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

Instructions

Protection of Research Participants

Instructions for:TraineeTrainer

Related Initiative

ROSiE

Goal

After completing this module learners will be able to: a) Identify potential risks to human research participants within the context of citizen science, and b) Understand strategies to minimize risks to research participants when practising citizen science.

Duration (hours)

2

For whom is this important?

All stakeholders in researchCitizen Scientists

Method

Blended learning Individual learning

Part of

ROSiE

Steps

1Introduction

2Learning about Key Issues

3Test your Knowledge

4Case Study

What is this about?

Citizen science, according to the European Citizen Science Association (ESCA), is "an ‘umbrella’ term that describes a variety of ways in which the public participates in science. The main characteristics are that: (1) citizens are actively involved in research, in partnership or collaboration with scientists or professionals; and (2) there is a genuine outcome, such as new scientific knowledge, conservation action or policy change."

Why is this important?

Currently, citizen science is becoming more and more important in different fields of science. For example, in natural sciences, it enables large-scale data collection by involving a vast number of individuals which would be challenging to achieve for traditional research methods within the same timeframe and resources. This training will guide you through the crucial elements of responsible citizen science, including protection of human research participants, plants, animals and ecosystems; rights of citizen scientists; conflicts of interest; quality of research outputs etc. By the end of this training, you will gain a deeper understanding of responsible open science and acquire the following skills and attitudes necessary for responsible practising of citizen science:

Practical Tips

This module is part of the ROSiE training on Responsible Open Science for Citizen Scientists. To complete the trainig please complete the other modules in the citizen science guide.

By the end of this training, you will gain a deeper understanding of responsible open science and acquire the following skills and attitudes necessary for responsible practising of citizen science:

Local and Global Citizenship:

• Awareness of the importance and social benefits of Open Science in local and global contexts.
• Participation in ethics and integrity self-regulation of Open Science and citizen science community.

Personal and Social Responsibility:

• Personal and professional responsibility for implementation of Open Science and production of results.
• Openness to share own research data, results, tools and publications and appreciation of efforts of others.

Epistemic Skills

• Ability to organize, present and use open data and knowledge with integrity.
• Ability to critically assess data, knowledge and scientific results produced by others.
• Ability to identify ethical and integrity issues in Open Science.

Collaborative Problem-Solving

• Ability to apply critical thinking skills in collaborative analysis of ethical and integrity problems in Open Science.
• Discussing, finding solutions and making decisions to handle ethics and integrity issues within the Open Science community.

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

Learning about 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 your Knowledge

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:

Steps

Other information