Table of content - Health Research Web€¦ · Web viewThe Kingdom of Swaziland through the Ministry of Health has set up structures to promote and manage health research in the

National Health Research Review Board Guidelines

Ministry of Health

Research Department

Guideline for researchers – Ministry of Health, Swaziland

Table of content

Ref. Topic Page numberExecutive Summary 3

1 Introduction 42 Scope 43 Purpose 44 The Review Board 4,5

4.1 Appointment 44.2 Composition 54.3 Co-opting and constitution of sub-committee 54.4 Secretariat 54.5 Tenure of office 54.5 Functions 5

5 Application process 6-95.1 Application steps 65.2 Application fees 6,75.3 Submission check list for new applications 75.4 Additional requirements for clinical trials 8

5.4.1 Steering committee 85.4.2 Data monitoring and ethics committee 85.4.3 Compensation of clinical trial participants 8

5.5 Protocol clearance 85.6 Turnaround time of review process 9

6 Extension of relapsed approval 97 Amendment of approved protocols 98 Reporting of adverse events 109 Waiver of ethical review 10

10 Information and data management 1111 Transfer of research skills 1112 Transfer of specimens and materials 1113 Quality and compliance assurance 1114 Dissemination of study results 1115 Final research reports 11

Annex 1 (sample of protocol format) 12-14Annex 2 (sample of informed consent statement) 15-22Annex 3 (same of application form) 23-28

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Acronyms

CRF Case Report Format

FWA Federal Wide Approval

IBR Institutional Review Board

MTA Material Transfer Agreement

NGO Nongovernmental Organization

NHRRB National Health Research Review Board

NHSSP National Health Sector Strategic Plan

PI Principal Investigator

QA Quality Assurance

QI Quality Improvement

RHINO ?

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Executive Summary

The Kingdom of Swaziland through the Ministry of Health has set up structures to promote and manage health research in the country. One such structure is the Health Research Unit which was established in 1998 with the support of the world Health Organization. As a primary function, the Health Research Unit is mandated to facilitate and manage development and coordination of research interest in the country. As part of this mandate, the Health Research Unit has facilitated development of the national research policy and strategic plan and establishment of an autonomous National Health Research Review Board and a Technical Working Group. The unit has also convened three national health research conferences with the objective of providing a space for researchers to disseminate results and findings of their research projects. Impetus for the most recent developments in the health research arena of the country has been drawn from the National Health Sector Strategic Plan (2008 – 2013) which identified health research as one of its priority areas.

These guidelines are issued as part of actions of the National Health Research Review Board. Its intention is to provide guidance to researchers who intend to conduct health related research in the country. It outlines requirements and the process for obtaining approval to carry out research activities in the country. The document represents a desire of the National Health Research Review Board to promote research which is both scientifically and ethically sound: research which respects as well as protects interests and rights of humans who participate as subjects of research projects.

The jurisdiction of these guidelines extends only to clinical research, biomedical research, health services and health systems research as well as Social, cultural, environmental, and behavioral and population research. Among key considerations, the guidelines indicate that all health research carried out on human subjects carried out in the country shall require approval of the NHRRB. They also describe the application process as including four steps namely: obtaining, completing, submitting and awaiting feedback. The guidelines provide a fee schedule and state that applications will only be considered after proof of payment has been received by the NHRRB. The guidelines furthermore require

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Principal Investigators are required to submit annual renewal applications in the case of multiyear studies. Modification to approved protocols similarly requires a full NHRRB review. Principal investigators are also required to reports on any adverse events occurring during the research study as well as to facilitate disseminating of research findings to relevant. Data generated from research subjects residing in Swaziland shall be considered to a property of the country. As such approval of the ministry of health shall be required in cases of a need for international exportation or transfer of raw data and specimen. The guidelines provide for Researchers to apply for waiver of review by the NHRRB under prescribed circumstances. International supported researchers are encouraged to involve local researchers in proposed research from the design stage to report writing as a means of skills transfer. The NHRRB may commission audits of on-going studies particularly clinical trials as part quality assurance. The guideline provide additional requirements that include establishment of a Trial Steering Committee for clinical trials, Trial Data Monitoring and Ethics Committee and a compensation plan to support research participants in case of damaged suffer as result of participating in a clinical trial

1. Introduction

In 1998, the Ministry of Health established the Health Research Unit to coordinate health research in the sector. In 2006 the Scientific and Ethics Committee was established to review and approve all health research studies carried out in the country. The National Health Sector Strategic Plan (HSSP) 2008-2013 identified research as a key component for strengthening policy, planning, monitoring and evaluation of systems in the health sector. The re-establishment of the Health Research Unit in 2009 was in line with the aspiration of the NHSSP to develop research capacity in the country. In order to safe guard the dignity, rights, safety and wellbeing of research participants; the National Health Research Policy (2014-2023) dictates the establishment of the semi-autonomous (NHRRB as the final authority for approval of health research. The NHRRB replaces the MOH Scientific and Ethics Committee.

2. Purpose

The purpose of the guidelines is to provide guidance on the review process and conduct of research in the country. The guidelines are designed with the intention of providing assurance to the research community, general public and research subjects that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research that

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is carried out in the country. To accomplish this purpose, the NHRRB uses a formal process to review research protocols and related materials.

3. Scope

The NHRRB will receive and review all health research protocols that involve human subjects conducted in the country including traditional and alternative medicine. The research in question includes the four pillars of health research as describe below: Clinical Research (focused towards improving diagnosis and treatment of

disease and injury): Biomedical Research (focusing on understanding the normal and

abnormal functioning at molecular, cellular and organ systems of the body)

Health services and health systems Research (focusing on improving efficiency and effectiveness of the health systems),

Social, cultural, environmental, behavioral and population research (focusing on social and cultural determinants of health)

4. The Review Board

4.1.Appointment

The National Health Research Review Board is appointed by the Minister of Health based on merit and after expression of interest. Its membership consists of not more than 9 members comprising of a Chairperson, Vice chairperson, Secretary and six other members

4.2.Composition

Membership of the board shall consist of the under-listed areas of competency:

Ref.

Area of competency

1 Statistician2 Epidemiology3 Research4 Legal/human

rights5 Public health6 laboratory

technology

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7 Medicine 8 Other clinical

areas9 Community

representative

[4.3.] Co-opting and constitution ofconstitution of subcommittees

The NHRRB is authorized to co-opt reviewers as well as recommend the establishment of sub-committees. Reviewers will be co-opted to work with the board from time to time based on needs.

4.3.[4.4.] Secretariat

The Board secretarial services are provided by the National Health Research Unit.

4.4.[4.5.] Tenure of office

The Board shall serve for a period of 3 years with possibility of renewal for one additional term.

4.5.[4.6.] Functions

Function of the National Health Research Review BoardReceive, review and adjudicate on research protocols submitted.

Encourage proper management and dissemination of research findings

Provide advice on scientific and ethical issues to the research community

Take decision on protocols that have exceeded their duration

Monitor the implementation of approved

Renewal of Federal Wide Approval (FWA) and Institutional Review Board (IRB) numbers

protocols including spot checks Submit quarterly reports to the appointing authority

Management of databases and transfer of specimens and research materials

Deliberate on matters of the board

Take action on research that has breached approved protocol or because of adverse events Close out reports for studies

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5. Application approval process

All health research on human subjects to be carried out in the country requires approval of the NHRRB. This section provides guidance on the review process. Review of protocols shall be based on the Declaration of Helsinki and its amendments as well as Principles of Good Clinical Practice. It shall therefore be incumbent upon researchers to familiarize themselves with dictates of these guidelines. Applications that have been received in a particularly month shall be reviewed during the subsequent month.

5.1.Application steps

An application for research approval should be submitted to the NHRRB prior to implementation of any aspect of the study following the steps which are outlined below:

5.2.Application fees

Applications must be accompanied by proof of application fee payment as outlined in the table below. Applications will only be considered after proof of payment has been received by the NHRRB. The application fee does not guarantee study approval, and is non-refundable irrespective of the outcome of the application. The full application fee applies to new submissions, sub-studies and relapsed approvals. The scheduled renewals will be subject to 50% of the obtaining full application fee. Application fees will be reviewed periodically.

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Obtain/Retrieve the application form from the NHRRBComplete all sections of the application formSubmit (physically or online) the completed application form, the research protocol and required supporting documents to the NHRRB (see checklist belowAwait feedback from the NHRRB: acknowledgement of receipt of the application, and the outcome of the review (see section on turnaround time below)


Study ownership Details Amount(by funding source)Domes

tic Internatio

nal

Under graduate students

E100 $100

Post graduate students

Masters, PhD E500 $ 500

Individual/freelance researcher

Not affiliated to any institution E500 $1000

Institutions, foundations

Tertiary academic institutions, hospitals, NGOs, government departments

E1000 $5000

Corporations e.g. pharmaceutical companies E10,000

$10,000

5.3.Submission check list for new applications

One hard copy and one soft copy of each of the following documents must be submitted to the NHRRB. The NHRRB may request for additional documents depending on the type of research study

Ref.

Check list items

1 Completed application form 2 Cover letter 3 Evidence of administrative permission to conduct the research by

involved institutions/sites (where applicable)4 Detailed current resume or curriculum vitae of Principal Investigator/s

including Principal investigators declaration 5 Summary resume or biography for other investigator(s)6 Evidence of approval/rejection by other Ethics Committees, including

comments and requested alterations to the protocol, where appropriate.7 Research protocol (see outline in Annex 1)8 Questionnaires and interview guides (with back-translated versions

where applicable)9 Case report forms (CRFs), abstraction forms and other data collection

tools10 Participant/subjects Information Statement(s) (where applicable)11 Informed consent form(s) including photographic and electronic media

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consent statements.12 Advertisements relevant to the study (where applicable)13 Source of funding and detailed budget breakdown including material and

incentives to participants if applicable14 Notification form for adverse effects/events.15 Proof of payment 16 Proof of insurance cover for research subjects in clinical trials or where

applicable17 Any other special requirements should be stated, if applicable

5.4. Additional requirement for clinical trials

5.4.1.Clinical Trial Steering Committee

All clinical trials are expected to have established Trial Steering Committee which will provide overall supervision to the trial prior to submitting an application for protocol approval. Most members of the Steering Committee including the chairperson should be completely independent of the trial, host institutions and sponsors of the trial. One or two members of the Steering Committee should be senior members of the trial team. Membership of the Steering Committee should include a representative of the NHRRB. Representatives of the study host institution and sponsors should sit on the committee as observers.Documentation to be supplied as part of the application documents should therefore include a list of proposed members, their respective resumes, written indication of willingness to serve on the committee, and terms of reference of the committee.

5.4.2.Trail Data Monitoring and ethics Committee

All clinical trials are expected to have established a completely independent of the Trial Data Monitoring and Ethics Committeesprior to submitting an application for protocol approval. The primary responsibility of such a committee will be to prevent exposure of trial participants to any excess. Membership of such Trial Data Monitoring and Ethics Committee should include a one or two clinicians with experience in clinical trials and biostatistician/epidemiologist. Documentation to be supplied as part of the application for approval should include a list of proposed members, their respective resumes, indication of willingness to serve on the committee, and terms of reference of the committee.

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5.4.3.Compensation of clinical trial participants

All clinical trials are expected present a detailed compensation agreement to be signed by both the trial sponsor/s and study participants. The agreement shall depict how the said compensation will be financed and the degree to which it will sufficiently cover a study participant’s claim for compensation that arises from participation in the study including ancillary expenses such as legal costs

5.5. Protocol approval

The application must include written evidence of ethical clearance of the study by other jurisdictions in cases where research protocols are subject to multiple ethical reviews. Research protocols with approval from other ethics committees shall not be exempt from obtaining approval from the country’s NHRRB; however any prior approval will be taken into consideration when the NHRRB considers the research application. The decision of the NHRRB will be final regardless of approvals obtained from other review boards.

5.6. Review process turnaround time

Each protocol shall be assigned to a team of reviewers within seven working days of submission. The team of reviewers will consider the scientific content, ethical /human subjects protection aspects of the study, and all supporting documentation included in the submission. Reviewers will submit review comments reports (checklist) to the NHRRB secretariat within 20 working days of receiving the protocol. The NHRRB secretariat will in turn communicate feedback to applicant in writing within seven working days of receiving the comments from reviewers, allowing the applicant to make recommended adjustments and to resubmit. Where these timeframes cannot be met, the NHRRB and applicants shall communicate via email. The principles of integrity, timeliness, responsiveness and professionalism shall apply to all parties involved.

6. Extension of relapsed approvals

A Principal Investigator (PI) is required to submit an annual renewal application form for NHRRB review and approval three months before the protocol’s expiry date. (The expiry date may be less than one year from the

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protocol’s approval date if the NHRRB determines an early review is appropriate to the degree of risk.) The NHRRB does not permit extensions of human subject’s research projects beyond the approval date.Protocol’s expiry date is indicated on the approval letter. The PI retains the responsibility for submitting requests for continuation. If the protocol’s approval expires the researcher must submit a new application before one continues can continue with his/her research project (including subject enrollment, collecting data, etc.). If the renewal form is not received by the expiry date, the protocol will be closed and a new protocol application must be submitted to continue research with human subjects. If research continues beyond the expiry date, it is considered to be unapproved research.

7. Amendment of approved protocols

A request for approval of an amendment may be incorporated into a request for continuation. The PI must indicate that an amendment is being made at time of continuing review and submit the Modification Form along with supporting documentation. A PI may amend his/her approved protocol by submitting a Modification Form. This includes changes that reduce risks to subjects as well as administrative changes such as adding or removing investigators. Requests for modification must be submitted for review and approval prior to being implemented. The PI is responsible for providing all material requested on the instructions. An exception may be made when the changes are necessary to eliminate apparent immediate hazards to the participants. Protocols requiring full NHRRB review must be submitted 6 weeks before the protocol’s expiry date to ensure it will be renewed in time. Expedited (those that do not require full board review) protocols must be submitted 2 weeks before the expiry date. Requests for expedited continuation will be forwarded by the NHRRB secretariat to the Chair for review and approval as they are received.

8. Reporting of adverse events

The Principal investigator shall inform the NHRRB of any adverse events occurring during the research study and mitigation measures taken no later than five days of occurrence. Harm, exceptional events, unexpected outcomes, deaths or changes in the relationship between the sponsor or employer and researcher(s) must be reported to the board.

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9. Waiver of ethical review

9.1.1. Researchers can apply for waiver of review by the NHRRB under the following circumstances:

9.1.2.When proposed research relies exclusively on publicly available information that is legally accessible to the public and appropriately protected by law or is publicly accessible and there is no reasonable expectation of privacy.

9.1.3.When proposed research involves observation of people in public places where there is no intervention or interaction on the part of a researcher and where the targeted individuals or groups have no reasonable expectation of privacy and the dissemination of research results would not allow for the identification of individuals.

9.1.4.When proposed research relies exclusively on secondary use of anonymous information or anonymous human biological materials provided that the results do not generate identifiable information.

9.1.5.When proposed research involves secondary use of research information which was originally collected for a purpose other than the current research purpose and such information was collected anonymously.

9.1.6.Quality assurance and quality improvement (QA/QI) studies, program evaluation activities, and performance reviews, or testing within normal educational requirements, when used exclusively for assessment, management or improvement purposes that do not constitute research. Otherwise QA/QI projects that contain an element of research do require review and a determination of whether a project requires review is often difficult to make

9.1.7.Individual case reports do not meet the definition of research, they are considered to be a medical/educational activity. The NHRRB expect that patients will be made aware that the author investigator plans to create a report about their case which may be published. If more than two cases are involved in the analytical activity, the activity will normally constitute "research" and be subject to review

9.1.8.Applications for ethical review waiver should provide a synopsis of data collection and findings plans

10. Management of data and study information

Data generated from research subjects residing in Swaziland shall be the property of the country. The NHRRB shall maintain a data base for all

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studies, protocols, raw data, reports etc that have been carried out in the country. Hard copies will be archived and obtainable at the library of the research department. Electronic copies will be obtainable from RHINNO. Archived documents will be kept for a minimum period of five years. The Principal Investigator has the responsibility of ensuring that the electronic and hard copies are submitted to the NHRRB for archiving purposes no later than six months after finalization of the report. Researchers interested in using existing raw data shall seek approval of the NHRRB based on the application process for protocol approval.

11. Transfer of Research Skills

Researchers whose research is supported from external sources of funding are required to involve local researchers (Swazi citizens) in proposed research from the design stage to report writing as a means of skills transfer. Protocols should indicator roles and responsibilities of each research team member. Protocols that just list local researchers without meaningful involvement and participation shall not be considered for approval

12. Transfer of specimens and materials

International/External transfer of raw data and specimen will require approval of the Ministry of Health based on a Material Transfer Agreement (MTA). Use of transferred materials shall be specified in the MTA. The responsibility to apply for transfer of materials and specimen shall reside with the Principal Investigator(s) of the entity interested in the transfer.

13. Quality and compliance assurance

In order to ensure that data collected is reliable and that studies adhere to approved protocols and ethical requirements, the NHRRB may commission audits of on-going studies particularly clinical trials. Appointed auditors shall be independent of the NHRRB and target studies

14. Dissemination of research results

The Principal Investigator shall be responsible for disseminating research findings to relevant stakeholders no later than six months from completion of the study report. The Principal Investigator shall similarly ensure that the National Health Research Department and NHRRB are informed timely and invited to the dissemination event.

15. Submission of final research reports

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Principal Investigators are required to submit copies of reports of completed studies to the NHRRB in both hard and soft copies as parts of project closure. Failure to do so will compromise approval of subsequent applications from involved Principal Investors together with related host and funding organizations.

ANNEX 1: SAMPLE OF PROTOCOL FORMAT (Courtesy of the Lebanese American University)

1. SynopsisThis is similar to an abstract and should be about the same length (250-300 words). It acts as a standalone summary of the study and should be present in large protocols. It generally consists of 1-2 sentences background then the concise objective or aim followed by a brief outline of description of participants, intervention, methods, outcome measures and proposed analysis.

2. Abbreviations and AcronymsList Abbreviations and Acronyms3. Introduction / Background *

This should include the following: Introduction to the topic of interest. What is known already - literature review of relevant findings (Brief and focused) Highlight area where there is missing information in the literature State the aims of this study– what the study is going to find out, and in one sentence how

this is going to be achieved. Impact - this is where you indicate how the study will substantially add to science,

change practice, save money and best of all save lives or improve quality of life in substantial numbers of people. Include an economic impact if possible. (note impact is sometimes placed at the end of the protocol)

A handful of relevant references The background should not be an exhaustive literature review. At the end the reader should have a clear idea of what is the research question, an understanding that it is original and relevant, and how this research will help fill the gap in the literature.

4. Objectives * Clear statement of primary and secondary objectives of the study If relevant include a clearly defined hypothesis here

5. Study Methodology * Describe study *

Type of study Where is it going to be carried out (also known as setting) Sample size calculation or justification of numbers (Should be based on previous

data) Study comparison & intervention *

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What interventions are you comparing? If you are doing a cohort study or survey then what are the exposures or predictors of interest?

Details of the interventions – this has to be very detailed if you are planning a drug / device study.

6. Study population Subjects *

Source of participants - where and when are you going to recruit them? How many participants? Inclusion/Exclusion criteria

7. Study procedure * Patient informed consent process, if applicable Details on how interventions are going to be delivered if applicable Who is going to deliver them? Blinding For randomized studies; how patients are going to be randomized (a simple

diagram showing treatment arms is often useful here) Other details of particular ways the subject will be treated during the study independent

to the specific intervention(s) (for example will other drugs not be allowed or will patient’s diet or environment be controlled)

Outcome * (Note there should be only one primary outcome) What are the primary and secondary outcomes Details of the outcome measures used

Data collection * What data are you going to collect, how is it collected, who collects it and when?

Details of intervention data Details of outcome data Details of all demographic data and other potentially confounding data Details of safety data and adverse events

Further subject follow-up, if applicable When and for what? Especially for adverse events How often? What data is collected at each time point?

Study timelines: Expected duration of the study& start times, stages of the study such as screening, treatment phase (Visit numbers), etc

Patients withdrawal Are there any conditions that will cause a patient to be withdrawn from the study? What happens if a patient wishes to withdraw consent?

Risk / benefit8. Data Management *

Where and how is data going to be stored? Case record forms Database

Will there be any attempts to de-identify data? Privacy and Confidentiality

9. Adverse Event Reporting Provide a definition of an Adverse Event (AEs) and Serious Adverse Event (SAEs) based

on the study

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Include methods and timings for assessing, recording, and managing adverse events and safety parameters

Also include how will you report these procedures and stopping rules for a study participant

10.Statistical Analysis Analysis plan

Details on how the primary and secondary outcomes will be analysed. Statistical methods to be used Who is going to carry out the analysis?

11.Quality assurance, monitoring & safetyAny external committees overseeing the study such as Study Steering Committees or Data andSafety Monitoring Committees?

Will there be an interim analysis? How will adverse events be identified and acted upon? Are there any specific safety measures or is there important safety data being collected?

12.Ethical Issues Have interventions been used before? What goes beyond standard practice? Identify and justify any dual relationships, coercion or inducement Identify and justify any non-negligible risk or burden

13. Finance and resource use*Details of funding bodies Budget including direct and indirect costs

14.Dissemination of Results and Publication policyThe protocol should specify not only dissemination of results in the scientific media, but also to the community and/ or the participants, and consider dissemination to the policy makers where relevant. Publication policy should be clearly discussed- for example who will take the lead in publication and who will be acknowledged in publications, etc.

15.References *

16.Appendices

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Annex 2: Sample of informed consent statement(Courtesy of the World Health Organization)

[YOUR INSTITUTIONAL LETTER HEAD]

[Informed Consent Form for _________________________________]

Name the group of individuals for whom this consent is written. Because research for a single project is often carried out with a number of different groups of individuals - for example counselors, community members, clients of services - it is important that you identify which group this particular consent is for.

(Example: This informed consent form is for social service providers in the community X and who we are inviting to participate in research Y, titled “The Community Response to Malaria Project".)

You may provide the following information either as a running paragraph or under headings as shown below.

[Name of Principle Investigator] [Name of Organization] [Name of Sponsor] [Name of Project and Version]

This Informed Consent Form has two parts: • Information Sheet (to share information about the study with you) • Certificate of Consent (for signatures if you choose to participate)

You will be given a copy of the full Informed Consent Form

Part I: Information Sheet

Introduction Briefly state who you are and that you are inviting them to participate in research which you are doing. Inform them that they may talk to anyone they feel comfortable talking with about the research and that they can take time to reflect on whether they want to participate or not. Assure the participant that if they do not understand some of the words or concepts, that you will take time to explain them as you go along and that they can ask questions at anytime.

(Example: I am X, working for the Y organization. I am doing research on the disease malaria which is very common in this country and in this region. I am going to give you information and invite you to be part of this research. You do not have to decide today whether or not you will participate in the research. Before you decide, you can talk to anyone you feel comfortable with about the research.

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This consent form may contain words that you do not understand. Please ask me to stop as we go through the information and I will take time to explain. If you have questions later, you can ask them of me or of another researcher.)

Purpose of the research Explain the research question in lay terms which will clarify rather than confuse. Use local and simplified words rather than scientific terms and professional jargon. In your explanation, consider local beliefs and knowledge when deciding how best to provide the information. Investigators however need to be careful not to mislead participants, by suggesting research interests that they do not have. For example, if the study wants to find out about treatments provided by local practitioners, wording should not suggest that they want to find out about how the practitioners are advertising themselves. Misleading participants may be essential and justified in certain circumstances, but that needs to be carefully argued, and approved by an ethics committee.

(Example: Malaria is making many people sick in your community. We want to find ways to stop this from happening. We believe that you can help us by telling us what you know both about malaria and about local health practices in general. We want to learn what people who live or work here know about the causes of malaria and why some people get it. We want to learn about the different ways that people try to stop malaria before someone gets it or before it comes to the community, and how people know when someone has it. We also want to know more about local health practices because this knowledge might help us to learn how to better control malaria in this community.)

Type of Research InterventionBriefly state the type of intervention that will be undertaken. This will be expanded upon in the procedures section but it may be helpful and less confusing to the participant if they know from the very beginning whether, for example, the research involves a vaccine, an interview, a questionnaire, or a series of finger pricks.

(Example: This research will involve your participation in a group discussion that will take about one and a half hour, and a one hour interview).

Participant Selection Indicate why you have chosen this person to participate in this research. People wonder why they have been chosen and may be fearful, confused or concerned.

(Example: You are being invited to take part in this research because we feel that your experience as a social worker (or as a mother, or as a responsible citizen) can contribute much to our understanding and knowledge of local health practices.)

Example of question to elucidate understanding: Do you know why we are asking you to take part in this study? Do you know what the study is about?

Voluntary Participation Indicate clearly that they can choose to participate or not. State, only if it is applicable, that they will still receive all the services they usually do if they choose not to participate. Explanation: It may be more applicable to assure them that their choosing to participate or not will not have any bearing on their job or job-related evaluations. This can be repeated and expanded upon later in the form as well. It is important to state clearly at the beginning of the form that participation is voluntary so that the other information can be

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heard in this context. Although, if the interview or group discussion has already taken place, the person cannot 'stop participation' but request that the information provided by them not be used in the research study.

(Example: Your participation in this research is entirely voluntary. It is your choice whether to participate or not. If you choose not to participate all the services you receive at this Centre will continue and nothing will change. OR The choice that you make will have no bearing on your job or on any work-related evaluations or reports. You may change your mind later and stop participating even if you agreed earlier.)

Examples of question to elucidate understanding: If you decide not to take part in this research study, do you know what your options are? Do you know that you do not have to take part in this research study, if you do not wish to? Do you have any questions?

Procedures A. Provide a brief introduction to the format of the research study.

(Example: We are asking you to help us learn more about malaria in your community. We are inviting you to take part in this research project. If you accept, you will be asked to….:)

B. Explain the type of questions that the participants are likely to be asked in the focus group, the interviews, or the survey. If the research involves questions or discussion which may be sensitive or potentially cause embarrassment, inform the participant of this.

(Example 1 (for focus group discussions) take part in a discussion with 7-8 other persons with similar experiences. This discussion will be guided by [name of moderator/guider] or myself.The group discussion will start with me, or the focus group guide or moderator (use the local word for group discussion leader), making sure that you are comfortable. We can also answer questions about the research that you might have. Then we will ask you questions about the malaria and give you time to share your knowledge. The questions will be about malaria in your community, how is it recognized, what people do to stop it from spreading to other people, who people go to for help and what happens when people become sick with it.We will also talk about community practices more generally because this will give us a chance to understand more about malaria but in a different way. These are the types of questions we will ask…... We will not ask you to share personal beliefs, practices or stories and you do not have to share any knowledge that you are not comfortable sharing. The discussion will take place in [location of the FGD], and no one else but the people who take part in the discussion and guide or myself will be present during this discussion. The entire discussion will be tape-recorded, but no-one will be identified by name on the tape. The tape will be kept [explain how the tape will be stored]. The information recorded is confidential, and no one else except [name of person(s)] will have access to the tapes. The tapes will be destroyed after ______number of days/weeks.

Example 2 (for interviews)participate in an interview with [name of interviewer] or myself. During the interview, I or another interviewer will sit down with you in a comfortable place at the Centre. If it is better for you, the interview can take place in your home or a friend's home. If you do not wish to

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answer any of the questions during the interview, you may say so and the interviewer will move on to the next question. No one else but the interviewer will be present unless you would like someone else to be there. The information recorded is confidential, and no one else except [name of person(s)] will access to the information documented during your interview. The entire interview will be tape-recorded, but no-one will be identified by name on the tape. The tape will be kept [explain how the tape will be stored]. The information recorded is confidential, and no one else except [name of person(s)] will have access to the tapes. The tapes will be destroyed after ______number of days/weeks.

Example 3 (for questionnaire surveys)fill out a survey which will be provided by [name of distributor of blank surveys] and collected by [name of collector of completed surveys].OR You may answer the questionnaire yourself, or it can be read to you and you can say out loud the answer you want me to write down. If you do not wish to answer any of the questions included in the survey, you may skip them and move on to the next question. [Describe how the survey will be distributed and collected]. The information recorded is confidential, your name is not being included on the forms, only a number will identify you, and no one else except [name of person(s) with access to the information] will have access to your survey.)

Duration Include a statement about the time commitments of the research for the participant including both the duration of the research and follow-up, if relevant.

(Example: The research takes place over ___ (number of) days/ or ___ (number of) months in total. During that time, we will visit you three times for interviewing you at one month interval and each interview will last for about one hour each. The group discussion will be held once and will take about one and a half hour.)

Examples of question to elucidate understanding: If you decide to take part in the study, do you know how much time will the interview take? Where will it take place? Do you know that we will be sending you transport to pick you up from your home? Do you know how much time will the discussion with other people take? If you agree to take part, do you know if you can stop participating? Do you know that you may not respond to the questions that you do not wish to respond to? Etc. Do you have any more questions?

Risks Explain and describe any risks that you anticipate or that are possible. The risks depend upon the nature and type of qualitative intervention, and should be, as usual, tailored to the specific issue and situation.

(If the discussion is on sensitive and personal issues e.g. reproductive and sexual health, personal habits etc. then an example of text could be something like "We are asking you to share with us some very personal and confidential information, and you may feel uncomfortable talking about some of the topics. You do not have to answer any question or take part in the discussion/interview/survey if you don't wish to do so, and that is also fine. You do not have to give us any reason for not responding to any question or for refusing to take part in the interview"OR If for example, the discussion is on opinions on government policies and community beliefs, and in general no personal information is sought, then the text under risks could read something like "There is a risk that you may share some personal or confidential information by chance, or that you may feel uncomfortable talking about some of the topics. However, we do not wish for this to happen. You do not have to answer any

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question or take part in the discussion/interview/survey if you feel the question(s) are too personal or if talking about them makes you uncomfortable.)

Benefits Benefits may be divided into benefits to the individual, benefits to the community in which the individual resides, and benefits to society as a whole as a result of finding an answer to the research question. Mention only those activities that will be actual benefits and not those to which they are entitled regardless of participation.

(Example: There will be no direct benefit to you, but your participation is likely to help us find out more about how to prevent and treat malaria in your community).

ReimbursementsState clearly what you will provide the participants with as a result of their participation. WHO does not encourage incentives beyond reimbursements for expenses incurred as a result of participation in the research. These may include, for example, travel costs and reimbursement for time lost. The amount should be determined within the host country context.

Example: You will not be provided any incentive to take part in the research. However, we will give you [provide a figure, if money is involved] for your time, and travel expense (if applicable).

Examples of question to elucidate understanding: Can you tell me if you have understood correctly the benefits that you will have if you take part in the study? Do you know if the study will pay for your travel costs and time lost, and do you know how much you will be re-imbursed? Do you have any other questions?

Confidentiality Explain how the research team will maintain the confidentiality of data with respect to both information about the participant and information that the participant shares. Outline any limits to confidentiality. Inform the participant that because something out of the ordinary is being done through research, any individual taking part in the research is likely to be more easily identified by members of the community and therefore more likely to be stigmatized. If the research is sensitive and/or involves participants who are highly vulnerable - research concerning violence against women for example - explain to the participant any extra precautions you will take to ensure safety and anonymity.

(Example: The research being done in the community may draw attention and if you participate you may be asked questions by other people in the community. We will not be sharing information about you to anyone outside of the research team. The information that we collect from this research project will be kept private. Any information about you will have a number on it instead of your name. Only the researchers will know what your number is and we will lock that information up with a lock and key. It will not be shared with or given to anyone except [name who will have access to the information, such as research sponsors, DSMB board, your clinician, etc])

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The following applies to focus groups: Focus groups provide a particular challenge to confidentiality because once something is said in the group it becomes common knowledge. Explain to the participant that you will encourage group participants to respect confidentiality, but that you cannot guarantee it.

(Example: We will ask you and others in the group not to talk to people outside the group about what was said in the group. We will, in other words, ask each of you to keep what was said in the group confidential. You should know, however, that we cannot stop or prevent participants who were in the group from sharing things that should be confidential.)

Example of question to elucidate understanding: Did you understand the procedures that we will be using to make sure that any information that we as researchers collect about you will remain confidential? Do you understand that the we cannot guarantee complete confidentiality of information that you share with us in a group discussion Do you have any more questions?

Sharing the Results Your plan for sharing the findings with the participants should be provided. If you have a plan and a timeline for the sharing of information, include the details. You may also inform the participant that the research findings will be shared more broadly, for example, through publications and conferences.

(Example: Nothing that you tell us today will be shared with anybody outside the research team, and nothing will be attributed to you by name. The knowledge that we get from this research will be shared with you and your community before it is made widely available to the public. Each participant will receive a summary of the results. There will also be small meetings in the community and these will be announced. Following the meetings, we will publish the results so that other interested people may learn from the research.)

Right to Refuse or Withdraw This is a reconfirmation that participation is voluntary and includes the right to withdraw. Tailor this section to ensure that it fits for the group for whom you are seeking consent. The example used here is for a community social worker. Participants should have an opportunity to review their remarks in individual interviews and erase part or all of the recording or note.

(Example: You do not have to take part in this research if you do not wish to do so, and choosing to participate will not affect your job or job-related evaluations in any way. You may stop participating in the [discussion/interview] at any time that you wish without your job being affected. I will give you an opportunity at the end of the interview/discussion to review your remarks, and you can ask to modify or remove portions of those, if you do not agree with my notes or if I did not understand you correctly.)

Who to ContactProvide the name and contact information of someone who is involved, informed and accessible -a local person who can actually be contacted. State also the name (and contact details) of the local IRB that has approved the proposal. State also that the proposal has also been approved by the WHO ERC.

(Example: If you have any questions, you can ask them now or later. If you wish to ask questions later, you may contact any of the following: [name, address/telephone number/e-mail] This proposal has been reviewed and approved by [name of the local IRB], which is a committee whose task it is to make sure that research participants are protected from harm. If you wish to find about more about the IRB, contact _____ .)

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This proposal has been reviewed and approved by [name of the local IRB], which is a committee whose task it is to make sure that research participants are protected from harm. If you wish to find about more about the IRB, contact [name, address, telephone number.]). It has also been reviewed by the Ethics Review Committee of the World Health Organization (WHO), which is funding/sponsoring/supporting the study.

Example of question to elucidate understanding: Do you know that you do not have to take part in this study if you do not wish to? You can say No if you wish to? Do you know that you can ask me questions later, if you wish to? Do you know that I have given the contact details of the person who can give you more information about the study? Etc.

You can ask me any more questions about any part of the research study, if you wish to. Do you have any questions?

Part II: Certificate of Consent

This section must be written in the first person. It should include a few brief statements about the research and be followed by a statement similar the one in bold below. If the participant is illiterate but gives oral consent, a witness must sign. A researcher or the person going over the informed consent must sign each consent. Because the certificate is an integral part of the informed consent and not a stand-alone document, the layout or design of the form should reflect this. The certificate of consent should avoid statements that have "I understand…." phrases. The understanding should perhaps be better tested through targeted questions during the reading of the information sheet (some examples of questions are given above), or through the questions being asked at the end of the reading of the information sheet, if the potential participant is reading the information sheet him/herself.

Example: I have been invited to participate in research about malaria and local health practices.

(This section is mandatory)I have read the foregoing information, or it has been read to me. I have had the opportunity to ask questions about it and any questions I have been asked have been answered to my satisfaction. I consent voluntarily to be a participant in this study

Print Name of Participant__________________Signature of Participant ___________________Date ___________________________

Day/month/year

If illiterate 1

I have witnessed the accurate reading of the consent form to the potential participant, and the individual has had the opportunity to ask questions. I confirm that the individual has given consent freely.

1 A literate witness must sign (if possible, this person should be selected by the participant and should have no connection to the research team). Participants who are illiterate should include their thumb print as well.

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Print name of witness____________ Thumb print of participant

Signature of witness _____________

Date ________________________ Day/month/year

Statement by the researcher/person taking consent

I have accurately read out the information sheet to the potential participant, and to the best of my ability made sure that the participant understands that the following will be done:

1.2.3.

I confirm that the participant was given an opportunity to ask questions about the study, and all the questions asked by the participant have been answered correctly and to the best of my ability. I confirm that the individual has not been coerced into giving consent, and the consent has been given freely and voluntarily.

A copy of this ICF has been provided to the participant.Print Name of Researcher/person taking the consent________________________

Signature of Researcher /person taking the consent__________________________

Date ___________________________ Day/month/year

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Annex 3: Sample of application form for ethical clearance

APPLICATION FORM

Name and Status of Principal Investigator(s):

(Please underline responsible Investigator where appropriate)

…………………………………………………………………………………………………..

…………………………………………………………………………………………………..

Institution/Department..............................................................................................................

………………………………………………………………………………………………….

………………………………………………………………………………………………….

Title of Investigation …………………………………………………………………………………………………

…………………………………………………………………………………………………

…………………………………………………………………………………………………

…………………………………………………………………………………………………

SECTION A: INVESTIGATORSA.1 Do Principal Investigator have a previous experience of, and / or adequate training in, the Methods employed?

Yes No

A.2. Will data collectors / students be under the direct supervision of an experienced Principal Investigator?

Yes No

A.3. Will data collectors / students be expected to undertake physically invasive Procedures during the course of the research?

Yes No

A.4. Are researchers in a position of direct authority with regard to Yes No

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participants

SECTION B: PARTICIPANTS

B1. Vulnerable GroupsWill participants be knowingly recruited from one or more of the following vulnerable groups?

B1.1 Children under 18 years of age Yes No

B1.2 People over 65 years of age Yes No

B1.3 Pregnant woman Yes No

B1.4 People with mental illness Yes No

B1.5 Prisoners/ Detained persons Yes No

B1.6 Other vulnerable group (please specify_______________________)

Yes No

B2. Chaperoning ParticipantsIf appropriate, Studies which involve vulnerable participants, taking physical measure or Intrusion of participants privacy:

B2.1 Will participants be chaperoned by more than one investigator at all times ?

Yes No N/A

B2.2.Will at least one investigator of the same sex as the participant(s) be present throughout the investigations?

Yes No N/A

B2.3.Will participants be visited at home? Yes No N/A

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Section C: Methodology/Procedures

Please indicate whether the proposed study:

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C1.Involves taking bodily samples Yes

No

C2.Involves invasive methods of collecting bodily fluids Yes

No

C3.Involves procedures which are likely to cause physical, psychological, social or emotional distress to participants

Yes

No

C4.Expose participants to distress and painful memories Yes

No

C5.Prescribe intake of substance additional to daily diet or other dietary Manipulation/ supplementation

Yes

No

C6.Involve testing new equipment Yes

No

C7.Involves pharmaceutical drugs Yes

No

C8. Involve use of radiation which exposes participants to ionizing radiation –e.g. X-rays.

Yes

No

C9.Involves use of hazardous materials Yes

No

C10. Involves methods of contraception Yes

No

C11. Involves genetic engineering Yes

No


Section D: Observation / Recording

D1. Does the study involve observation and /or recording of participants?

Yes No

D2. Will those being observed and/ or recorded be informed that the observation and/ or recording will take place?

Yes No

Section E: Consent and Deception

E1. Informed consentE1.1.Will participants give informed consent* freely? Yes No

Ensure all participants complete a consent form; please enclose the consent form with the research proposal to SEC.

E1.2 Will participants be fully informed of the objective of the investigation and all the details disclosed?

Yes No

E1.3 Will participants be fully informed of the data collected? Yes No*Note: where it is impractical to gain individual consent from every participant, it is acceptable to allow Individual participant to ”opt out” rather than “opt in”.

For children under the age of 18 or participants who have impairment of understanding or communication:

E1.4. Will consent be obtained (either in writing or by some other means)?

Yes

No N/A

E1.5 Will consent be obtained from parents or other suitable person?

Yes

No N/A

E1.6 Will they be informed that they have the right to withdraw regardless of parents /guardian consent?

Yes

No N/A

E1.7 For investigations conducted in schools, will approval be granted in advance from the Head-teacher and /or the Director of Education of the appropriate Local Education Authority

Yes

No N/A

E1.8 For the detained persons, members of the forces, employees, students and other persons judges to be under duress, will care be taken over gaining freely informed consent?

Yes

No N/A

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E2 DeceptionE2.1.Does the study involve deception of participants (i.e withholding of information or the misleading of participants) which could potentially harm or exploit participants?

Yes No

If yes complete the Deception section below.E2.2 Is deception an unavoidable part of the study? Yes No

E2.3 Will participants be debriefed and the true object of the research revealed at the Earlier stage upon completion of the study

Yes No

E2.4 Has consideration been given on the way that participants will react to the withholding of information or deliberate deception?

Yes No

Section F: Withdrawal

F1. Will participants be informed of their right to withdraw from the investigation at any time and to require their own data to be destroyed?

Yes No

Section G: Storage of Data and Confidentiality G1.Will all the information on participants be treated as confidential and not identifiable unless agreed otherwise in advance, and subject to the requirements of law?

Yes

No

G2.Will storage of data comply with Government Data Protection Act?

Yes

No

G3.Will any video/audio recording of participants be kept in secure place and not released use by third parties?

Yes

No

G4.Will video/audio recordings be destroyed within a specified period as stated in government procedures after completion of the investigation?

Yes

No

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Section H: Incentives

H1.Have incentives (other than those contractually agreed, salaries or basic expenses) been offered in to the investigator to conduct the investigation?

Yes

No

H2.Will incentives (other than basic expenses) be offered to potential participants as an inducement to participate in the investigation?

Yes

No

Please sign the declaration below,

DeclarationI have read and completed the SEC application form. I confirm that the above named investigationcomplies with ethical principles and guidelines of professional bodies associated with my research discipline.

Signature of Principal Investigator …………………………………....

Signature of Data collector (if appropriate) ….………………………………...

Signature of Head of Department/ Institution …..………………………….. …..

Date …………/…………/..…………..

Upon approval or disapproval of the proposal the SEC representatives shall indicate the outcome of the decision and sign as indicated below.

Signature of SEC Chairperson …………………………………

Signature of SEC Secretary …………………………………

Signature of SEC Member as appropriate ………………………………...

Date …………/…………/…………

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Documents

Table of content - Health Research Web€¦ · Web viewThe Kingdom of Swaziland through the Ministry of Health has set up structures to promote and manage health research in the