legal rights which you otherwise would have as a participant in this study by signing this form. Further detailed information on the payment of medical treatment and compensation due to injury can be obtained from me. I have a copy of the ABPI Guidelines (version 2014) and the Insurance Certificate, should you wish to review them. The insurance does not cover and . (the Sponsor) will not pay for: Medical treatment of other injuries or illnesses Injury caused by non-observance of the protocol I am indemnified by (the Sponsor) conditional upon: My compliance with the applicable requirements of the study protocol My compliance with the regulations of the South African Health Products Regulatory Authority and the 91Ƭ, Human Research Ethics Committee (HREC). The handling and administration of the study medication in accordance with instructions and guidelines provided in the protocol, subsequent amendments and related documents The indemnification is not intended to be and is not a substitute for my personal malpractice insurance. Please note that if you have a life insurance policy you should enquire whether your insurance company requires notification of your intention to participate in a clinical study. Information to date is that it should not affect any life insurance policy taken out. Nevertheless, you are strongly advised to clarify it with the company concerned. The 91Ƭ, Human Research Ethics Committee (Medical) exercises final discretion and oversight over compensation and that injury would have to be reported to the HREC as an Adverse/Serious Adverse Reaction for determination.  HYPERLINK "http://www.abpi.org.uk/publications/ct-compensation" http://www.abpi.org.uk/publications/ct-compensation 25. ETHICAL APPROVAL: This clinical study protocol has been submitted to the 91Ƭ, Human Research Ethics Committee (HREC) and written approval has been granted by that committee. The study has been structured in accordance with the Declaration of Helsinki (last updated: October 2024), which deals with the recommendations guiding doctors in biomedical research involving human participants and consistent with the South African Good Clinical Practice: Clinical Trial Guidelines. Third Edition (SA GCP 2020) and South African Ethics in Health Research Guidelines: Principles, Processes and Structures, 2024, 3rd Edition (NDoH 2024). A copy of each guideline may be obtained from me should you wish to review it. This study is sponsored by . (Insert name of Sponsor) I do not have any financial or personal interests with this organisation that may bias my actions. 26. SOURCE OF ADDITIONAL INFORMATION: For the duration of the study, you will be under the care of (Insert name of study doctor). If at any time between your visits, you feel that any of your symptoms are causing you any problems, or you have any questions during the study, please do not hesitate to contact me. Other doctors from this department who are working on this study are: List contact details and designation (Principal Investigator/Co- or Sub-Investigator) of the study doctors: The 24-hour telephone number through which you can reach me or another authorised person, is . If you want any information regarding your rights as a research participant, or complaints regarding this research study, you may contact Prof. Paul Ruff, Chairperson of the 91Ƭ, Human Research Ethics Committee (HREC), which is an independent committee established to help protect the rights of research participants at (011) 717 2301 /  HYPERLINK "mailto:EthicsRegulatory@witshealth.co.za" EthicsRegulatory@witshealth.co.za. For research information you can contact (Name and designation of dedicated person Sponsor) at 27. SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY SAHPRA If you have questions about this trial you should first discuss them with your doctor or the ethics committee (contact details as provided on this form). After you have consulted your doctor or the ethics committee and if they have not provided you with answers to your satisfaction, you should write to the South African Health Products Regulatory Authority (SAHPRA) at: The Chief Executive Officer South African Health Products Regulatory Authority Loftus Park Building A 402 Kirkness Street Arcadia, Pretoria 0083 E-mail: HYPERLINK "mailto:Boitumelo.Semete@sahpra.org.za"Boitumelo.Semete@sahpra.org.za Tel: 012 501 0413  28. CONFIDENTIALITY: All information obtained during the course of this study, including hospital records, personal data and research data will be kept strictly confidential. Data that may be reported in scientific journals will not include any information that identifies you as a participant in this study. Your data will be collected, processed and stored according to the South African Protection of Personal Information (POPI) Act of 2013. This information will be reviewed by authorised representatives of (the Sponsor). The information might also be inspected by the National Health Research Ethics Council (NHREC), 91Ƭ, Human Research Ethics Committee (HREC), the South African Health Products Regulatory Authority (SAHPRA) and/or the United States Food and Drug Administration (FDA), as well as your personal doctor. Therefore, you hereby authorise me to release your medical records to (the Sponsor), its employees or agents, domestic and foreign regulatory health authorities, the South African Health Products Regulatory Authority (SAHPRA), the National Health Research Ethics Council (NHREC), and the 91Ƭ, Human Research Ethics Committee (HREC). These records will be utilised by them only in connection with carrying out their obligations relating to this clinical study. Any information uncovered regarding your test results or state of health as a result of your participation in this study will be held in strict confidence. You will be informed of any finding of importance to your health or continued participation in this study but this information will not be disclosed to any third party in addition to the ones mentioned above without your written permission. The only exception to this rule will be cases of communicable diseases where a legal duty of notification of the Department of Health exists. In this case, you will be informed of my intent to disclose such information to the authorised state agency. [NOTE FOR INVESTIGATORS: MANDATORY REPORTING REQUIREMENTS South Africa has provided for mandatory reporting since the adoption of the Child Care Act of 1983. The relevant provision was amended in 1991 and again in 1996 to provide for a more extensive system with criminal sanctions for breach. Mandatory reporting was also included in the superseding Childrens Act of 2005. South Africas Criminal Law (Sexual Offences and Related Matters) Amendment Act 2007 (commonly referred to as the Sexual Offences Act) also requires persons to report knowledge of a sexual offence against a child. These provisions require that a broad range of persons must report any minor that has been sexually abused, deliberately neglected or abused in a manner causing physical injury, based on a reasonable belief or a disclosure made. Study staff should therefore engage key stakeholders such as statutory social workers, psychologists and child protection organisations to secure expertise in making determinations about abuse or neglect as a mandatory reporting obligation to mitigate risk, and to provide services to affected minors. To ensure consistency, study staff would follow the guidance given in the SOP for mandatory reporting and to include this in all protocols and proposals involving research with minors.] EXAMPLE OF WORDING TO INCLUDE IF APPLICABLE: PARENT/LEGAL GUARDIAN CONSENT FORM: In the event that you or your child reports any abuse, unlawful sexual activity involving your child, or your child is found to be pregnant, the situation will be managed with sensitivity and support will be provided. It is important for you to know that we are required by law to report this to relevant authorities (usually a statutory social worker). You and your child will be referred for counselling and therapy within the health system if required. The site doctors may also refer your child for additional medical and psychological evaluations as needed. ASSENT FORM 12-17 YEARS: Since we are most concerned for your wellbeing, we encourage you to tell us if you are involved in sexual activity. If you are found to be involved in sexual activity or pregnant, we will handle it with sensitivity and support will be provided. If the sexual activity is considered against the law, it is important for you to know that we would need to report this to relevant authorities to investigate (usually a statutory social worker). We will also send you for extra medical tests, and to other healthcare workers like psychologists and social workers to speak to you and find out the circumstances to ensure you are kept safe. POPIA COMPLIANCE In accordance with the provisions of the Protection of Personal Information Act 4 of 2013 (as amended), I hereby consent: My personal information (hereinafter data) being collected, processed, shared and stored in accordance with the research protocol as approved by the WITS Human Research Ethics Committee (Medical); To my anonymised data being shared, processed and transferred by third parties and between third parties, and where relevant beyond the jurisdictional borders of South Africa; To all findings and results flowing from my anonymised data being broadly shared and published on the conclusion of the research. 29. PERSONAL DOCTOR / SPECIALIST NOTIFICATION OPTION: Please indicate below, whether you want me to notify your personal doctor or your specialist of your participation in this study: YES, I want you to inform my personal doctor / specialist of my participation in this study. NO, I do not want you to inform my personal doctor / specialist of my participation in this study. I do not have a personal doctor / specialist 30. PARTICIPANT QUESTIONS ?: Did the participant raise any questions? YES / NO If YES What where they:  INFORMED CONSENT: I hereby confirm that I have been informed by the study doctor, ....... (Insert name of study doctor), about the nature, conduct, benefits and risks of clinical study ..... (Insert protocol number and title of study) I have also received, read and understood the above written information (Participant Information Leaflet and Informed Consent) regarding the clinical study. I am aware that the results of the study, including personal details regarding my sex, age, date of birth, initials and diagnosis will be anonymously processed into a study report. In view of the requirements of research, I agree that the data collected during this study can be processed in a computerised system by ..(the Sponsor) or on their behalf. 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: Printed Name Signature / Mark or Thumbprint Date and Time I, ....... (Insert name of study doctor), herewith confirm that the above participant has been fully informed about the nature, conduct and risks of the above study. STUDY DOCTOR: Printed Name Signature Date and Time TRANSLATOR / OTHER PERSON EXPLAINING INFORMED CONSENT(DESIGNATION): Printed Name Signature Date and Time WITNESS (If applicable): Printed Name Signature Date and Time THE WITS HREC REQUIRES SEPARATE INFORMED CONSENT FOR PARENTS/LEGAL GUARDIANS, ASSENT FORM FOR MINORS AGED 7-11 AND ASSENT FORM FOR MINORS AGED 12-17 YEARS: SEPARATE ASSENT FORM FOR MINORS .. (Insert name of study doctor) has provided me with a copy of the Participant Information Leaflet and Assent regarding clinical study ....... (Insert protocol number and title of study) and has fully explained to me the nature, risks, benefits and purpose of the study. The study doctor has given me the opportunity to ask any questions concerning both the medicine and the study. It has been explained to me that I will be free to withdraw from the study at any time, without any disadvantage to future care. I have understood everything that has been explained to me and I assent to participate in this clinical study. PARTICIPANT ASSENT: * (Seven (7) years old and above) Printed Name Signature / Mark or Thumbprint Date and Time (* Minors competent to understand must participate as fully as possible in the entire procedure) SEPARATE INFORMED CONSENT FORMS FOR PARENT/LEGAL GUARDIAN: (ON BEHALF OF MINORS UNDER 18) . (Insert name of study doctor) has provided me with a copy of the Participant Information Leaflet and Consent regarding clinical study ....... (Insert protocol number and title of study) and has fully explained to me the nature, risks, benefits and purpose of the study. The study doctor has given me the opportunity to ask any questions concerning both the medicine and the study. It has been explained to me that I will be free to withdraw my child from the study at any time, without any disadvantage to future care. I have understood everything that has been explained to me and I consent for my child to participate in this clinical study. 1. PARENT/LEGAL GUARDIAN 1: Printed Name Signature / Mark or Thumbprint Date and Time PARENT/LEGAL GUARDIAN 2 : Printed Name Signature / Mark or Thumbprint Date and Time If both parents/legal guardians are not available, the consenting parent/legal guardian to sign the following clause: As the consenting adult providing permission for this child to participate in the study, I acknowledge that (please check one of the following):  FORMCHECKBOX  I am the biological or adoptive parent of the child  FORMCHECKBOX  I am the legal guardian or legally authorized representative/legally acceptable representative of the child I also acknowledge that (please check one of the following):  FORMCHECKBOX  I have sole legal responsibility for the care and custody of the child.  FORMCHECKBOX  The other adult(s) with whom I share parental rights and responsibilities in respect of the identified child in terms of the Children's Act (for example, biological parent, adoptive parent, or legal guardian or representative) is (1) aware of and agrees with my granting permission for this child to participate in the study OR (2) deceased, unknown, incompetent, or not reasonably available (someone is not reasonably available when he/she cannot be reached by phone/mail/email/text because, for example, he/she is on active military duty or is incarcerated). Printed Name Signature / Mark or Thumbprint Date and Time STUDY DOCTOR: Printed Name Signature Date and Time TRANSLATOR / OTHER PERSON EXPLAINING INFORMED CONSENT:..(DESIGNATION): Printed Name Signature Date and Time WITNESS (If applicable): Printed Name Signature Date and Time WHEN PARTICIPANT OR LEGALLY ACCEPTABLE REPRESENTATIVE IS ILLITERATE: Where the participant or the legally acceptable representative is illiterate, consent should be obtained in the presence of an impartial witness. The participant should indicate willingness to participate by making a mark (either a cross or a finger print). The witness signs to affirm that the participant willingly consented to participate. The witness dates the mark and his/her signature. I, the undersigned, ....... (Insert name of study doctor) have read and have explained fully to the participant, named ......................... and/or his/her relative/friend/legal representative, ....., the participant information leaflet. The account I have given has explained both the possible risks and benefits of the study as well as the alternative treatments available for his/her illness. The participant and/or his/her relative/friend/legal representative understands these. The participant and/or his/her relative/friend/legal representative indicated that he/she understands that the participant will be free to withdraw from the study at any time for any reason and without jeopardising his/her subsequent treatment. I have also informed the participant and/or his/her relative/friend/legal representative of the existence of relevant compensation arrangements in case of an injury attributable to the medicine(s) used in the clinical study, to which he/she agrees. I hereby certify that, the participant and/or his/her relative/friend/legal representative, acting on his/her behalf, has agreed to participate in this study. PARTICIPANT: Printed Name Mark or Thumbprint (if applicable) Date and Time STUDY DOCTOR: Printed Name Signature Date and Time TRANSLATOR / OTHER PERSON EXPLAINING INFORMED CONSENT:..(DESIGNATION) Printed Name Signature Date and Time PARENT/LEGALGUARDIAN/LEGALREPRESENTATIVE/FRIEND:(RELATIONSHIP) Printed Name Signature / Mark or Thumbprint Date and Time WITNESS: Printed Name Signature Date and Time SUPPLEMENTARY INFORMED CONSENT FOR WOMEN OF CHILDBEARING POTENTIAL (14 YEARS AND OLDER): I understand that as I am a woman of childbearing potential and in order to participate in this study, I should not be pregnant or breastfeeding. If I am sexually active, I must be using an effective method of contraception. I must have a negative pregnancy test before I can enter this study. A pregnancy test will be performed before and at various intervals during the study. I understand that .. (study medicine) is investigational and not yet approved by the South African Health Products Regulatory Authority (SAHPRA). The safety of the study medicine during pregnancy has not been established and the use of this study medicine may involve risks to me or my unborn child, should I become pregnant while receiving this medicine. (Delete if not applicable) If I should become pregnant, I will be immediately withdrawn from the study and be referred for medical care for my pregnancy. All aspects of health care related to my pregnancy and infant will be my responsibility. I will allow. (the Sponsor) access to my medical records and my childs medical records from the time I became pregnant and for a minimum of .weeks after the baby is born. The study doctor and/or a member of the study staff has reviewed information on pregnancy prevention for women of childbearing potential with me. I understand that I may be receiving an investigational medicine and should not become pregnant while I am participating in this study. I understand that I should immediately call ....... (Insert name of study doctor) or .. at if: I am or think I may be pregnant I have missed my menstrual cycle or it is late, or I have a change in my usual menstrual cycle (for example, heavier bleeding during my menstrual cycle or bleeding between cycles) I should also call if I have changed or plan to change my birth control method, or if I need to take any medication not given to me by the study doctor. This supplementary informed consent has been explained to me to my satisfaction and in my home language. I have been given the chance to ask questions and they have been answered to my satisfaction. I hereby voluntarily consent to participate in this study. I understand that I will receive a copy of this supplementary consent form. PARTICIPANT: Printed Name Signature / Mark or Thumbprint Date and Time STUDY DOCTOR: Printed Name Signature Date and Time TRANSLATOR / OTHER PERSON EXPLAINING INFORMED CONSENT: .(DESIGNATION) Printed Name Signature Date and Time WITNESS (if applicable): Printed Name Signature Date and Time      Page  PAGE 8 of  NUMPAGES 12 PAGE  PAGE 8 Protocol .. English Informed Consent 2. Version. (Dated dd.mmm.yyyy) Participant Initials: ____ ____ __ Investigators name Approved by 91Ƭ HREC 5. Date approved: dd.mmm.yyyy Participant Number: _______________ REF: SOP-HREC-002 Version: Our Version Control No: HREC version August 2025  FILENAME \p R:\ETHICS REGULATORY DEPARTMENT.2025\APPLICATIONS AND SUBMISSION FORMS 2025\110.Informed Consent example.doc For document control please ensure that Version number and date of documents are inserted 1 2 3 - 4 & 5 Salutations: Investigator should greet and introduce themselves to the participants Please Note: this is a template and includes guidelines to assist in drawing up and compiling your Informed Consent Documents in line with what the 91Ƭ Human Research Ethics Committee requirements for Informed Consent. We have numbered the items against the checklist to assist in double-checking that most of the elements are included in the IC and to avoid unnecessary delays and queries in the approval process. Please use the checklist. Should there be anything that we have not included please add your relevant information and delete that which is not necessary. The elements listed are to assist only. To delete the call out boxes click on the outline and delete To the potential Participant: This consent form may contain words that you do not understand. Please ask the study doctor or the study staff to explain any words or information that you do not clearly understand. You may take home an unsigned copy of this consent form to think about or discuss with family or friends before making your decision. Please date and version control documents Version Control Version Number Version for Approval Date Invite the participant Is the tone friendly? 8. Explanation Placebo Arm include justification letter to HREC with submission 9. Duration 33. Age 10. Explanation 30. Blood Samples Teaspoons and mls 31. Number of times Blood will be drawn 32. Twenty Four Hour Telephone number 28. 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