When would a researcher have access to the information and samples stored by the Biobank?
When researchers wish to use the information and samples stored in a biobank, they would have to apply to the Biobank Access Committee for permission. This Committee is composed of representatives of various interests, including:
• Researchers (from a university or research institute)
• Community members
• Government representatives (such as from the Department of Health and Human Services)
This committee would review all applications to use the biobank resources (samples and information) to assess whether they are scientifically and ethically sound. The aim of the committee would be to protect participant interests.
If a biobank is established there will be clear policies and regulations regarding who governs access. The composition of representatives of the Biobank access committee would be written into these regulation.
Are they the only people who will regulate access?
No. There is also the Human Research Ethics Committee (‘HREC’), But the Biobank Access Committee could refuse access even if the HREC has granted permission to an applicant’s research proposal.
In addition to the Biobank Access Committee, explained above, all applications also need to be reviewed by the relevant institutional HREC before they can begin.
In other words, firstly, the HREC would check that the research proposals are ethically acceptable and comply with standards and guidelines concerning research involving human participants. And secondly, for access to the actual samples, the Biobank Access Committee would review the research and check that the research is scientifically and ethically sound with particular emphasis on the interests of participants (people who have donated samples.) They may also check that the research proposed is in line with the objectives of the biobank.