Implications of Ethics Determinant on Dentistry and Pharm... | NCT05195671

Studies
Implications of Ethics Determinant on Dentistry and Pharmacy Research

NCT05195671

Sponsor

Misr International University

Status

Completed

Last Update Posted

Jan 19, 2022Actual

Enrollment

131Actual

Phase

Not provided

Conditions

Review, Research Peer

Interventions

Review

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2021Actual

Primary Completion Date

Dec 1, 2021Actual

Completion Date

Dec 10, 2021Actual

First Submitted Date

Dec 27, 2021

First Submission Date that Met QC Criteria

Jan 13, 2022

First Posted Date

Jan 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2022

Last Update Posted Date

Jan 19, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

131Actual

Name	Type	Description	Arm Group Labels	Other Names
Review	Other	Reviewing all protocols

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ethical concerns	Frequencies and percentages of ethical concerns	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all protocols submitted to IRB

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All students' research, Post-Grad and Research protocols submitted to MIU Institutional Review Board

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mahassen M Farghaly, Professor	Vice president of community services and environmental awareness	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Misr International University		Cairo			Egypt

References Module

Citations

PubMed Identifier	Type	Citation
	Background	1- Allison M. DiMatteo, BA, MP. The Legacy of Dental Research. Inside Dentistry. 2006, June; (2), Issue 5.
7983264	Background	Gillett GR. Ethics and dental research. J Dent Res. 1994 Nov;73(11):1766-72. doi: 10.1177/00220345940730111401.
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