Conditions of Use
- Data and samples from the 1958BC resource cannot be used for commercial purposes and any commercial involvement would breach the basis on which the access has been awarded.
- Third party sharing of either data or biosamples is strictly prohibited. Any third party seeking to use the data, samples or derived variables or genotypes must apply directly to the Access Committee for CLS Cohorts to obtain access permission in their own right.
- The Access Committee requires that, where possible, individual level data items created de novo are made available to other users in accordance with contemporary best practice and taking appropriate account of ethico-legal restrictions and recognising any potential risks of disclosures of summary level genotypesi. If you believe that there is some reason that you can’t meet this stipulation, please contact the Secretariat for the Access Committee.
- For applications involving linked phenotype and genotype data it is important to note that once an award has been made, any future additions to the dataset (for example, if an additional linked phenotype variable is required) will have to be processed by the 1958 Birth Cohort Access Committee (Technical Review Team) and must comply with the original application. If you do need additional variables to be added, you should therefore inform the Secretariat of the Access Committee.
- Applicants are reminded that the Terms and Conditions for the cohort explicitly forbid any attempt to identify individuals or to compromise or otherwise infringe the confidentiality of information on data subjects and their right to privacy.
- In signing their original consent forms for inclusion in the 1958BC Biomedical Survey (2002-2003), consenting participants agreed that they would not receive feedback about any individual genetic results: “…no information found in the DNA will be given to me” (NCDS Medical Follow-Up, Consent Form 2 – blood samples). In keeping with this wording the current policy of the METADAC is that no genotypic information (regardless of its nature) will be returned to cohort members.
To date, most informed commentators have seen this position as ‘good practice’ because nobody has really known how to interpret the clinical relevance of the genetic variants that have been identified: their effects have typically been rather small and there has been no agreed way in which to respond to the limited increases in risk they may convey. But in common with many of the world’s major cohort studies and biobanks, the 1958BC recognises that national and international views of what constitutes ‘best practice’ might be about to change. For example, as outlined by a senior international commentator in the field2, it is possible that in the future it may become mandatory to report genetic results to participants if they satisfy three key requirements:
- scientific validity (the genotyping is of adequate quality)
- clinical significance (the disease or condition caused by the genetic variant is potentially serious) , and
- potential benefit (i.e. a valid approach exists to prevent or cure the condition/disease of concern and that early knowledge of the genetic risk to which an individual is exposed could enhance the efficacy of that prevention/cure).
At present a change in what is seen as best practice remains no more than a hypothetical possibility, but findings that satisfy the three stated criteria are likely to become more common as the global scientific focus moves to full sequencing of genes and/or longer segments of DNA. The METADAC therefore wishes to help contribute to the national and international evidence-base on which any future strategic decisions might be made regarding policy for feeding back genetic results.
The METADAC now requires that if in the course of any analysis of DNA from any participant in the 1958BC, a genetic variant is found that could potentially be viewed as meeting all three of the criteria stated above, that information must be transmitted to the ACCC. At this stage this is no more than an exercise in collection of key data to assist us in developing an appropriate future strategy for the 1958BC – transmission of any information in this manner does not absolve the research group which generates the relevant finding from having their own internal policy to deal with this globally recognised problem. It is also important to ensure that your research group policy is consistent with the facts that: (1) at present NO genetic information can be returned to 1958BC participants; and (2) even if that policy were to change, all such contacts with cohort members would necessarily be undertaken by the Centre for Longitudinal Studies (contactable via ACCC). These requirements are immutable under any circumstances – even at the direction of an ethics committee that has reviewed your (the research group’s) project.
Acknowledgement of 1958 Birth Cohort Study Resources in Publications
- To acknowledge the use of the 1958BC biomedical resource (data and samples) please use the following statement:
- To acknowledge GWAS data generated by WTCCC:
- For data and samples granted before 1st May 2011 please use the following text:
- To acknowledge use of the Rahman data held at the EGA-EBI (Study reference EGAS00001000971 Dataset EGAD00001001021). Please use the following text:
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