Modules

Research Ethics and Integrity: Governance and Processes

Instructions for:TraineeTrainer

Goal

The aim is to provide learners from different backgrounds and disciplines with an overview of how research ethics and integrity matters are governed, including the mechanisms and processes for ethics approval.

The learning outcomes

At the end of this module, learners will be able to:

Explore the governance mechanisms for research ethics and integrity at different levels (like international, national, institutional).
Identify and consider the research ethics and integrity codes and guidelines that are relevant to their own research.
Describe the process of research ethics approval including when it is needed, from whom and what it entails.

Duration (hours)

2

For whom is this important?

Postgraduate students

Part of

iRECS

Steps

1What is Research Governance?

2Applying for Ethics Approval

9Relevant Ethics Codes and Guidelines

10Research Ethics Committees

11REC Chair Interview

12REC Chair Interview

13Research Ethics Approval And Waivers

14Research Ethics Approval and Waivers cont.

1

What is Research Governance?

Research governance can be thought of as the broad range of regulations, principles, processes and systems that help to ensure good practice in the management and conduct of research. Governance regulations and systems aim to:

safeguard the interests of those who are affected by the research (for example, participants, researchers, animals, environments, society, and institutions),
foster accountability and trustworthiness, and
promote high-quality research.

It is often repeated that research ethics was ‘born in scandal’ because its evolution has been repeatedly triggered by revelations about exploitation of participants in research. For instance, early medical experiments undertaken by physicians and biomedical scientist involved the use of vulnerable individuals (like orphaned children or prisoners) as ‘human guinea pigs’. History shows us that many of the early ethics codes and governance mechanisms were developed in response to such scandals in research.

For instance, the Nuremberg Code was formulated in 1947, as a direct response to the abhorrent medical experiments by Nazi and Japanese doctors during the Second World War. While major scandals in research may not be commonplace nowadays, the development and refinement of research ethics codes and processes is ongoing as new ethical challenges and problems come to light.

Today, there are a multitude of ethics codes, policies and systems for research governance at international, national, organisational, and institutional levels. Finding out which governance mechanisms are relevant to a research study is of primary importance for all researchers when designing and conducting research.

2

Research Ethics

The most well-known and widely used example of research ethics guidelines comes from the World Medical Association, which was established in 1947 after World War II, to address growing concerns about unethical medical practice. The Declaration of Helsinki – Ethical principles for medical research involving human subjects, (henceforth, ‘the Declaration’) was first adopted in 1964.

The Declaration set the standard for ethical medical research involving humans. Even though it acts as a guideline rather than a document with international legal implications, the Declaration has had a great influence on the formulation of regulations and legislation of research, as well as the development of other codes of research ethics. Since its inception, the Declaration has been revised several times.

The 37 principles encoded in the Declaration cover a wide range of issues with the primary aim of ensuring the welfare of research participants. Fundamental to this aim is the individual’s rights to self-determination, and the provision of sufficient information to be able to make an informed decision when considering participation in a research study.

Today, there are a profusion codes of ethics and guidelines across the world operating at international, national, organisational, and institutional levels. Some are aimed at setting out behavioural standards for professionals such as lawyers, psychologists or policing services. The largest collection of codes is held by the Center for the Study of Ethics in the Professions in Illinois, which contains around 4,000 codes and ethics guidelines.

Research Ethics and Integrity: Governance and Processes Step2_Video

3

Research Integrity

The European Federation of Academies of Sciences and Humanities (ALLEA), describes research integrity as:

"crucial to preserving the trustworthiness of the research system and its results. It encompasses the basic responsibility of the research community to formulate the principles of research, to define the criteria for proper research behaviour, to maximise the quality, reliability, and robustness of research and its results, and to respond adequately to threats to, or violations of, good research practices." (ALLEA, 2023:3)

The most well-known guidelines for research integrity, The Singapore Statement on Research Integrity was published in 2010. The statement was the result of an international, collaborative effort to develop more comprehensive standards, codes and policies to promote research integrity at local and global levels.

The Singapore Statement calls for:

Honesty in all aspects of research
Accountability in the conduct of research
Professional courtesy and fairness in working with others
Good stewardship of research on behalf of others

In addition, the statement outlines 14 professional responsibilities to ensure the integrity of research.

These responsibilities include the need for researchers to take responsibility for the integrity of their research, adherence to regulations, the use of appropriate research methods, the keeping of good research records, prompt and open sharing of research findings, responsible authorship and publication acknowledgement practices, participation in peer review, declaration of any conflicts of interest, clear public communication, reporting and responding to irresponsible research practises, fostering research environments that support research integrity, and recognising societal considerations relevant to their research.

Research Ethics and Integrity: Governance and Processes Step3_Video

4

Relevant Ethics Codes and Guidelines

The identification of ethics codes and guidelines that are relevant to your research is vital from the earliest stages of conceptualising and designing your study. As a researcher, you

will need to find out which codes and guidelines apply to your research. A good starting point is to find out which of your institutional codes and processes are relevant. We also strongly recommend that you check the professional, national and international requirements that apply generally to your field of research and specifically to any studies that you are involved in.

You can seek advice from your institution’s research ethics committee and/or your supervisors or colleagues in the wider research team if you have any doubts about which ethics codes and guidelines are relevant to your research.

Research Ethics and Integrity: Governance and Processes Step4_Audio

5

Research Ethics Committees

Research governance mechanisms typically include a system for ethics approval of research. For many types of research, including research with humans, human data or animals, ethics review is compulsory, and approval must be granted before data collection can begin.

Reviews are normally undertaken by committees who seek to protect the interests of research participants, the institution, and other stakeholders.

They also ensure that research complies with local and internationally accepted ethics guidelines and legal requirements. In many countries, these committees are known as research ethics committees or RECs. In other countries, they may be known institutional review boards (IRBs); ethics review boards (ERBs); or ethics review panels (ERPs).

RECs are normally comprised of members from a range of disciplines or professional backgrounds to ensure relevant expertise and input from different perspectives. RECs must be free from influence by the researchers, funders or other stakeholders so they can provide an unbiased opinion.

RECs have the power to authorise a project, request modifications or prevent studies that do not conform to accepted ethical norms and standards. There are different types of RECs. For instance, many countries have centralised systems for clinical research that involves patients or healthcare staff. Many universities have their own RECs and some have different RECs for different disciplines.

RECs can have different templates and processes for applications, but all have the same basic requirements. They want to know:

- About the research proposal - why the research is being conducted and exactly what it will involve
- How the research and the researchers are complying with all the relevant legal and ethical requirements
- What risks are associated with the project and how these are being mitigated

RECs have a critical role in upholding ethical standards in research. With their significant combined expertise, they can spot potential problems in research proposals and help to ensure that both researchers and participants are protected from harm.

Research Ethics and Integrity: Governance and Processes Step5_Video

6

REC Chair Interview

Francis Kombe shares his perspective as a REC chair working in Africa.

Research Ethics and Integrity: Governance and Processes Step6_Video

7

REC Chair Interview

David Shaw shares his perspective as a REC chair working in Europe.

Research Ethics and Integrity: Governance and Processes Step7_Video

8

Research Ethics Approval And Waivers

Not all research studies need research ethics approval. For example, a study that is solely based on a review of research literature is unlikely to need ethics approval. You can work through the following decision tree to assess whether ethics approval is necessary for a project (real or imagined).

Research Ethics and Integrity: Governance and Processes Step8_Audio Transcript

9

Research Ethics Approval and Waivers cont.

Requirements for ethics approval differ between institutions and some may insist upon completion of an ethics form for every study, even if just to make it clear that formal ethics approval is not needed. But other institutions may not even have a REC. What do you think researchers should do when they do not have ready access to a REC?

10

Applying for Ethics Approval

Preparing an application for the ethics approval of a research study can be a time-consuming process which is best approached methodically to ensure a coherent application with all required documentation. The process differs between institutions and organisations, but normally involves the following steps.

Engagement with research ethics and integrity from the very start of a study helps researchers to design studies that are both ethical and of high quality.

Nevertheless, identifying and dealing with ethical issues is not just something that happens at the beginning of a study; ethics awareness is required throughout, as researchers sometimes find themselves dealing with unforeseen consequences and navigating uncharted territory. This is especially the case for research involving new technologies. Some fields, like artificial intelligence and extended reality, are developing rapidly and this requires ongoing assessment of challenges and ethics guidance as it becomes available.

Research Ethics and Integrity: Governance and Processes Step9_quiz

11

End of Module Quiz

ou can try these questions to see whether your learning from this module addresses the intended learning outcomes. No one else will see your answers. No personal data is collected.

Research Ethics and Integrity: Governance and Processes Step10_Quiz

12

Module Evaluation

Thank you for taking this irecs module!

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1. To improve the irecs e-learning modules

2. For research purposes to evaluate the outcomes of the irecs project

To this end we have developed a short questionnaire, which will take from 5 to 10 minutes to answer.

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This link will take you to a new page; https://forms.office.com/e/K5LH08FyvQ

Thank you!

13

Glossary Of Terms

Accountability

In the context of research governance, accountability entails researchers and research institutions taking responsibility for the ethical conduct, integrity, and outcomes of their research activities. This includes adhering to regulatory requirements, ethical guidelines, and best practices in research methodology. Accountability in research governance also involves transparency in reporting findings, acknowledging conflicts of interest, and ensuring that research benefits society while minimising potential harm.

Ethics dumping

Ethics dumping is a term used to describe situations when researchers from privileged settings offshore unethical research to lower income settings. It can happen on purpose, but also due to lack of awareness and cultural misunderstandings. Probably the best-known type of ethics dumping is the application of double standards, where exploitative practises that are not accepted in a high-income setting are used in a lower income setting.

Methodology

Methodology refers to the systematic methods or procedures used in a particular field of study or discipline. It encompasses the principles, techniques, and rules for conducting research or investigation within that field. It can be regarded as a framework for planning, executing, and evaluating research activities.

Methods

In research, the term ‘methods’ refers to the specific tools or processes that are used for data collection or analysis. For instance, methods might take the form of a survey, interviews or experiments.

Trustworthiness

Trustworthiness in the research context refers to the credibility, reliability, and integrity of the research process and its outcomes. It encompasses adherence to ethical standards, transparency in methods and reporting, consistency in findings, and the avoidance of biases or conflicts of interest. Trustworthiness is essential for establishing confidence in research results among peers, stakeholders, and the broader community.

Stewardship

In the research context, stewardship involves the ethical and responsible management of research resources, including funding, data, facilities, and intellectual property. It entails ensuring that these resources are used efficiently, transparently, and in accordance with established guidelines and ethical standards. Stewardship in research also involves promoting the integrity of the research process, fostering collaboration, and safeguarding the interests of participants, stakeholders, and the broader community.

14

Bibliography

ALLEA (2023) The European Code of Conduct for Research Integrity, Revised edition, available from: https://allea.org/

World Medical Association, Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

ENERI (nd) National RE and RI infrastructure, available from: https://eneri.eu/national-re-and-ri-infrastructure/

The San Code of Research Ethics, available from: https://www.globalcodeofconduct.org/affiliated-codes/

Singapore Statement, available from: https://www.wcrif.org/downloads/main-website/singapore-statements/223-singpore-statement-a4size/file

The TRUST Global Code of Conduct for Equitable Research Partnerships, available from: https://www.globalcodeofconduct.org/

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