Table 2: METADAC assessment criteria

1. The application has been submitted by bona fide researchers (using the MRC definition [21]).

2. The application does not risk producing information that may allow individual study participants to be identified.

3. The application does not violate (or potentially violate) any of the ethical permissions granted to the study and/or any of the consent forms signed by the participants or their guardians.

4. The application addresses topics that fall within the acknowledged remit of the project, as understood by participants.

5. There is no significant risk that the application might upset or alienate study members or of reducing their willingness to continue as active participants.

6. There is no significant risk that the application might harm individuals in the study, or the study as a whole.

7. The application does not require access to a depletable finite resource (whole blood extracted DNA, blood, saliva and urine). OR The quality of the science has been reviewed formally by independent external reviewers (agreed by METADAC) and has been judged to merit the use of finite biological samples. NB: Applications for finite bio-samples are seen as being in competition with other potential future uses of those samples, and therefore the quality of the science is reviewed formally.

8. Includes a high quality plain language summary—following METADAC guidance.