By Jeannie Padowski, Chair for the WSU Biomedical and Health Sciences IRB and Mike Kluzik, Director of the Office of Research Assurances
Research on humans serves as a vital step in learning how a new discovery will impact the way we live and think. From medical breakthroughs to learning about psychological and behavioral patterns, research allows scientists to delve deeper into how people live, think and maintain their health.
Research using human subjects requires the assurance that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. The Institutional Review Board (IRB) serves as a critical component to ensuring that research methods are ethical.
Protecting the rights of human subjects
The IRB is comprised of faculty and staff representatives from various academic disciplines and regional campuses at WSU; physicians, researchers, and non-scientific members; and community representatives who are not affiliated with the University. This multi-stakeholder group review serves an important role in the protection of the rights and welfare of human research subjects.
IRBs are most commonly used for studies in the fields of health and the social sciences, including anthropology, sociology, and psychology. Such studies may be clinical trials of new drugs or devices, studies of personal or social behavior, opinions or attitudes, or studies of how health care is delivered and might be improved.
The IRB review assures appropriate steps are taken to protect the rights and welfare of humans participating as research subjects, both in advance and by periodic review of the project. Our primary goal is to develop a fair and transparent process in which subjects voluntarily decide to take part in a study based on an intelligent and knowledgeable assessment of the risks and benefits of the research.
To accomplish this, the IRB thoroughly reviews research protocols and related materials. The group determines and certifies that the proposed project conforms to the regulations and policies set forth by the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), and Washington state regulations and University policies regarding the health, welfare, safety, rights, and privileges of human subjects. The IRB also assists investigators in conducting ethical research which complies with regulations and policies in a way that permits accomplishment of the research activity.
Under FDA regulations, individuals are considered “subjects” when they agree to participate in research, either as recipients of the test article or as controls. If the research involves a medical device, individuals are considered “subjects” when they participate in an investigation where the device is used. Under DHHS regulations, “human subject” means a living individual from whom an investigator conducting research obtains data through intervention or interaction with an individual, or there is identifiable private information about behavior that occurs in a setting that an individual can reasonably expect no observation or recording is taking place.
When the IRB office receives an IRB application, a coordinator will determine if the activity meets the definition of Human Subject Research, including if the research meets the Federal Exempt requirements. If it does not, the coordinator will inform the PI that he or she does not need IRB approval.
Supporting faculty research
The University, investigators and their research staff, and the IRB share the collective responsibility for the ethical conduct of research. Upholding the highest standards allows us to build public support for the pursuit of knowledge in a safe research environment. In preparing an application, the investigator is creating an ethical research strategy that should reflect the norms and standards of the scientific community and the society served by the research.
The IRB’s duty is to inform and assist investigators and advisors with ethical and procedural issues related to the use of human subjects in research in order to facilitate compliance with University policies and procedures, federal regulations and state law.
The Principal Investigator’s (PI) duty is to carry out all human subject protections, as required by good clinical practice, WSU policy, and state and federal regulations. When the protocol is designed and carried out by a student, his or her faculty advisor must submit the IRB application as the PI. The responsibility of ensuring human subject protections ultimately rests on the PI. The Faculty Advisor-PI has an obligation to consider carefully whether an individual (student or staff) is qualified to adequately safeguard the rights and welfare of subjects.
WSU has two IRBs: a social-behavioral IRB and a biomedical IRB. The separate biomedical IRB was established in 2018 in part to support projected research growth on WSU’s Health Sciences campus.
Changes to human subjects regulations and policies
The Federal Policy for the Protection of Human Subjects in research is known as Common Rule. The Common Rule was established in 1991 and adapted by DHHS, as well as by 18 other federal agencies. The Common Rule outlines the responsibilities and requirements for IRBs, informed consent, and Assurance of Compliance.
Major revisions have been made to the Common Rule and are referred to as Revised Common Rule. Rules before the revisions are now known as pre-2018 rules. The intent of these revisions is to strengthen protections for people who volunteer to participate in research, while ensuring that the oversight system does not add inappropriate administrative burdens and allowing more flexibilities, particularly to low-risk research. The general compliance and implementation date for the requirements was January 21, 2019.
However, the FDA and Department of Justice (DOJ) have not signed on to the Revised Common Rule yet. Until the final harmonization is complete, Human Subjects Research policies at WSU will comply with the existing FDA regulations and DOJ regulations for research conducted under these agencies. At WSU, the Revised Common Rule implementation process for actions taken before the compliance dates are “grandfathered.” This policy means that ongoing research studies, which were initially approved by WSU’s IRB or determined to be exempt before the effective date, will not be required to comply with the changes. Additionally, such research may continue to completion or closure without change.
Here are a few things to know about the Revised Common Rule.
Revised consent forms must quickly and clearly capture the research study. Informed consent is meant to help ensure that participants or their legal representatives fully understand what it means to participate. Thanks to one significant Common Rule revision, informed consent forms that are greater than 2,000 words will now have text at the top of the form that provides key information about the study. This means people will no longer have to read through lengthy consent forms to find crucial information.
Less-risky studies will have less paper work. Under the new rule, minimal-risk studies will not need a yearly check-in. That should help lighten the administrative burden for many researchers. However, researchers will still need to keep the IRB updated about any problems or other noteworthy developments, which will require researchers to be vigilant about documentation and communication to ensure research subjects are protected.
For now, the rules for biospecimens have not changed. The Revised Common Rule does not cover unidentified biospecimens, which includes blood and tissue not associated with private information that could be used to identify the donors. This proviso may change in the future. Federal officials will regularly work to determine whether emerging technologies like genome sequencing alter what it means for biospecimens to be identifiable. If at some point they decide that biospecimens are inherently identifiable, then studies that use them will have to comply with the rules as well.
WSU’s exempt application and informed consent templates were updated in order to comply with the Revised Common Rule. The non-exempt application was also updated to address questions about data security. Updated materials are now available on the IRB website. The WSU IRB staff is also hosting information sessions to individual departments and areas.
Strategically addressing the human subject research needs of WSU
The IRB serves as a critical component to the infrastructure in place for researchers to perform their work. By supporting researchers and ensuring their compliance with federal policies, we ultimately support the Drive to 25 mission of growing WSU’s research portfolio.
Human Research Protection Program (HRPP) was established in 2017 and protects the rights and welfare of human research participants, guided by ethical principles and in compliance with applicable laws. HRPP accomplishes these important goals by providing administrative support to the University’s IRBs. This support ensures that all research involving human subjects receive required approvals before research activities are initiated, creating an environment at the University for respect for and understanding of the rights and welfare of research participants; educating the University community about federal, state, and University research regulations, policies and practice pertaining to human subjects protection; and promoting activities to enhance compliance with requirements of the HRPP.
In order to decrease the time required for protocol review, we have added two full-time support staff to the recently created HRPP. These newest members of our staff are Heather Brackett, human subjects review coordinator, and Neil Paterson, program assistant.
Brackett brings regulatory, confidentiality, and compliance experience from WSU’s Financial Aid Office. Her position involves review and verification of exempt or expedited review-level projects; interfacing with investigators to answer questions related to research ethics and compliance with federal, state and university policies; and coordination of IRB full board meetings. Paterson manages and assigns incoming applications for review, and works directly with investigators to assist with application submission. He also will update and review the IRB and HRPP websites.
In addition, WSU is in the process of recruiting an HRPP Assistant Director, who will lead the program and identify broad objectives and mission statements to facilitate ethical human research and develop and administer relevant research compliance policies and procedures. This director will also monitor progress of all program metrics, and develop and implement training programs to ensure achievement of the HRPP’s mission and the university’s objectives.
Increased staffing has allowed the HRPP office to establish drop-in consultation hours to answer questions, particularly related to the Revised Common Rule, and to discuss issues with protocol development. These consultations are advisory in nature and not a formal IRB review. At WSU Pullman, the hours are from 11 a.m. to noon every Friday in Neil 416. Please contact IRB staff via email at firstname.lastname@example.org or call (509) 335-7646. On the Health Sciences campus in Spokane, contact Ayesha Ahmed for drop-in consultation time. She is available on Wednesdays from 2-3 p.m., and can be reached by email at email@example.com or by phone at (509) 368-6667. Researchers from other campuses and extension can call the IRB staff at WSU Pullman for consultation during the reserved time.
We also have created a listserv to easily communicate important updates, announcements, and training sessions from the HRPP staff to PIs and Co-PIs who are conducting human subjects research at WSU. It is easy to join. Just subscribe to the Institutional Review Board (IRB) listserv.
Finally, the HRPP is excited to announce that we are developing a web-based IRB application system with support from the Office of Research Information Technology group. We anticipate that the system will go live by fall 2019.