IBRH3AU Ethics and Regulatory Issues

The Integrated Biorepository of H3Africa Uganda (IBRH3AU)is committed to promoting and educating staff for adherence to high ethical standards and practices in the reception, processing, storage and distribution of human biospecimen and accompanying data for research purposes. Processes such as consent, collection, storage and proposed research shall be reviewed and approved by a legal officer qualified in research ethics (both national and international) and an appropriately constituted Research Ethics Board/Institutional Review Board to ensure that among other things the research is in line with the patient consent. The standard of "minimal risk" shall be considered in the review process.

Confidentiality

Personal and medical information and research results relating to the participant and biospecimen shall always be treated as confidential. The participant shall be made aware of the type of personal and medical information that will be used by researchers, and what safeguards will be in place to protect their confidentiality and anonymity. All members of the biobank that have access to biospecimen and accompanying data shall sign confidentiality agreements

Commitment to maintaining confidentiality

The IBRH3AU will maintain strict measures to protect confidentiality, and will ensure that data and samples are (reversibly) anonymised, linked and stored to very high standards of security. The same protection will be extended under contract for any handling or analysis of data or biospecimens by third parties engaged to provide services necessary for developing the resource. Research users will only be given access to anonymised data and samples.

Economic Factors

Economic factors may provide motivation for participants to provide biospecimens but this could compromise the quality and safety of the collection. Subjects shall not be offered or receive any financial compensation for participation in the program. Participants may be reimbursed for costs involved in participation. Human biological material (HBM) collected from participants shall be treated as gifts. Human Biological Materials shall not give rise to financial gain. The biobank shall not sell (for a profit) biospecimens that they have collected. A reasonable payment from users of the biobank to recover cost of managing, maintaining, processing and handling the biobank collection is however acceptable.

Custodianship of Biospecimen and Data

The biobank shall bear responsibility for the biospecimen and data in the collection that they manage and maintain. The biobank shall bear responsibility for keeping proper records of all uses that have been made of the materials, by themselves. If transfer of material occurs, appropriate material transfer procedures shall be followed and documented. The IBRH3AU as Custodians of "Existing Collections" shall ensure that they make optimal use of the resource they control and seek the advice of the established Institutional Review Board through periodic (e.g. annual) review. Access to biospecimen and accompanying data shall be through a documented and approved procedure