5 EVALUATING BIOHISTORICAL RESEARCH PROPOSALS

CHS-ISLAT investigators have drafted a preliminary set of questions to facilitate the evaluation of biohistorical research proposals; ethical guidelines will be published at a later date. The questions were developed following a review of published biohistorical studies and human subject regulations, consultation with a range of specialists, and analysis of codes of ethics and practice for a selected group of professional associations.

5.1 PROTOCOL DEVELOPMENT

• Who will assume primary responsibility for evaluating the proposed investigation?
• Has an appropriate interdisciplinary and/or intercultural team of consultants been assembled for planning and implementing the project as well as interpreting and disseminating project results?
• Has adequate consideration been given to the historical, scientific, and social implications of the proposed investigation?
• Have potential conflicts of interest been identified?
• What federal, state, or local laws are applicable?
• What provisions have been made for the responsible stewardship of cultural artifacts that will be sampled for the investigation?
• Who has “ownership” of or rights to the intellectual property generated?

5.2 HISTORICAL ANALYSIS

• Have the investigators critically engaged previous historical scholarship and existing evidence?
• What are the investigators' motivations for the proposed research?
• Can the historical question be answered with nonbiological evidence?
• Is the provenance of proposed biological samples reliable?
• Does the significance of the historical question justify destructive sampling or analysis of cultural artifacts?

5.3 SCIENTIFIC INVESTIGATION

• Can the proposed methodologies answer the historical question?
• Have nondestructive methodologies been adequately considered?
• Do the investigators have previous experience and a reasonable success rate with the proposed materials and methodologies?
• Is the laboratory facility appropriate for the proposed investigation?
• If genetic testing has been proposed:

• Have preliminary tests confirming the nature of suspected biological traces been performed?
• Does the condition of biological materials suggest that aDNA is more likely to be present than not?
• Have the proposed sampling and testing techniques been validated on similar aged and fragile materials?
• What are the likely sources of contamination, and can they be controlled by standard protocols?
• Is an authenticated DNA reference sample available for comparative analysis?
• Is the laboratory facility solely dedicated to human aDNA analysis?

5.4 SOCIAL CONSIDERATIONS

• Who are the stakeholders in the proposed investigation, and have the investigators demonstrated a commitment to initiating and maintaining a dialogue with them?
• What are the potential negative consequences of biohistorical knowledge production for human subjects as well as their relatives and communities?
• Are appropriate safeguards in place to protect human subjects as well as their relatives and communities?
• Provisions for informed consent and confidentiality should consider:

• Who will be asked to provide consent and why?
• What provisions have been made for securing identifying information?
• Who will have access to test results and control of acquired data?
• How and where will samples be stored and for how long?
• What provisions have been made for used vials, leftover samples, or destruction of test materials?