Starting a tissue bank requires hard work
Starting a tissue bank requires hard work
Expert offers guidance
When clinical research professionals decide to start a tissue bank, one of the most important details they should consider is how to provide informed consent to patients.
This process might begin while the patient is still adjusting emotionally to the new cancer diagnosis, and it should be specific enough to meet all HIPAA regulations, but general enough to enable the tissue to be useful to researchers.
One way to satisfy these needs is to put a statement in the informed consent that says the tissue will be held for an indefinite period of time and that any researcher who wants access to the tissue would have to have an IRB-approved study, says Betty Johnson, RN, CCRP, a nurse administrator of clinical trials for the University of South Carolina School of Medicine, pediatric department. Johnson was involved in starting a cancer tissue bank six years ago.
"We would introduce ourselves to patients and say we were research nurses and part of the clinical trial department and that we were sorry they were there to have surgery," Johnson says. "Then we'd say we were sorry to have to approach them at this point because we knew they had a lot on their plate, but due to the pending surgery we needed to talk with them."
The research nurses would bring the family into the discussion and explain what a tissue bank is and what the history of their cancer was in the state of South Carolina, she adds.
"We explained that in our state there is a high rate of African-American women who have breast cancer that present with smaller tumors at advanced stages, and we were trying to find a way to help determine why they had cancer earlier and faster," Johnson says. "We were trying to find ways to stop and cure cancer, and there were many research projects going on in our institution, and so we were in the process of establishing this tissue bank so researchers would have tissue available for the various research projects."
Nurses also would explain that if, at any point in time, the patient did not want her tissue used, then all she had to do is notify Johnson in writing that she wanted the remaining tissue pulled from the bank, and it would be destroyed.
"At the beginning, I was one of the main ones who provided the informed consent, and we had a very high success rate, especially with breast cancer patients," Johnson says. "A lot of it has to do with how it is presented."
Johnson offers these suggestions for starting a tissue bank and obtaining informed consent for possible research projects involving the stored tissue:
• Obtain IRB approval and buy-in from key people.
Research staff met with the pathologist to obtain buy-in, and they met with the oncologist and surgeons, explaining to medical professionals involved in the process that the tissue bank's informed consent process had received IRB approval, Johnson says.
"They wanted to make sure the patient was giving consent, and they wanted to know what the time and expense would be for them," Johnson says. "There wasn't any funding for their time in taking the leftover tissue and putting it in tubes."
Johnson would meet with physicians at the weekly hospital tumor board meetings, reminding them of the tissue bank and the need for surgeons to speak to patients about it at the time of scheduling a mastectomy or other surgery, Johnson says.
"If I'd presented this idea cold turkey, it would have been a lot harder to obtain buy-in," Johnson says. "Physicians were good about it, but it took a lot of teaching on our part, and meeting with surgeons, pathologists, and others in the hospital system was a big project."
The informed consent process also included the explanation that there could be additional research that the investigator would like to speak to the patient about and, if this is the case, then the clinical trials research nurse would call the patient and ask him or her if it would be okay to speak with the investigator about further participation, Johnson says.
That meant the patient's identity would be revealed to the clinical trial staff for this purpose, and the IRB looked closely at this issue, she recalls.
"We took that protocol through 10, maybe 15 changes, and the informed consent through even more than that," Johnson says. "We had a protocol for the tissue bank, including information on how to do the consenting, who would perform the informed consent, how to identify the specimens, who would have access to the database, and we had it all approved by the IRB."
• Establish an informed consent process.
"We always tell patients as part of our informed consent process that we do not take additional tissue, but only take the tissue that remains from the surgery and would otherwise be put in the trash," Johnson says. "We did start to draw blood, but we were trying to get that done as patients would go to the oncologist for a follow-up and would have other blood draws."
Or if patients were having lab tests and blood drawn on the day of surgery and there was extra blood, the research staff would obtain permission to store the additional blood, she adds.
"In order to do that you have to get the laboratory staff on board and have a contact down there asking the person if there were any tubes leftover that weren't needed that day," Johnson says.
Sometimes the nurse obtaining informed consent would find that a family member objected to the process.
"I'd say, 'That's fine, but would you please explain to me if there's something we're doing wrong so we can go back and improve the process,'" Johnson says. "Most of the time the family member objected out of fear of research, having the patient be a guinea pig."
Then Johnson would explain that the patient's tissue would be given a unique identifier number and that no one could tie that specimen to the patient except for the clinical trials department staff who had the database and key to linking the information.
"Even the surgeons or oncologist couldn't link the patient to the tissue," Johnson says.
• Dedicate a staff member to obtaining informed consent.
Nurses, particularly those who have professional and/or personal experience with the patient's disease, often are the most successful in obtaining informed consent for obtaining samples for a tissue bank.
"I've had a bilateral lumpectomy, and it's a very scary thing," Johnson says. "With some women I'd share my experience and with others I wouldn't — it depends on the woman."
The key was having one person dedicated to the role of obtaining the informed consents, Johnson notes.
When the institution had a nurse educator serve in a dual role of obtaining informed consent and discussing the breast cancer diagnosis with patients, the success rate was very limited, Johnson recalls.
Once a nurse took over with the dedicated role of providing informed consent, the rate of patients agreeing to be involved with the tissue bank rose considerably, she adds.
• Map a detailed process for obtaining, storing specimens.
When a research nurse obtains informed consent from a patient, the nurse will put a unique identifier number on six tubes and take these to a designated research person in the pathology department, Johnson explains.
The nurse also brought the pathology staff member a copy of the research authorization and the informed consent.
Oncologists would take a slice of the tissue obtained during surgery and put these in tubes that were directly delivered to the pathology area, Johnson says.
Then the pathology staff member would put tissue in the tubes with the correct identifier number from the surgical staff, flash freeze them, and have them transported once a week from the pathology department freezer to the actual tissue bank freezer, which is kept chilled at minus 70 degrees Fahrenheit freezer. Each specimen is placed on the tissue bank freezer's shelf that corresponds to the particular disease.
• Recruit tissue specimens through approved processes.
"We had IRB approval for the protocol to screen all patients scheduled for surgery," Johnson says.
"You could tell from the schedule if they were having a mastectomy, and we had access to pathologist reports in the hospital," Johnson says. "So if the patient came in for a mastectomy, then we could go in and see if they had a positive pathology report."
The tissue bank was included in a partnership between the hospital system and a medical school, and the research staff were also employed by the hospital system, she says.
"It's a worthwhile thing to start a tissue bank, but it's a lot of work," Johnson notes. "You have to have a dedicated institution that really wants this because there are a lot of departments involved, and it costs a lot of time and money."
When clinical research professionals decide to start a tissue bank, one of the most important details they should consider is how to provide informed consent to patients.Subscribe Now for Access
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