We are collecting human saliva as an outcome measure as part of our study. I would like to know what all the important ethical issues are which may be involved in the study.
This is a very timely question. I am sure there are many aspects to consider (such as the age of your human test subjects and the laws of the countries involved). However, answering purely from the standpoint of a lawyer, I think your main concern should be respecting the privacy rights of each individual that provides you with saliva. Saliva can reveal all types of things such as genetic make-up (via DNA), medical problems, dietary habits, and ingestion of illegal substances. Therefore, you need to advise your subjects of this fact, and include a detailed statement of what you intend to use the saliva for and how you will dispose of it afterwards. With regard to disposition of the saliva, before I would let a client of mine sign a waiver giving you leeway to dispose of it as you see fit, I would insist upon a written guarantee that neither the saliva (nor the results of your testing of the saliva) would fall into the hands of any other person or entity outside of your organization. I would certainly not want it to fall into the hands of any law enforcement authority, insurance company or any identity data base that is being maintained by law enforcement authorities. For male clients, I would want a bonded guarantee that while the saliva is in your possession, it will not be used to establish paternity in any pending lawsuits or adoption proceedings.
Thank you so so much for that interesting answer. To be honest, I didnt seriously think about the legal angles involved. You have provided a fascinating angle and thanks for the wonderful explanations. I will make sure that we address these issues in our study. If you would be able to provide me some reference for further study, it will be very much appreciated.
hi Kesava! From a bioethical approach I'll be interesting in knowing what the study is for, who are the research subjects, if you are going to gain some scientific information that can be of use for the research subjects, whether you'll be keeping the samples and if so for what purpose, if you are going to work with identified, anonimous, anonimized or double coded samples. All this information should be in the protocol and in the informed consent.
I think Gwendolyn's provision potentially commits the investigator to breaking the law. You can't legally decline a subpoena. What you can do is discard the sample after testing, commit yourself to doing so, and inform the patient of the availability of the sample to law enforcement agencies while the sample exists in physical form. Similarly, you can de-identify data, but a state authority with a subpoena can force you to re-identfy it. Note, also, that in some jurisdictions, research results are subject to audit by public or private regulatory agencies to ensure scientific integrity.