1. Dartmouth Human Research Protection Program (HRPP) 1
Dartmouth Human Research Protection Program (HRPP) 1. Dartmouth as the IRB of Record 2. Use of an External IRB 3. NIH, Common Rule Requirements: Single IRB Brown Bag Series: Noon / First Tuesday of the Month March 7, Auditorium B

2. Updates Implement for non-federally funded research
Effective date of new human research subjects regulations : January 19, 2018
Implement for non-federally funded research
Introduce: Leigh Burgess
Questions during the session?  Ann O’Hara and we will try
to respond during our Q&A following the presentation:

3. Expiration Date in Rapport: none
Update continued: new regulations implementation
Elimination of CPHS continuing review for non federally funded minimal risk research meeting certain criteria.  
Gradual transition : For each study meeting the criteria, the PI and Primary contact will receive notification via Rapport (as a comment) and a CPHS letter indicating continuing review is no longer required. 
Expiration Date in Rapport: none
Please close the study in Rapport when all study procedures are completed. 

4. Excerpt from Richard Rothstein announcement:
Leigh Burgess, MHA, MEd, MA, has joined Dartmouth-Hitchcock as our Vice President of Research Operations.
Responsible for providing strategic vision, direction and the day-to-day management and oversight of all research trial activities occurring at Dartmouth-Hitchcock (D-H), and ..affiliated D-H institutions.
Lead the creation of requisite governance, leadership and reporting structures
Experienced operations and administrative leader with more than 15 years of experience and demonstrated competencies in strategic planning, revenue management, operations, executive level project management and information technology.
Previously, she was the chief research operations officer at the Duke Cancer Institute (DCI)
3 master degrees: education in administration; health services administration; organizational management and development. Pursuing a doctorate in human and organizational systems (anticipated graduation is 2018).

5. 1. Dartmouth as the IRB of Record 2. Use of an External IRB 3
1. Dartmouth as the IRB of Record 2. Use of an External IRB 3. NIH, Common Rule Requirements: Single IRB
History: federal regulations geared towards local IRB review
The Dartmouth CPHS has both been the IRB of Record and accepted another IRB as the IRB of Record
for several years.
Other institutional reviews:
Budget, Conflict of Interest, Institutional Biosafety, Clinical Trial Agreement

6. First step: multi-site research ?
When is an institution considered to be “engaged in research”?

7. Engaged in human subjects research when its employees or agents:
obtain data or individually identifiable private information about individuals for research purposes
Or obtain the informed consent of human subjects..
An institution is considered to be engaged in human subjects research whenever it receives a direct HHS award to support such research, even if all of the human subjects activities will be performed by agents or employees of another institution.
Simply informing potential subjects about a research study is not considered engagement in research.
Providing written information about a research study, including how to contact the investigators for information and enrollment, and seeking and obtaining prospective subjects' permission for investigators to contact them are not considered engagement in research.
However, obtaining informed consent from a research participant is considered engagement in research.

8. Second step: Is the study federally funded ?
All institutions engaged in human subjects research (not exempt) and is conducted or supported by any HHS agency must be covered by an Office for Human Research Protections-approved assurance of compliance. The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP.

9. If the site is not engaged … or the research is exempt...
No requirement for formal IRB Reliance (Authorization) Agreement
If the site is engaged in minimal risk or full review research …
Next question ...

10. Who will be the IRB of Record ?
If Dartmouth is the grantee organization
If the Dartmouth PI is the lead PI
= Dartmouth CPHS as the IRB of Record

11. 1. Dartmouth as the IRB of Record
Notify CPHS Office – call with inquiries ; enter information into Rapport
CPHS Qualification Form - send to site(s)
IRB Reliance Agreement
Other institutional reviews:
Budget, Conflict of Interest, Institutional Biosafety, Clinical Trial Agreement

14. Request to Rely on Dartmouth College CPHS Qualification Form
Section 1: Relying Organization Information:
1. Legal name of the Relying Organization:   
2. Local Context--Describe any Relying Organization's local policies, requirements, and community attitudes such as religious,
ethical, ethnic or economic, regarding the conduct of human research that the Dartmouth College CPHS
must account for during its review process.
3. State laws--Identify and cite any special laws (such as experimental bill of rights, age of majority,
laws related to protected health information, reporting requirements, legally authorized representatives) that
govern the conduct of research at the Relying Organization.
4. Relying Organization Policies/Requirements--Identify or describe any Relying Organization's policies or requirements
related to the conduct of human research that the Dartmouth College CPHS must account for during its review process.
5. Facilities--Describe the facilities that are available at the Relying Organization in support of this project,
including but not limited to, facilities to treat life threatening emergencies if they occur.  

15. 6. Personnel--Describe the number and types of personnel that are on-site and available to assist in the
conduct of the research study.
Indicate if these personnel are available to treat life-threatening reactions, if they occur.
 7. Policies and Procedures--Describe how research personnel at the Relying Organization
have access to policies and procedures regarding the conduct of research.
 8. What is the name and address of each site where research activities for this study will take
place (if any in addition to Relying Organization named here):

16. 9. Do research personnel at your site undergo human subjects protections education, such as the CITI program?
10. Describe the mechanisms for oversight of research. Does the organization have a quality assurance/audit group responsible for overseeing ongoing research or another mechanism of oversight?
11. Is there a conflict of interest review process as part of this organizations structure?
12. Has the organization been subject to any governmental inquiries or investigations over the past three years that may be material to the activities that would be conducted under the proposed IRB Authorization Agreement? If yes, describe and include, without limitation, research compliance problems or investigations, and the status of such matters.

17. Section 2: Dartmouth College Investigator (For completion by the Dartmouth College research team)
What is the CPHS # and the name of the study to which this reliance agreement pertains:
What research activities will the external site undertake as part of this project:
☐ Recruitment
☐ Active intervention
☐ Interviews or focus groups
☐ Data Analysis
☐ Other:
Management of external site conduct
Please provide a brief description of your plans to provide oversight and support to the relying sites:
************************************************************************************************************************************
CPHS review fee:
The CPHS charges a fee for provision of IRB review for outside sites.  
 Minimal Risk
Full Committee

18. IRB Reliance (Authorization) Agreement
…..The Reviewing IRB shall follow written procedures for reporting its findings and actions to appropriate officials at the Relying Entity.
....The Relying Entity retains responsibility for ensuring compliance with the Reviewing IRB’s determinations, and with the terms of its own FWA, as applicable.
This agreement incorporates Appendix A, which describes the activities of the Reviewing IRB and its expectations of the Relying Entity and Principal Investigator for any research project covered by this agreement.
The parties agree to cooperate in the development of mutually acceptable and beneficial processes to track and monitor the human research activities subject to this agreement….
Appendix A : Roles and responsibilities

19. Appendix A
The Relying Entity shall:
….Notify the CPHS promptly of any known instances of;
termination of the research;
complaints from subjects;
restriction or suspension of the activities of an investigator
Assure that the local facilities are adequate for the conduct of the research;
Assure the local investigator is appropriately qualified to conduct the proposed research;
It is important to ensure objectivity in the design, conduct, and reporting of research. The Relying
Entity is responsible for ensuring the project is being conducted in an unbiased manner. If there are concerns or questions, the Relying Entity should notify the reviewing IRB.
Arrange for appropriate human research training for personnel involved in the conduct of that research;
Maintain compliance with applicable law and institutional policies regarding human research;

20. Appendix A
Additionally, the Dartmouth Investigator shall work with the external investigator/s and:
Send to the CPHS appropriate documentation of changes to the approved study protocol, plan, or consent form before initiating the changes in practice and wait for CPHS approval, unless changes are necessary to eliminate apparent immediate hazards to human subjects;
documents for continuing review in a timely fashion prior to the lapse of the previous CPHS approval;
Report to the CPHS any serious and unexpected adverse events and unanticipated problems involving risks to subjects;
Promptly report to the CPHS any serious or unresolved complaints and protocol deviations;
Notify the CPHS of changes in funding;
Notify the CPHS about the termination of each study.

21. The researcher at the Relying Institution should have a copy of this agreement and should understand the responsibilities as outlined in Appendix A. 
Signature of the Relying Site’s Investigator:
I have reviewed this agreement including the appendix that outlines responsibilities. 
I agree to comply with the responsibilities as outlined in Appendix A.
______________________________________________                Date: _____________________
Name
Title

22. External IRB: SmartIRB: https//smartirb.org/
Catalyst, NCI IRB, Western (WIRB), Chesapeake,
Copernicus, Academic Medical Center
2. Use of an External IRB :
Lead site may send qualification form or Master Agreement / Transfer of Obligation Form
Department and Scientific Review at Dartmouth
CPHS Office receives: consent form and protocol
consent form should have local information
CPHS Chair review / IRB Reliance Agreement
Other institutional reviews:
Budget, Conflict of Interest, Institutional Biosafety, Clinical Trial Agreement
Report local SAEs, non compliance to CPHS and External IRB

23. 1. Can easily add – contact cphs.tasks@dartmouth.edu
5. Leave blank

24. 3. Single IRB required for U. S
3. Single IRB required for U.S. based multi-site studies NIH effective date: September Common Rule Effective date: January 20, 2020

25. Thank you for your time.
Questions ?