Data Collection

Research Ethical Clearance: Quick Guide for Young Researchers

Aug 9, 2021
Data Collection

Dear Diary,

I have been struggling with an eating disorder for the past few years. I am afraid to eat and afraid I will gain weight. The fear is unjustified as I was never overweight. I have weighed the same since I was 12 years old, and I am currently nearing my 25th birthday. Yet, when I see my reflection, I see somebody who is much larger than reality.

I told my therapist that I thought I was fat. She said it was 'body dysmorphia'.
She explained this as a mental health condition where a person is apprehensive about their appearance and suggested I visit a nutritionist. She also told me that this condition was associated with other anxiety disorders and eating disorders. I did not understand what she was saying as I was in denial; I had a problem, to begin with. I wanted a solution without having to address my issues.

Upon visiting my nutritionist, he conducted an in-body scan and told me my body weight was dangerously low.

I disagreed with him.

I felt he was speaking about a different person than the person I saw in the mirror. I felt like the elephant in the room- both literally and figuratively. He then made the simple but revolutionary suggestion to keep a food diary to track what I was eating.

This was a clever way for my nutritionist and me to be on the same page. By recording all my meals, drinks, and snacks, I was able to see what I was eating versus what I was supposed to be eating. Keeping a meal diary was a powerful and non-invasive way for my nutritionist to walk in my shoes for a specific time and understand my eating (and thinking) habits.

No other methodology would have allowed my nutritionist to capture so much contextual and behavioural information on my eating patterns other than a daily detailed food diary.
However, by using a paper and pen, I often forgot (or intentionally did not enter my food entries) as I felt guilty reading what I had eaten or that I had eaten at all.

I also did not have the visual flexibility to express myself through using photos, videos, voice recordings, and screen recordings. The usage of multiple media sources would have allowed my nutritionist to observe my behaviour in real-time and gain a holistic view of my physical and emotional needs.

I confessed to my therapist my deliberate dishonesty in completing the physical food diary and why I had been reluctant to participate in the exercise. My therapist then suggested to my nutritionist and me to transition to a mobile diary study.

Whilst I used a physical diary (paper and pen), a mobile diary study app would have helped my nutritionist and me reach a common ground (and to be on the same page) sooner rather than later.

As a millennial, I wanted to feel like journaling was as easy as Tweeting or posting a picture on Instagram. But at the same time, I wanted to know that the information I  provided in a digital diary would be as safe and private as it would have been as my handwritten diary locked in my bedroom cabinet.

Further, a digital food diary study platform with push notifications would have served as a constant reminder to log in my food entries as I constantly check my phone. It would have also made the task of writing a food diary less momentous by transforming my journaling into micro-journaling by allowing me to enter one bite at a time rather than the whole day's worth of meals at once.

Mainly, the digital food diary could help collect the evidence that I was not the elephant in the room, but rather that the elephant in the room was my denied eating disorder.

The elephant in the room


My first time applying for research ethics clearance was for a study assessing knowledge on childhood cancer among healthcare workers in Mwanza, Tanzania. 

The study aimed at measuring the knowledge, especially on the symptoms and treatment for childhood cancer among health care workers, and I was lucky to be helped by Dr Kristin Schroeder, a pediatric oncologist at Bugando Medical Centre.

The application process was a novel experience for me despite already learning the theory of biomedical research ethics in my epidemiology class session in 2020.

A famous quote from one of the greatest American biologists, Edwin Conklin, says, "Ethics has been well known as the religion of science." 

Why ethics is so important in research

In layman's terms, ethics means the rules that help us distinguish between right and wrong. 

According to the World Health Organization, research ethics govern the standards of conduct for scientific researchers. These principles help to protect the dignity, rights and welfare of the human participants recruited in research.    

I get terrified when I think of a time before research ethics. Sadly, scientific advancement was used to justify many unethical human experiments in history. 

The most famous ones being the following:

Tuskegee Syphilis Study

The Tuskegee Study is unethical research conducted from 1932 to 1972 among African-American males suffering from syphilis disease. Most of them joined the study believing there was a special treatment (cure) for their conditions.

Even though by 1972, Penicillin was considered the standard treatment for syphilis but surprisingly, the researchers only gave Placebo to the human subjects in the Tuskegee study.

This act violates the principle of beneficence which stipulate that there should be a balance between the advantages and risks of the study to human participants.

Willowbrook Hepatitis Experiments

This study began in 1956 where over 700 mentally disabled children at Willowbrook state school, the children were recruited and purposely infected with hepatitis disease.

Researchers falsely convinced parents to sign consent forms making them believe that it was reasonable and necessary for their children's admission at the school.

This study led to the discovery of multiple strains of hepatitis but numerous deaths of innocent children at the cost.

There was no integrity in this experiment since it lacked transparency, especially on the information given to the parents. 

Holmesburg Prison Experiments 

The experiment was immoral and dangerously done in Philadelphia around the 1970s, where Dr Albert Kligman conducted several skin experiments on the inmates without their consent.

He tried to develop acne treatment by studying the reaction between chemicals and human skin and removing thumbnails to see how fingers react to abuse. There was no informed consent, and the subjects did not purely volunteer for enrollment in the study. 

Vulnerable groups suffered most from these atrocities; according to WHO, these groups include prisoners, children, patients and people with mental disabilities. 

Authorization for any research study/ experiment involving human beings should take place after evaluating the researcher's motives.

To eradicate these inhuman acts, several agreements on research ethics, including the Nuremberg Code, Belmont Report, and Helsinki's declaration, were made in 1947, 1978 and 1964, respectively.

Seeking approval from a Research Ethical Committee

Currently, any researcher who wants to conduct research involving human beings is first required to seek ethical approval from the relevant Research Ethical Committee (REC), which can either accept or reject the study depending on whether the protocol observes the following parameters:

  1. Safety of both researchers and their subjects. 
  2. Provision of freely given informed consent to the participants
  3. Potential of the study to generate findings of value (scientific value)

The REC comprises scientific members (those with research experience) and non-scientific members (from diverse disciplines/fields) to ensure a quality ethical evaluation. The primary principles that need to be upheld in any study involving human beings are non-maleficence, justice, beneficence and utility. 

Five different ethics committee proposals

According to the WHO, there are five types of reviews for research proposals depending on the procedure's invasiveness, urgency, and design.

Full committee review of proposals

All research indicating significant risk to human subjects need to be thoroughly reviewed by at least two members of the REC before presenting them to the full committee for further discussions and decision making.

Expedited review of proposals

Two REC members should review researches indicating a minimal risk to human subjects or communities before giving feedback to the secretariat within ten working days. Finally, rejection or acceptance of the proposal occurs.

Exemption from REC review

Studies collecting information from the public domain have no threat/ risk to human beings. Therefore most don't require ethical approval. 

Accelerated review

Most public health emergencies require this review. For example, during 2014 - 2016, the WHO REC created a subcommittee for reviewing ethics of various interventional and observational studies within an average of six working days for immediately controlling the outbreak.

Continuing review

Some studies take a very long time, thus requiring periodic renewal of approval and REC reviews to monitor the study's progress.  

What do I need to include in the application?

When applying to ethical approval, the first thing to remember is to understand that scientific rigorousness is a product of proper documentation and planning. 

The review board will seek signs of insufficient planning.

What is a Research protocol?

The research protocol is a study guidebook that describes what the researcher will do and how they will do it.

Here is a list of 26 items that a research protocol usually includes:

1. Research protocol checklist

This summary helps the REC know the documents included in the application, and it reminds you have forgotten any required documents.

Your institution might have different requirements to what the research protocol might include. Make sure to ask the review committee if they have a checklist already that you can use.

2. Project summary

This is an abstract that comprises all central elements like populations, objectives, rationale, methods, time frames and expected outcome

3. General information

Comprises of protocol title, name and address of sponsors and investigators, and research settings institutions.

4. Rationale and Background information

 It should give concrete reasons for doing the study and its relevance.

5. Study goal and objective

These statements should indicate the proposal hopes to accomplish both broadly and specifically.

6. Study design

It should give detailed information on the type of study, population, sampling frame and both inclusion and exclusion criteria for participants.

7. Methodology

This is the essential part of the protocol, which needs to clearly show the interventions, procedures, and measures to be taken in the study.

For social sciences research, interventions can be training for participants and procedures can be questionnaire surveys or focus group discussions.

8. Safety consideration

How will the health and rights of participants be safeguarded and protected.

9. Data management and statistical analysis

How will the data be collected, will it be paper-based or with an Electronic Data Capture software. Is the system that will be used compliant with Good Clinical Practice (GCP) and privacy laws such as GDPR.

10. Quality assurance

Includes all techniques employed to ensure quality control, data integrity, and reliability. For example, Good clinical research practice ensures standards in designing, conducting and recording data  in clinical research involving human beings.

11. Expected outcome of the study

It should clearly show how the study will contribute to advancing knowledge.

12. Dissemination of results and publication policy

Where will the results be disseminated and in what format, for example academic paper, reports or social media publications.

13. Duration

What is the schedule for data collection, analysis and reporting.

14. Anticipated challenges

What makes this study particularly challenging or what primary risks should be addresses for the success of this study.

15. Project management

It should detail each team member's responsibility and roles in the study.

16. Ethics

It should highlight issues that might raise ethical concerns and an informed consent process.

17. Conflicts of interest

A conflict of interest occurs when the team behind the study could perceive an external economical benefit if this study would be carried out. An example of this is if the researchers are conducting a clinical trial to validate the clinical benefits of an invention of their own.

18. Data sharing

The impact of your research can be multiplied when you make your raw data openly available to other researchers. For this to be successful and ethical, there is a need for proper planning. Here is a specific checklist you can use to plan for making your data publicly available:

19. Participant information sheets

This document contains details of the study that are shared with the subjects before deciding to participate in the study.

20. Consent forms

This signifies that the participants have freely decided to join the study.

21. Recruitment material

This document includes posters and leaflets used to attract research participants. The REC makes sure there are no coercive words.

22. Questionnaires

This document helps data collection. The REC has to make sure the researcher doesn't ask for unnecessary insensitive information from the participants.

23. Interview schedules

This is for qualitative studies which employ interviews for data collection. The REC should be aware of the schedules for interviews.

24. Information about researchers (curriculum vitae)

This provides details of the qualifications and experience possessed by the researcher.

25. Budget and other financial support

What are the costs involved and who will be funding this study.

26. References

References to previous publications on this topic.


In summary, I do concur that application for ethical approval can sometimes be a very tedious process. Still, it's necessary to ensure there is no abuse of human rights in the name of science and research. 

Researchers who wish to get ethical approval from the REC should maintain transparency, honesty and avoid exploiting the participants. 

They should also try to be systemic and well organized to ensure all the necessary documents required for the ethical review process are submitted in time.

Finally, it's okay to get a rejection for ethical clearance; it's not the end of the world or your career! We should remember a famous quote from one of the greatest inventors of all time, Thomas Edison, "I have not failed. I've just successfully discovered 10,000 things that won't work."


- WHO - Recommended format for a 'research protocol' :


If appropriately used in the 21st century, data could save us from lots of failed interventions and enable us to provide evidence-based solutions towards tackling malaria globally. This is also part of what makes the ALMA scorecard generated by the African Leaders Malaria Alliance an essential tool for tracking malaria intervention globally.

If we are able to know the financial resources deployed to fight malaria in an endemic country and equate it to the coverage and impact, it would be easier to strengthen accountability for malaria control and also track progress in malaria elimination across the continent of Africa and beyond.

Odinaka Kingsley Obeta

West African Lead, ALMA Youth Advisory Council/Zero Malaria Champion

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Dear Digital Diary,

I realized that there is an unquestionable comfort in being misunderstood. For to be understood, one must peel off all the emotional layers and be exposed.

This requires both vulnerability and strength. I guess by using a physical diary (a paper and a pen), I never felt like what I was saying was analyzed or judged. But I also never thought I was understood.

Paper does not talk back.Using a daily digital diary has required emotional strength. It has required the need to trust and the need to provide information to be helped and understood.

Using a daily diary has needed less time and effort than a physical diary as I am prompted to interact through mobile notifications. I also no longer relay information from memory, but rather the medical or personal insights I enter are real-time behaviours and experiences.

The interaction is more organic. I also must confess this technology has allowed me to see patterns in my behaviour that I would have otherwise never noticed. I trust that the data I enter is safe as it is password protected. I also trust that I am safe because my doctor and nutritionist can view my records in real-time.

Also, with the data entered being more objective and diverse through pictures and voice recordings, my treatment plan has been better suited to my needs.

No more elephants in this room

Goodluck's avatar

Goodluck Nchasi

I am a 3rd-year medical student at Catholic University Of Health And Allied Sciences, faculty of Medicine, located in Mwanza, Tanzania. I am also a member of the Tanzania Medical Students Association (TAMSA), as a student research mentor. I love sharing my ideas through writing health and research articles. I also have great enthusiasm towards medical research since it shows our faults and how to improve so as to ensure better global healthcare.

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