The best way to ensure that a study is carried out with the highest standards of research integrity and ethics is to have a clear research plan. A clear research plan is based on a review of the literature, identifies specific research questions, and lays out a plan for answering these questions. Researchers have many opportunities to write down their research plan. It can be part of a grant application, a thesis proposal (for students), a preregistration or registered report, a research ethics application, or even two or more of the aforementioned documents.
Some things that researchers should think about during their planning are:
A good research plan demonstrates that the study is well-planned, well-designed, and achievable. It shows that the researcher is knowledgeable about the topic and has the skills and resources needed to carry out the study responsibly and successfully.
Even researchers with great ideas and good intentions might not realize that they forgot something or have something wrong with their plan. Therefore it is expected that an independent committee can review what a researcher is planning to do. Any research that involves recruiting human participants to answer questions, perform tasks, or be observed (with or without audio or video recording) require ethics approval.
Here are some steps that a researcher should take for a successful ethics application:
Getting ethics approval is a way to show that your study had been evaluated by objective reviewers and that your study design falls within acceptable research practices. Seeking approval from a local research committee in a low- and middle-income country also ensures that the study protocol had been judged as appropriate by experts or community leaders who are familiar with the laws and cultural norms in the community or country being studied.
Different ethics committees have different requirements. Typically, ethics committees ask researchers to fill up an application form containing details of who is doing the research, the research aims and objectives, who will be recruited (and how), the study protocol, and samples of the materials to be used. Some important documents that are usually included are:
The ultimate goal is for participants to understand what the study is about, what is being asked of them, and what their rights are as participants. The BPS recommends preparing a participant information sheet containing details about the study1, such as the following:
| Examples of statements or information you can provide | |
|---|---|
| What the study is about | |
| The aim(s) of the study | “To understand how teachers deliver oral language teaching for 3- to 6-year-olds” |
| What data will be collected | Demographic information, opinions or attitudes about something, scores on a task |
| How data will be collected | Through individual interviews and focus group discussions |
| How long it will take to participate | “Two sessions lasting 30-40 minutes each” |
| Participants’ rights | |
| The right to withdraw participation | “You are free to withdraw from the study at any time without giving any reason and with no negative consequences” |
| The right to withdraw data | “You may request for your data to be destroyed” (until a certain date) |
| How data gathered will be treated | |
| Confidentiality | “Your data can only be accessed by members of the research team” |
| Anonymity | “Your answers will be anonymised and we will not use your name in any publications from this project” |
| Planned data use and outcomes | “We will compute the average scores across participants and report these in scientific articles/reports” |
| Risks and benefits of participating in the research | |
| Risks of participation and how they are managed | “You may get tired from answering a long survey; hence we are limiting the session to 30-40 minutes” |
| Reimbursement or compensation; if none, this should also be stated | Note: Participants should not be coerced to participate by offering disproportionate rewards for participating or punishments for not participating |
| Potential benefits of the research, which may be direct or indirect to the participant | “There are no direct benefits to you; however, the results of this study will contribute to our understanding of oral language development” |
| How to contact the research team | |
| Who is in charge of the project? | Name and contact details of the named research association, the India co-investigator and the principal investigator |
As you can see, this is a lot of information to share! Make sure to give enough time for the participant to think about whether they still want to participate after receiving this information. Also, make sure to answer any questions that they might have about the study.
Because the goal is for participants to understand what they are being asked to do, this information sheet needs to be written in simple language and in a language understood by the participant. When research is conducted in communities with low literacy or where paper records are viewed with suspicion or even as a safety threat, researchers should consider alternative ways of providing information, such as sharing the information orally.
Getting informed consent is a confirmation that a participant understood what a study is about and that they are voluntarily participating in it. Consent should be gained before collecting research data from that individual. Children (under age 16 or 18, depending on where you are) are considered vulnerable. Their participation in research requires consent from an adult, normally a parent or the primary caregiver. When recruitment is done through schools, then the researcher must first get consent from the schools and be allowed to contact parents about the study. The standard procedure is for two copies of a written consent form to be signed, one for the research team and one for the participant (or participant’s parent) to keep.
In certain cases, consent might be taken orally with an audio recorder or with a researcher record of oral consent. However, some ethics committees or local authorities might be very strict with their requirements. For example, some might only accept written consent forms, require additional signatures from witnesses, or require both parents to sign the consent form for a child. Make sure that you know what local regulations require and plan your research accordingly.
Although many research committees consider parental or caregiver consent to be enough for child participants, it is also ideal to gain assent from the children participating in the study. Assent from a child is an active agreement to participate in the research study. Ways of gaining assent will differ depending on the age of the child. For example, a teenager may be able to read and sign an assent form, but for a younger child, the researcher may need to explain what is happening orally and/or with the aid of pictures.
Many universities have templates for participant information sheets and consent (and assent) forms that you could freely download; for example, here is a website where you can find English language templates used at The University of Oxford, approved procedures for non-invasive research methods with children recruited via an organisation, and a best practice guide for collecting data online wherein researchers may not have any direct contact with participants.
Check if your research group, organization, or ethics committee has required or preferred templates. Also, don’t forget to plan for the time and effort it takes to write these materials in the participants’ or communities’ local language(s).
Although a lot of information needs to be given to participants, this ensures that participants know exactly what they are participating in and they can make an informed decision to participate in the study or not. Making sure that complete information is given to adults in low-literacy or disadvantaged communities, using language that is understandable and non-patronizing, and that children have the opportunity to give assent, ensures that every individual is treated with respect regardless of who they are. Following these procedures minimize harm by reducing the chance of exploitation or deceiving people into participating in research with incomplete or inaccurate information about the study and their rights as participants.
It is important to remember that (1) data collection should not begin before ethics approval is received and (2) ethics approval should not be sought retroactively or after a study has been completed. To avoid such problems, be aware of submission deadlines and how long it takes for ethics committees to process your application. Ethics committees might meet every month, every few months, or when necessary (as in the case of ad hoc committees). The situation varies for every organisation and there can be periods in time when committees receive a higher number of submissions than usual.
In the best-case scenario, the ethics committee will approve your study and you may begin collecting data. In some cases, the ethics committee might send feedback or request revisions before they give formal approval. In the worst-case scenario, the ethics application is rejected and the researcher needs to start all over again. Therefore, it is really important to plan your research extensively and prepare a well-written and well-justified ethics application.
Sometimes, you realize that some things in your plan are not working or need to be changed. Sometimes the changes are significant, such as changing the method of investigating the research question or completely changing the type of participants to be recruited. Often the changes are minor, such as minor corrections in the consent documents. When large changes are made, it is good to contact your ethics committee about the changes to know if these are acceptable or if these require a new ethics application. When you are unsure if a change is significant enough, the safe thing to do is to contact the ethics committee for their advice.
Submitting an ethics application for review and keeping your ethics committee informed about changes to your research protocol are ways to ensure honesty and transparency in your research. It is important to submit an application that describes your research accurately and in the way you intend to do it. When you submit your application for review, you are being a good citizen of the scientific community by acknowledging the importance of outside opinion and acknowledging your limitations as a researcher, who may not see all the ethical implications of what you plan to do in your study. After all, it is better to identify potential problems early than to discover them halfway into your data collection!
Ethics does not end with planning and getting ethics approval. It continues during the implementation of the study and after that. But before we proceed, how about a quiz?