One-time general consent for research on biological samples

 Appendix 1

Appendix 2

Appendix 1: Literature Search. Posted as supplied by the author

Appendix 2: Consent process for research with human biological samples. Posted as supplied by the author

Six main elements

Request to obtain samples for future research

Risks, if any

Absence of direct benefits

Information, if any, to be provided to individuals

Reliance on ethics committee to review and approve future research provided it is ethical and poses no greater than minimal risk

Solicitation of individual concerns or questions

Example wording

Research with biological samples can help find better ways to protect and improve people’s health. We would like to obtain a sample of your blood (tissue) for future studies. The researchers conducting these studies will not contact you for more information. Your sample will be used only when an independent group, called an REC (IRB), determines that the research is ethical and poses no more than minimal risk to you. These future studies will not benefit you personally, and are not needed for your medical care. All information you provide will be kept confidential as far as possible. However, there is always a very small chance that some information may be released.

Additional considerations when relevant

Optional provision: no matter what you decide, it will not affect your medical care.

Individual information: we will provide you with any information from future studies that may have an impact on your health.

Study information: information on the nature (findings) of future research projects will be posted on our website (provided in some other way).

Future removal: if you decide in the future that you no longer want your sample to be used for research, please contact the study doctors and any remaining sample will be destroyed.