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

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.