Exemption Form Cpr-esr

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 1. 2.

3.

Title of Project: Principal Investigator: Department: Phone / Pager: Fax: Email address: Mail Code or Off-Site Address: Location of Study:

"Outcomes of Cardiopulmonary Resuscitation in William Beaumont Hospital and the Influence of Patients' Comorbidities on the Outcome" Adrian Dumitrascu, MD Internal Medicine 248 992 2232 [email protected] 100RO ✘

WBH - RO Other*

WBH - Troy

WBH GP

Physician Offices*

*Provide name and address of non-Beaumont hospital local facilities where research will be performed:

Section B: Type of Research Review Requested

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Form Date: 01/31/08

Study Title:

4.

5.

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 ✘ None Please check what information can be shared PI Name or listed on the HIC website. Study Title Brief Description

Section C: Study Description 6. 7.

Date of expected study completion: State funding source:

April 2009 ✘

None

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Form Date: 01/31/08

Study Title: 8.

9.

10 . 11 . 12 . 13 .

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 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. 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. 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. Is data collection tool template NO – Explain: ✘ YES attached: If using identifiers initially in The cases will be assigned random research ID numbers. The identifiers will be stored separately and linked to the deorder to extract de-identified identified data through an identifier key. The identifier key data, describe how the initial list will be kept secure and will be available only with the will be destroyed: 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.

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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 (Alphabetize by Last Name)

Adrian Dumitrascu

Department

Internal Medicine

Division*

% of Time**

01

Resear ch Role PI

CITI or NIH*** Training Yes/No yes

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.

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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.

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Form Date: 01/31/08