IRB: Federal changes to reduce burden for human participant researchers to take effect Jan. 21
December 12, 2018
The Scholarly Integrity and Research Compliance division of the Office of the Vice President for Research and Innovation is implementing changes to comply with new federal Institutional Review Board (IRB) regulations. A primary goal of the revised regulations is to reduce the regulatory burden on researchers, and these changes will benefit researchers at Virginia Tech. The revisions to the Common Rule for the protection of human research participants go into effect on Jan. 21, 2019.
“The revised Common Rule gives us the opportunity to update our processes at Virginia Tech in ways that will help reduce the burden on researchers and improve protections for research participants,” said Lisa M. Lee, associate vice president for research and innovation, who leads the Division of Scholarly Integrity and Research Compliance.
Some of the key regulatory changes include:
- Abbreviated reviews for studies with less risk.
- A single IRB review for multisite studies.
- Improvements in what is required in consent forms to help participants make informed decisions about joining a study.
To take advantage of the burden reducing provisions of the new Common Rule, researchers should consider submitting new protocols to the IRB after Jan. 21, 2019. For protocols that cannot wait until that date, HRPP and the IRB request that they be submitted by Jan. 3, 2019 to allow enough time to complete the review cycle prior to the regulatory change. Protocols that have not completed the review process by Jan. 21 will need to be revised to meet the new regulatory requirements. For protocols submitted between Jan. 3 and Jan. 21, WIRB will serve as the reviewing IRB. Amendments, continuing reviews, protocol deviations, and adverse events should be submitted as usual during this period.
Preparing for the Change: Education and Training
In preparation for the upcoming changes and to improve the IRB process overall, Lee’s division created a Human Research Protections Program (HRPP) to support researchers whose work involves human participants. HRPP has improved education and training to bring researcher training to industry standard by Jan. 21, 2019. Virginia Tech will now use the same training required at other universities and federal research institutions. The Collaborative Institutional Training Initiative (CITI) training is transferrable and meets requirements for collaborative or multisite studies. If a researcher has previously taken CITI human protections training either at Virginia Tech or at another institution, they can affiliate with Virginia Tech through their CITI account to transfer completed courses without retaking them.
HRPP enlisted researchers and stakeholders from across campus to review the updated Human Research Protection Training Requirements Standard Operating Procedure. Input from Rosemary Blieszner, dean of the College of Liberal Arts and Human Sciences, and Professors Kevin Carlson, Karen Roberto, Marie Paretti, and Kathy Hosig provided helpful insights from the user perspective.
“The new requirements will ensure that all of our faculty and students have consistent, up-to-date education and training in the ethics of conducting of human research, regardless of their content area of focus,” said Roberto, director of the Institute for Society, Culture, and Environment and University Distinguished Professor.
CITI training is available online and is self-paced to meet the researcher’s schedule. It provides information on both the regulatory requirements and the ethical context necessary to understand human research protections. “We expect that researchers who have completed the training will be able to write improved protocols and receive faster approval,” said Suzie Lee, IRB chair.
CITI human subjects research training will be available beginning Jan. 21, 2019. The new training will be required for all initial researcher training starting on that date.
Details on Key Regulatory Changes
Studies with less risk may have abbreviated reviews and/or no annual review
Under the new rule, some studies may receive only a brief review of certain protections instead of a full review by the IRB. In addition, some minimal-risk studies will no longer require annual review. It is important to note that even without an annual review, researchers are still required to keep the HRPP office up-to-date on any concerns or events to ensure that research subjects are protected.
Multiple sites – one IRB
Although NIH-funded multisite studies have been required to use a single IRB review since 2018, the federal-wide requirement to have a single IRB oversee studies that are conducted at multiple sites does not go into effect until January 2020. Once implemented, a single IRB will serve as the reviewing board for all sites involved in a multisite study. This will reduce multisite review delays that have occurred in the past when the different sites’ IRBs attempted to reconcile the various, sometimes contradictory, requirements.
Regulatory consent changes help participants understand the risks and benefits
One of the most substantial changes to the federal regulations addresses research participant consent. The change requires that consent forms outline up front the key information that potential participants need to make the decision about whether to join the study. This information includes potential risks and benefits of the research and the impact these might have on the participant. To help potential participants find and understand this crucial information, informed consent documents will now open with a summary, written at a level consistent with average reading levels of the study population. In addition, the consent documents will explain to potential participants whether the results of the research will be shared with them at the end of the study.
HRPP Coordinators and Departmental Human Subjects Advisors
Researchers will have the opportunity to work with HRPP Protocol Coordinators. To support the growing research environment, Virginia Tech is hiring several new HRPP Protocol Coordinators to augment the existing IRB support staff. An HRPP coordinator will be assigned to handle each study throughout the lifecycle of the protocol — from preparation for IRB submission through study closure. Coordinators will be available to answer questions, direct researchers to resources, and provide updates on where the researcher’s study is in the process.
HRPP is also enhancing the training of and strengthening its connection with Departmental Human Subjects Advisors. This corps of advisors comprises faculty and staff with expertise in their unit’s human subjects research portfolio and additional expertise in research ethics and IRB regulations. They serve as a bridge between faculty, HRPP, and the IRB and can assist fellow faculty with research ethics and IRB-related questions. In many instances, they can provide the initial determination of whether or not a protocol must undergo IRB review.
To comply with the revised regulations, HRPP is updating its standard operating procedures with a nationally vetted toolkit and accompanying training from Huron Consulting. Vice President for Research and Innovation Theresa Mayer added, “The toolkit will include additional guidance, researcher checklists, and other job aids to ensure that we put the right tools into the hands of researchers.” These additional tools walk researchers through the process and help them to understand how the regulatory changes affect their studies. These tools will be a part of the updated website coming soon.
The Virginia Tech HRPP is also continuing to integrate our internal processes with an external IRB to ensure that there are subject matter experts available to review protocols in a timely manner. Phase 3 of our Protocol Management system, which reduced the number of steps required to use our external IRB, was released on Oct. 22, 2018, and Phase 4 planning and development is underway.