Raising FAIRness in health data and health research performing organisations (HRPOs) WG rev-002

Reuse of health and clinical research data (including social care, and hereafter referred to as health research  data)  has  major  restrictions  when  compared  to  other  research  data  in  the  biomedical domain.  This  primarily  pertains  to  the  concerns  imposed  by  privacy,  sensitivity  and  ethical  issues raised by making data freely available. Meanwhile, research data management (RDM) practices such as  the  creation  of  data  management  plans  (DMP),  sharing  datasets,  the  deposition  of  data  in repositories,  and  the  application  of  FAIR  data  principles  to  research  outcomes  are  becoming increasingly  common  as  they  are  required by funder mandates. Besides this requirement placed by funders  there  is  also  the  wider  need  for  researchers  to  share,  find  and  access  data  to  progress common goals as the primary value, and promote integrity and reproducibility.

The last few years have seen a rapid rise in uptake of the FAIR principles, which originated in the life sciences domain, but which have now been adopted to varying degrees across all research domains. Concomitant  with  the  rise  of  FAIR  datasets  has  been  an  increase  in  open  research  which  urges researchers to make their data available for reuse, especially those that are publicly funded. However, an  important  caveat  when  thinking  about  FAIR when compared to open research is the phrase “as open as possible, as closed as necessary”.

The recent enforcement of the GDPR in Europe is a prime example of a legal framework that makes strict regulations around the processing and sharing of personal data and places the onus on the data controller  to  make  sure  provisions  are  in  place  to  ensure  this.  Although  the  GDPR  is  the  most  far reaching  data  protection  legislation  currently  in  the  world,  there  are  other  territories  that  have restrictions  on  secondary  use  of  personal  data  and  health  data,  e.g.  USA (HIPAA), Ireland (Health Research  Regulation),  India  (Personal  Data  Protection  Bill)    and  S-Africa  (Protection  of  Personal Information Act). As well as internationally enforced restrictions, there are those at national and local levels, and together they all require evidence that the sharing and reuse of health research data are carried out responsibly and in-line with stated aims. The legislation is not meant to impose barriers but to protect individuals’ rights.

FAIR adoption in the health research domain is complicated by numerous factors including concerns regarding:  ethical,  moral,  cultural,  technical,  and  legal  constraints  of  primary  source  data.  We therefore propose this WG to address some of these issues to:

●    Analyse and report legal and ethical issues surrounding data privacy of health research data at the national level.

●    Identify  commonalities  across  territories  that  can  be  a  foundation  for  harmonisation  of guidelines on FAIR adoption.

●    Provide  Health  Research  Performing  Organizations  (HRPOs) with a set of clear and simple guidelines for implementing FAIR Open Data policy in health research.

Therefore,  the  main  purpose  of  this  WG is to provide HRPOs (such as universities, public research institutes, hospitals, medical charities etc.) with a set of clear and simple guidelines, which will define, establish  and  enable  implementation  of  an  aligned FAIR data policy at the institutional level.

RDA_HRPO_FAIR_policy_WG_case_statement_0.pdf