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Ethical_Review

Page history last edited by Administrator 5 years, 5 months ago

DIYgenomics Citizen Ethicist Review

DIYgenomics wiki homepage

  

Q&A per Citizen Ethicist Review of Study Protocols, thank you to citizen ethicists:

Alexander Gerlyand, Biotechnology professional

Amanda Kahn-Kirby, Biotechnology professional

 

1) How has the system handled safety issues to date, i.e.; who should the participant contact in case of adverse reactions/events? Their primary physician/therapist? How is that data captured?

 

DIYgenomics studies have not been involving pharmaceuticals so far, so there is no specific guidance other than for participants to contact their own physician in the case of adverse events. It would be expected that study participants would note any adverse reactions, unexpected outcomes, or other problematic aspects in the usual process of reporting their experience with the study. 

 

2) Does the medium/platform, DIYgenomics, assume sponsor-like/ CRO responsibilities?  Clearly the studies (in this case, the Social Intelligence Genomics and Self-Tracking Diabetes studies) are rather on the low low risk side, but what happens if the intervention begins to dial up that risk?

 

Study participants accede to Informed Consent (overseen by an academic Institutional Review Board) which discloses the risks of study participation and whom to contact in the event of emergency or other situation. 

 

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