Reasons for Resubmission of Research Projects to the Research Ethics Committee of a University Hospital in SÃO Paulo, Brazil

Abstract

INTRODUCTIONIt is important to know the reasons for resubmitting research projects to the Research Ethics Committee in order to help researchers to prepare their research projects, informed consent forms and needed research documentation.OBJECTIVESTo verify the reasons for resubmitting projects that were previously rejected by the Ethics Committee.METHODThis is a cross-sectional study that evaluated research projects involving human beings. Research projects were submitted in 2007 to the Research Ethics Committee of the Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo.RESULTSOne thousand two hundred and fifty six research projects were submitted to the ethics committee and the average time for evaluating the research projects and related documents until a final decision was reached was 49.95 days. From the total, 399 projects were reviewed in 2 or more meetings until a final decision was reached. Of these, 392 research projects were included in the study; 35 projects were subsequently excluded for involving animals. Among the research projects included, 42.5% concerned research with new drugs, vaccines and diagnostic tests, 48.5% consisted of undergraduate students’ research projects, 68.9% of the research had no sponsorship, and 97.5% were eventually approved. The main reasons for returning the projects to the researchers were the use of inadequate language and/or difficulty of understanding the informed consent form (32.2%), lack of information about the protocol at the informed consent form (25.8%), as well as doubts regarding methodological and statistical issues of the protocol (77.1%). Other reasons for returning the research projects involved lack of, inaccuracy on or incomplete documentation, need of clarification or approval for participation of external entities on the research, lack of information on financial support.CONCLUSIONAmong the research projects that were returned to the researchers for additional clarification, the main reasons were inadequacies or doubts about the terms used in the informed consent form as well as lack of information regarding the research at the informed consent form and methodological and statistical issues regarding the protocol.

Ethical issues in research involving minority populations: the process and outcomes of protocol review by the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, Thailand

“…However, it was found in this study that the rate of requests for protocol revision after initial review was the same for studies involving minority groups, regardless of extra-vulnerability, at about 90%. The reasons for which proposals were not granted simple approval, and the matters for which clarification and amendment were requested, were similar to other studies [ 11 - 15 , 17 ], and were mostly related to the informed-consent document and process, and the unclear study design. The rate of deferment/non-approval among studies with and without minority populations at FTM-EC (5-7%) appears not different from ethics committees elsewhere.…”

“…The main objective of this study was to review and analyze the FTM-EC research proposal review process and outcomes, with particular attention to minority populations. Other studies exploring the ethical review process suggested that study investigators were typically requested to clarify the proposal’s informed consent process; other issues included failure to comply with good clinical practice, lack of adequate information, and discrepancies in the information provided [ 11 , 12 ]. This study also examined the main issues for which clarification/revision were requested, particularly from initial and continuing reviews of studies involving minority groups, and deferred or non-approved studies.…”

Overall Assessment of Human Research and Ethics Committees in the United Arab Emirates

“…It is difficult to objectively assess the time taken for review by the HRECs. Our data show that decisions about clinical studies were made on an average within 8 weeks depending on the complexity of the studies, very much similar to others (Bueno et al, 2009). Data indicate that training to review clinical research proposals for ethics was not provided for most of the HREC members in the UAE (Figure 1).…”

The effect of study type on research ethics committees’ queries in medical studies

“…One of the main tasks of the REC is to ensure the safety and well-being of study participants (WMA, 2013). However, previous work suggests that only 8-20 percent of REC queries directly address risks and benefits associated with participation (Boyce et al, 2002;Bueno et al, 2009;Martín-Arribas et al, 2012;van Lent et al, 2014). There also seems to be variability between RECs in risk-benefit evaluation.…”