Attachment P

Naval research protocol documentation for "Rapid diagnosis and
treatment of bacterial meningitis," including participant consent
forms, October 10, 1979


			FOR REFERENCE SEE (5bb02)

			        FORM


				   1


			   RECOMMENDATION OF
		COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS

PRINCIPAL INVESTIGATOR: Girgis, N.I., M.D.

TITLE OF RESEARCH PROJECT: Rapid diagnosis and treatment of
Bacterial meningitis

RECOMMENDATION: APPROVE: DISAPPROVE

In our opinion the protocol and safeguards described on the
attached application are adequate to meet the standards of 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 risk
involved.

Investigator: (Signature) Date:

Department Head: (Signature) Date:

Initial Review by the Committee Date:

Periodic Review by the Committee Date:

Research extended beyond two years Date:

Comments: The committee finds this study meets or exceeds the
standards of Medical Care of this community and is not in
conflict with the laws, customs and practices of the Host
Country.

Committee Members: Signatures:

CDR M.E. Kilpatrick, MC, USN

LCDR Henrik V. Petersen, MSC, USN

HM1 L.E. Houseworth, USN

Dr. Nabil Ayad El-Masry

Chairman of Committee
US Naval Medical Research Unit #3
FPO, New York 09527

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CONSENT FOR ENTRY INTO STUDY

NAMRU-3 MENINGITIS WARD
ABBASSIA FEVER HOSPITAL
CAIRO, EGYPT

I understand that I/NAME OF PATIENT have the signs and symptoms
of meningitis (infection about the brain) and require(s)
admission to the NAMRU-3 Meningitis Ward of the Abbassia Fever
Hospital.

I freely agree to the routine collection of blood, cerebrospinal
fluid, urine, stool, or sputum from myself/ NAME OF PATIENT as
may be deemed necessary in the judgement of the medical staff. I
understand that special studies may be made upon these specimens
in order to diagnose the specific cause of the meningitis. I
understand that these studies will pose no risk or discomfort to
me/ NAME OF PATIENT I also understand that my refusal or
subsequent withdrawal of consent to have these special studies
done on the specimens collected will in no way jeopardize or
adversely affect / NAME OF PATIENT medical care. I understand
that anonymity of patients in the study will be respected in any
presentations or publications of the study results.

PATIENT'S SIGNATURE

SIGNATURE OF RELATIVE RELATIONSHIP

Consent given by family member due to patient's being incapable
of giving consent because of illness.

I certify that this statement has been read to the patient and
the patient's family and understood by them. I certify that
verbal agreement with this consent form has been freely given by
the patient/patient's family member(s).

PARTICIPANT CONSENT

I understand that I was admitted to the NAMRU-3 Meningitis
Ward-Abbassia Fever Hospital because I appeared to have
meningitis. Dr. has explained to me that tests show or indicate I
have tuberculous meningitis and I will receive the standard three
antitubercular antibiotics (isoniazid, streptomycin, and
ethambutol). I have also been told that steroids are sometimes
used in this disease but it is not known if they are helpful. I
agree to participate in a study randomizing the use of steroids.
I will/will not receive steroids.

I understand that this study poses no known risks to me, that I
am free to withdraw from the study at any time without
prejudicing my medical care, and that I will remain anonymous in
any presentations or publications of data from this study.

I also agree to have the following special procedure done:

The risks
have been explained to me and I freely give my consent.

SIGNATURE OF PATIENT

I certify that this statement has been read to the patient and/or
his family and verbal agreement has been freely given.

Signature           Position