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Video poses confidentiality and consent challenges
Videotaping subjects may require extra safeguards
Videography can be a useful data collection tool in research, giving researchers access to information — records of events, subtle non-verbal cues — that can't be elicited any other way.
But the introduction of a video camera into a research setting raises unique issues for IRBs. How do you protect privacy and confidentiality when there is an identifiable face or voice on tape? At a time when a potentially sensitive image can be uploaded to YouTube in seconds, how can researchers securely store digital images?
Researchers at the University of Pittsburgh's School of Nursing explored the ethical issues raised by the use of videography in a study of communication between non-speaking ICU patients and their nurses.
In the study, which involved patients who were intubated, videotapes of the interactions between clinician and patient were seen as a vital tool to collect data about alternative means of communication, says Mary Beth Happ, PhD, RN, associate professor of acute and tertiary care in the University of Pittsburgh's School of Nursing as well as assistant professor in the university's Center for Bioethics and Health Law.
But the team recognized the potential concerns about patient privacy and the security of the digitalized videos. They outlined extra steps taken to protect their subjects — both patients and nurses — in an article published recently in the journal Nursing Research.1
"We had presented some preliminary results from this work at different conferences and there was a lot of interest generated in using videotape," says Lauren M. Broyles, BSN, BA, RN, a doctoral student and pre-doctoral fellow at the School of Nursing. "People really were hungry for a lot of the how-to information from a technical aspect — selecting camera equipment, processing and coding the videos.
"But we also got several comments such as 'Wow, did you have any trouble with the IRB on that?'"
In fact, she and Happ say their IRB didn't raise serious objection to the videotaping, although they did ask detailed questions about video storage and what would happen to videotapes if subjects withdrew from the study.
"I think part of the reason why we didn't have a problem is because we took it very seriously and did a lot of up-front work, looking at what needed to be considered in the consenting process and on the consent form," Happ says. She notes that the team searched the literature for guidance on human subjects considerations in videotaping but was unable to find much.
Capacity to consent
The Study of Patient-Nurse Effectiveness with Assisted Communications Strategies involved the use of a small hand-held digital video camera in an ICU setting.
"I think it does help that the technology of video cameras has improved so much," Happ says. "We're not setting up the tripod, a big microphone, or lots of lights. It has a little microphone extension that's about the size and shape of a cigar and that's it."
Nurses involved in the project were consented beforehand, but patients were approached after they had been admitted and were in a bed.
An important step in the process was to assess whether the patient had the decisional capacity to consent to participate. If a patient was found incapable of consenting, family members were asked, but the patient still had to understand what was involved, including the videotaping, and to give assent.
Even if the patient was found capable of consenting to participate, family members usually were included in the discussions, says Judith A. Tate, MSN, RN, project director at the School of Nursing.
"Because I can imagine a family member just perchance coming upon us videotaping their sick family member who had consented," she says. "I just didn't want any surprises, or any kind of tension."
If consent was obtained through the family and the patient became decisionally capable again, he or she was asked to provide consent personally.
In explaining the study to potential participants, Tate says she would describe for the patient the entire process, including security and data storage safeguards.
"We had built into the consent that we won't be filming anything that would put them in an untoward position, for instance, videotaping hygiene or emergency situations," she says.
Patients could ask the team to stop filming at any time if they became uncomfortable.
Despite the safeguards, Tate says some patients declined to enroll in the study because of the videotaping, while others refused because the researchers would have access to their medical records.
There also were refusals by nurses, because of concerns about their work being videotaped or because they were worried that the cameras would get in the way in the ICU.
The team obtained a federal Certificate of Confidentiality for the study, primarily for the benefit of the clinicians, Broyles says. The certificate would protect the investigators — and subjects — from having records subpoenaed by the courts in the event of a lawsuit or other court proceeding.
"Usually the Certificate of Confidentiality covers sensitive material such as sexual behavior or drug use," she says. "In this case, we were concerned about clinicians having their practice videotaped in any kind of emergency situation and then having it used in some sort of legal proceeding."
Protecting tapes' security
Once the filming was done, it was transferred to a DVD, again with extra steps taken to optimize security.
"We do not hold them on a hard drive or a server for any length of time," Happ says of the tapes. "For analysis purposes, we'd take the DVD out and view it and code it and put the DVD back into secure storage. Then, all we have [with the DVD] is numbers coded and deidentified."
Participants were asked to give consent in two parts: one for the taping itself and one if the participant would allow clips from their tapings to be shown for educational purposes. A participant could agree to the first but opt out of the second.
When the team wanted to use a particular clip at conferences or in other educational settings, they first would ensure that both patient and clinician had agreed to that use.
"If both agreed, then we use either a memory stick or a DVD that is secured to take it to the presentation venue," Happ says. "We do not send our presentations ahead of time to any venue."
The researchers don't allow their presentations to be videotaped at conferences, and are careful to delete any video clips from the podium computers before they leave.
"That's probably overkill, because the participants did say we could use them," Happ says. "But when we started this in 2001, there wasn't easy access to video through YouTube, and sites like that. We just feel like we need to be extra careful."
Broyles says that IRBs considering a protocol that involves videography should consider several potential concerns:
• Informed consent issues: The potential for patients to be identifiable through a videotape adds an extra layer of concern when assessing a patient's decisional capacity, Broyles says.
"You have people who have altered mental status because of their illness or because of their medications, so I think it's pretty paramount to do an assessment," she says. "You have the ability for proxy consent, but then it's important to return to the person once they become more alert and ensure that they still want to continue."
It also may benefit subjects to give additional consents for different potential uses of the video.
If patients withdraw from the study, it should be clear whether they will allow use of any videotaping to that point, or if they are denying such permission, which would prompt the need to destroy the recordings.
• Privacy and confidentiality: Broyles says that in some studies, it may be possible to blur faces or place black bars over subjects' eyes to protect identities. In their own study, however, that was not possible, since it would have masked the information they were trying to collect.
"It's about communication between nurses and patients, so we needed to be able to see faces," she says.
Care should be taken to protect patient modesty in clinical settings, and to protect other patients, clinicians, and family members from inadvertently being taped.
• Data storage and access: How will the videos be stored, and for how long? Will images be stored on a computer for any length of time?
• Participant burden: Will videotaping in a clinical setting cause stress or anxiety in patients or clinicians? What steps will be taken to keep equipment and personnel out of the way?
"Videotape is the best way to gather data on communication," she says. "But I think the gratuitous use of videotaping would be worrisome. I would want to make sure that the use of the videotape matches the research question and that there aren't other ways that the data can be safely and accurately obtained without the use of videotape.
"Videotaping is a new, appealing, popular medium that more people have access to and have become technically comfortable with, and you have to worry that it could be overused."
But in cases where it's an appropriate tool, Broyles says IRBs shouldn't shy away from allowing it.
"Traditional human subjects protections can easily be applied to this situation," she says. "There isn't necessarily a need for IRBs to be overly squeamish or for serious red flags to fly up, as long as some of these particular considerations are examined."