Table 3.

Ethical considerations for use of archived biospecimens without specific consent

Ethical issues	Key questions
Scientific value	Is the proposed research feasible? Is it important? What is its potential impact?
Risks to participants	What is the likelihood and nature of the harm to biospecimen donors if the research is approved?
Risks to family and groups	In cases involving germline genetic research or data sharing, is there potential for harm to the participant's family or racial or ethnic group?
Potential conflict with nonwelfare interests of participants	Is the proposed research on a subject that could raise religious, political, or cultural objections among participants?
Language in the ICD regarding the research in question	To what extent does the ICD directly prohibit the research practice in question? Is the proposed research prohibited or simply omitted?
Language in the ICD regarding future research	If the ICD does not directly address the proposed research, is broad use and/or data sharing otherwise stated or implied?
Potential to recontact participants	Can biospecimen donors be recontacted to seek consent for the research?
Unique Biobank or dataset	How novel and important is the biobank? Can a similar biobank be developed from new donors to support the research question, and what would this require?
Potential benefits to participants	Are their anticipated or potential direct benefits to participants if the research proceeds?
Potential benefits to relatives and groups	Are their anticipated or potential benefits to relatives of participants or those with shared genetic traits from the research?
Distribution of potential benefits from the science	Will results of successful research (new drug or biomarker development) be accessible to members of the participants community?

Abbreviation: ICD, informed consent document.