Significant changes made in response to public comments
The U.S. Department of Health and Human Services and 15 other federal agencies today issued a final rule to update regulations that safeguard individuals who participate in research. Most provisions in the new rule will go into effect in 2018.
The new rule strengthens protections for people who volunteer to participate in research, while ensuring that the oversight system does not add inappropriate administrative burdens, particularly to low-risk research. It also allows more flexibility in keeping with today’s dynamic research environment.
The current regulations, which have been in place since 1991, are often referred to as the “Common Rule.” They were developed at a time when research was conducted predominantly at universities and medical institutions, and each study generally took place at a single site. Since then, research with human participants has grown in scale and become more diverse and data has become digital.
In September 2015, HHS and the other Common Rule agencies published a Notice of Proposed Rulemaking (NPRM), which drew more than 2,100 comments. In response to concerns raised during the extensive review process, the final rule contains a number of significant changes from the proposed rule, including the removal of a provision that would have required researchers to obtain consent before using a study participant’s non-identified biospecimens. The final rule maintains the current practice with respect to oversight of these specimens.
The final rule will now generally expect consent forms to include a concise explanation – at the beginning of the document – of the key information that would be most important to individuals contemplating participation in a particular study, including the purpose of the research, the risks and benefits, and appropriate alternative treatments that might be beneficial to the prospective subject.
“Over the years, many have argued that consent forms have become these incredibly lengthy and complex documents that are designed to protect institutions from lawsuits, rather than providing potential research subjects with the information they need in order to make an informed choice about whether to participate in a research study,” said Jerry Menikoff, MD, who directs the HHS Office for Human Research Protections, which led the government’s efforts to overhaul the regulations. “We are very hopeful that these changes and all the others that reduce unnecessary administrative burdens will be beneficial to both researchers and research participants.”
Important elements in the final rule issued today include:
- The requirement for consent forms to provide potential research subjects with a better understanding of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate.
- Requirements, in many cases, to use a single institutional review board (IRB) for multi-institutional research studies. The proposal from the NPRM has been modified, however, to add substantial increased flexibility in now allowing broad groups of studies (instead of just specific studies) to be removed from this requirement.
- For studies on stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement. As under the current rule, researchers will still not have to obtain consent for studies on non-identified stored data or biospecimens.
- The establishment of new exempt categories of research based on the level of risk they pose to participants. For example, to reduce unnecessary regulatory burden and allow IRBs to focus their attention on higher risk studies, there is a new exemption for secondary research involving identifiable private information if the research is regulated by and participants protected under the HIPAA rules.
- Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
- Requirement that consent forms for certain federally funded clinical trials be posted on a public website.
The final rule differs in important ways from the proposed rule. Some examples of proposals that, based on feedback from the public, are not being adopted, include:
- The final rule does not adopt the proposal to require that research involving non-identified biospecimens be subject to the Common Rule, and it does not require that consent be obtained in order to conduct such research. In general, researchers can continue to use such biospecimens in the way they are currently using them.
- To the extent that some of the NPRM proposals relied on tools or standards that had not yet been proposed, the final rule either does not adopt those proposals or includes revisions to eliminate such reliance. Examples of items that were not included in the final rule include a template to be used for broad consent forms, and a decision tool to be used for making exemption determinations.
- The final rule does not expand the policy to cover clinical trials that are not federally funded.
- The final rule does not adopt the NPRM’s proposed concept of “excluded” activities. Generally, activities proposed to be excluded are now described as not satisfying the definition of what constitutes research under the regulations or are classified as exempt.
- The final rule does not include the proposed standardized privacy safeguards for identifiable private information and identifiable biospecimens. Instead, in most respects, it retains the current approach to privacy standards.
- The final rule does not adopt the proposal for more stringent criteria for obtaining a waiver of the consent requirements for identifiable biospecimens.
Medical advances would not be possible without individuals who volunteer to participate in research. Oversight and protection of research participants is an important safeguard and essential to advancing the research enterprise. Today’s action reaffirms the federal government’s commitment to all those who participate in research studies.
To view the final rule, click here.
This article was originally posted by the US Department of Health & Human Services and can be found here.
Georgia Southern University’s online programs have again been recognized for excellence in rankings released by U.S. News & World Report for the best online programs among colleges and universities across the country for 2017.
Georgia Southern jumped from the 114th spot in 2016 into the top 100 this year, tying with six other universities for the 92nd spot for the 2017 Best Online Bachelor’s Programs. Because it considers students enrolled in these ranked programs likely to be working professionals in their 20s to 40s looking to advance or change their careers, U.S. News chose factors that weigh how these programs are being delivered and their effectiveness at awarding affordable degrees in a reasonable amount of time.
Three online University programs were ranked in the top 50 of their respected list, including the online Master of Science in Computer Science program (MSCS), online Master’s of Business Administration (MBA) program and online graduate business programs (non-MBA).
The online MBA at Georgia Southern tied with five other universities for 36th out of nearly 200 ranked programs on the list of 2017 Best Online MBA Programs.
Additionally, the University’s online graduate business programs (non-MBA) tied for 45th with St. Joseph’s University (Haub) out of more than 100 schools included in the list. The 2017 Best Online Graduate Business Programs rankings assess master’s-level business degree programs that are not MBA programs. Examples of non-MBA graduate business programs include degrees in accounting, finance, insurance, marketing and management.
Georgia Southern’s MSCS program tied with Florida Institute of Technology, Marquette University and Pace University for the 21st spot on the list of 2017 Best Online Graduate Computer Information Technology Programs.
The University’s online graduate education program tied for 77th with six other schools out of more than 200 schools nationwide.
U.S. News publishes numerical ranks for only the top three-fourths of each ranking category, and selects factors to assess each program in the categories of student engagement, admissions selectivity, peer reputation, faculty credentials and training, and student services and technology.
Georgia Southern University, a public Carnegie Doctoral/Research University founded in 1906, offers more than 125 degree programs serving 20,674 students. Through eight colleges, the University offers bachelor’s, master’s and doctoral degree programs built on more than a century of academic achievement. Georgia Southern is recognized for its student-centered and hands-on approach to education. Visit GeorgiaSouthern.edu.
This article was originally posted on January 12, 2017 and can be found here.
The James H. Oliver, Jr. Institute for Coastal Plain Science (IPCS) invites Georgia Southern University graduate students in any scientific discipline to apply for a $4,000 summer research assistantship to support his/her thesis research efforts. Two such awards will be made on a competitive basis in Summer 2017 with priority given to projects of high quality that fulfill the mission of the ICPS.
Students in scientific disciplines who are in good academic standing in the master’s program in the Jack N. Averitt College of Graduate Studies are eligible. BS or BA students who have been accepted into the Master of Science program at Georgia Southern and will clearly be in the graduate portion of their degree program during the summer of support are also eligible. The research proposed should be directly related to the applicant’s completion of degree requirements and a student may receive this form of support only once.
Applications and additional details can be found on the ICPS website here.
All applications should be emailed to firstname.lastname@example.org
Deadline to apply is February 28, 2017. Applications will not be accepted after the deadline.
The Office of Research Services & Sponsored Programs at Georgia Southern University would like to congratulate the following GSU faculty and/or staff members.
Dr. Lisa Stueve, with the Department of Leadership, Technology, & Human Development, who received research funding from the Dodge County Board of Education.
Dr. Chester Jackson, with the Department of Geology & Geography, who received research funding from the U.S. Fish and Wildlife Service.
Dr. Subhrajit Saha, with the Department of Biology, who received research funding from the Southern Company.
Dr. Matthew Horst, with the Shooting Sports Education Center, who received research funding from the National Shooting Sports Foundation, Inc.
Dr. Marina Eremeeva, with the Department of Environmental Sciences, who received research funding from the National Institute of Health.
Dr. Jaynie Gaskin, with the Department of Geology & Geography, who received research funding from the American Museum of Natural History.
Dr. Atin Adhikari, with the Department of Environmental Sciences, who received research funding from The Center for Construction Research & Training.
Dr. John Carroll, with the Department of Biology, who received research funding from Stony Brook University.
Rural areas are often viewed as lower risk for lead poisoning with toxic exposures seriously impacting development of the brain and central nervous system. This study examined the prevalence of elevated blood lead levels from children <6 years of age in rural Ben Hill County, GA.
Lead surveillance data from the Georgia Department of Public Health (DPH) were analyzed using SAS®v-9.3 to calculate the prevalence of elevated blood lead levels (≥5ug/dL) among those children in Ben Hill County who had been tested for lead; the results were compared to Georgia and national data.
Preliminary analysis of 2010-2015 screening data indicated that 8.73% (95%- CI: 7.4%-10.1%) of children tested for lead exceeded the Centers for Disease Control reference level (≥5ug/dL) and is approximately 3.5 and 2.4 times higher, respectively, when compared to the National (2.5%) and State (3.64%) percentages of children exposed to lead at or above the reference level. In addition, this analysis demonstrated low overall testing rates for children <6 years of age, impacting the estimate of population prevalence for childhood lead poisoning in Ben Hill County.
While these data are preliminary and more analysis is planned to ascertain the full breadth, source, and scope of the problem, it highlights lead poisoning risks rural communities face that are often overlooked in population-based risk analysis and research on lead exposure in children.
“A preliminary examination of elevated blood lead levels in a rural Georgia county,” was published in the Journal of the Georgia Public Health Association.
Dr. Chris Rustin, Assistant Professor of Environmental Health Sciences at the Jiann-Ping Hsu College of Public Health Georgia Southern University was the lead author.
This article was originally posted on January 3, 2017 and can be found here.