Complaints or just seeking answers?
Consider caller's emotions
Human research protection programs (HRPPs) often must balance the need to handle research complaints with the goal of conducting fair and reasonable investigations into any potential problem. HRPPs also must use staff time efficiently and not get bogged down in disputes that clearly are not pertinent to protecting research subjects, an expert says.
All research-related complaints at Vanderbilt University in Nashville are handled by the institution's human research protection program, regardless of their source, says Jan Zolkower, MSHL, CIP, CCRP, regulatory compliance manager at Vanderbilt University Human Research Protection Program (VUHRPP).
"Once we get these complaints we substantiate them and we conduct an investigation," Zolkower says. "We match up corrective action plans compared to the level of the situation it addresses; if it's a minimal risk, we do a lower level of investigation."
All of the institution's informed consent forms give subjects a toll-free number to call if they have any concerns about their rights as a research participant, and that number leads them to Zolkower.
Zolkower divides complaints in two categories: contacts and complaints. Contacts are calls, emails, or other communication that is not directly related to a research study's compliance, conduct, or staff. Complaints are issues that are related to the research study and staff and that need to be investigated further.
Some calls can fall into either category depending on the caller's level of emotion and whether it appears to be a legitimate gripe, even if it isn't directly research-related. Here are some examples of contacts and complaints:
• Contacts: Some of the most common calls are from research participants who have not received their compensation checks, Zolkower says.
"I had a person call me last week who had not gotten the compensation but had participated in the study two days earlier," she explains. "We tell participants it can take up to four to six weeks to get their compensation; that one was classified as a contact — not a complaint."
Zolkower also receives questions about a study from research participants. If these are specific questions about the study and research, she'll refer the caller to the study's investigator. If they involve general questions about the study, such as direct benefits or risks, she will look at the study's informed consent document and repeat the information in that.
"I count those as contacts," she says.
Another example of a contact is the call in which a research participant needs help with something that is not directly related to the research.
For example, Zolkower heard from a participant who had received her research compensation check in the mail but didn't have a bank account and could not get the check cashed.
"She needed a mechanism to cash it and wanted to know what I could do in this situation," she says. "Ultimately we worked it out with the study staff by having them provide another mechanism for providing her compensation. It could be a gift card instead of a check."
• Complaints: Contacts can be filed as complaints, depending on the level of distress of the caller, Zolkower says.
Complaints also are calls that directly relate to a study investigator or staff's behavior or to some problem that occurred during the study or as a result of the study. Studies that involve genetic testing sometimes result in calls about subjects' individual genetic results, even when the informed consent document explicitly states that individual results cannot be given to participants, Zolkower says.
"We had a gentleman who participated in a study on the prostate," she says.
"The study looked at markers for the cancer and the man went on to develop prostate cancer a couple of years later," Zolkower adds. "He called to ask us for information to see if his cancer could have been detected sooner, but the informed consent document clearly said the results couldn't be provided."
The study's data had been stripped of all identifiers and could not be tracked back to individual participants.
"Fortunately, most folks who call get our phone number from the consent form," Zolkower says. "When they call me, they will have that informed consent form in front of them, so I just ask for the investigator's name and the title of the study."
When she receives calls about personal data results, Zolkower routinely tells the caller she'll look into the issue and return the call within 24 hours. She checks the study's electronic information, including the signed consent form to make sure study staff provided all information according to what the IC form states. Then she calls the participant.
If the IC form said that no results would be given, Zolkower might explain this by saying, "When you agreed to participate, you were told the results would not be provided, and this is what we agreed to up front. So, unfortunately, I am not able to provide research-related results to you."
She might also add: "In genetic testing, the sample has been stripped of all identifiers so there is not even a mechanism for us to go back and check your sample."
Most of the time, callers will let the issue go when they hear these explanations she says.
Human research protection programs (HRPPs) often must balance the need to handle research complaints with the goal of conducting fair and reasonable investigations into any potential problem. HRPPs also must use staff time efficiently and not get bogged down in disputes that clearly are not pertinent to protecting research subjects, an expert says.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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