Protection of Study Participants

All mauscripts submitted to Biomedica that involve sampling and/or data related to human subjects, alive or dead, shall compeltely fulfil the highest ethical standards. The investigators must exhibit an in-depth understanding of their primary responsibility for protecting the rights, welfare, and well-being of the subjects involved in research. 

The investgators and researchers, before submitting the manuscript for publication to Biomedica, must ensure compliance to the following points related to protection of research participants. Relevant documnetary evidence may be submitted where and when required. 

1

In case of human subjects, have you, before conducting the research, read and understood the WMA declaration of Helsinki – ethical principles for medical research involving human subjects available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

2

In case of research on animals, have you, before conducting the research,  read and understood the WMA statement on animal use in biomedical research available at: https://www.wma.net/policies-post/wma-statement-on-animal-use-in-biomedical-research/

3

Have you taken the written informed consent from all study participants who are capable of giving consent with a right to free withdrawal  from study at any time ??

4

Does the PI/co-PIs of the project (early stage/experienced) have appropriate scientific skills and experience for execution of the project under consideration?

5

Does the study involve participants who are particularly vulnerable? (e.g refugees, prisoners, victims of violence, patients with sensitive medical conditions e.g HIV/AIDS, drug addictions) or are unable to give informed consent (e.g. children, people with learning disabilities)?

6

Does the study involve archival material collected during research/routine laboratory testing and the material cannot be traced to its origin or cannot be accessed?

7

If the answer to the items 3,4,5 is yes, then have you taken formal approval from the collaborating institutes/ organizations/centers ?

8

Will the study involve discussion of sensitive topics (e.g. sexual activity, drug use) or induce embarrassment, psychological stress or anxiety or cause harm or negative consequences?

9

Is there any potential conflict of interest relating to the study? If yes then have you declared the nature of conflict ?

10

Will financial inducements (other than reasonable expenses and compensation for time) be offered to participants?

11

Will drugs, placebos, or other substances (e.g. food or drink constituents, dietary supplements) be administered to the study participants? If yes, is the proposed research registered with Clinical Trial Registry (International or Local )? 

12

Does this study involve handling, transportation and storage of Infectious agents, toxins, or chemicals (pathogenic to humans, animals or plants).If yes, then are the standard biosafety measures (contamination control, spill response, waste management, use of protective apparel, and inventory control) ensured for the execution of this project ?

13

If the study involves distribution of questionnaires to the participants, the right to Response Omission and Anonymity provided?

14

In case of animal studies, have you considered alternatives (in vitro systems, computer simulations and/or mathematical models) to reduce or replace the use of animals if possible

15

Will you make sure that the health of humans/animals be given prior consideration and avoid or minimize discomfort, distress, and all procedures will be kept aseptic, painless and minimally intrusive?

16

Will you provide adequate care to all humans/animals and ailing study subjects shall be properly treated by the qualified care providers and will be removed from further study?

17

Will you ensure confidentiality and data protection related to study participants?

18

Will you make sure that the results are only used for research purpose and information disseminated through research publications keeping the anonymity and confidentiality of each participant, unless he/she consents for disclosure.