IRB requirements for PAPGI
IRB Requirements for PAPGI project
- coordiated by Dr. Poh San Lai (Singapore. Lai Poh San <email@example.com>)
1. IRB should bear the title of our project, ie. the Pan-Asian Population Genomics Initiative or at least cover the scope of the PAPGI’s objectives, such as to study the genetic diversity of populations in Asia and to generate data and resources that can facilitate future biological studies to improve health. Some flexibility will be accepted if title of project approved by the local IRB is different as long as the scope and objectives of PAPGI are covered.
2. Samples do not belong to individual PIs but to the institutions of the researchers, hence appropriate IRB approval for use must come from the respective PI’s Institution.
3. Documents submitted to the IRB of the PI’s Institution and the Inform consent form should cover the following areas:
(i) It is recommended that all samples for this project will be anonymized with no phenotypes or identifiers.
If identifiers are present, they should only be held by the original collector or PI. Phenotypes can be collected with informed consent if this is within the description of the PI’s project and covered with IRB approval. Local PI then takes responsibility in ensuring anonymization of the data shared with the other PAPGI members.
(ii) All data generated from the project will be available as open-access and shared by both PAPGI members as well as others so that everyone can benefit from the research.
(iii) It is recommended that Donors be informed that they have any option to withdraw their sample from the study at any point in time but they should be made to understand that their data, if already shared or deposited in the database in anonymized format, cannot be withdrawn due to technical and physical reasons.
(iv) Include a option for donors to decide if their samples can be used anonymously for other future studies as legacy samples after the primary whole genome sequencing or microarray genotyping work is finished (in case, we expand to other analytical methods - eg. mitochondrial, methylation studies, etc.)
4. PI involved for each study is responsible for addressing these issues specific to their own population collection in their IRB application:
- ensure protection of confidentiality (address any concerns abt stigmatization)
- ensure compliance to the national/local laws, policies and guidelines in their own country and institution
- evaluate storage/access of samples policies for their samples
- address any commercial interests that may be posed towards use of their samples
- explain mechanisms for community engagement/consultation
- address return of any useful data to population, if applicable