LOSS OF PRIVACY TO RESEARCH PARTICIPATION
Your privacy may not be protected if you participate in a medical reseach study.
Ethically, researchers must protect your privacy and confidentiality of their data. They get certificates of confidentiality, which are authorized by our federal government and granted by the US Dept. of Health and Human Services (HHS).
Collected research information if revealed could adversely damage your finances, affect your employment and insurability, and even your reputation.
The Certificates offered nearly absolute privacy protection up to now. It protected studies in biomedical, behavioral, clinical and other research. You were protected and no Federal, state, or local civil, criminal administrative, legislative or other proceeding could identify you.
Certificates just became important in the last decade. The NIH and the National Cancer Institute both feel a certificate should be obtained for all studies. The US case law system relies heavily on precedent.
RECENT LEGAL CASES THAT PREVENT YOUR ABSOLUTE PRIVACY
In the following cases, lawyers convinced the court not to get broad disclosure of the records and instead permitted only restricted disclosure, but did not provide absolute protection.
In 1992, Duke Health Systems had a study of psychiatric disorders among young rural and urban kids. They got a Certificate from the National Institute of Mental Health to get information about all their subjects psychosocial problems, substance abuse, illegal behavior and their genetic traits.
This Study Certificate was challenged in a criminal case in 20004. The defendant was charged with indecent liberties with a minor, and statutory rape. The prosecution knew the defendant was a participant in the 1992 study. The court granted the request, noting the defendant was entitled to the record. It was to be confidential and only used for sentencing at the trial.
The judge did not know about the Certificate. The Duke University, as the records were subpoenaed, found out about the challenge to the Certificate. Duke then filed a protective motion order stating the Certificate should not be disclosed. They even argued the person whose records were sought was not the alleged victim. Duke would not say if the witness was a participant in the study. After long legal rambling, the judge said he had not realized about the Certificate, and said the defense was unlikely to find any exculpatory evidence there anyway. The court said it only issued the protective order after deeming the defendant’s reasons for seeking the records insufficient.
The defendant was tried and convicted. Months later, the defendant’s lawyer filed a motion to get to the sealed records. The same judge was hearing this request. This time, he said the records should be given to the defense and shared with the state. Duke again appealed, citing the People v. Newman Certificate case. The case of People v. Newman was the first case to challenge the protections afforded by the Certificate. A grand jury subpoena was obtained in a murder investigation. The Court backed down and the certificate successfully prevented disclosure of the participant being in a drug program.
Duke said the defendant failed to show the documents were relevant to his defense. Duke however, in the end, did give the documents to the defense lawyers.
The defendant lawyers argued that the Newman case did not govern this situation because the state was looking for information in a criminal prosecution. In this case, they argued, a criminal defendant should have the constitutional right to due process and get any information that would help his defense. The Court of appeals granted the defense access and would not consider Dukes’ argument that the records were statutorily privileged. The court also argued that Duke would not say if they would fight to protect the Certificate records if it had been material to the defense case.
WHAT DOES THIS ALL MEAN TO YOU?
An institution that receives a subpoena needs to get a lawyer with appropriate expertise. The NIH legal advisors provide citation to the statue and case law. But the NIH will not get involved in third party litigation or give legal advise to non NIH entities.
An institution might not want to get involved in a costly legal battle and might not defy the courts, even if the research study wanted to protect the participants.. Just giving some disclosure that a person participated in a study might be damaging to the person. The investigators and institutions could also get fined or imprisoned if they were found in contempt.
All parties in criminal and civil suits have the right to get material relevant to their case. The Courts have the power to enforce these rights and resolve the disputes by balancing each side’s interest. They could care less about protecting research records.
When a criminal defendant wants the records opened in the certificate, he claims he is seeking his constitutional rights to a fair trial.
A future case could raise a question of your constitutional rights being overcome by a Certificate. If the records are considered relevant to national security, the government gets broad legal powers (after the Patriot Act passage) to get any confidential information it wants. It will be hard for researchers to resist.
The legal effect of Certificates is now unclear, and your participations in a research study may not protect your legal rights of privacy as it is claimed.
Source: Science Nov 14, 2008
Your comments are always appreciated.
Visit www.drneedles for more information on controversial subjects. We don’t try to convince you what to think, but only how to think about medical controversial subjects.
No comments:
Post a Comment