Detailed rules about the ethics and governance of the UK Biobank have been outlined by researchers.
Health and lifestyle information of volunteers will be confidential
The ground-breaking project will collect the DNA and medical histories of 500,000 people and track their health for at least 10 years.
It is hoped that the information collected by the Biobank will provide clues to how genes and environmental factors conspire to make us ill.
Its backers said the framework announced on Wednesday "sets new standards for ethics and governance in UK science."
Stakeholders have one month to comment on the draft document.
The framework says participation will be entirely voluntary and all participants will have the right to withdraw at any time.
Confidentiality will be maintained by keeping all identifying information completely separate from personal details, such as health and lifestyle data.
All researchers, whether from the private sector, charities, or the public sector, will only gain access to the data if they meet rigorous ethical and scientific criteria.
That will include scientific peer review and approval by an NHS research ethics committee.
An ethics and governance council will also be appointed as an "independent guardian" of the framework.
Biobank chief executive Professor John Newton said the "safeguards being proposed go well beyond what is required by law in a number of areas".
He added that recruitment of volunteers would not begin until the ethical and scientific framework was in place.
But critics of the £60m project say it is too expensive, taking money from other research and that it will not deliver.
The Commons science and technology select committee reported that funding for other research projects is suffering because of the huge cost of the Biobank.
Committee chairman Labour MP Dr Ian Gibson said: "Our select committee report was quite rough and savage.
"It criticised the MRC (Medical Research Council) for going down this line and many, many people are having their grants put under amazing pressure."
'Belt and braces'
There were also concerns about the future and as-yet-undetermined use of the DNA samples, which would be counter to existing ethics.
A spokeswoman from pressure group Genewatch, Dr Helen Wallace, said Biobank would "essentially tear up those rules, and say 'give your sample to us and we'll decide in future how it's going to be used'."
However, Professor Newton told BBC Radio 4's Today programme that the framework was a "belt and braces" approach to protecting the volunteers' information, through both scientific and ethical barriers.
This would be to "prevent people using the data for purposes that the participants wouldn't have expected and wouldn't necessarily have agreed with".
The Biobank is backed by the Medical Research Council, the Wellcome Trust and Department of Health.