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tumor in a test tube
Photo by Rhoda Baer
The US Department of Health and Human Services (HHS) and 15 other federal agencies have issued a final rule to update regulations intended to safeguard individuals who participate in research.
Most provisions in the new rule will go into effect in 2018.
The HHS says 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.
The current regulations, which have been in place since 1991, are often referred to as the “Common Rule.”
In September 2015, HHS and the other Common Rule agencies published a proposed new rule regarding research subjects—a notice of proposed rulemaking (NPRM)—which drew more than 2100 comments.
In response to concerns raised during the review process, the final rule contains a number of significant changes from the NPRM.
Research covered
The final rule does not cover clinical trials that are not federally funded.
The Common Rule has historically applied only to research conducted or supported by a Common Rule department or agency. And, although the NPRM proposed changing this policy, the final rule remains in line with the Common Rule.
Consent
The final rule requires consent forms to provide potential research subjects with a better understanding of a project’s scope so they can make a more fully informed decision about whether to participate.
Consent forms should include a concise explanation—at the beginning of the document—of the 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.
The rule also requires that consent forms for certain federally funded clinical trials be posted on a public website.
Institutional review boards
The final rule requires, in many cases, use of a single institutional review board (IRB) for multi-institutional research studies.
However, the final rule has been modified from the NPRM to add substantial increased flexibility in now allowing broad groups of studies (instead of just specific studies) to be removed from this requirement.
Privacy
The final rule does not include the standardized privacy safeguards for identifiable private information and identifiable biospecimens that were proposed in the NPRM.
In most respects, the final rule retains the current approach to privacy standards.
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 not have to obtain consent for studies on non-identified stored data or biospecimens.
Exemptions
The final rule establishes 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 are protected under the HIPAA rules.
Review
The final rule removes the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
For more details, see the final rule. 
tumor in a test tube
Photo by Rhoda Baer
The US Department of Health and Human Services (HHS) and 15 other federal agencies have issued a final rule to update regulations intended to safeguard individuals who participate in research.
Most provisions in the new rule will go into effect in 2018.
The HHS says 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.
The current regulations, which have been in place since 1991, are often referred to as the “Common Rule.”
In September 2015, HHS and the other Common Rule agencies published a proposed new rule regarding research subjects—a notice of proposed rulemaking (NPRM)—which drew more than 2100 comments.
In response to concerns raised during the review process, the final rule contains a number of significant changes from the NPRM.
Research covered
The final rule does not cover clinical trials that are not federally funded.
The Common Rule has historically applied only to research conducted or supported by a Common Rule department or agency. And, although the NPRM proposed changing this policy, the final rule remains in line with the Common Rule.
Consent
The final rule requires consent forms to provide potential research subjects with a better understanding of a project’s scope so they can make a more fully informed decision about whether to participate.
Consent forms should include a concise explanation—at the beginning of the document—of the 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.
The rule also requires that consent forms for certain federally funded clinical trials be posted on a public website.
Institutional review boards
The final rule requires, in many cases, use of a single institutional review board (IRB) for multi-institutional research studies.
However, the final rule has been modified from the NPRM to add substantial increased flexibility in now allowing broad groups of studies (instead of just specific studies) to be removed from this requirement.
Privacy
The final rule does not include the standardized privacy safeguards for identifiable private information and identifiable biospecimens that were proposed in the NPRM.
In most respects, the final rule retains the current approach to privacy standards.
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 not have to obtain consent for studies on non-identified stored data or biospecimens.
Exemptions
The final rule establishes 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 are protected under the HIPAA rules.
Review
The final rule removes the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
For more details, see the final rule.
tumor in a test tube
Photo by Rhoda Baer
The US Department of Health and Human Services (HHS) and 15 other federal agencies have issued a final rule to update regulations intended to safeguard individuals who participate in research.
Most provisions in the new rule will go into effect in 2018.
The HHS says 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.
The current regulations, which have been in place since 1991, are often referred to as the “Common Rule.”
In September 2015, HHS and the other Common Rule agencies published a proposed new rule regarding research subjects—a notice of proposed rulemaking (NPRM)—which drew more than 2100 comments.
In response to concerns raised during the review process, the final rule contains a number of significant changes from the NPRM.
Research covered
The final rule does not cover clinical trials that are not federally funded.
The Common Rule has historically applied only to research conducted or supported by a Common Rule department or agency. And, although the NPRM proposed changing this policy, the final rule remains in line with the Common Rule.
Consent
The final rule requires consent forms to provide potential research subjects with a better understanding of a project’s scope so they can make a more fully informed decision about whether to participate.
Consent forms should include a concise explanation—at the beginning of the document—of the 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.
The rule also requires that consent forms for certain federally funded clinical trials be posted on a public website.
Institutional review boards
The final rule requires, in many cases, use of a single institutional review board (IRB) for multi-institutional research studies.
However, the final rule has been modified from the NPRM to add substantial increased flexibility in now allowing broad groups of studies (instead of just specific studies) to be removed from this requirement.
Privacy
The final rule does not include the standardized privacy safeguards for identifiable private information and identifiable biospecimens that were proposed in the NPRM.
In most respects, the final rule retains the current approach to privacy standards.
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 not have to obtain consent for studies on non-identified stored data or biospecimens.
Exemptions
The final rule establishes 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 are protected under the HIPAA rules.
Review
The final rule removes the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
For more details, see the final rule.