HUMAN SUBJECTS RESEARCH PROTECTION

Human Subject Research Protection

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Human Subject Research Protection

The issue of consent is a growing concern in clinical researches, and it is creating major problems in such researches when the investigators do not inform the participants about the purpose of the study and when the results are falsified and fabricated. In order to fill the gaps, informed consent is a key component because it explains the nature of the research and also the purpose of their participation in this study. There are various components of informed consent which includes a statement of the study involved, the purpose of the study, the total duration of the participant's involvement in the research, description of the procedures involved, a proper explanation of any foreseeable risks to the participants or any unexpected benefit to the participants. All these elements are included to make sure the authenticity of the study and also to take the participants in confidence ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"EZUVf7dZ","properties":{"formattedCitation":"(Koonrungsesomboon, Laothavorn, & Karbwang, 2015)","plainCitation":"(Koonrungsesomboon, Laothavorn, & Karbwang, 2015)","noteIndex":0},"citationItems":[{"id":1434,"uris":["http://zotero.org/users/local/4C6u8dIT/items/B8GMEV7G"],"uri":["http://zotero.org/users/local/4C6u8dIT/items/B8GMEV7G"],"itemData":{"id":1434,"type":"article-journal","title":"Understanding of essential elements required in Informed Consent Form among researchers and institutional review board members","container-title":"Tropical medicine and health","page":"117-122","volume":"43","issue":"2","author":[{"family":"Koonrungsesomboon","given":"Nut"},{"family":"Laothavorn","given":"Junjira"},{"family":"Karbwang","given":"Juntra"}],"issued":{"date-parts":[["2015"]]}}}],"schema":"https://github.com/citation-style-language/schema/raw/master/csl-citation.json"} (Koonrungsesomboon, Laothavorn, & Karbwang, 2015).

In the past, various unethical researches have been done on a certain population without informing them about the nature of the study or even using humans an experimental animals, the Tuskegee syphilis case study and also the history of HeLa cells are some of the prominent examples in this regard and most of these studies were done on the African Americans and racial discrimination is clear in this regard ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"Rs0lCmnC","properties":{"formattedCitation":"(Bracken-Roche, Bell, Macdonald, & Racine, 2017)","plainCitation":"(Bracken-Roche, Bell, Macdonald, & Racine, 2017)","noteIndex":0},"citationItems":[{"id":1433,"uris":["http://zotero.org/users/local/4C6u8dIT/items/HDEYHTHJ"],"uri":["http://zotero.org/users/local/4C6u8dIT/items/HDEYHTHJ"],"itemData":{"id":1433,"type":"article-journal","title":"The concept of ‘vulnerability’in research ethics: an in-depth analysis of policies and guidelines","container-title":"Health research policy and systems","page":"8","volume":"15","issue":"1","author":[{"family":"Bracken-Roche","given":"Dearbhail"},{"family":"Bell","given":"Emily"},{"family":"Macdonald","given":"Mary Ellen"},{"family":"Racine","given":"Eric"}],"issued":{"date-parts":[["2017"]]}}}],"schema":"https://github.com/citation-style-language/schema/raw/master/csl-citation.json"} (Bracken-Roche, Bell, Macdonald, & Racine, 2017). In order to avoid such incidents, there are a certain set of ethical guidelines that need to be followed prior to do any researches. These ethical guidelines mainly focus on the safety of the participants and if at any point the participants would feel threatened to them then these are allowed to leave the research and such populations are not only based on race but minors including children, prisoners, decisionally impaired individuals, all are considered as vulnerable population and in their case also the process of informed consent is quite important ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"xS9ZRszZ","properties":{"formattedCitation":"(Yip, Han, & Sng, 2016)","plainCitation":"(Yip, Han, & Sng, 2016)","noteIndex":0},"citationItems":[{"id":1436,"uris":["http://zotero.org/users/local/4C6u8dIT/items/QI83YWAY"],"uri":["http://zotero.org/users/local/4C6u8dIT/items/QI83YWAY"],"itemData":{"id":1436,"type":"article-journal","title":"Legal and ethical issues in research","container-title":"Indian journal of anaesthesia","page":"684","volume":"60","issue":"9","author":[{"family":"Yip","given":"Camille"},{"family":"Han","given":"Nian-Lin Reena"},{"family":"Sng","given":"Ban Leong"}],"issued":{"date-parts":[["2016"]]}}}],"schema":"https://github.com/citation-style-language/schema/raw/master/csl-citation.json"} (Yip, Han, & Sng, 2016) .

The role of nurse is quite crucial in this regard because nurses previously have played a significant role in advocating the rights of people who were at risk due to clinical researches and the Tuskegee Syphilis case study is an example of nurse intervention in such cases, the nurses can help to explain the nature of study to the people clearly and if there is some threat to the participants then he/she can explain it to the participants ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"hAx9BcK0","properties":{"formattedCitation":"(Shin, Jeong, Lee, & Yang, 2015)","plainCitation":"(Shin, Jeong, Lee, & Yang, 2015)","noteIndex":0},"citationItems":[{"id":1435,"uris":["http://zotero.org/users/local/4C6u8dIT/items/8WU7MRT3"],"uri":["http://zotero.org/users/local/4C6u8dIT/items/8WU7MRT3"],"itemData":{"id":1435,"type":"article-journal","title":"Experiences of ethical issues and needs for ethics education in clinical nurses","container-title":"Journal of Korean Academy of Nursing Administration","page":"327-339","volume":"21","issue":"3","author":[{"family":"Shin","given":"Ja Hyun"},{"family":"Jeong","given":"Seok Hee"},{"family":"Lee","given":"Myung Ha"},{"family":"Yang","given":"Youngran"}],"issued":{"date-parts":[["2015"]]}}}],"schema":"https://github.com/citation-style-language/schema/raw/master/csl-citation.json"} (Shin, Jeong, Lee, & Yang, 2015). Nurses can play a role by making the security and safety of the patients on priority and by directly communicating with the vulnerable population

References

ADDIN ZOTERO_BIBL {"uncited":[],"omitted":[],"custom":[]} CSL_BIBLIOGRAPHY Bracken-Roche, D., Bell, E., Macdonald, M. E., & Racine, E. (2017). The concept of ‘vulnerability' in research ethics: an in-depth analysis of policies and guidelines. Health Research Policy and Systems, 15(1), 8.

Koonrungsesomboon, N., Laothavorn, J., & Karbwang, J. (2015). Understanding of essential elements required in Informed Consent Form among researchers and institutional review board members. Tropical Medicine and Health, 43(2), 117–122.

Shin, J. H., Jeong, S. H., Lee, M. H., & Yang, Y. (2015). Experiences of ethical issues and needs for ethics education in clinical nurses. Journal of Korean Academy of Nursing Administration, 21(3), 327–339.

Yip, C., Han, N.-L. R., & Sng, B. L. (2016). Legal and ethical issues in research. Indian Journal of Anaesthesia, 60(9), 684.