ETHICAL CONCERNS REGARDING A STUDY INVOLVING HUMAN SUBJECTS

Research Involving Human Subjects

RCSAS strictly follows the guidelines of COPE (https://publicationethics.org/case/ethical-concerns-about-study-involving-human-subjects).

When Manuscripts reporting research involving human participants, human data or human tissue, authors are required to submit a written consent and ethics approval declaration (even in cases where clearance was not required); the name of the ethical committee that endorsed the study, along with the committee’s reference number (if applicable). In this regard authors should follow the rules of the Declaration of Helsinki of 1975 (https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/), and later it was revised in 2013.

Whenever the study discusses research involving vulnerable groups, further verification may be done. The editorial office will review the submitted paper, and if requested, documented evidence (blank consent forms and any pertinent ethics board discussion materials) must be provided. Moreover, an explanation of why such categorization was necessary must be made apparent in the article when research characterizes groups by color, ethnicity, gender, handicap, disease, etc.

Research Involving the Use of Animals

The editors will require that the potential advantages of any animal-harming study are remarkable in relation to any cost suffered by animals, and any treatments used are unlikely to offend most readers.

Authors should make sure that their study conforms to the generally accepted “3Rs” in specific (https://www.animalethics.org.au/three-rs).

• • Replacement of animals by alternatives wherever possible;
  • Reduction in number of animals used; AND
  • Refinement of experimental conditions and procedures to minimize the harm to animals.

RCSAS endorses the ARRIVE guidelines (arriveguidelines.org/) for reporting experiments using live animals. Authors and reviewers must use the ARRIVE guidelines as a checklist ( https://arriveguidelines.org/sites/arrive/files/documents/ARRIVE%20Compliance%20Questionnaire.pdf.)

Research Involving Cell Lines

When using human cells, authors must specify which cell lines were used and provide information on the cell line’s source, indicating how and when it was obtained, as well as whether it has recently undergone authentication. The following information must be included in the paper if the cells were purchased from a life science company: cell type, cell line number, and batch of cells. Authors are advised to examine the NCBI database (https://www.ncbi.nlm.nih.gov/) for contamination and incorrect identification of human cell lines. This process might save authors a great deal of time and work by alerting them of potential cell line issues. However, authors will obtain the needed information from the International Cell Line Authentication Committee (https://iclac.org/).

The study’s approval by an institutional or independent ethics committee, along with the committee’s name, and that informed consent was acquired from the donor or next of kin, should both be stated in the authors’ statement.

Research Involving Plants

Institutional, governmental, or international regulations must be followed when doing experimental study on plants (both cultivated and wild), including the gathering of plant material. Authors should follow the guidelines of The Convention on Biological Diversity (https://www.cbd.int/convention/) and the Convention on the Trade in Endangered Species of Wild Fauna and Flora ((https://cites.org/eng). Each manuscript that is submitted must include supporting genetic data and origin. Voucher specimens must be deposited in an accessible herbarium or museum for study papers involving rare and non-model plants.

Clinical Trials Registration

RCSAS abides by the International Committee of Medical Journal Editors (ICMJE) recommendations, which demand and suggest that clinical trials be registered in a public trials registry at or before the time of initial patient registration in order to be taken into consideration for publication.

Studies that are just observational don’t need to be registered. A clinical trial is any study that involves participant randomization and group categorization in the context of the intervention being evaluated. It does not simply relate to studies that are conducted in hospitals or that use medications.

Pre-registering clinical trials with the international clinical trials register is strongly advised, and the registration should be included in the Methods section. Suitable databases include those mentioned by the World Health Organization International Clinical Trials Registry Platform, clinicaltrials.gov, and the EU Clinical Trials Register.

Participants’ Consent

For all studies involving human subjects, participants’ freely given and informed consent to take part in the study must be acquired (or, in the case of participants under the age of 16, their parent or legal guardian), and a statement to this effect must be included in the publication.

Articles discussing human transplantation experiments must provide a disclaimer that no prisoners’ organs or tissues were used, as well as the institution(s), clinic(s), or department(s) from where the organs or tissues were received.

The editor will take particular precautions and may refer manuscripts reporting studies involving vulnerable groups where there is a risk of coercion or where agreement may not have been given voluntarily or fully informed.

Participants may give their permission to take part in a study yet object to having their information published in a journal article. Before submitting their manuscript to a journal, authors should be sure to get everyone’s permission to publish their data. Case studies in particular can benefit from this.

Data Protection, Confidentiality and Anonymity

In this regard, RCSAS strictly follows the guidelines of COPE. When gathering, analyzing, and reporting data, confidentiality and anonymity are ethical procedures used to protect the privacy of human subjects. Separating or altering any personally identifying data provided by participants from the data is referred to as confidentiality. Anonymity, on the other hand, is the practice of gathering data without getting any identifiable, personal information. In quantitative investigations, anonymity is typically the protocol used, and confidentiality is upheld in qualitative studies. In both situations, the researcher collects data from participants, and it is this data that will be examined. Researchers are required to respect their subjects, but they are not as interested in detailing a specific subject’s behavior.

Authors should make sure that participants are informed about the types of (personal) data that will be handled, how they will be used, and for what purpose before biological material is donated for study or data is collected as part of a research project. In the case of data obtained through a bio-bank or bio-repository, it is possible that they employ a broad consent that enables study participants to agree to a wide range of uses of their data and samples and is deemed by research ethics committees as specific enough to be considered “informed”.