Instruction:F21d621e-abe7-4583-b823-906f3970a68e

Instructions

Protection of Research Participants

Instructions for:TraineeTrainer

Goal

• Identify potential risks to human research participants within the context of citizen science.
• Understand strategies to minimize risks to research participants when practising citizen science.

Duration (hours)

2

For whom is this important?

Citizen Scientists

Part of

ROSiE

Steps

1Introduction

2Learning about Key Issues

3Test your Knowledge

4Case Study

Why is this important?

1

Introduction

The term 'research participant' refers to an individual who voluntarily takes part in a research study, for example, a patient who takes part in a biomedical research study on new treatment methods or a community member who is interviewed by citizen scientists (like in this citizen science project on people living in London's neighborhoods). Research participants are essential contributors to scientific research, including citizen science projects, and their involvement can vary widely depending on the nature of the study. The rights and interests of research participants lie at the core of research ethics and the same time should apply to citizen science as well. However, citizen science raises new challenges in this regard for at least two reasons. First, there is a great variety of citizen science projects and many of them are conducted outside institutional settings which makes applying the traditional research ethics frameworks challenging. Second, citizen scientists might play different roles in the research, usually, they are involved only as citizen scientists, but in some cases (e.g., in biomedical citizen science research) they might play both roles - a citizen researcher and a research subject.

2

Key Issues

In many cases participation in research does not pose risks to research participants, for example, filling in an anonymous questionnaire usually is easy, and no risks are associated with it (nevertheless, sometimes sensitive questions may pose psychological risk). In some other types of research, participation can pose physical or psychological risks. For example, participants of biomedical research who are exposed to experimental treatments might face risks to physical well-being; research in psychology may lead to emotional distress among participants; studies dealing with sensitive information may raise risks for the privacy and confidentiality of participants; some research topics may be socially sensitive and research participants might face social consequences or stigma. In citizen science, sharing data sometimes might pose a privacy risk to the citizen scientists themselves. This might be a case when, for example, management of citizen science programs requires collecting private information about volunteers.

The rights and interests of research participants are arguably the cornerstone of research ethics and in the traditional research ethics setting there has been developed a certain framework of how these rights are applied in different fields of research. Citizen science however introduces some additional challenges that need to be addressed. Many citizen science projects are conducted outside traditional academic or commercial settings. This raises the issue of ethics oversight of these studies and whether citizen scientists have the necessary research ethics training.

Research involving human research participants is guided by various laws and ethical guidelines. These legal and ethical standards embody important ethical principles and requirements (Emanuel et al 2000; Resnik 2019):

• Social value means that to justify the participation of human subjects, research should be expected to yield results that can benefit society.
• Evaluation of the risk/benefit ratio means that risks posed by participation in a research study should be minimized and justified in terms of the potential benefits to the research participants and society.
• Informed consent means that research participants should receive adequate information about the planned research and their voluntary consent should be sought and appropriately documented.
• Confidentiality is required to protect personal data and privacy of research participants.
• Data safety monitoring means that research data should be adequately protected to avoid harming, e.g., stigmatizing research participants.
• Fair selection of subjects means that the selection of research participants should be based on sound scientific and ethical criteria.
• Protection of vulnerable subjects requires to ensure additional protections for research participants who may be vulnerable to coercion, exploitation, or harm.
• Independent review is a requirement applied to some types of research, e.g. biomedical research involving human research participants should be reviewed by an independent research ethics committee according to the national legal framework.

For a research study to be ethical, researchers, including citizen scientists, must comply with all the requirements and principles mentioned above. For example, poorly designed studies will not yield valuable results and therefore, the risks that research participants have been exposed to during the study will be unjustified. One of the suggested ways to avoid these problems is to closely collaborate with professional scientists who are experts in a particular field of research (Resnik 2019).

References

1. Emanuel, E. J., Wendler, D., & Grady, C. (2000). What Makes Clinical Research Ethical? JAMA, 283(20), 2701–2711. https://doi.org/10.1001/jama.283.20.2701
2. Resnik, D. B. (2019). Citizen scientists as human subjects: Ethical issues. Citizen Science: Theory and Practice, 4(1). https://doi.org/10.5334/cstp.150

3

Test

Use the flashcards below to test your knowledge!

ROSiE Test: Protection of research participants rights in open science

4

Case Study

Watch the interactive video below and complete the exercises!

Protection of Research Participants - Case Study

Remarks

Additional Resources:

1. The Embassy of Good Science: "Balancing harms and benefits"
2. The Embassy of Good Science: “Informed consent”
3. The Embassy of Good Science: “Privacy in research”
4. The Embassy of Good Science: "Protecting research subjects"
5. The Embassy of Good Science: "Research ethics committees"

Steps

Other information