Services
Advantages
Domain Experts
Services
Ethics and policy resources 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.
(*We do not provide legal opinions.)
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?
We provide a one-stop shop for institutional policy and research ethics needs.
In particular, institutions can contact us to:
- Ensure that ethical issues pertaining to on-site research are properly addressed before the launch of projects.
- Provide customized research ethics training for researchers and research staff.
- Assist institutional ethics committees with ad hoc domain-specific expertise (e.g. for specialized research areas such as data-intensive research, genomics, etc.).
- Prepare policy and ethics documentation for multi-jurisdictional or multi-institutional projects.
Domain Experts
Domain Experts
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