Mock IRB Meeting: Waiver of Informed Consent You are members of the Mission Valley Medical Center IRB. Yesterday you received a memo via email from Dr. Smith, the IRB Chair, asking you to attend an...

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Analyze the Informed Consent Waiver case in the attached file




Mock IRB Meeting: Waiver of Informed Consent You are members of the Mission Valley Medical Center IRB. Yesterday you received a memo via email from Dr. Smith, the IRB Chair, asking you to attend an unusual meeting of the Board today. The memo follows: Dear Colleagues, As you know, MVMC has embraced the ideals of the “learning healthcare system” in order both to serve our patients better and to advance the science of medicine. IRBs like ours are going to have to learn to address new study designs, raise appropriate questions, and look for creative solutions to apparent problems as we collect and study more data from our patients. I’ve called a special meeting for August 24 because I’ve been approached by a faculty member and his research team about a study for which they argue that informed consent should be waived. I want to consult with the Board about this proposal in advance, so that we can best advise the PI how to finalize the proposal for our review and disposition. Please read the following brief description and list of questions in order to prepare for our meeting. I would like this meeting to conclude with some proposed guidance for the PI and the research team as they finalize their protocol and prepare their IRB application. The Acute Kidney Injury Alert study Acute kidney injury (AKI) is an abrupt loss of kidney function that is surprisingly common, occurring in 5-10% of all hospitalized adult patients. It has a very high inpatient mortality rate, estimated at greater than 20%. AKI is usually signaled by an increase in serum creatinine (measured in a standard panel of blood tests) or a decrease in urine output. Careful attention to drug dosages and appropriate fluid and electrolyte balance are the principal recommended management tools. Temporary dialysis is also sometimes required. Unfortunately, AKI is missed in affected patients about 50% of the time. Importantly, however, there is little information about whether timely management is effective in lowering mortality rates. The AKI Alert Study is designed to address the following questions: (1) Will alerting attending physicians that patients have developed AKI alter their management behavior in comparison to physicians who do not receive alert notices? (That is, will physicians who get a text alert respond promptly and appropriately to AKI more often than physicians who do not get a text alert? Physicians should be monitoring serum creatinine levels and urine output in all their hospitalized patients anyway.) (2) Will altered AKI management behavior alter patients’ outcomes? (That is, does what we think should be done for AKI really do any good?) The research team has created a computer algorithm to check changes in creatinine levels for all hospitalized patients. When the serum creatinine increases sufficiently, and sufficiently rapidly, in a patient to meet the criteria of the algorithm, a text alert will automatically be sent to the patient’s attending physician: “This patient has AKI, based on serum creatinine level. Please consider diagnostic and therapeutic measures. Please note that this alert does not fire for all patients who develop AKI.” Data will be gathered about the diagnosis, treatment, and outcomes of all patients who develop AKI during the study period, regardless of whether an alert was sent about that patient. Patients, not their attending physicians, will be randomized -- to ALERT or NO ALERT. In order to prevent physicians from changing their practices on learning about the study, the study team does not plan to notify physicians who will be working during the study period about the research at all. The whole medical staff will simply be told that some quality improvement measures are being implemented, including a text alert system for some conditions that can be captured by computer algorithms, in order to supplement standard medical management. The study team argues that there is no good way to obtain informed consent from patients who develop AKI – and the time at which they develop AKI is the time at which they are enrolled in the study. The study team also argues that there is no good way to obtain patients’ prior consent to participation, for instance on admission or at some other time during the hospitalization and before any AKI has developed. That would essentially mean getting consent in advance from all hospitalized adults, even though only 5-10% are likely to become research subjects, and that 5-10% is of course not predictable in advance. Finally, the research team argues that there is no risk at all to this research, since everything that is being done for patients is standard treatment. In fact, they point out that the study itself does not entail any direct intervention on patients, and the investigators have no interaction at all with patients. The alerts do nothing that standard practice does not already prescribe. Therefore, they argue, the IRB should not even consider the harms associated with AKI in balancing the harms and benefits of the research, and they request a waiver of informed consent. My questions for our meeting I appreciate the study team’s reasoning but have concerns nonetheless. Yet I can’t quite put my finger on what troubles me about this research project. Please help me by thinking about the following: Is informed consent ethically necessary for this research? If so, why? If not, why not – and is anything less than full informed consent necessary instead? Or is complete waiver ethically acceptable? Are there ethical reasons to waive consent here? Is it really not possible to obtain informed consent from the subjects of this research? That is, are there practical reasons to waive consent here? If seeking informed consent were both necessary and possible, what should the consent form say about the study? Are there reasons that providing full information is ethically problematic in this study? If consent is not possible, what about notification and opt-out? Or even a broad notification about the study? Or are there ethical or practical reasons for not providing that information? What other questions and comments do you have? 1
Answered Same DayFeb 16, 2022

Answer To: Mock IRB Meeting: Waiver of Informed Consent You are members of the Mission Valley Medical Center...

Garima answered on Feb 17 2022
105 Votes
Mock IRB Meeting: Waiver of Informed Consent
Q1. Is informed consent ethically necessary for this research? If so, why? If not, why not – and is anything less than full informed consent necessary instead? Or is co
mplete waiver ethically acceptable? Are there ethical reasons to waive consent here?
According to Human Health and Services Policy (HHS, 2018) (45 CFR 46.116 and 45 CFR 46.117) and as allowed by Food & Drug Administration regulatory policy (21 CFR 50.23 and 21 CFR 50.24), there are certain situations under which institutional review board (IRB) can waive off certain components of informed consent form or waive off the entire consent form document (Revised HHS Policy, 2018 and Code of Federal Regulations, 2022). These include:
(a) Research studies that involve minimal risk or no more than minimal harm e.g., studies involving interviews, surveys, telephonic conversations, online interviews, blood drawing with needle etc.
(b) The informed consent waive off does not comprise on the rights and welfare of the subjects.
(c) To waive off informed consent form for practical reasons such as large number of subjects, some subjects have left the hospital, analysis on existing data available, research that involves using bio specimen or information for which subjects’ identification is necessary etc.
(d) Research studies that involve studying deception or behaviors and taking informed consent would compromise on the scientific validity of the data.
(e) Research studies on sensitive topics like sexual behaviors, violence, illegal activities etc where signing the consent form would harm the privacy of the person.
(f) To waive off informed consent for subjects of some cultures or community where signing forms is not normally accepted.
In the case study presented, the informed consent from the patients is not necessary for this research due to following reasons:
(a) This research study involves no more than minimal harm. First, all the participants will be getting standard care of treatment that their condition demands and there is no separate intervention of a new drug (outside of standard care treatment) on the...
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