Ethical Challenges

5. Current and Unresolved Issues

Consent

Consent for future research

Other issues involve consent for research that will extend over a period of time.  In doing research on degenerative diseases, e.g. Alzheimer’s disease, we do not know that a person who consented when competent is willing to continue participation in research after s/he has experienced cognitive and emotional changes and whose cognitive capacity is questionable.  In such situations a research advance directive may be helpful.  A research partner or other person may be able to give substitute or surrogate consent and/or, as an advocate who knows the person well, judge whether the advance directive should be followed.  In such situations, the consent process should include information on whether the data can be used if the participant withdraws from the research, and whether follow-up information can be sought.

Example 4

A person with mild cognitive impairment and a family history of Alzheimer’s Disease is a research participant who has consented to longitudinal cognitive testing. Years later the disease has progressed. During the testing session, the participant is agitated and objects to the research. Should the cognitive testing continue?

Specimens collected at one point in time may be used later for purposes not known at the time of consent. Is this ethical? Can a research participant give consent for future use of specimens or data when the purpose of the future research is not known?