What are the best practices of creating an informed consent?

1. Introduction

2. Research the ethical and legal implications of clinical research in the Kingdom of Saudi Arabia.

3. Understand international principles and guidelines which have to be followed when performing clinical trials

4. What aspects of clinical research design helps to protect the human subjects?

5. Name key principles of ethical considerations during clinical research and development

6. Discuss ethical concerns for designing, conducting and reporting the results obtained through the conduct of clinical trials

7. What are the best practices of creating an informed consent?

8. Create an informed consent and include all the components that you have found are necessary to protect the patient.

9. Conclusion

Write a paper 5 pages not including the title and references. (Explain each answer for a minimum of 100 words for question)

Use bullet points to 3-5 words for headings and include your discussion (100 word for each section) explaining your findings for each slide.

Your presentation should meet the following structural requirements:

· Provide support for your statements with in-text citations from a minimum of seven scholarly articles.

·

This is good introduction but need paraphrase

The implementation of clinical research projects requires conscientious review of research projects not only in terms of their scientific quality but also in regard to their ethical adequacy and appropriateness. How can we balance the risk-benefit of our projects? Given the importance of ethics for the conduct of drug development and research, it should come as no surprise that many different professional associations, government agencies, and universities have adopted specific codes, rules, and policies relating to research ethics. Each of these aspects will be carefully considered and discussed in the context of international and national principles and guidelines. These issues need to be carefully adhered to strengthen the health of the clinical trial enterprise to the benefit of patients and the overall health of the public.

References

· Kwan, C., & Walsh, C. A. (2018). Ethical issues in conducting community-based participatory research: A narrative review of the literature. The Qualitative Report, 23(2), 369-386.

· Lin, K. (2016). Integrating ethical guidelines and situated ethics for researching social-media-based interactions: Lessons from a virtual ethnographic case study with Chinese youth. Journal of Information Ethics, 25(1), 114-131,150.

· Powell, M. A., Graham, A., & Truscott, J. (2016). Ethical research involving children: Facilitating reflexive engagement. Qualitative Research Journal, 16(2), 120-144.

· Bazarbashi, S., Hassan, A., Eldin, A. M., Soudy, H., & Hussain, F. (2015). Awareness and perceptions of clinical trials in cancer patients and their families in saudi arabia. Journal of Cancer Education, 30(4), 655-659. doi:10.1007/s13187-015-0797-0

· Jamjoom, A. B., Jamjoom, A. M., Samman, A. M., & Gahtani, A. Y. (2015). Fate of registered clinical trials performed in saudi arabia. Saudi Medical Journal, 36(10), 1245-1248. doi:10.15537/smj.2015.10.12506

· Almutairi, K. M., Alonazi, W. B., Alodhayani, A. A., Vinluan, J. M., Moussa, M., Al-Ajlan, A. S., . . . Alotaibi, N. E. (2017). Barriers to cancer clinical trial participation among saudi nationals: A cross-sectional study. Journal of Religion and Health, 56(2), 623-634. doi:10.1007/s10943-016-0306-8

· Al-Tannir, M. A., Katan, H. M., Al-Badr, A. H., Al-Tannir, M. M., & Abu-Shaheen, A. K. (2018). Knowledge, attitudes, practices and perceptions of clinicians towards conducting clinical trials in an academic tertiary care center. Saudi Medical Journal, 39(2), 191-196. doi:10.15537/smj.2018.2.21093

· Al-Tannir, M. A., El-Bakri, N., & Abu-Shaheen, A. K. (2016). Knowledge, attitudes and perceptions of saudis towards participating in clinical trials. PloS One, 11(2), e0143893. doi:10.1371/journal.pone.0143893