Human Subjects and BioStatistics

An important issue that almost everyone working in biostatistics must face is the protection of any human subjects involved. In "Privacy Rules" Nature, 14 April 2016, Vol 532, page 273, Alania Levine writes,

"An important first step in many areas of biomedical research is for scientists to become familiar with the privacy laws that affect their work. In the United States, human-tissue research is governed mainly by two wideranging laws: the HIPAA and the Federal Policy for the Protection of Human Subjects, which is also known as the Common Rule. These laws dictate how researchers can obtain and use tissue and how they may store and protect the personal information that they collect."

An Important Note

In most (but not all) cases, research you do based on anonymous public data is not a problem.

The Health Insurance Portability and Accountability Act (HIPAA)

In 1996 Health Insurance Portability and Accountability Act (HIPAA) became law in the United States. This is a complex law with strong health records privacy provisions supported by the Federal regulations detailed in 45 CFR 164. As summarized in the Wikipedia HIPAA article this has had a serious impact on acceptable research practices:

" HIPAA restrictions on researchers have affected their ability to perform retrospective, chart-based research as well as their ability to prospectively evaluate patients by contacting them for follow-up. ...

"In addition, informed consent forms for research studies now are required to include extensive detail on how the participant's protected health information will be kept private. While such information is important, the addition of a lengthy, legalistic section on privacy may make these already complex documents even less user-friendly for patients who are asked to read and sign them.

" These data suggest that the HIPAA privacy rule, as currently implemented, may be having negative impacts on the cost and quality of medical research. ..."

The Common Rule

Long before HIPAA, the scientific community had become sensitive to the need to protect the rights of human subjects in scientific research. To quote from the U.S. HHS web page on Human Subjects Protection http://www.hhs.gov/ohrp/humansubjects/commonrule/:

" The current U.S. system of protection for human research subjects is heavily influenced by the Belmont Report, written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report outlines the basic ethical principles in research involving human subjects. In 1981, with this report as foundational background, HHS and the Food and Drug Administration revised, and made as compatible as possible under their respective statutory authorities, their existing human subjects regulations.

The Federal Policy for the Protection of Human Subjects or the Common Rule was published in 1991 .... The HHS regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the Common Rule; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children. Each agency includes in its chapter of the Code of Federal Regulations [CFR] section numbers and language that are identical to those of the HHS codification at 45 CFR part 46, subpart A. For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance. Human subject research conducted or supported by each federal department/agency is governed by the regulations of that department/agency. The head of that department/agency retains final judgment as to whether a particular activity it conducts or supports is covered by the Common Rule. If an institution seeks guidance on implementation of the Common Rule and other applicable federal regulations, the institution should contact the department/agency conducting or supporting the research."

You will find the regulations at 45 CFR 46 It might seem at first glance that these rules only apply to work specifically funded by the 15 Federal agencies involved, but almost every school and research institution makes some use of federal funding in its operations, and the Federal regulations are supported by state-by-state human subjects protections. It would be extremely unwise to do any biostatistics research to does not conform to the common rule.

Human Subjects Protection at RIT

All faculty, staff and students at RIT are supported in dealing with issues of human subjects protection by the Human Subjects Research Office. That office and the chair of the RIT IRB can provide guidance in understanding the regulations and in getting approval to go forward with research that is covered or being sure that research you think may not need approval in fact does not need approval.