Institutional Review Board

Human Research Seminar Series

The Einstein Institutional Review Board (IRB) is pleased to offer the following educational sessions during the 2013-2014 academic year. 

Seminar Title and Content  Date, Time & Location 
Reportable Events: Requirements and Differences
  • Review of the new policy, summary of the differences between the old policies and the new one, and answers to your questions.
 
Wednesday, 10/1/13
3:00 - 4:15 pm*
Location: Price 551 (Einstein)
Reportable Events: Requirements and Differences
  • Review of the new policy, summary of the differences between the old policies and the new one, and answers to your questions.
 
Monday, 11/11/13
12:30 - 1:45 pm**
Location: Price 451 (Einstein)
Investigator-Initiated Device Studies: How IRBs Can Help Researchers Work with the FDA
  • Whether you’re an investigator or an IRB member, you may have questions about the complex and challenging process of submitting an investigational device exemption (IDE) application to the US Food and Drug Administration (FDA).
  • At this session you'll gain the tools you need to determine whether an IDE is necessary, chart a timeline for the application process, and identify the respective responsibilities of investigators and IRBs.
  • NOTE: The format of this session will consist of a webinar presented by PRIM&R, courtesy of the Einstein IRB.
 
Thursday 1/30/14
1:00 - 2:30 pm**
Einstein Location: Dean's Conference Room (Belfer 303)
Montefiore Location: Moses Research Tower, CRC Conference Room
Handout available upon request  
More Sessions TBA!
  • Feel free to contact us with suggestions/requests.
 
 

*Refreshments will be served.
**Lunch will be served.
 

The Einstein Institutional Review Board (IRB), the Office of Clinical Trials (OCT), and the Institute for Clinical and Translational Research (ICTR) offered the following educational sessions during the 2012-2013 academic year. Handouts from the sessions are available for download below.

Seminar Title and Content  Date, Time & Location 
Responsible Conduct of Research
  • This session will cover data management practices including data collection, data ownership and data protection.  We will also discuss the sharing of data and the “rules of the road” regarding authorship. 
 
Friday 10/5/12
12-1:30 pm**
Dean's Conference Room
Belfer 303 (Einstein)
Download Handout  
What Requires IRB Review?
  • Definitions; Categories (full/expedited/exempt); how to choose the appropriate IRB application; how to differentiate between QA, Research, Clinical Care, Quality Assessment; tutorial on IRB website.
 
Monday 10/22/12
9:30-11 am*
Tishman 5 (Montefiore)
Download Handout 
  Use of Specimens in Research
  • Use of existing data/specimens; ongoing collection of data/specimens; research involving data/specimen analysis as part of a collaboration
 
Wednesday 10/24/12
9:30-11 am*
Dean's Conference Room
Belfer 303 (Einstein)
Download Handout 
Conduct of Genetic Research
  • Definition of Genetic Research; consent requirements (GWAS/dbGaP); Storage of Specimens - repositories; use of specimens collected for other purposes;
 
Thursday, 11/8/12
9:30-11 am*
Binswanger Auditorium (Montefiore)
Download Handout 
How to Prepare a Budget for NIH and Private Industry Sponsored Trials
  • Definitions of Direct Costs Overhead, Personnel Budgets, Fringe Benefits, Administrative Costs - Institutional Requirements.
 
Thursday 11/15/12
12-1:30 pm**
Dean's Conference Room
Belfer 303 (Einstein)
Download Handout
 
Research Billing Compliance
  • Audience is coordinators and support staff: overview of elearning module on Billing Compliance, Consequences of non-compliance; Q&A.
 
Tuesday 12/11/12
9:30-11 am*
Dean's Conference Room
Belfer 303 (Einstein)
Canceled 
IRB, ICTR and OCT Open House: Get Your Questions Answered
  • Come and meet the staff
  • Have your questions answered
  • Find out what institutional resources are available to assist you
 
Wednesday 12/19/12
3 - 4:30 pm*
Neuro Conf Room
023 NW1 Blue Zone (Montefiore)
Recruitment of Research Subjects
  • Advertisements; Recruitment tools; Use of the internet; transmission of data
 
Tuesday 1/15/2013
9-10:30 am*
Tishman 5 (Montefiore)
Download Handout 
Common Findings of the IRB, OHRP and FDA
  • How to navigate the IRB website, Common findings related to Informed Consent, Recordkeeping, Protocol Deviations, What is OHRP?, Overview of 45 CFR 46, FDA Regulations, Determination letters, warning letters, published statistics.
 
Friday 2/1/13
12-1:30 pm**
Dean's Conference Room
Belfer 303 (Einstein)
Download Handout
 
IRB, ICTR and OCT Open House: Get Your Questions Answered
  • Come and meet the staff
  • Have your questions answered
  • Find out what institutional resources are available to assist you  
 
Thursday 2/7/13
9 am - 10:30 am*
Dean's Conference Room
Belfer 303 (Einstein)
Informed Consent
  • Required elements; review of consent templates; translations services and short forms; consents for minors and other vulnerable subjects (cognitively impaired, unable to consent, limited English proficiency; HIPAA Authorizations (including waivers, alterations and exemptions), Informed consent process; informed consent waiver guidelines; alternate consent mechanisms.
 
Monday 2/11/13
12-1:30 pm**
Tishman 4 (Montefiore)
Download Handout 
Post IRB Approval Requirements: Progress Reports, Amendments, Adverse Event Reporting
  • Progress Reports; amendments; adverse event reporting - internal and external AE policies; what to report; protocol deviation policy; how to close a study
 
Wednesday 2/27/13
12-1:30 pm**
Board of Overseers Room Forchheimer G28
Download Handout 
What Requires IRB Review?
  • Definitions; Categories (full/expedited/exempt); how to choose the appropriate IRB application; how to differentiate between QA, Research, Clinical Care, Quality Assessment; tutorial on IRB website.
 
Thursday 3/14/13
12-1:30 pm**
Dean's Conference Room
Belfer 303 (Einstein)
 Download Handout 
Research Misconduct
  • Definition of research misconduct; institutional policies; how to handle subject complaints.
 
Monday 3/18/13
12-1:30 pm**
Tishman 4 (Montefiore)
Data Safety Monitoring
  • How to develop an appropriate plan for your study; factors to consider: single v. multisite studies; blind v. open label, randomized v. non-randomized; risks to subjects; investigator monitoring; external board monitoring; who could/should be on a DSMC/B; how to document monitoring activities.
 
Thursday 4/4/13
9:30-11 am*
Tishman 4 (Montefiore)
Download Handout  
IND/IDE Requirements
  • IND Overview (What is an IND? When is an IND required? How does the IND impact clinical trial?)
  • IDE Overview (What is an IDE? Responsibilities under an IDE; challenges & potential compliance issues; recommendations for mitigating)
 
Tuesday 4/16/13
12-1:30 pm**
Dean's Conference Room
Belfer 303 (Einstein)
Download Handout 
Statistical Integrity of Research Proposals
  • What is a Pilot Project; What are the criteria; What are the requirements.
 
Wednesday 4/24/13
12-1:30 pm**
Tishman 4 (Montefiore)
Download Handout 
Handling/Administration/Documentation of Study Drugs
  • A session for nurses and research coordinators on administering care to patients who are enrolled as study subjects - record keeping, storage and dispensing for on site study drugs; how to acquire research medications stored in the pharmacy; device studies
 
Friday 5/3/13
12-1:30 pm**
Tishman 5 (Montefiore)
Download Handout 
Humanitarian Devices and Emergency Use Procedures
  • Clinical Care v. Research; Institutional Policies; consent issues; Emergency Use
 
Monday 5/6/13
9:30-11 am*
Tishman 4 (Montefiore)
Download Handout 
How to Maintain Research Data
  • Subject Research Files; How to maintain a regulatory binder; how to prepare for a sponsor or FDA audit; clinical notes vs. research documentation; secure maintenance and transfer of data.
 
Tuesday 5/21/13
12-1:30 pm**
Dean's Conference Room
Belfer 303 (Einstein)
Download Handout 
New Research Coordinators: What Do I Need to Know About Data?
  • EPF and CareCast - Electronic Medical Records, Using software to track research, Clinical Looking Glass (CLG), data for the clinical trial record
 
Monday 6/3/13
12-1:30 pm**
Tishman 5 (Montefiore)
Handout TBA  
Investigator Initiated Protocols: Key Elements to Consider
  • Ensuring elements are well documented in the protocol: randomization; implementation; how confidentiality/blinding is maintained; drug dispensing; data safety plan; sample size, etc.
 
Wednesday 6/19/13
9:30-11 am*

Dean's Conference Room
Belfer 303 (Einstein)
Canceled 
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