PRECOPE - Preparedness and Response for Ethical Challenges in Human Subject Research during COVID-19 and similar PandEmics

The WHO research roadmap for COVID-19 highlights as key priority to “articulate and translate existing ethical standards to salient issues in COVID-19”. The PRECOPE study aims to address these needs by preparing for and responding to the practice-/decision-oriented challenges in translating ethical principles into concrete human subject research on COVID-19.

In part 1 PRECOPE addresses the preparedness by summarizing current ethical challenges in COVID-19 research via literature reviews and interview research with relevant stakeholder groups.

In part 2 PRECOPE addresses the response via the development of hands-on guidance for the 3-5 “most-pressing/relevant” ethical challenges. The selection of these challenges will again include the relevant stakeholder groups. The development process will include external experts (funded by work-contracts). Furthermore, part 2 will closely cooperate with the AKEK (Association of Medical Ethics Committees in Germany) representing all 52 German research ethics committees (REC).

In part 3 we analyze and discuss with involved stakeholders and experts the SWOT (strengths, weaknesses, opportunities, threats) of all PRECOPE activities to inform future planning for COVID-19 like pandemics.

In April 2020, we conducted a survey across all 52 German research ethics committees (RECs), in close cooperation with the AKEK (Association of Medical Ethics Committees in Germany) to identify perceived ethical challenges and potential solutions with reviewing proposals for COVID-19 studies. The results of this survey inform part 1 of the project and can be found here (in German | attachments on demand). The prepint publication can be found here.