Revised Common Rule for Human Subject Research
Changes to modernize, strengthen and streamline the federal rule for the Protection of Human Subjects go into effect January 2019. What does this mean for human-research investigators and participants?
The federal policy for the Protection of Human Subjects, commonly referred to as the Common Rule, provides ethically based regulations for the review and conduct of human research. The U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP) issued changes to modernize, strengthen and streamline the rule in January 2017. However, the rule was amended to delay the effective compliance date. Most changes go into effect January 21, 2019.
The new rule strengthens protections for people who volunteer to participate in research, while ensuring that oversight does not add inappropriate administrative burden, particularly to low-risk research. It also allows more flexibility in keeping with today's dynamic research environment. While much of the revised regulations apply to Institutional Review Board (IRB) review and management, investigators will see a few changes in policy and forms.
One key goal of the new rule is ensuring the risks and benefits of participation are clear. Informed consent forms will have text at the top of the form that provides key information about the study. This means people will no longer have to wade through lengthy consent form language to find crucial information. There are also new requirements for additional consent elements related to the use of de-identified information, the use of biospecimens, potential for commercial profit and return of clinically-relevant results.
The Revised Common Rule:
- Broadens the types of research that qualify for exemption. Several exempt categories have been revised, and there are new categories of exemptions;
- Removes the requirement for comprehensive continuing review for minimal risk research and for full-board research that is in long-term follow-up or data analysis only, unless the research is FDA-regulated. Research Integrity will follow up with an annual status report on many minimal risk research studies for oversight;
- Shifts focus of informed consent to the potential participant applying a reasonable-person standard; it facilitates the participant’s understanding of the key reasons he or she would or would not choose to participate in research and provides key information essential to that decision;
- Requires permission from the participant for any future research with identifiable information or specimens; the consent form must describe potential commercial profit, whole genome sequencing and plan to return research results;
- Requires consent waivers to use identifiable data and specimens; the IRB must now discern that it would be impracticable to use data that is not identified.
Changes that an investigator may expect include:
- IRBNet Exemption forms will have minor text changes to align with revised rules;
- IRB correspondence text will describe any changes specific to the revised rules;
- Expedited research under pre-2018 rule may now be determined to meet exemption category; no amendments or status reports will be required by the IRB.
Additional changes pertain to informed consent:
- Informed Consent form (1-4 pages in length) will summarize key information at the top of the first page;
- Informed Consent form (4 pages or more in length) will contain three sections: 1) key information page (concise summary), 2) detailed consent (main body of information specific to elements in OHRP regulations/guidance), and 3) appendices (may be used to present tables, charts, illustrations, etc.);
- Informed Consent form will contain certain specific statements if using identifiable private information or biospecimens;
- Consent forms for Clinical Trial studies funded by a federal agency will be publicly posted on the appropriate federal website; the posting must occur no more than 60 days after the last study visit by any participant.
The Research Integrity team is updating our website with additional guidance documents. A number of IRB policies, procedures and forms also will be updated as a result of the changes to the rule. Please note that only studies approved or altered after January 21, 2019, will be governed by the new rule. In most cases, ongoing research will remain under the pre-2018 regulations (those issued in 1991), and the IRB will maintain two sets of Standard Operating Procedures. Investigators are not required to make any changes to ongoing research unless requested by the IRB after review of an amendment or continuing review. If you have specific questions regarding your research study, contact me.
Research Integrity, part of the Research & Innovation division, is passionate about joining with investigators to protect the rights and welfare of human research participants while also contributing to the quality of research being conducted. We offer faculty and students the resources necessary to conduct ethical and compliant research projects, provide tools to help avoid plagiarism and academic misconduct, and we help research participants become better informed about their rights as a research subject. To learn more about our services and resources, visit .
