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Revista de investigación clínica

On-line version ISSN 2564-8896Print version ISSN 0034-8376

Rev. invest. clín. vol.72 n.4 Ciudad de México Jul./Aug. 2020  Epub Apr 04, 2021

https://doi.org/10.24875/ric.20000166 

Letter to the editor

The Role of Research Ethics Committees in Observational Studies: Epidemiological Registries, Case Reports, Interviews, and Retrospective Studies

Isaac Maldonado-Castellanos1  * 

Ignacio Mora-Magaña2 

1Postgraduate Program in Bioethics, Postgraduate Unit, Universidad Nacional Autónoma de México (UNAM), Mexico City, Mexico

2Sub-directorate of Evaluation and Educational Programming, Instituto Nacional de Pediatría, Mexico City, Mexico


Dear Editor

The article written by González-Duarte et al.1 proposes an analysis for different research projects that use qualitative methods presented to the ethics research committees. Notwithstanding, we believe that the analysis proposed for this type of projects fails in not including a growing group of qualitative techniques and methods such as ethnography, focus groups, and biographical/narrative studies.

When gathering information, these techniques also present ethical challenges. For instance, the technology employed (i.e., audio and video equipment) could modify the phenomenon under study. Therefore, the ethical controversy is whether the study can be done without informed consent so that the participants do not change their behavior and their responses.

We believe that informed consent should be an unavoidable communication process. Nonetheless, we urge methodologists and bioethicists to reflect as Gonzalez-Duarte1 did to find an ethical and methodologically balanced response regarding the use of video recording while performing a qualitative study without modifying participant’s responses.

As Miles and Huberman2 pointed out, qualitative research is an artisanal work and must avoid the submission to strict and inflexible methodological rules while respecting ethical guidelines.

REFERENCES

1. González-Duarte A, Kaufer-Horwitz M, Zambrano E, Durand-Carbajal M, Alberú-Gómez J, Galindo-Fraga A, et al. The role of research ethics committees in observational studies:epidemiological registries, case reports, interviews and retrospective studies. Rev Invest Clin. 2019;71:149-56. [ Links ]

2. Miles M, Huberman AM. Qualitative Data Analysis:an Expanded Sourcebook. Thousand Oaks:SAGE Publications;1994. [ Links ]

Received: April 17, 2020

* Corresponding author: Isaac Maldonado-Castellanos E-mail: i_maldonadoc@hotmail.com


Author’s reply

Alejandra González-Duarte3  * 

3Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Dear Dr. Maldonado-Castellanos and Dr. Mora-Magaña:

We appreciate your Letter to the Editor in regards to our article1 and recognize that the observational studies mentioned in your letter were not included in our analysis. We also agree in that these kinds of studies are of paramount importance within the scope of modern research. Moreover, as you point out in your Letter, a balance should be achieved regarding the need for consent and the possibility of bias in the information obtained when a thorough description of the study is performed. We certainly think that this important issue should be discussed in a different article putting special emphasis on your observations. Thank you again for your valuable comments.

REFERENCES

1. González-Duarte A, Kaufer-Horwitz M, Zambrano E, Durand-Carbajal M, Alberú-Gómez J, Galindo-Fraga A, et al. The role of research ethics committees in observational studies:epidemiological registries, case reports, interviews and retrospective studies. Rev Invest Clin. 2019;71:149-56. [ Links ]

* Corresponding author: Alejandra González-Duarte E-mail: gonzalezduarte@aol.com

Creative Commons License Instituto Nacional de Cardiología Ignacio Chávez. Published by Permanyer. This is an open ccess article under the CC BY-NC-ND license