Starting in 2011, the Department of Health and Human Services (HHS) began a process to revise the Common Rule, which has not been changed since 1991. Last year, HHS issued a Notice of Proposed Rulemaking (NPRM) which spells out the changes being proposed. This article will briefly review some of the changes directly relevant to sociology and also announces a Policy and Research Workshop to be held on the subject at the ASA Annual Meeting in Seattle (“What You Need to Know About the New Common Rule”).
The rules are only proposed at this time, and many organizations, including the ASA through COSSA, have commented on them (see www.cossa.org/2016/01/12/cossa-and-members-comment-on-proposed-revisions-to-the-common-rule/). The final rules will likely differ from the proposed rules. If the final rules are released before the annual meeting, we will provide updates at the Seattle workshop.
The goals HHS gave for changing the Common Rule are related to changes in the research process that have taken place since the Common Rule was established. In particular, they are 1) to better protect human subjects involved in research, and 2) to simplify the current oversight system and reduce inappropriate administrative burdens. In the process, this should also reduce the burden, delay, and ambiguity for investigators, and facilitate valuable research.
What Kinds of Changes?
Most of the proposed changes will affect biomedical researchers much more than social and behavioral researchers. Three areas in the NPRM that will have the most impact on sociologists relate to: 1) changes to the format and layout of informed consent documents; 2) many social/behavioral studies now considered expedited will be exempt; and 3) many exempt studies will be excluded from review. A minor change that will affect sociologists minimally is that expedited studies will no longer require continuing review.
The proposed changes to the informed consent documents include requiring a list of the most important information at the top of the document. That is, information essential for the participants to determine if they want to participate will be listed first. For sociologists, these include any reasonably foreseeable risks or benefits to the participants or others, contacts for questions about the research, and a statement that participation is voluntary. The NPRM will also allow researchers to more easily get waivers for signed consent if the practice follows community norms, and also to use alternate methods for documenting consent for minimal risk studies.
In the NPRM, many social and behavioral studies currently classified as “Expedited” will be considered as exempt from the regulations. In particular, the expedited categories which cover most sociological research will be exempt. This change will allow researchers to collect sensitive, private information, plus the secondary use of identified data to be considered as exempt category so long as strong privacy protections are used. While exempt studies will not be reviewed by the IRB, researchers will be required to use a decision tool to be developed by HHS to determine if the research is exempt. The decision tool has not yet been described.
Perhaps the most significant proposed change is to exclude many social and behavioral studies from any review. The research currently considered as exempt (i.e., surveys, interviews, educational tests, observations) would be excluded. More information on how researchers will determine if their research is excluded will be released later.
Some Implications of the Changes
The obvious immediate implication of the proposed changes will be a period of time (probably an extended one) when there will be confusion at the local IRB level regarding the decisions about how specific research projects will be handled. In order to avoid delays, sociologists embarking upon research projects during this period would be well advised to be conversant with the proposed changes.
In addition, the ASA Code of Ethics, which is currently in the process of revision, will reflect any changes in the Common Rule (see www.asanet.org/about/ethics.cfm). This will likely affect those standards dealing research, informed consent, and confidentiality. Since the membership of the ASA must approve any changes to the Code of Ethics, all recommended changes will be publicized and open for comment. At our workshop in Seattle we will further elaborate the changes in the Common Rule and their implications for the revisions to the Code.