Page History

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| Title: | Conflict of Interest in Research --- Human Subjects |
| Publication date: | 1/2/2012 |
| Effective date: | 12/16/2010 |

h2. BRIEF


h3. Policy Summary

All protocol applications for research involving human subjects must be submitted to and approved by the LBNL Human Subjects Committee (HSC), which is Berkeley Lab's Institutional Review Board. All protocol applications must include disclosure of any financial or other personal considerations that may compromise, or have the appearance of compromising, the researchers' professional judgment in conducting or reporting research so as to adversely affect the rights and welfare of subjects.

h3. Who Should Read This Policy

This policy applies to personnel who propose and/or conduct research involving human subjects at Berkeley Lab, including the Protocol Lead Investigator(s) and any individuals having direct contact with human subjects.

h3. To Read the Full Policy, Go To:

[http://www.lbl.gov/Workplace/RPM/R10.09.html|http://www.lbl.gov/Workplace/RPM/R10.09.html]


h3. Contact Information

Human and Animal Regulatory Committee Office
[[email protected]|mailto:[email protected]]
(510) 486-5399
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| Title: | Conflict of Interest in Research --- Human Subjects |
| Publication date: | 1/2/2012 |
| Effective date: | 12/16/2010 |

h2. POLICY

Details of this policy have not yet been converted to the new format.
Please go to this page to find the details:

[http://www.lbl.gov/Workplace/RPM/R10.09.html|http://www.lbl.gov/Workplace/RPM/R10.09.html]



h3. Contact Information

Human and Animal Regulatory Committee
[[email protected]|mailto:[email protected]]
(510) 486-5399

h3. Revision History

| *Date* | *Revision* | *By whom* | *Revision Description* | *Section(s) affected* | *Change Type* |
| 1/2/2012 | 0 | Stoufer | Rewrite for wiki | all | Minor |
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h2. DOCUMENT INFORMATION

| Title: | Conflict of Interest in Research --- Human Subjects |
| Document number | 05.02.004.000 |
| Revision number | 0 |
| Publication date: | 1/2/2012 |
| Effective date: | 12/16/2010 |
| Next review date: | 1/2/2015 |
| Policy Area: | COI in Research |
| RPM Section (home) | Conflict of Interest |
| RPM Section (cross-reference) | 10.09 |
| Functional Division | Research and Institutional Integrity Office |
| Prior reference information (optional) | RPM Section 10.09 |

h3. Source Requirements Documents

* The U.S. Department of Health and Human Services, _Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subjects Protection_

h3. Implementing Documents

| *Document number* | *Title* | *Type* |
| | Declaration: Principal/Protocol Lead Investigator's List of Responsible Personnel Who Must File Disclosures of Financial Interest for Human Research (Form DFI-H1) | Form |
| | LBNL Positive Disclosure of Financial Interests (Form DFI-3) | Form |

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h2.
{builder-show:group=rpm2-admins}h2. ADDITIONAL INFORMATION

| Title: | Conflict of Interest in Research --- Human Subjects |
| Document number | 05.02.004.000 |
| Revision number | 0 |
| Publication date: | 1/2/2012 |
| Effective date: | 12/16/2010 |
| Next review date: | 1/2/2015 |
| Policy Area: | COI in Research |
| RPM Section (home) | Conflict of Interest |
| RPM Section (cross-reference) | 10.09 |
| Functional Division | Research and Institutional Integrity Office |
| Author name/contact info | M. Stoufer |
| | |
| Revision 0 publication date | 1/2/2012 |
| Retirement date | n/a |
| Prior reference information (optional) | RPM Section 10.09 |
| | |
| Inputs from more than one Functional Area? | No |
| List additional Functional Areas & contacts | |
| | |
| Inputs from more than one Policy Area? | No |
| List additional Policy Areas & contacts | |
| | |
| 30-day notification needed? | No |
| 30-day start date | n/a |
| 30-day end date | n/a |
| | |
| LDAP protected? | No |
| | |
| Need TABL reminders? | No |
| Frequency | n/a |
| Brief reminder text: | n/a |
| | |
| Approval Sheet for this revision received (date) \\
\[Note: author is responsible\} | |

h3. Key labels/tags:

* COI in Research
* Conflict of Interest

h3. New terms that need to be added to Glossary/Acronym list:

* (list items not found  and context (Policy Area name) -- full definition would be included in Policy)

h3. Implementing Documents restricted to department/functional use

(optional -- these will be used for tracing between requirements and associated documents)
| Document number | Title |
| | |
| | |
\\
\\  *Side bars:*
Side bar 1 location (cite by Policy Section # - for example: Section D.2.a)
Sidebar 1 text:
\\
Sidebar 2 location
Sidebar 2 text:
\\
Sidebar 3 location
Sidebar 3 text:

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