ATTACHMENT I

RESEARCH INVOLVING VIABLE NEONATES, NEONATES OF UNCERTAIN VIABILITY OR NON-VIABLE NEONATES

COMIRB #: Approval Stamp here:

Principal Investigator:

Protocol Title:

Version date:

VHA Regulations: Research in which the subject is a fetus, in-utero or ex-utero (including human fetal tissue) must not be conducted by VA investigators while on official duty, or at VA facilities, or at approved off-site facilities.

Definition: Neonates are defined as birth to 30 days of age

I. All Neonates:

Section A

1)  What is the reason for including neonates?

Describe:

2)  What are the risks to the neonate from being enrolled in this study?

Describe:

3)  What are the benefits to the neonate from being enrolled in this study?

Describe:

4)  Describe scientifically appropriate, pre-clinical and clinical studies have been conducted and provide data for assessing potential risks to neonates:

Describe:

5)  Describe who will obtain parental permission, their level of experience and understanding of the potential impact of the research on the neonate:

Describe:

6)  Will individuals engaged in the research have any part in determining the viability of a neonate?

Yes No N/A

If yes, describe:

7)  Will neonates that have been determined to be viable be included in the

study? Yes No

[Viable, as it pertains to the neonate, means being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration. ]

If yes, then attachment for the research involving children [Attachment H] must also be completed.

II. Does the proposed research involve neonates of uncertain viability?

Yes No

If yes, answer all questions in section B

Section B.

1)  To enroll neonates of uncertain viability, either (a) or (b) must be satisfactorily met, along with (c):

a. Describe why the research holds out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective:

Describe:

b. Justify why the study is important in the development of important biomedical knowledge that cannot be obtained by any other means:

Describe:

And

c. Justify why there will be no added risk to the neonate resulting from the research:

Describe:

2)  Describe the consent process:

Note: The legally effective informed consent of either parent of the neonate or, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent of either parent’s legally authorized representative is required, except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.

III. Does the proposed research involve non-viable neonates? Yes No

[Nonviable neonate means a neonate after delivery that, although living, has futility of care concerns. Examples of futility of care are lethal congenital genetic defects, extreme prematurity or other lethal abnormalities.]

If yes, answer all questions in section C

Section C

1)  Will vital functions of the neonate be artificially maintained? Yes No

If yes, non-viable neonates may not be enrolled.

2)  Will the research or interventions terminate the heartbeat or respiration of the neonate? Yes No

If yes, non-viable neonates may not be enrolled.

3)  Will there be any added risk to the neonate resulting from the research?

Yes No

If yes, non-viable neonates may not be enrolled.

4)  Describe how the research will potentially lead to the development of important biomedical knowledge that cannot be obtained by other means:

5)  Describe the consent process:

Describe:

Note: Consent can not be waived. The legally effective informed consent of both parents of the neonate is required. However, if either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the informed consent of one parent of a non-viable neonate will suffice; also, the consent of the father need not be obtained if the pregnancy resulted from rape or incest. The consent of a legally authorized representative of either or both parents of a non-viable neonate will not suffice.

Attachment I: Research Involving Viable Neonates, Page 1 of 3

Neonates of Uncertain Viability or Non-Viable Neonates

CF-121, Effective 8/22/11