Research conducted in international settings poses particular challenges for the reviewing IRB, as it must possess adequate knowledge of laws and regulations in the country where the research is taking place, and be sensitive to the area’s cultural norms, in order to appropriately evaluate the study. Social, behavioral, and educational research (SBER) in particular may involve the study of stigmatized health conditions or behaviors, and may require the recruitment of marginalized populations and minors. Conducting research on these topics is important, but it is equally essential that IRBs and researchers mitigate the risk of social consequences that might result from subjects’ participation in the study, such as rejection in their communities or conflict within their families. The regulations regarding human subjects protections vary greatly between countries as well, which can lead to additional difficulties for IRBs.
On February 20, PRIM&R hosted the webinar SBER Across Borders: IRB Considerations and Cases for International Studies to provide expert guidance and instructive case studies for the oversight of SBER conducted abroad. The speaker panel was made up of John R. Baumann, PhD, associate vice president for research compliance at Indiana University, and Kelly O’Keefe, MPH, research ethics board manager for Population Services International (PSI), an international public health organization.
After the webinar, Dr. Baumann and Ms. O’Keefe responded to some of the attendee questions time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand.
One of the points in the presentation was to ensure IRB staff are knowledgeable about international laws, etc., specific to various countries. We propose that while this is important, there is equal need for study teams/researchers to be just as informed and knowledgeable about such issues.
John R. Baumann (JB): But one of the IRB’s responsibilities is to ensure that the research team is knowledgeable–so yes, I agree.
Kelly O’Keefe (KO): While the webinar did focus on the knowledge of the IRB staff, I completely agree that there is a need for the principal investigators (PIs)/researchers to be informed and knowledgeable about country-specific laws and regulations for human subjects research and risks related to participation (e.g., if study asks questions about illegal behavior, what would be the legal ramifications were there a breach of confidentiality?).
This knowledge is particularly important for PIs to fulfill the regulatory requirement of documenting local context. In addition, knowledge of the regulatory environment should inform the study design at nearly every stage to not only comply with local regulations but also to mitigate risks for subjects. For example: Researchers are interested in recruiting middle school students residing in school dormitories. Recruitment methods and consent procedures are directly impacted by local laws and regulations.
Our IRB does its part to gather information on country-specific human subject regulations, builds relationships with local boards where we have long-standing research, and reaches out to experts in our specific areas of research. Our IRB also communicates to PIs that they are expected to know their country-specific human subjects regulations and laws that relate to risks/participation to inform their study design and IRB submission.
Often, the pre-review process becomes a collaboration between our IRB and the PI to share knowledge, ask questions, and seek out more knowledge as needed.
The IRB is responsible for protecting research subjects. Does your HRPP do anything to protect researchers engaged in international research? Our institution wants to charge us with that as well.
JB: Our IRB does not do anything to ‘protect’ researchers–that is the mission of other offices within our university and not the mission of the IRB, which is focused on protections for subjects. Our IRB does, however, work with other offices that do have responsibility for protection of faculty and students. For instance, we notify one of our international offices whenever we get a submission that involves a student conducting human subjects research overseas. That office, and not the IRB, then follows up regarding student researcher protections.
How have you audited or monitored research conducted by your researchers in other nations?
JB: We have audited research being conducted internationally, but not on site. We have performed desk audits from the US and have made arrangements for a site to be monitored/audited by a local entity.
How do you identify a local board?
JB: Two primary resources for identifying local boards include OHRP (their database of IRBs/Research Ethics Committees [RECs] registered from other nations) and researchers (they often have contacts in the other nations).
A best practice is to ensure the PI has appropriate expertise to conduct research in a specific country. How can an IRB know if a PI has the appropriate expertise?
JB: IRBs should look to see that the PI has previous experience conducting research in that country, and the PI should demonstrate that they have local colleagues/contacts in that country.
How deep does your IRB get in terms of understanding another country’s human subjects research regulations?
JB: Our IRB goes as deep as possible and as deep as necessary based on the level of risk of the proposed research. We search for the other country’s regulations, identify key elements that might have a regulatory impact, contact institutions with IRB/RECs in that nation, and contact IRB/REC members who we may know or can find.
KO: Our regulatory environment in the US is complex, and many of us working in this field can still learn a new thing or two on a daily basis!
What if there is conflict with the local board? Have you ever had a situation where your IRB disagrees ethically with a board operating in another country?
JB: Yes, we have had disagreements. We generally go with the most restrictive, most protective course of action.
KO: The fundamental principles for many human subject regulations stem from the same sources such as the World Medical Association’s Declaration of Helsinki, UN Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Health-related Research Involving Humans, or the Nuremberg Code. This means that most country-specific regulations share far more similarities than differences. My organization’s research portfolio is exclusively international social behavioral research with a focus on public health. In my eight years working in this role, we’ve only had one situation that led to an impasse with a board operating in a different country. Typically, we are able to resolve issues fairly easily with communication and doing our best to keep our objective in mind: to protect the rights and welfare of subjects, as opposed to “the need to be right”.
The consent process is where we encounter differences most often. Our board is willing to consider a waiver of documentation of consent more often than many boards reviewing in-country. This is typically resolved easily by agreeing to a signed consent. Another area where we often encounter differences is the requirements around parental consent. We’ve had a few instances where the in-country reviewing boards would allow any adult to consent for the minor. The in-country board didn’t have the same requirement that the adult consenting should be a parent or a legal guardian. In some communities with many parents joining the migrant workforce and the legal status of guardians unknown, our own regulations presented challenges. In these instances, we worked within our regulations to find solutions and opened up communication with the reviewing board.
One time and one time only we disagreed with a reviewing board to the point of impasse. The consent to subjects stated that no identifying information would be collected during the study. Then, the reviewing board required boilerplate language to be added to the bottom of the consent document stating that since this research activity was happening at the hospital, researchers were granted full rights to the subjects’ medical records for seven years. The reviewing board told us not to worry about the discrepancy because no one would read it anyway. We communicated our concerns to our PI, the in-country co-PI, and the reviewing board. There were internal politics at play for the reviewing board that were much larger and much more complicated than our small research study, but we really felt we couldn’t approve the study with the boilerplate language in the consents. In the end, after several months, the boilerplate language disappeared, the study was approved, and we all breathed a sigh of relief!
PRIM&R thanks Dr. Baumann and Ms. O’Keefe for sharing their expertise.
The recording of this webinar is available for individuals to purchase in PRIM&R’s online store. If you would like to purchase the webinar for group viewing, please download the order form (PDF) and send it to email@example.com.