Central European Journal of Sport Sciences and Medicine

ISSN: 2300-9705     eISSN: 2353-2807    OAI    DOI: 10.18276/cej
CC BY-SA   Open Access   DOAJ  DOAJ

Research Ethics Policies for Clinical Trials and Studies Involving Human Subjects and Vulnerable Populations

It is important to note that these policies serve as general guidelines, and researchers should also consider specific ethical requirements and regulations applicable in their respective fields and jurisdictions. Additionally, researchers should consult international guidelines such as the Declaration of Helsinki.


Ethical Approval:

a. An ethical approval from relevant institutional review boards or ethics committees for all studies involving human subjects must always be obtained.

b. Researchers must follow the ethical guidelines and principles set forth by the respective review boards or committees and ensure that the study is performed in accordance with the ethical standards as specified in the Declaration of Helsinki.

c. A statement must be included in the final version of the manuscript  submitted for publication: e.g. The studies involving human participants were reviewed and approved by (name ethics committee/ trial registration number). The participants provided their (written) informed consent to participate in this study/ e.g. This is an observational study. The (name ethics committee) has confirmed that no ethical approval is required.

Authors are responsible for correctness of the statements provided in the manuscript. If any of the above mentioned are not relevant to your manuscript, please declare: Not applicable.

d. All clinical trials must obtain ethical approval from relevant institutional review boards or ethics committees.


Informed Consent:

a. Informed consent must be obtained from all participants before their participation in the study or clinical trial. Informed consent must be obtained from the minors and their legal guardians/parents before their participation in the study or clinical trial.

b. Participants should be provided with clear and comprehensive information about the study's or clinical trial purpose, procedures, potential risks and benefits, and their rights as participants. Information provided to minors and their guardians should be age-appropriate, clear, and comprehensible.

c. Participants/legal guardians must have the freedom to withdraw from the trial or decline their participation at any time without facing any negative consequences of their decision.

Participant Anonymity and Confidentiality:

a. Researchers must ensure the confidentiality as well as anonymity of participants' personal information and data.

b. Identifying information should be collected and stored separately from research data.

c. The identities of the participants should not be revealed in any published materials or presentation of research findings without an explicit consent.


Privacy and Data Protection:

a. Researchers should always protect participants' privacy and ensure the security of collected data. Privacy and confidentiality of the minors should be protected to the fullest extent possible.

b. Data should be stored securely with the access limited to the authorized personnel only.

c. It is necessary for the data to be anonymized or de-identified whenever possible to minimize the risk of re-identification.


Randomization and Control:

a. Randomization and control groups should be employed whenever appropriate to ensure scientific rigor and minimize bias.

b. The rationale for randomization and control group assignment should be based on scientific and ethical considerations.


Placebo Use:

a. The use of placebos should be based on scientific and ethical considerations.

b. The placebo group should be provided with appropriate care and treatment to ensure their well-being.


Minimization of Harm:

a. Researchers should minimize any potential physical, psychological, or social harm to human subjects. The study design should consider the age, developmental stage, and vulnerability of the minors involved.

b. The assessment of potential risks should take place prior to the study or trial.

c. Participants, if necessary, should be provided with proper support and resources, i.e. referrals to counseling services.

d. The safety of people is considered the highest priority in the clinical trial or study.

e. Researchers should monitor subjects for any negative events on a regular basis and always address them.


Conflict of Interest:

a. All the parties involved shall disclose any potential conflicts of interest that may influence the study design, conduct, or reporting.

b. Conflicts of interest should be managed or eliminated to ensure the integrity and objectivity of the research.


Reporting and Publication:

 a. Scientists should accurately report their findings and provide a transparent account of the methods used.

 b. Any limitations or ethical considerations found out during the study or clinical trial should be acknowledged.

 c. Plagiarism and any other form of scientific misconduct is unacceptable.


Continuous Monitoring and Review:

a. Constant monitoring and revision of studies involving human subjects and clinical trials is required to ensure compliance with ethical standards.

b. Researchers should promptly respond to any concerns or complaints of participants or other stakeholders.

c. Reassessment of ethical considerations should be conducted throughout the study or clinical trial on a regular basis.