The COVID-19 pandemic has heightened awareness of the need for high quality medical research.  Patients, families, physicians, policy makers, and research funders all have the expectation that research will be robust, even if produced under high pressure conditions like a pandemic.

When research quality problems arise, this can impact patient safety as well as public trust in science.  Consider the recent allegations of misconduct involving COVID-19 vaccine research (see Note 1).  In the face of vaccine sceptics and Internet misinformation, data integrity allegations are a blow to scientific efforts and trust-building (see Note 2).

Katrina Bramstedt, Chief Ethics Officer at Clarity Ethics, recently presented the topic of ISO37002 at the Whistleblowing Workshop sponsored by the European Network of Research Integrity Offices (ENRIO).  ISO37002 is a new guideline for organisations to design, implement, and manage their whistleblower management system (see Note 3).  Research integrity officers are at the interface of whistleblowing cases, when allegations of research misconduct are reported.  These allegations can include matters such as data fraud, plagiarism, conflict of interest, and animal welfare concerns.  Having safe and secure whistleblowing channels in the research arena is vital.  The ISO37002 guidance can help research performing organisations and integrity offices ensure that whistleblowers are supported and protected, that investigations are fair and unbiased, and that the system is resourced and monitored for quality.

Another vital key to robust research is ethics training.  It’s not enough to teach researchers about research integrity (e.g., data handling, authorship ethics, informed consent), researchers also need training in research ethics; that is, the virtues and values that build and fortify an ethical researcher.  These virtues and values are the DNA of the researcher that foster their capacity to act with integrity and empathy in the research setting.  Research ethics training also builds moral courage, so that researchers feel empowered to report misconduct when they observe it.

If you’d like information about our ISO37002 toolkit that helps organisations implement a robust whistleblower management system, or information about training to researchers on ethics and integrity, reach out to us at [email protected]

 

Notes:

1. Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

2. The carnage of substandard research during the COVID-19 pandemic: a call for quality

3. ISO 37002