• Ethical considerations are strongly linked to the quality of research
• More specifically, ethical practices reduce attrition and improve data quality
• How so?
  • Participants who feel respected are more likely to provide accurate and complete information
  • Participants deceived about study purpose might intentionally skew responses
  • Damaged relationships with communities can hinder future research and interventions
  • Example: The Tuskegee Study led to deep mistrust of medical institutions

Informed Consent Form for Participation in a Research Study

Study Title: Understanding Community Opinions on Local Park Improvements

Principal Investigator: [Researcher’s Name], [Researcher’s Affiliation], [Contact Information - Email and/or Phone Number]

1. Purpose of this Research:

We are conducting a research study to understand what people in our community think about possible improvements to [Name of Local Park]. We want to learn your opinions to help make the park better for everyone.

2. What you will be asked to do:

If you agree to participate, we will ask you to answer some questions in a short interview. This interview will take about 20-30 minutes. We will ask you about your use of the park, and your thoughts on different ideas for making it better, like adding new play equipment, walking paths, or picnic areas.

3. Potential Risks and Benefits:

• Risks: We do not expect any major risks from participating in this study. You might feel slightly tired from answering questions. You can skip any question you do not want to answer.
• Benefits: Your participation will help us understand community needs and preferences for park improvements. This could lead to a better park for you and everyone in our community. You will not receive direct personal benefit other than contributing to this knowledge.

4. Confidentiality:

Your answers will be kept private. We will not use your name or any information that could directly identify you in our report. All the information we collect will be combined with answers from other people to understand overall community opinions. Your individual responses will be kept secure and only seen by the research team.

5. Voluntary Participation and Right to Withdraw:

Your participation in this research is completely voluntary. You can choose not to participate at all. If you agree to participate, you can change your mind and stop at any time without penalty or negative consequences. Your decision will not affect your relationship with [Researcher’s Affiliation] or your access to community services.

6. Questions:

If you have any questions about this research, please feel free to ask me now or at any time during the study. You can also contact [Researcher’s Name] at [Contact Information - Email and/or Phone Number] if you have questions later.

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Consent Statement:

By signing below, you are confirming that:

• You have read and understood this consent form.
• You have had the opportunity to ask questions and have received satisfactory answers.
• You voluntarily agree to participate in this research study.

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Participant Name (Printed): _______________________________

Participant Signature: _______________________________

Date: _______________

Researcher Name (Printed): _______________________________

Researcher Signature: _______________________________

Date: _______________

• Institutional Review Boards (IRBs) are committees that review research proposals to ensure they meet ethical standards
• IRBs are required for federally funded research in the US and in many other countries
• They are composed of scientists, ethicists, and community members who evaluate the risks and benefits of research
• There is a formal (standard) application for the approval of research with human beings
• This is not optional. You cannot interact with human research subjects before this is approved
• The board may consider that your research is enabled to continue, but it is the board that decides this (not you)
• You are obliged to inform the board about “adverse events” of the research

• Description of the population of subjects, how they will be recruited, how they will be compensated (if they are), the context of the research and what you will do in it
• Consent form and standard elements necessary to explain the research to the study subjects
• The data collection instrument (survey questionnaire, etc.)
• Statement of the expected benefits and risks, including how the results will be disseminated
• How subjects can ask questions and report any problems to the review committee and/or you in real time
• How you will ensure the confidentiality, anonymity, and security of the data

• In some countries, the ethical review committee is located in a ministry of technology/science and will be more accustomed to dealing with medical research than with social science research
• Universities and research institutes or organisations often have their own ethical review committees
• Prepare to explain your research a little more
• Perhaps you could plan a meeting over coffee to contextualise social science research for a member of a medical review committee
• Knowledge of the local language and legislation is very important

Source: Kramer et al. (2014)

Source: Bursztyn et al. (2021)

• Two key points:
  • Do no harm (non-maleficence)
  • Maximise benefits, minimise risks (beneficence)
• Risk-benefit assessment is important for every study and it is your responsibility to ensure that the benefits of the research outweigh the risks
• Consider Equipoise: Genuine uncertainty about best approach
• Knowledge gain is great, but only if research is credible and well-designed
• Sometimes it is better not to run the experiment at all!

Source: Yeh et al. (2018)

• Adaptive randomisation is a technique that allows researchers to adjust the allocation of participants to different treatment groups based on interim results
• That is, the randomisation probabilities can be adjusted during the study, usually to include more people in the group that is performing better
• No more 50/50 randomisation!
• This procedure is quite popular in clinical trials and can be used to maximise the benefits of the research
• But it requires that the best solution is found quickly and that the researchers are able to adapt to the new information

Source: Pallman et al. (2018)

Source: Pallman et al. (2018)

Source: Bertrand et al. (2006)

Source: The PREVAIL II Writing Group (2016)

Source: Banerjee et al. (2008)