Are you undertaking a research study or an audit? What permissions do you need?  It is research if you use any information, take samples, or give any form of intervention (even if  a new form of training, for example) to a patient, and your intent is to use this for research and that the patient is identifiable because you are associating the measurements you take with that individual patient. 

If you are doing research, you will need 1) a protocol, 2) ethics committee approval, and 3) consent from your institution. This is important because it will allow your findings to be taken up and shared. Whether research or an audit, you need permission within your workplace and maybe the wider institution. We know that this step is the major barrier to health workers undertaking research and so there is help and support available.  

How do you decide which permissions and approvals you need? There are some things you need to consider in order to answer this question.  

  • One of the biggest considerations is your study population. Is your study population made up of real people? For example, you may wish to understand how targeting screening for some disease impacts the diagnosis of that disease among a particular population at risk. Your population of interest is made up of patients, and you will need to get those patients’ consent in order for them to be a part of your study.  

  • Another big consideration is your study setting or institution. Suppose you’re undertaking a study such as the one described in the previous point. In that case, you would likely be focusing on one or two hospitals for recruiting patients. You’d need to get ethical approval from those hospitals, as well as your own institution (if it is different from those hospitals).  

Obtaining permissions and approvals requires research protocols, which means that the institution needs to know what you plan to do before you start your research project. This is so that they can assess which parts of your research require participant consent or institutional approval. But how do you write a research protocol? There are several elements that a research protocol should include.  

  • What is the title of your study? And who is involved in conducting it? 

  • Provide a brief background of the problem you are trying to address.  

  • Has other research happened to try to address this problem? 

  • Why are you conducting your study? Has it never been done before? 

  • What questions are you looking to answer with your study? 

  • Who will participate in your study, and where will your study take place? 

  • Is there an intervention or program you will implement? 

  • What will you measure during your study? Will you measure things before and after an intervention? 

  • How do you plan to analyze what you will measure? 

  • Are there any potential risks in undertaking your study? 

  • Approximately how long will your study take? 

There is much more detail you can provide in your research protocol – the more detail, the better, but you also have to be concise.  A typical research protocol is no more than a few pages long. Writing transparent and detailed protocols are a part of good research practice and ethics is another big part of good research practice.   

Basic Ethical Principles 

There are some basic ethical principles that can help guide global health researchers to facilitate good research practice, particularly when it comes to data-driven research. Often, these principles are laid out in what’s called an “Ethics and Governance Framework”. There are many examples of these types of frameworks. One example is the Ethics and Governance Framework of the International COVID-19 Data Alliance (ICODA). The basic ethical principles it outlines are described below. 

DELIVER PATIENT BENEFIT: use data effectively in high-quality robust research and promote reporting of results  

FOSTER EQUITY: support LMIC-led research and recognize the contribution of those who produce the data. 

RESPECT THE PATIENTS AND RESEARCH PARTICIPANTS WHO CONTRIBUTE DATA: respect the data-sharing preferences of patients and maintain community engagement throughout the project 

PROTECT PRIVACY: ensure robust data security and manage who has access to it.  

PROVIDE RESPONSIBLE STEWARDSHIP: maintain transparency across all research activities. 

If you have any doubts or questions related to ethics and institutional approval, you can find information on the website of your national research ethics board:  

https://media.tghn.org/medialibrary/2023/11/Country_Research_Ethics_Boards.pdf  

Your institution will likely have its own ethical board as well – you can ask to meet with them, and they can answer any questions you have about ethics and institutional approval.  

Do you need more help with this? Please find links to additional resources.   

  • Institutional approval/support: 

  • Ethics approval:  

  • How to develop your protocol:  

  • After going through steps 1 to 3, you are ready to develop your study protocol. 

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