Core issue
The question tests what a principal investigator must do when an
unexpected event forces a break from an
observe-only protocol during data collection. The correct response is not to hide the event, silently continue, or quietly remove the household; it is to
report the protocol deviation to the research ethics committee and obtain new informed consent before resuming observation.
Why option 4 is correct
In a study where data collectors are instructed only to observe and record, any action that alters the participant’s condition or environment is a
protocol deviation. Taking the child to the RHU for treatment was ethically necessary, but it changed the household’s situation in ways that could affect the study data. The principal investigator must therefore:
| Step | Rationale |
|---|
| Document the event | The deviation from observe-only data collection must be recorded accurately, including what happened, why care was provided, and what treatment was given. |
| Report to the research ethics committee | Unexpected events and protocol deviations require ethics committee notification so the committee can determine whether the study can continue and how affected data should be handled. |
| Re-inform the mother | The family’s circumstances have changed. The mother must receive updated information about the study and the event. |
| Resume only with new consent | Observation may continue only if the mother freely agrees again after the new information is provided. |
Key point! The principal investigator does not unilaterally decide to drop the household or to keep the data. The ethics committee reviews the event, and the investigator follows the committee’s guidance about data handling and continuation.
Why the other options are incorrect
Option 1 — Recording the treatment as outcome data without reporting the event is a form of
data concealment. It hides the protocol deviation and prevents the ethics committee from evaluating whether the study’s integrity was compromised.
Option 2 — Resuming observation under the first consent ignores the fact that the family’s situation changed after the child received treatment. The original consent was given for an observe-only study; continuing without re-consent violates the principle of
ongoing informed consent.
Option 3 — Dropping the household without ethics committee review is a unilateral decision that may introduce
selection bias and does not follow proper research governance. The investigator cannot independently decide that the data are unusable.
Connecting to research ethics principles
The situation illustrates three core principles in human subjects research. First,
beneficence required the nurse to act when she saw a child who looked unwell; the obligation to protect the participant’s welfare overrides the study’s observe-only instruction. Second,
transparency requires reporting the deviation rather than hiding it. Third,
respect for persons requires re-informing the mother and obtaining new consent because the conditions under which she originally agreed have changed.
Watch out! In community-based studies, nurses often face situations where clinical duty and research protocol conflict. The correct response is always to provide needed care first, then follow the protocol for reporting unexpected events and obtaining re-consent. Providing care is not a reason to exclude a participant or conceal data; it is a reason to formally document and report.
Application to nursing research
For a nursing licensure examinee, this question tests understanding of
research governance in community health settings. A public health nurse conducting a study in a rural municipality must know that
ethics committee oversight continues throughout the study, not only at the approval stage. When an unexpected event occurs, the investigator’s role is to report, document, and seek guidance before making decisions about data or participant inclusion. This protects both the participants and the scientific validity of the study.