| IRB
Instruction Packet Revisions
This
special Edition of the R&SP Communicator is to announce
a new version of the IRB Instruction Packet, which includes all of the
IRB submission forms. Throughout the packet, new information and questions
have been added to address the new Health Insurance Portability and
Accountability Act (HIPAA) requirements. These, along with other specific
revisions are outlined below.
Because of the
need for new studies approved after April 14, 2003 (HIPAA effective
date) to comply with the new HIPAA regulations, this new packet is being
made available now. All new studies that will be submitted for approval
after April 14, 2003 must use these new forms. For those new studies
already submitted to the IRB for review, this will be made a provision.
Our office is in
the process of determining the appropriate use of the new summary safeguard
statement for on-going studies (e.g. for amendments and continuing reviews).
This policy will be announced in the near future. For now, if you are
submitting an amendment or a continuing review for an existing study
(one approved prior to April 14, 2003), it is acceptable to continue
using the (6/02) version of the summary safeguard statement. However,
once the policy has been established for the applicable use of the new
summary safeguard statement, it must be abided by.
We realize the
complexities of the new HIPAA requirements have resulted in many questions.
Please be assured that our office, along with the help of the HIPAA
task force and the Compliance Office within the School of Medicine are
working together to make the information as understandable as possible,
while still complying with the requirements.
For additional information
on HIPAA please visit - http://www.iupui.edu/~resgrad/hipaa/hipaa_menu.htm.
Specific revisions
include:
Section
III: Responsibilities of the Principal Investigator
Added sections include: Human Subjects Protection Test Requirement,
Reporting Protocol Deviations, and New Faculty in the Department
of Medicine.
Section
IV: Cooperating and Collaborating Investigators/Investigators
Added section includes: Definition of a Co-Investigator.
Section
VII: Additional Information
Added section includes: Scientific Review Committee.
Summary
Safeguard Statement:
| •
Section I |
Added
new HIPAA-related questions (e.g. determine if you are a covered
entity and whether you are using health information as part of your
research) |
| •
Section II |
Added IU Cancer
Center as a performance site |
| •
Section III |
Changed from
“Eligibility/Recruitment” to “Subject Population” |
| •
Section IV |
Changed from
“Subject Population” to “Recruitment.” More
detailed questions regarding recruitment (due to new HIPAA requirements)
have been added. |
| •
Sections V, VI, and VII |
Remain the
same |
| •
Section VIII |
Changed from
“Study Benefits” to “Confidentiality & Safeguards.”
More detailed questions regarding confidentiality and privacy of
data (due to new HIPAA requirements) have been added. |
| •
Section IX |
Changed from
“Risk-Benefit Ratio” to “Study Benefits.” |
| •
Section X |
Changed from
“Waiver of Informed Consent” to “Compensation.” |
| •
Section XI |
New Informed
Consent section to request waivers to the process. |
| •
Section XIII |
Changed to
“Authorization for the Use/Disclosure of Protected Health
Information.” This section was added to address the required
HIPAA authorization or waiver of authorization for a study. |
| •
Sections XIV, XV, XVI, XVII, XVIII, XIX and XX |
These sections
were in the previous version of the packet, but the section numbers
have changed due to the additional sections added. |
Informed
Consent Statement Checklist:
| •
Item 12 |
Clarification
of the required signatures |
Exempt Research
Checklist:
- Because of HIPAA
requirements, there are new categories that have been added. Please
read carefully to ensure the correct category is selected.
Expedited
Research Checklist:
- The signature
page has been removed. A signed Documentation of Review and Approval
will serve as the signature page for all Expedited studies.
New Forms/Templates:
- Checklist
to Determine if you are a Covered Entity or are Involving a Covered
Entity as Part of Your Research – (ref. Section I of summary
safeguard statement).
- Recruitment
Checklist – (ref. Section I of summary safeguard statement).
Required if you are a covered entity using health information to identify
or recruit potential subjects.
- Assent Template
– not mandatory, but recommended for minors 7-14 years of age.
- Protocol Deviation
Reporting Form – reporting form for certain protocol deviations.
Please refer to form for additional information.
Downloadable
IRB - Human Subjects Instruction Packets & Forms
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