INTRODUCTION

We invite you to take part in a research study at the National
Institutes of Health (NIH).

First, we want you to know that:

Taking part in NIH research is entirely voluntary.

You may choose not to take part, or you may withdraw from the study at
any time. In either case, you will not lose any benefits to which you
are otherwise entitled. However, to receive care at the NIH, you must be
taking part in a study or be under evaluation for study participation.

You may receive no benefit from taking part. The research may give us
knowledge that may help people in the future.

Second, some people have personal, religious or ethical beliefs that may
limit the kinds of medical or research treatments they would want to
receive (such as blood transfusions). If you have such beliefs, please
discuss them with your NIH doctors or research team before you agree to
the study.

Now we will describe this research study. Before you decide to take
part, please take as much time as you need to ask any questions and
discuss this study with anyone at NIH, or with family, friends or your
personal physician or other health professional.

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# INSERT CONSENT FORM TEXT HERE

# Please refer to "NHGRI IRB Guide to Writing Consent Forms" for suggested section headings and text @ http://www.genome.gov/10005807

> **CONFLICTS OF INTEREST**

The National Institutes of Health reviews NIH staff researchers at least
yearly for conflicts of interest. The following link contains details on
this process:
<http://ethics.od.nih.gov/forms/Protocol-Review-Guide.pdf>. You may ask
your research team for additional information or a copy of the Protocol
Review Guide.

As part of your participation in this study, it will be necessary to
test your blood for the presence of antibodies to the Human
Immunodeficiency Virus (HIV), the virus that causes Acquired Immune
Deficiency Syndrome (AIDS). In order to perform the test, a small amount
of blood (approximately 2 teaspoons) will be withdrawn from one of your
arms with a needle. You may experience some slight discomfort at the
needle entry site and there may be some bruising. In addition, there is
a very small risk of you fainting or of infection at the needle entry
site. If your test results are found to be positive, or if you are
otherwise diagnosed as having AIDS, you should be aware of the following
Clinical Center HIV Testing Policy:

1\. Your physician will notify you promptly of the HIV test results.

2\. Your physician and/or the Clinical Center HIV counselor will offer
you, and any current and/or ongoing sexual partner(s) (spouses are
generally considered to be current or ongoing sexual partners) or
needle-sharing partner(s) you identify, information on the meaning of
the test results and how to prevent the spread of the infection.

3\. Because the virus may be transmitted in several ways, it is
important that you inform sexual and/or needle-sharing partner(s) that
any, or all, of them may have been exposed to the HIV virus and
encourage them to be tested. If you request it, staff at the Clinical
Center will assist you in notifying your partner(s) and arrange
counseling for them through an HIV counselor.

4\. The results of your HIV test and/or documentation of the diagnosis
of AIDS will become a part of your Clinical Center medical record and,
as such, will be protected from unauthorized disclosure by the Federal
Privacy Act of 1974. In general, access to your medical record will be
restricted to those health care professionals directly involved in your
care or in the conduct of ongoing biomedical research, and information
is not usually released to other third parties without your permission
or that of your designated representative. However, there are some
particular routine uses of such information of which you should be
aware.

> a\. If you are unwilling or unable to notify your partner(s), the
> Clinical Center is responsible for attempting to contact and inform
> them of their possible exposure to the virus. Reasonable attempts will
> be made to protect your identity including withholding your name when
> notifying any partner(s) of their possible exposure. Some notification
> or counseling of current and/or ongoing partners may be carried out
> through arrangements with, or referral to, local public health
> agencies.
>
> b\. A summary of your care at the Clinical Center will be sent to the
> physician who referred you here for treatment.
>
> c\. The Clinical Center may report certain communicable diseases, such
> as HIV infection, to appropriate State and Federal government
> agencies.
>
> i\. For Clinical Center patients who are Maryland residents, the
> Clinical Center reports by "Patient Unique Identifier Number" (rather
> than by name) newly obtained HIV-positive results from its laboratory
> to the Maryland Department of Health and Mental Hygiene. Patient
> Unique Identifier Number is: last four digits of social security
> number, birth month, birth day, birth year, race and gender.
>
> ii\. For Clinical Center patients who are Maryland residents, the
> Clinical Center reports by name new cases of AIDS to the Maryland
> Department of Health and Mental Hygiene.

iii. For Clinical Center patients who are not Maryland residents, the
     Clinical Center reports

> HIV-positive results and/or AIDS to the patient's primary
> care/referring physician.

If you have any questions regarding the HIV testing or the information
provided above, you are encouraged to discuss them with your physician
and/or a Clinical Center HIV counselor: (301) 496-2381.

**OTHER PERTINENT INFORMATION**

**1. Confidentiality.** When results of an NIH research study are
reported in medical journals or at scientific meetings, the people who
take part are not named and identified. In most cases, the NIH will not
release any information about your research involvement without your
written permission. However, if you sign a release of information form,
for example, for an insurance company, the NIH will give the insurance
company information from your medical record. This information might
affect (either favorably or unfavorably) the willingness of the
insurance company to sell you insurance.

The Federal Privacy Act protects the confidentiality of your NIH medical
records. However, you should know that the Act allows release of some
information from your medical record without your permission, for
example, if it is required by the Food and Drug Administration (FDA),
members of Congress, law enforcement officials, or other authorized
people.

**2. Policy Regarding Research-Related Injuries.** The Clinical Center
will provide short-term medical care for any injury resulting from your
participation in research here. In general, no long-term medical care or
financial compensation for research-related injuries will be provided by
the National Institutes of Health, the Clinical Center, or the Federal
Government. However, you have the right to pursue legal remedy if you
believe that your injury justifies such action.

**3. Payments.** The amount of payment to research volunteers is guided
by the National Institutes of Health policies. In general, patients are
not paid for taking part in research studies at the National Institutes
of Health.

**4. Problems or Questions.** If you have any problems or questions
about this study, or about your rights as a research participant, or
about any research-related injury, contact the Principal Investigator,
.; Building 10, Room , Telephone: .

You may also call the Clinical Center Patient Representative at
301-496-2626.

**5. Consent Document.** Please keep a copy of this document in case you
want to read it again.

+-------------------------------+------------------------------+---+------+
| **COMPLETE APPROPRIATE        |                              |   |      |
| ITEM(S) BELOW:**              |                              |   |      |
+-------------------------------+------------------------------+---+------+
| **A. Adult Patient's          | **B. Parent's Permission for |   |      |
| Consent**                     | Minor Patient.**             |   |      |
+-------------------------------+------------------------------+---+------+
| I have read the explanation   | I have read the explanation  |   |      |
| about this study and have     | about this study and have    |   |      |
| been given the opportunity to | been given the opportunity   |   |      |
| discuss it and to ask         | to discuss it and to ask     |   |      |
| questions. I hereby consent   | questions. I hereby give     |   |      |
| to take part in this study.   | permission for my child to   |   |      |
|                               | take part in this study.     |   |      |
|                               |                              |   |      |
|                               | (Attach NIH 2514-2, Minor's  |   |      |
|                               | Assent, if applicable.)      |   |      |
+-------------------------------+------------------------------+---+------+
|                               |                              |   |      |
+-------------------------------+------------------------------+---+------+
| Signature of Adult            | Signature of                 |   |      |
| Patient/Legal Representative  | Parent(s)/Guardian Date      |   |      |
| Date                          |                              |   |      |
+-------------------------------+------------------------------+---+------+
|                               |                              |   |      |
+-------------------------------+------------------------------+---+------+
| **C. Child's Verbal Assent    |                              |   |      |
| (If Applicable)**             |                              |   |      |
|                               |                              |   |      |
| The information in the above  |                              |   |      |
| consent was described to my   |                              |   |      |
| child and my child agrees to  |                              |   |      |
| participate in the study.     |                              |   |      |
+-------------------------------+------------------------------+---+------+
|                               |                              |   |      |
+-------------------------------+------------------------------+---+------+
| Signature of                  |                              |   |      |
| Parent(s)/Guardian Date       |                              |   |      |
+-------------------------------+------------------------------+---+------+
|                               |                              |   |      |
+-------------------------------+------------------------------+---+------+
| **THIS CONSENT DOCUMENT HAS   |                              |   |      |
| BEEN APPROVED FOR USE\        |                              |   |      |
| FROM XX-XX-XXXX THROUGH       |                              |   |      |
| XX-XX-XXXX.**                 |                              |   |      |
+-------------------------------+------------------------------+---+------+
|                               |                              |   |      |
+-------------------------------+------------------------------+---+------+
| Signature of Investigator     | Signature of Witness Date    |   |      |
| Date                          |                              |   |      |
+-------------------------------+------------------------------+---+------+