Attachment Q

Application to and recommendations of the Navy Committee for
Protection of Human Subjects including consent statement,
November 15, 1980.

RECOMMENDATIONS OF THE
COMMITTEE FOR PROTECTION OF HUMAN SUBJECTS

PRINCIPAL INVESTIGATOR: HENDERSON, J. V., LCDR, MC, USN

TITLE OF RESEARCH PROJECT: Diagnostic aids aboard submarines:
biochemical evaluation of acute myocardial infarction

In our opinion, the protocol and safeguards described on the
attached application are adequate to meet the standards of the U.
S. Navy in regard to experiments utilizing people; namely that
the rights and welfare of individuals will be respected, that the
individuals or those responsible for their care have given their
informed consent, and that potential benefits outweigh any risks
involved.

Investigator: Date:

Department Head: Date:

Review by the Committee:

Recommendation: Approve Disapprove

Chairman of the Committee (Signature) Date

LT MC USN, Naval Undersea Medical Institute
NAVSUBASE NEW LONDON, GROTON, CT 06349
CDR, MSC, USN Optometrist, NSMRL

CAPT, CHC, NAVSUBASE NEW LONDON

LCDR, JAGC, NAVSUBASE NEW LONDON

APPLICATION TO COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS

I. PRINCIPAL INVESTIGATOR: Joseph V. Henderson MC USNR
Environmental Medicine
NAVSUBMEDRSCHLAB

ASSOCIATE INVESTIGATOR: Donald V. Tappan, PhD
Biochemistry Department
NAVSUBMEDRSCHLAB

II. TITLE OF RESEARCH PROJECT: Diagnostic aids aboard submarines:
biochemical evaluation of acute myocardial infarction

III. LOCATIONS WHERE STUDIES WILL BE PERFORMED: At one or more of
the following places
NRMC, San Diego, CA
NRMC, Portsmouth, VA
NRMC, Bethesda, MD

IV. A. HAS THIS PROJECT BEEN SUBMITTED FOR APPROVAL TO
COMMITTEE(S) FOR THE PROTECTION OF HUMAN SUBJECTS AT OTHER
INSTITUTIONS CONCERNED?

No

B. DISPOSITION BY OTHER COMMITTEE(S): N/A

V. APPROXIMATE DATES OF RESEARCH: FROM: 7807 to 8006

VI. DESCRIPTION OF RESEARCH.

1. a. BACKGROUND: Although myocardial infarction (MI) occurs
rarely aboard nuclear submarines, incidence of evacuation for
"rule-out" MI is relatively high. The criteria by which the
American Heart Association and the World Health Organization
diagnose acute MI require two of the following: typical signs and
symptoms, typical ECG changes, and typical cardiac enzyme
elevations. Since submarines have neither ECG nor serology,
corpsmen faced with a patient having acute chest pain cannot
establish a diagnosis of MI. At the Naval Submarine Medical
Research Laboratory we have developed a kit for performance of
Creatine Phosphokinase-MB (CPK-MB) isoenzyme determination aboard
a patrolling submarine. This enzyme specifically reflects
myocardial damage and is elevated 4 to 8 hours after MI.

Preliminary results indicate that the kit is compatible with the
environment of deployed submarines, can be accurately performed
without special training by members of the crew, and can be used
by submarine corpsmen in decreasing evacuations for suspected MI.
Now we intend to validate the system clinically by having Navy
corpsmen perform the assay on sera of patients admitted to Naval
Coronary Care Units for possible MI.

b. SUBJECTS: Subjects will be patients admitted to Coronary Care
Units (CCU) at one or more Naval hospitals.

c. PROCEDURE: From each of the patients admitted to Coronary Care
Units (CCU) at selected Naval hospitals with a provisional
diagnosis of acute MI, a 7 ml blood sample will be obtained at
the time of CCU admission, along with routinely drawn blood
samples, (The patient will be told that this sample will be used
for research.) Using the CPK kits, determination of CPK-MB will
be performed on each sample by a paramedic in the CCU. For each
patient, results of this assay will be compared with the standard
gel electrophoresis assay performed in the hospital's main
laboratory. A sample of 100 patients is desired. CCU staff will
not participate, <unreadable word> avoiding any effect on patient
care.

d. STRESSES: The only physical or psychological stress to the
patient is the one accompanying venipuncture. Since blood
sampling is a routine part of diagnosis and since the additional
blood sample is obtained with little or no increase in time or
discomfort, stresses of the procedure are considered minimal.

2. BENEFITS: Although this study will be of no immediate benefit
to the subject, it will help establish the validity of a
procedure designed to reduce unnecessary evacuation from
patrolling nuclear submarines. Avoiding such evacuations saves
money, avoids risks of evacuations, and preserves national
defense.

3. RISKS: Venipuncture is a routine part of patient work-up and
constitutes minimal risk to the patient. This study contributes
virtually no additional risk to the patient.

4. CONSENT: Informed consent will be oral or written or third
party. Oral consent is subject to all of the same standards that
apply to written consent, except that the signature of the
subject is not required. Where oral consent is used, the protocol
must specifically so indicate and provide adequate justification
for its use. Third party consent (i.e., that given by parents,
legal guardian, next of kin, or other legally authorized third
party representatives) may be used only when the respective human
subjects is incapable of giving informed consent.

5. PRIVACY: There will be no greater intrusion into the privacy
of subjects than is absolutely necessary for the conduct of the
study. No information, responses, data, specimens or other
matters will be solicited which are not pertinent to the
experiment. Investigators will employ at all times physical and
procedural safeguards to preclude the inadvertent or unauthorized
disclosure of all notes, diaries, logs, specimens and records or
other repositories of information. No information will be
released to others by the investigators without the authority of
the Commanding Officer, Naval Submarine Medical Research
Laboratory.

6. DE-VOLUNTEERING: The subject will be specifically informed via
the Consent Form that he may quit his participation in the
project at any time without prejudice to himself.

7. CHANGES: No changes are foreseen. The committee will be
informed if any changes are planned.

CONSENT STATEMENT

(Date)

From: Commanding Officer, Naval Submarine Medical Research
Laboratory

To:

Subj: Consent to participate voluntarily in an experiment

Encl: (1) Details of experiment
(2) Subject's inquiries (if any) and responses
(3) Privacy Act Statement

1. I hereby volunteer to participate as a subject in an
experiment entitled "Diagnostic aids aboard submarines:
biochemical evaluation of acute myocardial infarction."

2. Details of the experiment, which are described in enclosure
(1), have been explained to me. The explanation has included:

a. a description of the procedures to be followed and their
purposes, including identification of any procedures which are
not experimental.

b. a description of expected benefits; and

c. a disclosure of any alternative procedures that might be
advantageous to me.

3. My consent is given as an exercise of free will, without force
or duress of any kind. Any inquiries I have concerning the
experiment and the answers provided are recorded in enclosure
(2). I understand that I will be free to withdraw my consent and
discontinue my participation at any time without prejudice to
myself. In making my decision to volunteer, I am not relying upon
any information or representation not set forth in this statement
or in the enclosures thereto.

4. A Privacy Act Statement has been signed and is attached as
enclosure (3).

(Signature)

(Type name, grade, or rank)

(Date of birth)

(Signature of witness) This should be a person not directly
involved in the experiment.

INFORMATION FOR SUBJECTS

1. Procedure:

Upon your admission to the Coronary Care Unit, a 7 ml venous
blood sample will be taken along with routinely drawn blood
samples. This sample will be used for research to evaluate the
performance of a newly developed kit to identify an indicator of
a heart attack. This kit will be used by Navy hospital corpsmen
aboard patrolling submarines.

The only physical or psychological stress for you is the one
accompanying venipuncture. Since blood sampling is a routine part
of diagnosis and since the additional blood sample is obtained
with little or no increase in time or discomfort, stresses of the
procedure are considered minimal.

2. Benefits:

Although this study will be of no immediate benefit to you, it
will help establish the validity of a procedure designed to
reduce unnecessary evacuation from patrolling nuclear submarines.
In recent years misdiagnosed heart attack has resulted in costly
and unnecessary evacuations.

3. Risks:

Venipuncture is a routine part of patient work-up and constitutes
minimal risk to you.

4. Consent:

Informed consent will be oral or written or third party. Oral
consent is subject to all of the same standards that apply to
written consent, except that your signature is not required.
Where oral consent is used, the protocol must specifically so
indicate and provide adequate justification for its use. Third
party consent (i.e., that given by parents, legal guardian, next
of kin, or other legally authorized third party representatives)
will be used only when you are incapable of giving informed
consent. A copy of the consent form is attached.

5. Privacy:

There will be no greater intrusion into your privacy than is
absolutely necessary for the conduct of the study. No
information, responses, data, specimens or other matters will be
solicited which are not pertinent to the experiment.
Investigators will employ at all times physical and procedural
safeguards to preclude the inadvertent or unauthorized disclosure
of all notes, diaries, logs, specimens and records or other
repositories of information. No information will be released to
others by the investigators without the authority of the
Commanding Officer, Naval Submarine Medical Research Laboratory.

6. De-volunteering:

SUBJECT'S INQUIRIES AND RESPONSES

NAME OF SUBJECT:

RANK OR RATE: SSN:

TITLE OF EXPERIMENT: Diagnostic aids aboard submarines:
biochemical evaluation of acute myocardial infarction

DATE OF INQUIRIES:

PLACE INQUIRIES MADE:

NAME AND TITLE OF PERSON RESPONDING TO INQUIRIES:

SUBSTANCE OF INQUIRIES AND ASSOCIATED RESPONSES TO THESE
INQUIRIES (IN ORDER)

PRIVACY ACT STATEMENT

FOR EXPERIMENT ENTITLED: Diagnostic aids aboard submarines:
biochemical evaluation of acute myocardial infarction

1. AUTHORITY FOR COLLECTION OF INFORMATION INCLUDING SOCIAL
SECURITY NUMBER: 10 USC 5131 and 5132; 5 USC 301, Departmental
Regulations.

2. PRINCIPAL PURPOSE(S): To perform research studies and compile
statistical data.

3. ROUTINE USE(S): Officials and employees of the Department of
the Navy and other components of the Department of Defense in the
performance of their official duties relating to performance of
research studies and compilation of statistical data.

4. MANDATORY/VOLUNTARY DISCLOSURE, CONSEQUENCES OF REFUSAL TO
DISCLOSE INFORMATION: Disclosure of requested information,
including social security number, is voluntary. There are no
adverse consequences for refusing to provide requested
information, including social security number.

WITNESSED:                 RECEIPT OF PRIVACY ACT STATEMENT 
                                       ACKNOWLEDGED