William Beaumont Hospital Request for HIC Exemption Status

Human Investigation Committee Phone: (248) 551-0662 Fax: (248) 551-2884 Mail Code: 104 RBS

ALL HIC SUBMISSION FORMS MUST BE TYPEWRITTEN

Section A: Project Identification

Title of Project: "Outcomes of Cardiopulmonary Resuscitation in William Beaumont Hospital
1.
and the Influence of Patients' Comorbidities on the Outcome"
Principal Adrian Dumitrascu, MD
2.
Investigator:
Department: Internal Medicine
Phone / Pager: 248 992 2232
Fax:
Email address: adumitrascu@beaumont.edu
Mail Code or 100RO
Off-Site Address:
Location of Study: ✘ WBH - RO WBH - Troy WBH GP Physician Offices*
3.
Other*
*Provide name
and address of
non-Beaumont
hospital local
facilities where
research will be
performed:

Section B: Type of Research Review Requested

Page 1 of 5 Form Date: 01/31/08

Study Title:

4. Check the applicable category(s) for exemption:

Category 1: Research conducted in established or commonly accepted educational
settings, involving normal educational practices, such as (i) research on regular
and special education instructional strategies, or (ii) research on the effectiveness
of or the comparison among instructional techniques, curricula, or classroom
management methods.
Category 2: Research involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures or observation
of public behavior, where information obtained is recorded in such a manner that
human subjects cannot be identified, directly or through identifiers linked to the
subjects AND disclosure will not be damaging to subject (place subject at risk of
criminal or civil liability, damage financial standing, reputation, etc).
NOTE: If children are participants in the research and there is to be
interaction with them, a research exemption will NOT apply.
Category 3: Research involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures, or observation
of public behavior that is not exempt under item (2) of this section, if: (i) the
human subjects are elected or appointed public officials or candidates for public
office; or (ii) federal statute(s) require(s) without exception that the confidentiality
of the personally identifiable information will be maintained throughout the
research and thereafter.
✘ Category 4: Research involving the collection or study of existing data, documents,
records, pathological specimens, or diagnostic specimens, if these sources are
publicly available or if the information is recorded by the investigator in such a
manner that subjects cannot be identified, directly or through identifiers linked to
the subjects.
Category 5: Research and demonstration projects which are conducted by or
subject to the approval of department or agency heads, and which are designed to
study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii)
procedures for obtaining benefits or services under those programs;(iii) possible
changes in or alternatives to those programs or procedures; or (iv) possible
changes in methods or levels of payment for benefits or services under those
programs.
Category 6: Taste and food quality evaluation and consumer acceptance studies, (i)
if wholesome foods without additives are consumed or (ii) if a food is consumed
that contains a food ingredient at or below the level and for a use found to be
safe, or agricultural chemical or environmental contaminant at or below the level
found to be safe, by the Food and Drug Administration or approved by the
Environmental Protection Agency or the Food Safety and Inspection Service of the
U.S. Department of Agriculture
5. Please check what ✘ None

information can be shared PI Name

or listed on the HIC website. Study Title
Brief Description

Section C: Study Description

6. Date of expected study April 2009
completion:
7. State funding source: ✘ None

Page 2 of 5 Form Date: 01/31/08

Study Title:

8. State study objectives and/or endpoints:

- to determine the immediate outcome and the outcome at discharge from the hospital of the patients that
sustained a cardiopulmonary arrest and were resuscitated in the Royal Oak William Beaumont Hospital.
- to compare the CPR outcome of the patients that were treated according to the old ACLS guidelines
versus the outcome of the patients that were treated using the new ACLS guidelines introduced in 2005
- to evaluate how the patients' comorbidities influence the CPR outcome
- to evaluate if the level of training of the CPR team leader has a influence on the outcome
9. Describe study methodology:
Computer records and paper charts of the patients that had a cardiopulmonary arrest will be reviewed
and the information regarding patients' comorbidities, the course of the CPR process and the outcome
will be recorded. Using statistical analysis will attempt to note any statistically significant correlations
between comorbidities and outcome, between the CPR team leader level of training and the outcome.
10 Describe study population and state sample size:
. - all the patients that had a cardiopulmonary arrest that required CPR startind from September 2004
and untill present.
11 Describe Data source: (e.g. chart review; anonymous survey; use of existing* data,
. films, "waste" blood, urine or tissue samples). *Existing at time of submission
Paper chart and HDS records, charted CPR records review.
12 Is data collection tool template NO – Explain:
. attached: ✘ YES

13 If using identifiers initially in
. order to extract de-identified
data, describe how the initial list
will be destroyed:
The cases will be assigned random research ID numbers. The
identifiers will be stored separately and linked to the de-
identified data through an identifier key. The identifier key
will be kept secure and will be available only with the
permission of the primary investigator. After the data
collection will be completed the identifiers will be destroied. All
the hard copies will be shredded and all the date storage will
be erased with erasing software that will overwrite the storage
memory to prevent any data recovery.

Page 3 of 5 Form Date: 01/31/08

Study Title:

Section D: Key Personnel

* Division 01 = R.O. Hospital Employee, 02 = Troy Hospital Employee , 03= Grosse Pointe Employee,
08 = Research Employee

**For non-division 08 staff members only- Percentage of time during pay period spent on project

*** Physicians who have completed NIH Human Subjects Protection Training prior to 12/31/05 are not required to
complete CITI until July 1, 2009

Name D Department Division* % of Resear CITI

(Alphabetize by Last Name) Time** ch or
Role NIH***
Training
Yes/No
Adrian Dumitrascu Internal 01 PI yes
Medicine

Section E: Acceptance and Required Signatures

Principal Investigator Assurance

I assure that data will be maintained in a manner that cannot be linked by
identifiers to patients, either directly or indirectly (i.e. data abstracted from records,
samples or images must not include patient name, hospital I.D. number, or any other
information that would directly or indirectly link the abstracted information back to the study
subject), and that all regulations, policies and rules will be followed.

Signature Principal Investigator Printed name Title Date

Research Nurse Manager Signature (If you do not have a research nurse
manager for your department, please contact the Research Institute for sign off).
In signing the description of this research project, I have reviewed the project and am aware of
the budget considerations of this project.

Signature of Research Nurse Manager Printed name Title Date

Departmental Chairperson Signature

Note: If the Department Chairperson is also an Investigator, the signature of a related
Department Chair must be secured. The signature of the Department Chairperson, and
Divisional Chair if applicable, are required prior to application approval.

Page 4 of 5 Form Date: 01/31/08

Study Title:

I have reviewed the project and believe that the benefits outweigh the potential risks. I
consider it a suitable research project for this Department. Appropriate support will be
provided for the research project including adequate facilities and staff, and appropriate
scientific and ethical oversight has been and will be provided. If I become aware of any
information regarding the suitability of this research project, I will immediately notify the
Human Investigation Committee Chairman.

Signature of Departmental Chairperson Printed name Title Date

Directions for Protocol Submission:

Submit one copy of: the Request for HIC Exemption Status, the full protocol (if applicable), all survey
tool(s), data collection form(s), HIC Research Waiver of Authorization (if applicable) and updated CV(s)
for all key personnel (if applicable). There are no submission deadlines for Exempt Review requests.

Page 5 of 5 Form Date: 01/31/08