Academic CRO/Industrial Collaborations in Drug Discovery (Track)

Regulatory requirements in collaborative research

Ghada Al Tajir

Abstract:

Regulation is fundamental to allowing and supporting clinical research. The MENA region in general, and the United Arab Emirates in particular, have faced numerous challenges to research, with one of the most significant being inadequate regulation governing clinical trials.

Stakeholders involved in research on human subjects include public and private health sectors, industry, academia and clinical research organizations. For all parties concerned, appropriate and legal channels for authorizing research should be clear. Patients (and healthy subjects for Phase I trials) should know that any research they are involved in has been approved by an ethics committee, and with that comes the assurance that their rights as research subjects are protected.

The last year has witnessed  a changing phase for research regulatory affairs in the UAE. Previously there have been several research committees across the nation. Two of these committees, one based at Al Ain University and one based at Al Qassimi Hospital are registered with the Office for Human Research Protection (OHRP).  In the past six months, a Committee for Research at the level of the Ministry of Health, and the Higher Committee for Health Research, at the national level, have been established.

The challenges ahead include setting a regulatory framework, working towards consistency between Committees, developing a regulatory process that facilitates rather than impedes research and training on regulatory affairs.