Population based genetic biobanks (PBG biobanks) referred to in this article, are those repositories of donated human DNA and/or its information, collected from consenting persons or their surrogates, with or without disease, which is used for scientific exploration of genes that contribute to human disease. Federal legislation is involved in contemplating future development of statewide and national PBG biobanks.8-10
PBG biobanks do not currently exist in the US but are forecasted on the coming healthcare horizon. 10, 11
They are currently established in some European countries, Iceland, Japan, the Kingdom of Tonga, and Singapore. 10, 12
Canada also proposes collecting newborn genetic samples from a national cohort of Canadian infants to investigate genetic, psychological, and environmental interactions from birth to age 20.10
Nursing has yet to develop evidence based knowledge regarding its role in these GGBPH strategies and how best to manage risks of patient participation. A recently developed nursing conceptual framework has potential to stimulate scientific questions for neonatal nursing clinical practice, nurse-patient relationships and measurement instrument designs relevant to PBG biobank participation risks.13
Nursing has also considered an ethical assessment framework for addressing ethical issues that arise in genetics clinical practice.14
Although nursing's conceptual framework and ethical assessment framework are not tailored specifically to neonatal nursing practice, they are both adaptable to frame research surrounding ethical issues that arise in newborns' participation in PBG biobanks. Afor A call for nursing to develop skills in counseling families regarding newborns' risks in biobank participation exists when considering recently established public laws described in . The urgency is spurred by the 2006 announcement that a leading children's hospital would begin collecting DNA from infants and children in its hospital setting.15
Neonatal nurses, pursuant to recent consensus on genetic competency standards (See ), must develop proficiency in counseling families of infants on the risks, choices and benefits involved in consenting to contribute DNA to biobanks.
Discussions of ethical issues for persons providing DNA to biobanks currently question whether 1) lack of details regarding the DNA's future use circumvents informed consent 2) potential risk of privacy and misuse of genetic information outweighs benefit to an actual DNA provider and 3) right to withdraw is unprotected once DNA is given.16-18
Additional perceived risks to biobank participants that may effect willingness to participate include: 1) pain or bruising associated with blood draw, 2) inconvenience of follow up communications to update information, 3) genetic information from research staff conveyed to participants might emotionally upset a family and 4) insurability or employability problems caused by future unauthorized use of genetic information.19
Neonatal nursing staffs will be challenged to maintain genetic competence in advising on these issues to a degree needed for supporting parental decision-making in the biobanking consent process.
Will neonatal nurses who collect DNA samples be caring for conflicting interests of both present and future infants? Is it ethical to facilitate DNA contributions for research that benefits future neonates, at some yet to be quantified risk to the present neonate in the nurse's care? These are typical ethics questions that may face neonatal nurses. Neonatal nurses will need to self-monitor whether their employer's biobank consent protocol compromises the nurse's protection of and advocacy for the newborn patient in order to facilitate research for future, unknown beneficiaries. Nursing has already identified that a component of genetic nursing competency includes understanding ethical, policy and practice issues resulting from introduction of genetic testing into health care in order to minimize risk of harm to the patient, protect privacy rights and consider benefits vs. risk contexts.20
Likewise, understanding ethical, policy, and practice issues of biobank facilitation and participation in healthcare settings is a component of genetic nursing competency that must be addressed in all neonatal nursing facets: education, research and practice.
Fortunately, nursing and other disciplines have developed useful tools, best practices and some evidence based findings to apply to knowledge development in biobanking ethics issues. Research findings in best methods for obtaining informed consent in the NICU or from parents of children have been reported.21
Additionally, there has been study regarding how to facilitate better patient understanding of informed consent.22
There have been best practice standards recommended in biobank consent protocol that appear ready for scientific testing in clinical settings where biobank consent will be processed.23
Scales are accessible for measuring nurses' perceptions of conflicts of interest or distress related to genetic ethical issues: Moral Distress and Ethical Issues Scales.24