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UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
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About the HSRO

Basic Folder Information

26.4 Local Context

Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

March 7, 2007

26.4 Local Context

Pursuant to regulations, OHRP guidances (8/27/1998 and 7/21/2000) and UM ethical standards, the UM IRB must possess sufficient knowledge of the local context (i.e. the institution/site and community environment) in which research for which they are responsible will be conducted.  In certain circumstances, the UM IRB may rely upon the review by the local IRB for this information.  However, the UM IRB must have knowledge of the local context, even if the local IRB is also reviewing the research, if either of the following applies: 

1)  The UM study involves research being conducted by UM employees or agents at the foreign site

2)  UM is the prime awardee on a DHHS grant and some of the funds are  going to the foreign site for its engagement or involvement in the  research

If neither of these circumstances apply and if the study is determined to involve  no greater than minimal risk to subjects or vulnerable categories of subjects, the IRB may consider information from the local IRB as sufficient for its review of local research context. 

If neither of the above circumstances apply but the study is determined to involve greater than minimal risk to subjects, the IRB shall review information regarding local context from the local IRB and from at least one additional source such as:

1)  Personal knowledge from one or more IRB members, such knowledge having been obtained through extended, direct experience with the research institution, its subject populations, and its surrounding community

2)  Participation (either physically or through audiovisual or telephone conference) by one or more appropriate consultants in convened meetings of the IRB.  Such consultants should have personal knowledge of the local research context, such knowledge having been obtained through extended, direct experience with the research institution, its subject populations, and its surrounding community

3)  Prior written review of the proposed research by one or more appropriate consultants, in conjunction with participation (either physically or through audiovisual or telephone conference) by the consultant in convened meetings of the IRB, when such participation is deemed warranted either by the consultant or by any member of the IRB

4)  Systematic, reciprocal, and documented interchange between the IRB and elements of the local research context.  Such interchange should include:

a.   Periodic visits to the research site by one or more IRB members in order to obtain and maintain knowledge of the local research context, including the research institution, its subject populations, and its surrounding community; AND

b.   Periodic discussion with appropriate consultants knowledgeable about the local research context; AND

c.   Regular interaction with one or more designated institutional liaisons; AND

d.   Review of relevant written materials including reports from the principal investigator or other investigators related to ongoing visits or monitoring of the foreign site

If either of the two circumstances (above) apply,  the IRB shall demonstrate that it has obtained necessary information about the local research context from the local IRB and from at least one additional source (see above) and also from information from the Principal Investigator.  To accomplish this, Principal Investigators should include within study applications the following information when applicable to the study: 

1)  Explanations of cultural and ethical  differences (if any) that influenced the study design and the consent process

2)  The anticipated scope of the foreign institution's or site's research activities in the UM study

3)  The size and complexity of the foreign institution or site

4)  Standards of professional conduct and practice of the foreign institution or site

5)  The applicable commitments and regulations of the foreign institution

6)  Applicable foreign law that may influence study design or conduct

7)  The subject population likely to be involved in the study

8)  Languages understood by the prospective subjects 

9)  Method for equitable selection of subjects at the foreign institution

10)A rationale for conducting the study with the foreign population

11)Method for minimizing the possibility of coercion or undue influence in seeking consent

12)Information regarding the foreign institution's or country's IRB, Ethical Review Committee or equivalent organization and its review process

13)A description of the processes for assuring confidentiality for subjects and data and the methods for transporting and securing of data to the U.S. (if applicable)

14)If subjects will receive compensation in the form of money, goods or services, an explanation is needed as to how this compensation is proportionate to the average annual income of people in the foreign country

A study shall have only one local context review unless the IRB determines that there are significant changes in the protocol or the risks to the subjects that require another local context review.

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