Building ethics and policy tools for your research

Human health research evolves in a fast-paced environment and often raises a number of emerging ethico-legal questions. We provide guidance, training and assistance with the development of policy documents and tools to help researchers manage their projects.

Our sectors of expertise include genomics, data-intensive research, biobanking, cancer research, research with pediatric or vulnerable populations, stem cell research, populational studies and more.

(*Services do not constitute a legal opinion.)

GENERAL GUIDANCE

We offer general guidance and training sessions

TRAINING SESSIONS

regarding the research ethics committee submission process

TAILORED TRAINING SESSIONS

based on specific research needs and domains

Our experts provide consultancy on ad hoc questions related to ethico-legal aspects of research projects.

(*This guidance does not constitute a legal opinion.)

We collaborate with research teams to develop study documents in view of submission to institutional ethics committees.
In particular, we offer the following:

Assistance

Assistance with the development of the study protocol and governance framework

Preparation of study-specific policies and procedures (SOPs), or review of existing documents. For example, P3G2 develops policies relating to:

  • Consent and recruitment
  • Data access and sharing
  • Return of results
  • Privacy and security
  • Intellectual property
  • Publications

Alignment of retrospective datasets

i.e. use of legacy data/samples

Drafting recruitment material

Consent forms, information leaflets, guidance/promotional material, etc., or review of existing documents

Support for the development of template agreements, e.g.:

  • Data transfer agreements
  • Material transfer agreements

Consortium

Agreement templates for multi-site studies

(*This guidance does not constitute a legal opinion.)

We set up and manage independent study-specific committees responsible for the evaluation of access applications for research databases/biobanks, in line with requirements established by dataset custodians/consents.

*We do not provide legal opinions.

Why work with P3G2?

Data-intensive and biomedical research often intersect, and require alignment with policies on human health research. As experts in the domain, we offer guidance to start-ups and data handling companies on research ethics standards.

In particular, we assist with the following aspects of corporate activities and can:

  • Assess ethical risks associated with the proposed research initiatives.
  • Provide general training and guidance on the ethics review submission process.
  • Support the development of a comprehensive governance framework, at the project’s outset.
  • Develop governance policies.
  • Benefit from flexible pricing options depending on the range of services required. As a non-profit corporation, P3G2 operates on a cost-recovery basis.

Domain Experts

We rely on in-house expertise as well as collaboration with experts from the Centre of Genomics and Policy (McGill University). Many of these experts are or have been members of research ethics boards and can provide insight on expectations and requirements.

Domain-specific experts include:

  • Stem Cells/Regenerative Medicine
  • Data Access
  • Commercialization/Intellectual Property
  • Gene Therapy/Rare Diseases
  • Biobanking
  • Cancer
  • Pediatric genetic testing/screening/sequencing
  • Data Protection/Privacy and Data Sharing
  • Bioethics
  • Privacy/Bioinformatics
  • Epidemiology/Sociology