One IRB’s lessons in biorepository development
Consent timing studied
Biorepositories of tissue and blood samples are valuable resources for disease research. When developing the framework for a biorepository, IRBs and researchers must find the right balance of policies and procedures to fit the needs of the institution, ensure patient confidentiality, and fulfill regulatory requirements.
"Every biobank and every IRB have the same questions; it’s consistent across the board," says Yasmin Isler, PhD, Biorepository Research Specialist at ProMedica in Toledo, OH. ProMedica, a health system headquartered in Ohio that includes 12 hospitals, operates the Academic Health Center BioRepository (AHCBR), which began collecting samples in June 2012. Patients diagnosed with pre-cancer or cancer can choose to donate excess tissue samples from surgical procedures to the biorepository for use in biomarker research.
The idea of a biorepository was first floated in 2009, and development of the biorepository began in 2011. "They brought me in in January 2012 to get things moving forward with documents and procedures and get everything situated with the IRB," Isler says. "Once we got things rolling and got IRB approval, we collected our first specimen in June 2012." The focus is on samples from patients diagnosed with breast, colon, gynecological, kidney, prostate, liver, skin, lung, or pancreatic cancer or pre-cancer.
When developing the biorepository, the ProMedica IRB found that some of the biggest challenges surrounded informed consent. "You don’t want to do anything harmful or disrespectful to others," says Lee Booze-Battle, MPA, CIP, director of the ProMedica IRB and IBC. "We want to deal with an honest broker — how will the bank be set up? Will they release the samples with or without identification? What identifications can be used per federal regulations while still maintaining the confidentiality of subjects? Since there has been an influx of biobanks over the last 10 or 12 years, you can reach out and communicate with those who are already doing this work."
The willingness of other institutions to share information and best practices helped shape the policies of this biorepository, Isler says. "Other biorepositories are very helpful and want to help everyone else. We conferred with a lot of other ones to see what they did and whether it would work in our institution," she says.
The AHCBR is based at ProMedica Toledo Hospital and works directly with the pathology department for collecting samples. Pathology lets the biorepository team know when there is excess tissue available for banking. Samples are stored on site, de-identified, and largely consist of "highly sought" breast and gynecological tissue, Isler says.
"Everyone has to tailor their processes to their institution," Isler says. "We were seeing what others were doing and we would pick the best parts and piece together what would work for us."
Deciding what would work for the institution also included getting input from the health system’s surgeons. "Any of the samples that we collect, we have to work with every surgeon to see what would best suit them and work with how they work," Isler says. "There’s no real cut-and-dry method — we tailor it to their liking."
Informed consent study
One of ProMedica’s challenges in developing the biorepository was determining how and when to give patients informed consent. Some biobanks consent patients after their procedures, while others consent patients before. "Informed consent has been and always will be an ethical dilemma," Booze-Battle says. "The IRB office, the biorepository, and other areas want to learn from the unfortunate mishaps others encountered while doing what we wanted to do. We wanted to learn as much as we could while still protecting subjects. The way we found to do that was to just ask people."
The IRB conducted a pilot study in 2013 to determine whether patients would prefer pre-procedure or post-procedure consent. Fifty patients were enrolled and given a survey to determine consent preference. Questions included how well informed they felt on the subject of consent, if they had sufficient time to decide whether to participate, which approach — pre-op or post-op — was right for them, if they had participated in a biobank before, and whether they would feel inclined to participate again in the future. The consent process began for the patients in the weeks leading up to their procedure, during pre-operative testing. In all, 92% reported feeling very informed by the consent process, 6% felt somewhat informed, and 2% did not feel informed. Ninety-six percent said they preferred to be consented pre-procedure. All 50 participants felt they had sufficient time to consider the consent form, and all decided to participate in the biorepository.
Patients preferred the pre-procedure consent so they could have more time to think about it, Isler says. "Any time during a procedure is stressful," she says. "They preferred having time to sit in a room with you while they’re not in a hospital gown. It’s a more comfortable setting to ask questions. Those are some of the reasons they gave for it being the best time; [pre-procedure] is probably one of the least stressful times for them."
Lynnea Lau, MPH, CIP, ProMedica IRB coordinator, adds, "If the responses would have been in favor of being consented after the procedure, we would have considered revising our protocol to allow for consent both pre- and post-procedure."
To date, 267 people have been consented for the biorepository and there is a 92.6% success rate, Isler says. Consent takes place at the patient’s advance admissions appointment a week or two before the procedure, when blood work is done and the nurses explain the patient’s procedure. The consent process takes about 10 to 15 minutes of discussion, Isler says. "So far, there haven’t been any issues with the informed consent procedure. Before we collected our first specimen, we made sure the process we decided to go with would be the best one for us," she says. "We’ve tweaked it and made changes here and there, but haven’t had any hiccups. We’re continuously revising it to stay on top of things and make sure we adhere to all the standards and regulations."
The consent study and pre-procedure consent process also has support from surgeons at the center. "With such challenging ethical issues, our study attempted to evaluate the effectiveness of our consent process," says Fedor Lurie, MD, PhD, associate director of research, education, and vascular laboratory, at Jobst Vascular Institute of ProMedica. "The only person who can tell you whether the consent is appropriate is the research subject. We usually don’t ask them for their feedback. There are two important questions: Is sufficient information provided to the study participant, and — important to me — is sufficient time given to the subject in order to truly understand all the aspects of the consent? Our study demonstrated that most patients felt they had sufficient information and time to consider what they were asked to do. It is very important in the surgical settings. It often looks like you have enough time to consent before surgery, but the psychological pressure is so high that patients might not be capable to digest the issue. Our study showed that this did not happen. The consent process we have in place is quite effective."
