Review, Research PeerNCT05195671
Implications of Ethics Determinant on Dentistry and Pharmacy Research
An observational study of Review, Research Peer, run by Misr International University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Review, Research Peer
- What is being tested?
- Review
- How many people
- 131 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 10 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All students' research, Post-Grad and Research protocols submitted to MIU Institutional Review Board
Who may be able to join
- all protocols submitted to IRB
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implications of Ethics Determinant on Dentistry and Pharmacy Research: A Study of IRB Perspective
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.
Read the 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.
- Conditions
- Review, Research Peer
- Being tested
- Review
- Keywords
- Dental Ethics, Pharmacy Ethics, Institutional Ethics Committees
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReviewOther
Reviewing all protocols
What is being measured
The primary outcome is the main question the study is designed to answer.
Ethical concerns
Frequencies and percentages of ethical concerns
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Oct 2021
- Primary completion1 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Review, Research PeerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahassen M Farghaly, Professor, Study director, Vice president of community services and environmental awareness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195671
- Sponsor's protocol ID
- ETH12
- Status last verified
- Dec 2021
- First submitted
- 27 Dec 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1- Allison M. DiMatteo, BA, MP. The Legacy of Dental Research. Inside Dentistry. 2006, June; (2), Issue 5.
Gillett GR. Ethics and dental research. J Dent Res. 1994 Nov;73(11):1766-72. doi: 10.1177/00220345940730111401.
PubMed 7983264Navabi 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.
PubMed 23967427Mancl LA, Leroux BG, DeRouen TA. Between-subject and within-subject statistical information in dental research. J Dent Res. 2000 Oct;79(10):1778-81. doi: 10.1177/00220345000790100801.
PubMed 11077994Burt BA. Concepts of risk in dental public health. Community Dent Oral Epidemiol. 2005 Aug;33(4):240-7. doi: 10.1111/j.1600-0528.2005.00231.x.
PubMed 16008630Naik 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
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.
PubMed 21754933Deolia 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.
PubMed 25386512Dube-Baril C. The personalized consent form: an optional, but useful tool! J Can Dent Assoc. 2004 Feb;70(2):89-92.
PubMed 14756938Fitzgerald 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. doi: 10.1016/S0140-6736(02)11338-9.
PubMed 12414207Kadam 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.
PubMed 28828304Khallof 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.
PubMed 31879634Hon 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).
Lasers in Dentistry: A Review Chaya M David1, Pankaj Gupta; International Journal of Advanced Health Sciences • Vol 2 Issue 8 • December 2015, 7-13
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications of Ethics Determinant on Dentistry and Pharmacy Research: A Study of IRB Perspective
- ClinicalTrials.gov ID
- NCT05195671
- Acronym / sponsor ID
- ETH12
- Conditions
- Review, Research Peer
- Keywords
- Dental Ethics, Pharmacy Ethics, Institutional Ethics Committees
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All students' research, Post-Grad and Research protocols submitted to MIU Institutional Review Board
Key inclusion criteria (1 listed)
- all protocols submitted to IRB
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReviewReviewing all protocols | Other | – |
Primary outcome
Ethical concerns
Time frame: 1 month
Frequencies and percentages of ethical concerns
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Background1- Allison M. DiMatteo, BA, MP. The Legacy of Dental Research. Inside Dentistry. 2006, June; (2), Issue 5.
- Background: PubMed 7983264Gillett GR. Ethics and dental research. J Dent Res. 1994 Nov;73(11):1766-72. doi: 10.1177/00220345940730111401.
- Background: PubMed 23967427Navabi 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.
- Background: PubMed 11077994Mancl LA, Leroux BG, DeRouen TA. Between-subject and within-subject statistical information in dental research. J Dent Res. 2000 Oct;79(10):1778-81. doi: 10.1177/00220345000790100801.
- Background: PubMed 16008630Burt BA. Concepts of risk in dental public health. Community Dent Oral Epidemiol. 2005 Aug;33(4):240-7. doi: 10.1111/j.1600-0528.2005.00231.x.
- BackgroundNaik 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
- Background: PubMed 21754933El-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.
- Background: PubMed 25386512Deolia 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.
- Background: PubMed 14756938Dube-Baril C. The personalized consent form: an optional, but useful tool! J Can Dent Assoc. 2004 Feb;70(2):89-92.
- Background: PubMed 12414207Fitzgerald 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. doi: 10.1016/S0140-6736(02)11338-9.
- Background: PubMed 28828304Kadam 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.
- Background: PubMed 31879634Khallof 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.
- Principles of patient consent. London: 2009. General Dental CouncilLink provided by the sponsor.
- Ethnologue: languages of the world. Texas: 2021. SIL International.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahassen M Farghaly, Professor study director
Vice president of community services and environmental awareness
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Review, Research Peer, run by Misr International University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ethical concerns (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05195671, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.