Statement Regarding the Following of Ethical Guidelines

Dear __________

We are thankful for your feedback regarding the study’s approval by an Ethics Committee.

First, we apologize for any inconvenience related to publish our study without the approval by an Ethics
Committee.

As a solution to this issue, we provide you with this statement, signed by all authors of the study, which
provides evidence that our study follows general ethical recommendations.

In fact, the data of our study was self-collected by the first author, being the primary rationale of it its
education (this study is part of his/their bachelor thesis), and this rationale is the same for ethics’ expert
discussing self-collected data (Dresser, 2014; Parry & Buenz, 2018).

Therefore, in stricto sensu, the study did not involve the participation of several human participants but
rather only one author of the study.

In those cases, neither the Ethics Code nor the Regulations of our Institutional Review Board (IRB),
provide any specific guidelines.

Similarly neither the International ethical guidelines for health-related research involving humans nor
the Declaration of Helsinki, have any specific guidelines to “self-collected data” (Council for
International Organizations of Medical Sciences, 2016; World Medical Association, 1964).

For all those reasons, we hope you accept our study for publication.

Sincerely,

__________________

References

Council for International Organizations of Medical Sciences. (2016). International ethical guidelines for health-related research involving
humans. Geneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS).

Dresser, R. (2014). Personal knowledge and study participation. Journal of Medical Ethics, 40(7), 471 LP – 474.
https://doi.org/10.1136/medethics-2013-101390

Parry, G. J., & Buenz, E. J. (2018). Adventures in self experimentation. BMJ, 363, k5006. https://doi.org/10.1136/bmj.k5006

World Medical Association. (1964). Declaration of Helsinki: Ethical principles for medical research involving human subjects. Ferney-Voltaire,
France.