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Study title: Towards skilled attendance: A model to improve clinical leadership in labor wards of district hospitals of KwaZulu-Natal Include

a Greeting: Good morning Introduction: I am doing a research on improving clinical leadership. Research is just the process to learn the answer to a question. In this study we want to learn the clinical leadership capacity and competence in district hospitals of KwaZulu-Natal and how to improve labor wards supervisors in their clinical leadership roles.

Invitation to participate: You are invited to participate in this research study.

What is involved in the study study design, what the participants involvement in the study would entail, and how long the participant is expected to be in the study, standard procedures being done in the study, procedures that are being tested in the study, how many people will take part in the study, and if all from SA or also other countries Risks of being involved in the study, a description of the procedures for handling adverse events and what arrangements have been made for compensation. Potential Benefits of being in the study. Alternative procedures or courses of treatment that might be advantageous to the participant. The participant will be given pertinent and appropriate information on the study while involved in the project and after the results are available. Participation is entirely voluntary, that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and that the participant may discontinue participation at any time without penalty loss of benefits to which she or he is otherwise entitled. Reimbursements for out of pocket expenses: Provide details. Confidentiality: Every effort will be made to keep personal information confidential. Absolute confidentiality cannot be guaranteed. Personal information may be disclosed if required by law. Organizations that may inspect and/or copy your research records for quality assurance and data analysis include groups such as the Biomedical Research Ethics Committee, Data Safety Monitoring Committee and the Medicines Control Council (where appropriate).

If results are published, could this lead to individual / cohort identification? If so, specify or anonymise.

Contact details of researcher/s for further information / reporting of study related adverse events. Contact details of BREC Administrator or Chair for reporting of complaints/ problems: Biomedical Research Ethics, Research Office, UKZN, Private Bag X54001, Durban 4000 Telephone: +27 (0) 31 260 4769 / 260 1074 Fax: +27 (0) 31 260 4609 Administrator: Ms D Ramnarain Email: BREC@ukzn.ac.za

INFORMED CONSENT (sample document)


This document must be translated into a language and reading level understandable to the intended participants. (Please refer to the UKZN BREC Terms of
Reference at http://research.ukzn.ac.za/ResearchEthics11415.aspx)

CONSENT DOCUMENT
Consent to Participate in Research Greeting: Information about the researcher (provide) and the planned study (provide). You have been asked to participate in a research study (describe). You have been informed about the study by . . Where applicable: You have been informed about any available compensation or medical treatment if injury occurs as a result of study-related procedures; You may contact . at any time if you have questions about the research or if you are injured as a result of the research. You may contact the Biomedical Research Ethics Office on 031-260 4769 or 260 1074 or Email BREC@ukzn.ac.za if you have questions about your rights as a research participant. Your participation in this research is voluntary, and you will not be penalized or lose benefits if you refuse to participate or decide to stop at any time. If you agree to participate, you will be given a signed copy of this document and the participant information sheet which is a written summary of the research. The research study, including the above information, has been described to me orally. I understand what my involvement in the study means and I voluntarily agree to participate. I have been given an opportunity to ask any questions that I might have about participation in the study. ____________________ Signature of Participant ____________________ Signature of Witness (Where applicable) ____________________ Signature of Translator ____________________ Date _____________________ Date _____________________ Date (Where applicable)

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