Services
Advantages
Domain Experts
Services
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.)
Guidance and training:
the research ethics submission process

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
Consultation
on ethico-legal aspects of research projects
Our experts provide consultancy on ad hoc questions related to ethico-legal aspects of research projects.
(*This guidance does not constitute a legal opinion.)
Preparation
of ethics-related project documents
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.)
Establishment and management of independent study-specific data access committees
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.
Advantages
Why work with P3G2?
Aligning innovative data-intensive research with research ethics standards
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.
Domain Experts
Domain Experts
Wide range of biomedical ethics expertise
In the provision of our services, we rely on in-house expertise of policy 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