Routing of Electronic Proposals
Electronic proposals
continue to be under the same guidelines as paper proposals and must receive
institutional review and approval prior to submission to the funding agency.
Electronic submissions take various
forms including preparation of the proposal directly on an agency's web site
or the electronic transmission of files. In all cases, the appropriate number
of paper copies for internal use should be routed through the department,
dean's office, and Research and Sponsored Programs (R&SP) with a Route
Sheet. Once approved, R&SP will either submit the proposal electronically
or notify the project director to proceed with the electronic submission.
Contact R&SP for instructions or guidance.
New IRB Guidelines Effective Concerning Participation by Non-Affiliated Investigators
in Research Protocol at IUPUI/Clarian
When a researcher is aware of or reasonably
anticipates that a study subject may have any aspect of protocol-specific
procedures provided or performed by an investigator not employed or otherwise
affiliated with IUPUI/Clarian (e.g., their local physician) AND that non-affiliated
investigator does not have local IRB approval for the protocol at their facility,
steps should be included to address this scenario within the body of the protocol
and in the summary safeguard statement before submission of the protocol to
the IRB. When the participation of a non-affiliated practitioner is not anticipated
prior to submission of the protocol to the IRB, the research will require
IRB approval by means of an amendment to the study which will, most often,
require full board IRB review before the non-affiliated physician may participate
in protocol-specific procedures. The amendment must specifically describe
what procedures will be performed by the non-affiliated investigator.
A specific, written agreement must be established
in advance with any non-affiliated investigator (a sample is provided in Attachment
A). The purpose of the agreement is to establish a record of the non-affiliated
investigator's acknowledgment of complete understanding of the protocol as
well as the specific obligations of his/her participation. This agreement
must be executed for each non-affiliated investigator who will be performing
protocol-specific procedures. In situations where a single non-affiliated
investigator will be performing different protocol-specific procedures on
more than one subject, an agreement (and amendment) must be filed for each
subject. The responsibility for obtaining this agreement lies with the principal
investigator. It is the responsibility of the principal investigator to 1)
provide a copy of the informed consent and protocol to the non-affiliated
investigator, 2) explain expectations, 3) obtain written agreement with the
non-affiliated investigator prior to allowing him/her to conduct any part
of the protocol, and 4) obtain IRB approval of this agreement prior to allowing
the non-affiliated investigator to conduct any part of the protocol.
Requirements of the study sponsor more stringent
than those enumerated above will supersede institutional guidelines (e.g.,
if the sponsor does not allow protocol procedures to be conducted away from
the institution, those restrictions will apply).
For those studies involving non-affiliated investigators
which were in existence prior to the enactment of these guidelines, at the
time of continuing review, the circumstances involving the non-affiliated
investigator must be explained and the procedures performed by the investigator(s)
must be delineated.
These guidelines will apply to studies which
qualify for full board review. Studies that qualify for exempt or expedited
status will be reviewed on a case-by-case basis to determine if these guidelines
should apply.
Non-Affiliated Investigator Agreement
Name of Non-Affiliated Investigator: (hereafter
known as "Investigator")
Name of IUPUI/Clarian Principal Investigator: (hereafter known as "PI")
Name of Institution Providing IRB Oversight: Indiana University-Purdue University,
Indianapolis (IUPUI)/Clarian Health Partners
OHRP Federalwide Assurance Number or MPA Number: M1167
Research Covered Under This Agreement (Note: Please include the IRB study
number and explain what protocol specific procedures will be performed by
this investigator):
1. The above-named Investigator has reviewed
the Belmont Report: Ethical Principles and Guidelines for the Protection
of Human Subjects of Research, the U.S. Department of Health and Human Services
(DHHS) regulations for the protection of human subjects at 45 CFR 46, the
Food and Drug Administration (FDA) regulations for the protection of human
subjects at 21 CFR 50, the Assurance referenced above, and the relevant
institutional policies and procedures for the protection of human subjects.
2. The Investigator understands and hereby
accepts the responsibility to comply with the standards and requirements
stipulated in the above documents and to protect the rights and welfare
of human subjects involved in research conducted under this Agreement.
3. The Investigator will comply with all other
National, State, or local laws or regulations that may provide additional
protection for human subjects.
4. The Investigator will abide by all determinations
of the IUPUI/Clarian IRB designated under the above Assurance and will accept
the final authority and decisions of the IUPUI/Clarian IRB, including but
not limited to directives to terminate participation in designated research
activities.
5. The Investigator will complete any training
required by the IUPUI/Clarian IRB prior to initiating research covered under
this Agreement.
6. The Investigator will report promptly to
the PI who will then report to the IUPUI/Clarian IRB proposed changes in
the research conducted under this Agreement. The investigator will not initiate
changes in the research without prior IRB review and approval, except where
necessary to eliminate apparent immediate hazards to subjects.
7. The Investigator will report immediately
to the PI who will immediately report to the IUPUI/Clarian IRB any unanticipated
problems in research covered under this Agreement that involve risks to
subjects or others.
8. The Investigator will seek, document, and
maintain records of informed consent from the subject or the subject's legally
authorized representative as required under HHS regulations (or other international
or national equivalent) and stipulated by the IUPUI/Clarian IRB.
9. The Investigator acknowledges and agrees
to cooperate with the PI in IUPUI/Clarian's responsibility for initial and
continuing review, record keeping, reporting, and certification. The Investigator
will provide all information requested by the PI and IUPUI/Clarian IRB in
a timely fashion.
10. In conducting research involving FDA-regulated
products, the investigator will comply with all applicable FDA regulations
and fulfill all investigator responsibilities (or investigator-sponsor responsibilities,
where appropriate), including those described at 21 CFR 312 and 812.
11. The investigator will not enroll subjects
in research under this Agreement or perform any protocol specific procedures
prior to its review and approval by the IUPUI/Clarian IRB.
12. Emergency medical care may be delivered
without IRB review and approval to the extent permitted under applicable
Federal regulations and State law. However, such medical care may not be
included as part of Federally supported research.
13. This Agreement does not preclude the investigator
from taking part in research not covered under the Agreement
14. The investigator acknowledges that her/his
primary responsibility is to safeguard the rights and welfare of research
subjects, and that the subjects' rights and welfare must take precedence
over the goals and requirements of the research.
Signatures:
Non-Unaffiliated Investigator __________________________Date
IUPUI/Clarian Principal Investigator _____________________Date
IUPUI/Clarian IRB Institutional Official: ___________________Date
U.S. GOVERNMENT AGENCIES ARE SEARCHING FOR EXPERTS
This variance of opinion indicates the need to
gather together the best scientists. Even President Bush ordered Ridge and
others to get the facts and solve the problem fast according to the article.
Not coincidentally, an increasing number of government
agencies have been turning to COS to find experts. COS enables these agencies
to identify and contact the most capable individuals. Can they find you?
As a member of Community of Science, this is
the ideal time to update your COS Expertise profile. Encourage your staff
and colleagues to do the same. Include appropriate keywords and your most
recent research and publications to take advantage of emerging opportunities
and help government officials find you and your faculty.
If you need any assistance in locating funding
or in updating your COS profile, contact Ann Kratz, the COS liaison at IUPUI.
She can be reached at 278-0249, by e-mail akratz@iupui.edu,
or stop in to see her in UL 1140.
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Research and Sponsored
Programs
UN 618
General - 274-8285
Research Compliance - 274-8289
Sponsored Program Development - 278-0249
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