Research design

The participants section should include a full description of the subjects (sample) or participants who will be involved in the research, along with how they will be selected (purposeful or random sampling), details of the sample size and participant criteria. This allows the reader to make conclusions regarding the generalizability of the study. Criteria for becoming a participant, which may include demographic information such as age and sex, should be specified, along with descriptions of characteristics that are relevant to the research (e.g. years of experience, when they were diagnosed with the disease being researched, level of education etc.).

Outline the measures that will be taken to ensure participants feel free to express their opinions during interviews, focus group discussions and other data collection procedures. For example, are venues private? Are there power dynamics to consider so that participants do not feel intimidated or threatened to say exactly what they are feeling and thinking? For example, while interviewing a patient, they may not feel comfortable expressing their opinion in front of their physician, or while interviewing health care staff, they may not feel comfortable saying how they feel in front of their superiors or managers. Consider how your IR proposal can outline appropriate procedures to ensure that participants feel comfortable and confident to provide honest, reliable responses.

In your IR proposal, you should indicate which data collection methods you intend to use and why.

There are three general types of research methods: qualitative, quantitative or a combination of the two (mixed methods), depending on the purpose of the research. Quantitative methods are better for answering the question: What is happening? Qualitative methods are suited for answering the question: Why is it happening? These methods are presented and described in detail in the module on Research methods and data management in this toolkit. Several useful resource materials are included in the references.

Qualitative methods

In your IR proposal, you will need to justify why you have chosen to use a qualitative approach. If the focus of the research is generally used to explore values, attitudes, opinions, feelings and behaviour of individuals and understand how these affect the individuals in question, then this method is most appropriate.⁸ You will also choose qualitative methods, if your study is used to help explain the results of a previous quantitative study.

When it is preferable to collect data using more than one method –allowing the researcher to ‘triangulate’ (or cross-check/verify) the data – qualitative methods should be selected. If the research seeks to investigate themes (findings) in more detail as they emerge, your proposal will select the qualitative methods, as the related data collection process is more emergent and flexible.

Qualitative research uses data collection methodologies such as interviewing, focus group discussions, observation and documents (e.g. diaries, historical documents).

Quantitative methods

Quantitative methods involve the collection and analysis of objective data, often in numerical form. They are used when it is necessary to establish cause and effect relationships, where the researcher can manipulate a particular variable (experimental research) or in instances where no attempt is made to influence the variables (correlational research). The research design is determined prior to the start of data collection and is not flexible. The research process, interventions and data collection tools (e.g. questionnaires) are standardized to minimize or control possible bias.

In your proposal, explain where the data will come from (e.g. health centres, district hospitals, regions); how surveys will be delivered, who will facilitate delivery; how you will ensure anonymity; time required to complete survey; length of survey; number of questions in the survey; sample size; how the survey will be designed; is the survey validated, etc.

The data collection tools used (e.g. questionnaire) may be developed by the researcher or, preferably, may be one that has been previously developed and used. Developing an appropriate and effective instrument takes a lot of time and effort, and often requires special skills. If you are developing the tool, specify if you will conduct a pilot to test it.

Mixed methods

With the majority of IR problems requiring answers to both the ‘what’ and the ‘why’ in relation to research questions, the majority of proposals use mixed methods that combine qualitative and quantitative approaches. Under many circumstances, a mixed methods approach can provide a better understanding of the problem than either approach alone.⁹ Nevertheless, one of the main challenges may be to create the optimal combination (and sequence) of the two approaches. The module on research methods and data management provides detailed guidance in this area.

If your research team decides to use mixed methods in your study, you will need to describe why you chose this approach, explaining how the combination of qualitative and qualitative methods will provide information that helps you to address your research objectives and research questions. For example, using a mixed methods approach may be appropriate because you require a better understanding of the problem than either a quantitative or qualitative research approach could achieve alone. Your explanation may state that you want to create a design that provides the optimal combination and sequence of both approaches. Additional justification for using a mixed methods approach may be because your project is interdisciplinary, involving team members with diverse views and expertise, or that your project will be dealing with complex problems that will benefit from blending qualitative and quantitative data.

Whatever the method that is selected, your proposal will need to explain how the selected methods will provide information that will help you address your research objectives and research questions. This section of the proposal should have the following sub-sections:

• Rationale
• Participants
• Data collection
• Data analysis
• Trustworthiness

These are discussed in detail in the research methods and data management module of this toolkit.

It is important to outline a plan for data management and analysis in the proposal. The methods and models of data analysis should be in accordance with the proposed objectives and types of anticipated variables. The plan for data analysis should be developed with the target audiences in mind, with a focus on simplicity and interpretability. The proposal should specify the data collection strategies and tools to be used and why. The tests that you intend to conduct on the data should be explained. Indicate if any software will be used in your data analysis.

You should outline/highlight the following as they relate to your study:

• Demonstrate appropriate analysis procedures.
• Provide a general plan for data analysis and justify its technical and theoretical soundness.
• Describe what information is needed to complete the analysis, the potential sources of this information and the instruments that will be used for its collection.
• Provide sufficient detail to demonstrate the technical soundness of all data collection instruments and procedures.
• Identify and justify procedures for analysis, reporting and utilization.
• Identify any anticipated constraints on the analysis.
• Discuss who will be responsible for analysis, and the roles of any consultants or external personnel.

Embedding quality management into your proposal is not an optional step. Quality management is essential to ensuring that research meets or exceeds scientific, ethical and regulatory standards. Quality systems, control and assurance are integral to all research activities. Everyone engaged in the project carries the responsibility of ensuring quality. Quality management should be planned and strictly adhered to in the research design.

In your proposal, outline exactly how you will demonstrate that your research team will take consistent, ongoing measures to monitor and evaluate the quality and rigor of the research. Indicate how you will evaluate quality at various stages. How will you demonstrate that you will conduct due diligence at all stages of the data collection and data analysis process?

If your project lasts more than one year, you may want to stipulate that you intend to have annual quality monitoring evaluations and reports. Discuss a communication plan with all stakeholders to inform them of quality standard procedures to facilitate rapid adjustments and corrections.

Quality management should also express a constant and consistent concern for research participants. How will you protect their privacy? What measures will you take to protect them from harm (e.g. train staff, adhere to ethical standards in the research ethics application etc.)?

Some of the activities you can integrate into your IR proposal to help manage quality include:

• protocol review and approval;
• standard operating procedures;
• validation of research instruments;
• project team training;
• quality control and monitoring;
• evaluation of services provided;
• evaluation of the performance of service providers;
• review of reports.

There are many strategies that can be incorporated into your IR proposal to begin the quality standard monitoring process; they are discussed in details in the Planning Module of this toolkit.

Any research study that collects data from or involves human subjects must undergo an ethics review. You must stipulate that you intend to apply for ethics approval if you have not done so already. You should have an ethics section in your proposal that describes the steps you will take to ensure the protection, dignity, rights and safety of potential research participants before, during and after the research takes place. In addition, your IR proposal should describe how you will ensure that universal ethical values and international scientific standards will be adhered to in terms of local community values and customs in planning, conducting and evaluating the research. You may also be required to apply for a research permit in addition to ethical clearance in certain countries or disciplines. In some cases, you may be required to submit your protocol to the funding agency for ethical review by the agency ethical clearance unit in addition to obtaining local ethical review/research permit.

In the ethics section of your proposal, state explicitly how the research will address the following codes of ethics (it may, however, be worth going to the website of the review board to whom you are submitting your proposal, to make sure you have complied with all their specific requirements, including for example, evidence of having completed an online ethics course).

• Balance potential harm to participants against potential benefits. Possible harms fall into several categories such as physical injuries, loss of privileges, inconvenience (including wasted time, psychological injuries (e.g. embarrassment), economic loss, or legal risks).
• Maintain privacy, anonymity, and confidentiality:
  • when health care providers are research participants;
  • when reviewing medical records;
  • by maintaining the boundary between researchers and physicians;
  • when collecting data in field settings.
• Construct the informed consent letter and form (include in the proposal appendices). [The consent form has two parts: (a) a statement describing the study and the nature of the subject’s involvement in it; and (b) a certificate of consent attesting to the subject’s consent.
• Both parts should be written in sufficiently large letters and in simple language so that the subject can easily read and understand the contents. As far as possible, medical terminology should be avoided in writing up the consent form. (These should be included in the proposal appendices)].
• Where necessary, include a translation of the consent form in the appropriate local language(s) as this may be required by some ethical review committees.
• Obtain voluntary consent from all human subjects/participants. In the case of minors, parental/ guardian consent must be obtained, and in the cases where the information is to be obtained from a patient by a non-health worker, state the process to be followed.
• Subjects must be informed that their participation is voluntary and that they are at liberty to withdraw from the research at any time without explanation and/or prejudice.
• Research will be terminated at any stage if there is any reason to believe harm is being caused to the subjects/participants.
• Adequate provisions must be taken to protect participants.
• Demonstrate that results cannot be obtained by other methods or means.
• Avoid all unnecessary physical and mental suffering and injury.
• Risks do not exceed the humanitarian importance of the problem the research will solve.
• Cultural diversity must be considered to ensure participants understand the purpose of the study.
• Special attention should be paid if the research involves vulnerable subjects.
• Teams should involve scientifically qualified, well trained and properly supervised individuals.
• Protocols should be submitted for approval to the appropriate ethical and scientific review committees.
• Research procedures involving human subjects should be submitted for approval to an independent ethics committee before research begins.
• Research and related procedures must be conducted in adherence to the protocol that received scientific and ethical approval.
• Any subsequent alterations to the protocol should be re-submitted for ethics approval.
• Research results should be made freely available as a public good.
• Participants should be provided with the option to receive the results of the study in which they are participating.

The specific ethical considerations of the different aspects of the IR study are provided as appropriate across all the modules of this toolkit. With most ethical review boards primarily composed of experts with limited IR experience, it is important that the common pitfalls detailed in the planning module of this toolkit are avoided in the preparation of the research protocols for ethical approval.

Protocols for social science research involving human participants are subject to review, and IRB approval, of both a local and national institutional review board and where the research is funded by WHO, WHO’s Research Ethics Review Committee (ERC) ERC’s website can be consulted at http://www.who.int/ethics/en/.

Templates for consent forms can be found at the WHO research policy page http://www.who.int/ethics/review-committee/informed_consent/en/. These templates should be adapted to the local situation in which you elicit informed consent.

Ethics checklists

Checklists and other guidance documents for preparing proposals in the manner recommended by WHO’s Research Ethics Review Committee (ERC) are available online at http://www.who.int/ethics/review-committee/guidelines/en/. Remember to provide all necessary documentation and annexes. The protocol should provide the necessary information and details to comply with the questions proposed in the checklist. Also remember to attach any necessary explanations either in the proposal or relevant accompanying documents.