Implications of Ethics Determinant on Dentistry and Pharmacy Research
Sponsor
Misr International University (Other)
Overall Status
Completed
CT.gov ID
NCT05195671
Collaborator
(none)
131
1
2.3
57
Study Details
Study Description
Brief Summary
The ethical review of dental and pharmacy research protocols has its own challenges facing the institutional ethical committees. Seemingly low risk procedure might pose controversies among committees' members. The aim of this article is to describe some of the ethical concerns, particular to dental and pharmacy research that an ethics committee could face while reviewing dental research.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The investigators have read all protocols submitted to the MIU IRB and reviewed all meetings' minutes to outline the ethical concerns that warranted discussions in the meetings, and how the committee came to a resolution for those concerns.
Study Design
Study Type:
Observational
Actual Enrollment
:
131 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Implications of Ethics Determinant on Dentistry and Pharmacy Research: A Study of IRB Perspective
Actual Study Start Date
:
Oct 1, 2021
Actual Primary Completion Date
:
Dec 1, 2021
Actual Study Completion Date
:
Dec 10, 2021
Outcome Measures
Primary Outcome Measures
- Ethical concerns [1 month]
Frequencies and percentages of ethical concerns
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- all protocols submitted to IRB
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Misr International University | Cairo | Egypt |
Sponsors and Collaborators
- Misr International University
Investigators
- Study Director: Mahassen M Farghaly, Professor, Vice president of community services and environmental awareness
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Principles of patient consent. London: 2009. General Dental Council
- Ethnologue: languages of the world. Texas: 2021. SIL International.
Publications
- 1- Allison M. DiMatteo, BA, MP. The Legacy of Dental Research. Inside Dentistry. 2006, June; (2), Issue 5.
- Burt BA. Concepts of risk in dental public health. Community Dent Oral Epidemiol. 2005 Aug;33(4):240-7.
- Deolia SG, Prasad K, Chhabra KG, Kalyanpur R, Kalghatgi S. An Insight Into Research Ethics among Dental Professionals in A Dental Institute, India- A Pilot Study. J Clin Diagn Res. 2014 Sep;8(9):ZC11-4. doi: 10.7860/JCDR/2014/10118.4794. Epub 2014 Sep 20.
- Dubé-Baril C. The personalized consent form: an optional, but useful tool! J Can Dent Assoc. 2004 Feb;70(2):89-92.
- El-Dessouky HF, Abdel-Aziz AM, Ibrahim C, Moni M, Abul Fadl R, Silverman H. Knowledge, Awareness, and Attitudes about Research Ethics among Dental Faculty in the Middle East: A Pilot Study. Int J Dent. 2011;2011:694759. doi: 10.1155/2011/694759. Epub 2011 Jul 3.
- Fitzgerald DW, Marotte C, Verdier RI, Johnson WD Jr, Pape JW. Comprehension during informed consent in a less-developed country. Lancet. 2002 Oct 26;360(9342):1301-2.
- Gillett GR. Ethics and dental research. J Dent Res. 1994 Nov;73(11):1766-72.
- Hon YK, Narayanan P, Goh PP. Extended discussion of information for informed consent for participation in clinical trials. The Cochrane Database of Systematic Reviews. 2017 (8).
- Kadam RA. Informed consent process: A step further towards making it meaningful! Perspect Clin Res. 2017 Jul-Sep;8(3):107-112. doi: 10.4103/picr.PICR_147_16. Review.
- Khallof RO, Doumani M, Farid FAS, Mostafa D, Alhafian RAA. Dental education in the Arabic language vs English language: A survey among Arab dentists. J Family Med Prim Care. 2019 Dec 10;8(12):3908-3914. doi: 10.4103/jfmpc.jfmpc_572_19. eCollection 2019 Dec.
- Lasers in Dentistry: A Review Chaya M David1, Pankaj Gupta; International Journal of Advanced Health Sciences • Vol 2 Issue 8 • December 2015, 7-13
- Mancl LA, Leroux BG, DeRouen TA. Between-subject and within-subject statistical information in dental research. J Dent Res. 2000 Oct;79(10):1778-81. Erratum in: J Dent Res. 2000 Nov;79(11):1924.
- Naik SP, Nividan KS, Pinto B, Shobha R, Dutt AS, and Rahul N. Ethical Issue and Challenges in Dentistry. International Journal of Preventive and Clinical Dental Research. 2016 October - December; 3(4): 285-87
- Navabi N, Shahravan A, Modaberi A. Reporting of Ethical Considerations Associated with Clinical Trials Published in Iranian Dental Journals between 2001 and 2011. Iran J Public Health. 2013 Jun 1;42(6):594-601. eCollection 2013.
Responsible Party:
Misr International University
ClinicalTrials.gov Identifier:
NCT05195671
Other Study ID Numbers:
- ETH12
First Posted:
Jan 19, 2022
Last Update Posted:
Jan 19, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Misr International University