D2K, PEALS, Newcastle University

METADAC Application Process

Application Review

Full details of the workflow for applications to METADAC are described in the METADAC flowchart.260816.

New applications must be submitted at least 10 working days prior to the next METADAC meeting. New applications will be reviewed by the Technical Review Team to ensure that all basic technical and scientific questions are identified and addressed and all problems highlighted, and where possible, resolved, before an application is passed on to the METADAC for formal consideration. The METADAC formally ratifies applications that are straightforward and problem free, and provides a forum for discussion, problem resolution and rejection/acceptance for those applications that are other than straightforward. The METADAC also has responsibility for reviewing and developing new access policies to reflect rapid changes in the scientific, social and ethico-legal knowledge-base underpinning of this important area of bioscience.

All applications received are reported to the governing boards of the relevant studies.

Assessment Criteria

  1. Has the application been submitted by bona fide researchers?
  2. Does the application violate (or potentially violate) any of the ethical permissions granted to the study or any of the consent forms signed by the participants or their guardians?
  3. Does the application run the risk of producing information that may allow individual cohort members to be identified?
  4. Does the application run a significant risk of upsetting or alienating cohort members or of reducing their willingness to continue as active participants?
  5. For 1958BC: Does the application address topics that fall within the acknowledged remit of the project, as understood by participants?
  6. For 1958BC: Does the application request access to a depletable finite resource (whole blood extracted DNA, blood, saliva and urine)?
    Applications for finite bio-samples are seen as being in competition with other potential research projects, and the quality of the science is reviewed formally (if necessary using independent external reviewers). The 1958BC biosample strategy guidelines contain more detail.

Approval Process

When an application is approved by the METADAC committee, the applicant will be notified in a letter copied to the relevant contacts for the study. Applicants can then liaise directly with the study (or data repository) to arrange formal transfer agreements and receipt of data or samples.

ACCC Terms of Reference and Policy Document will be valid for 1958 BC applications to METADAC until March 2017.