Monitoring clinical research has been recommended by several organizations that funds clinical research to the Research Ethics Committee. Through monitoring clinical research the Research Ethics Board is able to ensure that approved standard in theory are applied.
It has been suggested that reviews should be done on a yearly regular basis. Reviews should require series of research aspects like consent process, adherence to approved protocols, and data integrity.
The sole purpose of monitoring is to educate research staff, quality assurance, and to avoid research misconduct. The government of Canada is one of the pioneers of this monitoring program. In response to the issues mentioned above, the government research funding bodies issued the Tri Council Statement: Ethical Conduct for Research Involving Humans in 1998.
The policy suggests that annual status reports must be submitted to the Board. Also, the review of research projects exceeding the threshold of minimal risk should include: formal review of the informed consent process, establishment of a committee to monitor safety, periodic review of a third party of the documents generated by the study, review of reports of adverse events, review of patients’ charts, and a random audit of the informed consent process.
In this study St. Mary’s Hospital Centre was subjected to monitoring. Review of research activity in the hospital is coordinated by the Research Review Office in the Department of Clinical Epidemiology and Community Studies. The research framework or policies of McGill University in 1994 was the basis for creating hospital research policies.
The monitoring policies and activities in the year 1997 are described in this study. Before a new research protocol is approved, investigators are required to describe the characteristics of patients who would be qualified for the protocol. An informal check is also done to determine overlap with patient populations of protocols under way. The Research Ethics Committee specifies the duration of approval which is usually 1 year after the initial approval.
The committee will also set other conditions and decides the most suitable type of monitoring by taking into account such factors like the type of protocol and the experience of investigator. By investigator we mean the staff member of St. Mary’s Hospital Centre who is designated by the Research Ethics Committee to be the primary contact person responsible for the protocol. This investigator may be the principal investigator, co-investigator, or local collaborator. Decisions are communicated with the investigator by the monitoring assistant to explain the details of the procedure.
Consent form audits are asked routinely for protocols involving written consent. Any consent form must be filed in the patient’s medical record with a brief summary of research interventions and outline of any potential risk including the name and phone number of one investigator. To ensure that documentations are being filed as required, the medical charts of the sample are checked periodically.
For research protocols that do not require hospital patients, but for which the Research Ethics Committee has undertaken responsibility, consent forms are reviewed in the investigator’s office. The monitoring assistant validates that the consent form is approved by the Research Ethics Committee and that the signatures and dates for every form is completed and consistent. Then the monitor assistant informs both the committee and the investigators about the results.
Interviews with research subject may be asked for protocols with minimal risk. The protocol is reviewed to determine an appropriate time to contact the subjects and the type of question to be asked. A meeting is arranged with the investigator to organize a method of contacting the subject. Subjects that are eligible are selected sequentially from the subject log provided by the investigator. The monitoring assistant contacts the subject and request verbal consent to conduct the interview. The Research Ethics Committee requests from each investigator an appropriate plan to assure and evaluate the quality of protocol data over the duration of data collection.
In a survey to evaluate monitoring, an anonymous evaluation was sent to 34 investigators in February 2000. A Likert-type response scale was given which includes 6 statement and comments on aspect of hospital monitoring.
From this survey results show that there were several instances in the monitoring of recruitment log in which the same individual have participated in more than one protocols. However the Research Ethics Committee concluded that this did not pose an undue burden on the patient or the caregiver. It was also revealed that the Research Ethics Committee help to negotiate an agreement with the investigators to achieve their enrollment targets, while preventing the same patients for being approached for more than one protocol. This is with respect to the situation here two protocols were approved for two protocols.
Results from the consent forms audit reveal that required forms were missing or incomplete for a substantial proportion of 123 hospital charts. A discrepancy between the age and age criteria of the protocol has been found out also to be legitimate due to a change in protocol approved by the funding organization. In this case the investigator did not coordinate this to the Research Ethics Committee.
In this study the subjects such as the hospital patients, the investigators are said to be the independent variable for the results obtained from the protocols would be based on the perceptions given by the hospital patients, and the investigators. The dependent variable would be the problems with regard to clinical monitoring. Factors that were considered to be answered by the hospital patients are said to be the dependent variable. As an assessment statistical parameters for this study were not defined.
Sampling of the study is said to be done sequentially and it was based on the recruitment log of the investigator. Interviews of subjects were also done. This method tends to open its doors for the investigator to manipulate his or her data. Moreover the study did not define how many samples should be taken and it did not consider the eligibility of its samples. The stud did not give a clear idea of what kind of protocols were given to the subjects and what are those factors to consider in evaluating monitoring. The problem that this study tries to address in not even clearly defined. However this paper were able to present the anomalies that happen among the subjects and the investigators during data gathering.
McCusker, J., Kruszewki, Z., Lacey, B., Schiff B. “Monitoring Clinical Research: Report of One’s Hospital Experience.” Canadian Medical Association Journal: (1 May 2001). Vol.164 n. 9 pag. 1321.
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