**APPLICATION FOR AUTHORIZATION**

**TO USE RADIATION IN RESEARCH**

# INVOLVING HUMAN SUBJECTS

**Form** **NIH 88-23(a)**

Attached is a Form 88-23(a) for your use. The NIH\'s policy on who may
submit an application the Radiation Safety Committee is reproduced
below.

**APPLICATION POLICIES FOR AUTHORIZATION TO USE RADIATION**

**IN RESEARCH INVOLVING HUMAN SUBJECTS**

Studies that require x rays, radionuclides, or both, with the resulting
exposure to ionizing radiation indicated solely for research, should be
considered at two levels: 1) Complex high dose procedures central to the
protocol involved and 2) Standard procedures often used in the practice
of medicine.

The following table specifies the background required of an applicant PI
or AI submitting a protocol using those modalities at the levels
indicated.

+----------------------+----------------------+----------------------+
|                      | Level #1             | Level #2             |
|                      |                      |                      |
|                      | Procedures that are  | Standard procedures  |
|                      | complex or high dose | often used in        |
|                      | is central to the    | medical practice     |
|                      | protocol             |                      |
+----------------------+----------------------+----------------------+
|                      |                      |                      |
+----------------------+----------------------+----------------------+
| Radiological         | RSC Authorized       | Credentialed         |
| examination          | credentialed         | clinician            |
|                      | clinician^1^ or a    |                      |
|                      | credentialed         |                      |
|                      | clinician with a     |                      |
|                      | relevant specialty   |                      |
|                      | board                |                      |
|                      | certification^2^     |                      |
+----------------------+----------------------+----------------------+
|                      |                      |                      |
+----------------------+----------------------+----------------------+
| Radionuclide use     | RSC Authorized       | Credentialed         |
|                      | clinician            | clinician with the   |
|                      |                      | actual procedure     |
|                      |                      | under super-vision   |
|                      |                      | of an RSC Authorized |
|                      |                      | clinician            |
+----------------------+----------------------+----------------------+
|                      |                      |                      |
+----------------------+----------------------+----------------------+

^1^ The RSC authorizes clinicians based upon the \"Applications for
Authorization to Administer Radioactive Material for Research With Human
Subjects\"

^2^ Such as cardiology, gastroenterology, or nuclear medicine

All studies involving research irradiation, whether at Level 1 or
Level 2, must be reviewed by the RSC with a single exception:
radiotherapy protocols involving external beam radiation from non-NRC
licensed sources need only be reviewed by the RSC when requested by the
IRB.

Reminders for completion of application:

1.  Fill out all parts of form completely. (This cover page should not
    be submitted; neither should blank pages.)

2.  Applications must be signed by applicant and PI, consistent with the
    above guidelines of the Committee.

3.  Be sure to include literature citations and other information
    sufficient to support dosimetry calculations.

Action Requested:

□ New Application

□ Amend Existing Rad Authorization

□ Triennial Review of Rad Authorization

(Radiation Safety Committee Use Only)

Action Item No. \_\_\_\_\_-\_\_\_\_\_

Rad Authorization No. \_\_\_\_\_\_\_\_\_\_\_\_

Clinical Project No. \_\_\_\_\_\_-\_\_\_\_\_-\_\_\_\_\_\_

**NIH 88-23(a)**

**APPLICATION FOR AUTHORIZATION**

**TO USE RADIATION IN RESEARCH**

**INVOLVING HUMAN SUBJECTS**

*PLEASE TYPE OR PRINT LEGIBLY*

+----------+----------+----------+----------+----------+------+
| **       |          |          |          |          |      |
| Applican |          |          |          |          |      |
| ts^\*^** |          |          |          |          |      |
+----------+----------+----------+----------+----------+------+
|          |          |          |          |          |      |
+----------+----------+----------+----------+----------+------+
| **Na     | I        | D        | Bl       | **SIGNAT | Date |
| me(s()** | nstitute | ivision/ | dg./Room | URE(S)** |      |
|          |          |          |          |          |      |
|          |          | Br       |          |          |      |
|          |          | anch/Lab |          |          |      |
+----------+----------+----------+----------+----------+------+
|          |          |          |          |          |      |
+----------+----------+----------+----------+----------+------+
|          |          |          | Email    |          |      |
+----------+----------+----------+----------+----------+------+
|          |          |          |          |          |      |
+----------+----------+----------+----------+----------+------+
|          |          |          |          |          |      |
+----------+----------+----------+----------+----------+------+
|          |          |          |          |          |      |
+----------+----------+----------+----------+----------+------+
|          |          |          |          |          |      |
+----------+----------+----------+----------+----------+------+
|          |          |          |          |          |      |
+----------+----------+----------+----------+----------+------+
|          |          |          |          |          |      |
+----------+----------+----------+----------+----------+------+
|          |          |          |          |          |      |
+----------+----------+----------+----------+----------+------+
|          |          |          |          |          |      |
+----------+----------+----------+----------+----------+------+
|          |          |          |          |          |      |
+----------+----------+----------+----------+----------+------+
| P        |          |          |          |          |      |
| rincipal |          |          |          |          |      |
| Inve     |          |          |          |          |      |
| stigator |          |          |          |          |      |
|          |          |          |          |          |      |
| (If      |          |          |          |          |      |
| d        |          |          |          |          |      |
| ifferent |          |          |          |          |      |
| than     |          |          |          |          |      |
| ap       |          |          |          |          |      |
| plicant) |          |          |          |          |      |
+----------+----------+----------+----------+----------+------+
|          |          |          |          |          |      |
+----------+----------+----------+----------+----------+------+
|          |          |          |          |          |      |
+----------+----------+----------+----------+----------+------+
|          |          |          |          |          |      |
+----------+----------+----------+----------+----------+------+
|          |          |          |          |          |      |
+----------+----------+----------+----------+----------+------+
|          |          |          |          |          |      |
+----------+----------+----------+----------+----------+------+

^\*^ Refer to current *Application Policies for Authorization to use
Radiation in Research Involving Human Subjects.*

TITLE OF RESEARCH PROJECT:

CLINICAL PROJECT NO.

RAD AUTHORIZATION NO.

+--------+--------+--------+--------+--------+--------+-------+---+---+
| Radio  |        |        |        |        |        |       |   |   |
| active |        |        |        |        |        |       |   |   |
| Ma     |        |        |        |        |        |       |   |   |
| terial |        |        |        |        |        |       |   |   |
| or     |        |        |        |        |        |       |   |   |
| Rad    |        |        |        |        |        |       |   |   |
| iation |        |        |        |        |        |       |   |   |
| Source |        |        |        |        |        |       |   |   |
| Pr     |        |        |        |        |        |       |   |   |
| oposed |        |        |        |        |        |       |   |   |
| for    |        |        |        |        |        |       |   |   |
| Use in |        |        |        |        |        |       |   |   |
| Human  |        |        |        |        |        |       |   |   |
| Su     |        |        |        |        |        |       |   |   |
| bjects |        |        |        |        |        |       |   |   |
+--------+--------+--------+--------+--------+--------+-------+---+---+
|        |        |        |        |        |        |       |   |   |
+--------+--------+--------+--------+--------+--------+-------+---+---+
| Radio  | □ DEXA | □ Hand |        |        |        |       |   |   |
| graphy |        | (Bone  |        |        |        |       |   |   |
|        | □      | Age)   |        |        |        |       |   |   |
|        | Chest  |        |        |        |        |       |   |   |
|        |        | □      |        |        |        |       |   |   |
|        | □ CT   | Spine  |        |        |        |       |   |   |
|        |        |        |        |        |        |       |   |   |
|        | □      | □      |        |        |        |       |   |   |
|        | Fluor  | Skull  |        |        |        |       |   |   |
|        | oscopy |        |        |        |        |       |   |   |
|        |        | □      |        |        |        |       |   |   |
|        | □      | A      |        |        |        |       |   |   |
|        | Angio  | bdomen |        |        |        |       |   |   |
|        | graphy |        |        |        |        |       |   |   |
|        |        | □      |        |        |        |       |   |   |
|        |        | Other  |        |        |        |       |   |   |
+--------+--------+--------+--------+--------+--------+-------+---+---+
|        |        |        |        |        |        |       |   |   |
+--------+--------+--------+--------+--------+--------+-------+---+---+
| Rad    | Compo  | M      | M      | Method | M      |       |   |   |
| ionucl | und(s) | aximum | aximum | of     | aximum |       |   |   |
| ide(s) |        |        | number | ad     | qu     |       |   |   |
|        |        | Ac     | of     | minist | antity |       |   |   |
|        |        | tivity | adm    | ration | of     |       |   |   |
|        |        |        | inistr |        | active |       |   |   |
|        |        | per    | ations |        | drug   |       |   |   |
|        |        | single | per    |        | or     |       |   |   |
|        |        |        | su     |        | co     |       |   |   |
|        |        | Ad     | bject: |        | mpound |       |   |   |
|        |        | minist |        |        | per    |       |   |   |
|        |        | ration |        |        | single |       |   |   |
|        |        |        |        |        | ad     |       |   |   |
|        |        | (mCi)  |        |        | minist |       |   |   |
|        |        |        |        |        | ration |       |   |   |
|        |        |        |        |        | (µg    |       |   |   |
|        |        |        |        |        | or mg) |       |   |   |
+--------+--------+--------+--------+--------+--------+-------+---+---+
|        |        |        |        |        |        |       |   |   |
+--------+--------+--------+--------+--------+--------+-------+---+---+
|        |        |        | Yearly | IV     | Oral   | Other |   |   |
+--------+--------+--------+--------+--------+--------+-------+---+---+
|        |        |        |        |        |        |       |   |   |
+--------+--------+--------+--------+--------+--------+-------+---+---+
| 1\.    |        |        |        |        |        |       |   |   |
+--------+--------+--------+--------+--------+--------+-------+---+---+
|        |        |        |        |        |        |       |   |   |
+--------+--------+--------+--------+--------+--------+-------+---+---+
| 2\.    |        |        |        |        |        |       |   |   |
+--------+--------+--------+--------+--------+--------+-------+---+---+
|        |        |        |        |        |        |       |   |   |
+--------+--------+--------+--------+--------+--------+-------+---+---+
| 3\.    |        |        |        |        |        |       |   |   |
+--------+--------+--------+--------+--------+--------+-------+---+---+
| 4\.    |        |        |        |        |        |       |   |   |
+--------+--------+--------+--------+--------+--------+-------+---+---+
|        |        |        |        |        |        |       |   |   |
+--------+--------+--------+--------+--------+--------+-------+---+---+

**REGULATORY STATUS OF RADIOPHARMACEUTICAL:**

(If more than one radiopharmaceutical is to be administered, use the
supplemental forms reproduced in attachment A to indicate the regulatory
status of each.)

□ [Radioactive Research Drug (Regulated under 21 CFR 361)]{.smallcaps}

Absence of pharmacologic effect \_\_\_\_ has / \_\_\_\_ has not been
demonstrated.

NOTE: Data available from studies in humans relating to any
pharmacologic effect must be included in protocol.

□ [Investigational New Drug]{.smallcaps}

□ Approved IND No. [ ]{.underline} (Attach copy of approval letter.)

□ Amendment to above IND No. sent to FDA on [ ]{.underline} (Attach copy
of letter to FDA.)

□ Application for IND submitted to FDA on [
]{.underline}\_\_\_\_\_\_\_\_\_ (date)[ ]{.underline}

□ Application for IND not yet submitted to FDA

□ [FDA approved drug]{.smallcaps}

□ [Other (Explain): ]{.smallcaps}

+----------+----------+----------+----------+----------+----------+
| ##       |          |          |          |          |          |
| STUDY PO |          |          |          |          |          |
| PULATION |          |          |          |          |          |
+----------+----------+----------+----------+----------+----------+
|          |          |          |          |          |          |
+----------+----------+----------+----------+----------+----------+
| Healthy  | Patients | Total    |          |          |          |
| Vo       | /Patient | Number   |          |          |          |
| lunteers | Vo       | of       |          |          |          |
|          | lunteers | Subjects |          |          |          |
+----------+----------+----------+----------+----------+----------+
|          |          |          |          |          |          |
+----------+----------+----------+----------+----------+----------+
| Per Year | For      | Per Year | For      | Per Year | For      |
|          | Duration |          | Duration |          | Duration |
|          | of Study |          | of Study |          | of Study |
+----------+----------+----------+----------+----------+----------+
|          |          |          |          |          |          |
+----------+----------+----------+----------+----------+----------+
|          |          |          |          |          |          |
+----------+----------+----------+----------+----------+----------+
|          |          |          |          |          |          |
+----------+----------+----------+----------+----------+----------+
|          |          |          |          |          |          |
+----------+----------+----------+----------+----------+----------+
|          |          |          |          |          |          |
+----------+----------+----------+----------+----------+----------+

Age: \_\_\_\_\_\_ to \_\_\_\_\_\_ years Sex: □ Male □ Female

(Minimum) (Maximum)

□ □ The limited life expectancy (specify) [ ]{.underline} of the
proposed

(Yes) (No) RESEARCH PATIENTS should be considered in evaluating the
risks of radiation exposure to these patients.

**PREGNANCY STATUS OF RESEARCH SUBJECTS:**

*The applicant accepts responsibility for determining the pregnancy
status prior to each administration by (a) obtaining a signed and
recorded statement regarding pregnancy status from the subject; (b)
perform­ing a pregnancy test (with date and results of test recorded in
the subject\'s record); or (c) making a direct entry into the subject\'s
record as to why the test is not indicated.*

**SUBJECT PARTICIPATION STATUS: OTHER RESEARCH RADIATION EXPOSURE:**

*The applicant accepts responsibility for determining whether healthy
volunteers have participated in other research protocols involving
radiation exposure.*

Subjects □ are / □ are not enrolled in other protocols that result in
*research *radiation exposure. If so, list other protocols:

+-------------+-----------------------+-------+
| Clinical    | Rad Authorization No. | Title |
|             |                       |       |
| Project No. |                       |       |
+-------------+-----------------------+-------+
|             |                       |       |
+-------------+-----------------------+-------+
|             |                       |       |
+-------------+-----------------------+-------+
|             |                       |       |
+-------------+-----------------------+-------+
|             |                       |       |
+-------------+-----------------------+-------+
|             |                       |       |
+-------------+-----------------------+-------+
|             |                       |       |
+-------------+-----------------------+-------+

The nature of these studies should be discussed in the protocol,
including the agents, doses (activity and radiation dose), and risks.
Dosimetry must be included on subsequent pages of this application,
e.g., on supplemental Tabulations of Radiation Doses to Subjects.

**REVIEW STATUS:**

**INSTITUTE INSTITUTIONAL REVIEW BOARD (IRB) APPROVAL:**

□ Protocol submitted to IRB for review on \_\_\_\_\_\_\_\_\_\_\_\_\_\_
and not yet approved.

(Date)

□ Protocol was approved by IRB on \_\_\_\_\_\_\_\_\_\_\_\_\_\_ by
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_,\_\_\_\_\_\_\_\_\_

(Date) (Name of Chairman, IRB) (Institute)

(Please include a copy of approval memo or other document with signature
and minutes from meeting at which the protocol was approved.)

**RADIOACTIVE DRUG RESEARCH COMMITTEE (RDRC) APPROVAL:**

□ Application to RDRC required.

□ Application approved by RDRC on \_\_\_\_\_\_\_\_\_\_\_\_\_\_.

(Date)

□ Signature of RDRC Chairman appears on approval memo or other document
dated \_\_\_\_\_\_\_\_\_\_\_\_\_\_.

(Please include copy of document with application.)

**RADIATION SAFETY COMMITTEE (RSC) APPROVAL:** (FOR RSC USE ONLY)

□ Application APPROVED by RSC on \_\_\_\_\_\_\_\_\_\_\_\_.

□ Application APPROVED w/ COMMENT (S) by RSC on \_\_\_\_\_\_\_\_\_\_.

□ Application APPROVED w/STIPULATION(S) by RSC on \_\_\_\_\_\_\_\_\_.

Stipulation(s) resolved on
\_\_\_\_\_\_\_/\_\_\_\_\_\_\_\_/\_\_\_\_\_\_\_

(Date)

□ Final review completed by RSC Clinical Protocol Administrator on
\_\_\_\_\_\_/\_\_\_\_\_\_/\_\_\_\_\_\_

(Date)

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_/\_\_\_\_\_\_/\_\_\_\_\_\_

(Signature of Reviewer) (Date)

Tabulation \_\_\_\_\_ of \_\_\_\_\_ Tabulations

+-------------------------------+-------------------------------+---+
| **Tabulation of Radiation     |                               |   |
| Doses to Subjects **          |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Radioactive Material or       |                               |   |
| Procedure:                    |                               |   |
+-------------------------------+-------------------------------+---+
| Administered Quantity or View |                               |   |
| of Exposure:                  |                               |   |
+-------------------------------+-------------------------------+---+
| Subject Age:                  |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| # ORGAN                       | **RADIATION DOSE (rem)**      |   |
|                               |                               |   |
|                               | **Per single Administration   |   |
|                               | Per Year (12 mos.)**          |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Adrenals                      |                               |   |
+-------------------------------+-------------------------------+---+
| Brain                         |                               |   |
+-------------------------------+-------------------------------+---+
| Breasts                       |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Esophagus ^1^                 |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Gallbladder Wall              |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| GI-tract: Lower Large         |                               |   |
| Intestine                     |                               |   |
+-------------------------------+-------------------------------+---+
| Small Intestine               |                               |   |
+-------------------------------+-------------------------------+---+
| Stomach                       |                               |   |
+-------------------------------+-------------------------------+---+
| Upper Large Intestine         |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Colon ^2^                     |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Heart Wall                    |                               |   |
+-------------------------------+-------------------------------+---+
| Kidneys                       |                               |   |
+-------------------------------+-------------------------------+---+
| Liver                         |                               |   |
+-------------------------------+-------------------------------+---+
| Lungs                         |                               |   |
+-------------------------------+-------------------------------+---+
| Muscle                        |                               |   |
+-------------------------------+-------------------------------+---+
| Ovaries                       |                               |   |
+-------------------------------+-------------------------------+---+
| Pancreas                      |                               |   |
+-------------------------------+-------------------------------+---+
| Red Marrow                    |                               |   |
+-------------------------------+-------------------------------+---+
| Bone Surfaces                 |                               |   |
+-------------------------------+-------------------------------+---+
| Skin                          |                               |   |
+-------------------------------+-------------------------------+---+
| Spleen                        |                               |   |
+-------------------------------+-------------------------------+---+
| Testes                        |                               |   |
+-------------------------------+-------------------------------+---+
| Thymus                        |                               |   |
+-------------------------------+-------------------------------+---+
| Thyroid                       |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Urinary Bladder Wall ^3^      |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Uterus                        |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| ** EFFECTIVE DOSE**           |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| NOTES:                        |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| DOSIMETRY SOURCE:             |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+

NOTES:

A. If more than one agent or radiation source is to be used, fill out
[additional]{.underline} copies of this tabulation (see attachment B).

B. If radiographic studies are involved, indicate primary site(s) or
organs to be irradiated and include skin or \"entrance\" dose.

C. Estimates of doses for the organs and tissues listed in the table
should be as accurate as possible. If this is inappropriate for some
sites, e.g., for those that are distant from the irradiated site in
radiographic studies, note the basis for dose estimates in the protocol
or leave blank, as appropriate.

NOTE

This page need NOT be completed if only *one* agent or source of
radiation is involved.

**TOTAL RADIATION DOSES TO SUBJECTS **from participation in this study

*(Summation of doses from ALL research radiation exposure in
[this]{.underline} authorization request):*

+-------------------------------+-------------------------------+---+
| # ORGAN                       | **RADIATION DOSE (rem)**      |   |
|                               |                               |   |
|                               | **Per single Administration   |   |
|                               | Per Year (12 mos.)**          |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Adrenals                      |                               |   |
+-------------------------------+-------------------------------+---+
| Brain                         |                               |   |
+-------------------------------+-------------------------------+---+
| Breasts                       |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Esophagus ^1^                 |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Gallbladder Wall              |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| GI-tract: Lower Large         |                               |   |
| Intestine                     |                               |   |
+-------------------------------+-------------------------------+---+
| Small Intestine               |                               |   |
+-------------------------------+-------------------------------+---+
| Stomach                       |                               |   |
+-------------------------------+-------------------------------+---+
| Upper Large Intestine         |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Colon ^2^                     |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Heart Wall                    |                               |   |
+-------------------------------+-------------------------------+---+
| Kidneys                       |                               |   |
+-------------------------------+-------------------------------+---+
| Liver                         |                               |   |
+-------------------------------+-------------------------------+---+
| Lungs                         |                               |   |
+-------------------------------+-------------------------------+---+
| Muscle                        |                               |   |
+-------------------------------+-------------------------------+---+
| Ovaries                       |                               |   |
+-------------------------------+-------------------------------+---+
| Pancreas                      |                               |   |
+-------------------------------+-------------------------------+---+
| Red Marrow                    |                               |   |
+-------------------------------+-------------------------------+---+
| Bone Surfaces                 |                               |   |
+-------------------------------+-------------------------------+---+
| Skin                          |                               |   |
+-------------------------------+-------------------------------+---+
| Spleen                        |                               |   |
+-------------------------------+-------------------------------+---+
| Testes                        |                               |   |
+-------------------------------+-------------------------------+---+
| Thymus                        |                               |   |
+-------------------------------+-------------------------------+---+
| Thyroid                       |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Urinary Bladder Wall ^3^      |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Uterus                        |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| ** EFFECTIVE DOSE**           |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+

NOTE

This page need NOT be completed if subjects are NOT also enrolled in
other studies that involve research radiation exposure.

**TOTAL RADIATION DOSES TO SUBJECTS **

From participation in this study [AND]{.underline} other ancillary
studies that involve [research]{.underline} radiation exposure

*(Summation of doses from ALL research radiation exposure in this
authorization and other authorization(s)):*

+-------------------------------+-------------------------------+---+
| # ORGAN                       | **RADIATION DOSE (rem)**      |   |
|                               |                               |   |
|                               | **Per single Administration   |   |
|                               | Per Year (12 mos.)**          |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Adrenals                      |                               |   |
+-------------------------------+-------------------------------+---+
| Brain                         |                               |   |
+-------------------------------+-------------------------------+---+
| Breasts                       |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Esophagus ^1^                 |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Gallbladder Wall              |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| GI-tract: Lower Large         |                               |   |
| Intestine                     |                               |   |
+-------------------------------+-------------------------------+---+
| Small Intestine               |                               |   |
+-------------------------------+-------------------------------+---+
| Stomach                       |                               |   |
+-------------------------------+-------------------------------+---+
| Upper Large Intestine         |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Colon ^2^                     |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Heart Wall                    |                               |   |
+-------------------------------+-------------------------------+---+
| Kidneys                       |                               |   |
+-------------------------------+-------------------------------+---+
| Liver                         |                               |   |
+-------------------------------+-------------------------------+---+
| Lungs                         |                               |   |
+-------------------------------+-------------------------------+---+
| Muscle                        |                               |   |
+-------------------------------+-------------------------------+---+
| Ovaries                       |                               |   |
+-------------------------------+-------------------------------+---+
| Pancreas                      |                               |   |
+-------------------------------+-------------------------------+---+
| Red Marrow                    |                               |   |
+-------------------------------+-------------------------------+---+
| Bone Surfaces                 |                               |   |
+-------------------------------+-------------------------------+---+
| Skin                          |                               |   |
+-------------------------------+-------------------------------+---+
| Spleen                        |                               |   |
+-------------------------------+-------------------------------+---+
| Testes                        |                               |   |
+-------------------------------+-------------------------------+---+
| Thymus                        |                               |   |
+-------------------------------+-------------------------------+---+
| Thyroid                       |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Urinary Bladder Wall ^3^      |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Uterus                        |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| ** EFFECTIVE DOSE**           |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+

## ATTACHMENT A

**REGULATORY STATUS OF RADIOPHARMACEUTICAL**

WHEN MORE THAN ONE AGENT IS INVOLVED

### [Name of Radioactive Drug]{.smallcaps}[ ]{.smallcaps}[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.smallcaps}

□ Radioactive Research Drug (Regulated under 21 CFR 361)

Absence of pharmacologic effect \_\_\_\_ has \_\_\_\_ has not been
demonstrated.

NOTE: Data available from studies in humans relating to any
pharmacologic effect must be included in protocol.

□ Investigational New Drug (IND)

□ Approved IND No. [ ]{.underline} (Attach copy of approval letter.)

□ Amendment to above IND No. sent to FDA on [ ]{.underline} (Attach copy
of letter to FDA.)

(Date)

□ Application for IND submitted to FDA on [
]{.underline}\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_[ ]{.underline}

(Date)

□ Application for IND not yet submitted to FDA

□ New Drug Application has been approved by the FDA for this drug

□ Other (Explain): [ ]{.underline}

Note: Duplicate this form if additional radioactive drugs are
involved.**ATTACHMENT B**

EXTRA COPIES OF \"TABULATION OF RADIATION DOSES TO SUBJECTS\"

FOR USE WHEN MULTIPLE SOURCES OF RADIATION ARE INVOLVED

THIS SEPARATOR PAGE IS NOT TO BE SUBMITTED AS PART OF AN APPLICATION

Please arrange tabulations of doses in order, placing tabulations

for individual agents/sources BEFORE summation pages

Tabulation \_\_\_\_\_ of \_\_\_\_\_ Tabulations

+-------------------------------+-------------------------------+---+
| **Tabulation of Radiation     |                               |   |
| Doses to Subjects **          |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Radioactive Material or       |                               |   |
| Procedure:                    |                               |   |
+-------------------------------+-------------------------------+---+
| Administered Quantity or View |                               |   |
| of Exposure:                  |                               |   |
+-------------------------------+-------------------------------+---+
| Subject Age:                  |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| # ORGAN                       | **RADIATION DOSE (rem)**      |   |
|                               |                               |   |
|                               | **Per single Administration   |   |
|                               | Per Year (12 mos.)**          |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Adrenals                      |                               |   |
+-------------------------------+-------------------------------+---+
| Brain                         |                               |   |
+-------------------------------+-------------------------------+---+
| Breasts                       |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Esophagus ^1^                 |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Gallbladder Wall              |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| GI-tract: Lower Large         |                               |   |
| Intestine                     |                               |   |
+-------------------------------+-------------------------------+---+
| Small Intestine               |                               |   |
+-------------------------------+-------------------------------+---+
| Stomach                       |                               |   |
+-------------------------------+-------------------------------+---+
| Upper Large Intestine         |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Colon ^2^                     |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Heart Wall                    |                               |   |
+-------------------------------+-------------------------------+---+
| Kidneys                       |                               |   |
+-------------------------------+-------------------------------+---+
| Liver                         |                               |   |
+-------------------------------+-------------------------------+---+
| Lungs                         |                               |   |
+-------------------------------+-------------------------------+---+
| Muscle                        |                               |   |
+-------------------------------+-------------------------------+---+
| Ovaries                       |                               |   |
+-------------------------------+-------------------------------+---+
| Pancreas                      |                               |   |
+-------------------------------+-------------------------------+---+
| Red Marrow                    |                               |   |
+-------------------------------+-------------------------------+---+
| Bone Surfaces                 |                               |   |
+-------------------------------+-------------------------------+---+
| Skin                          |                               |   |
+-------------------------------+-------------------------------+---+
| Spleen                        |                               |   |
+-------------------------------+-------------------------------+---+
| Testes                        |                               |   |
+-------------------------------+-------------------------------+---+
| Thymus                        |                               |   |
+-------------------------------+-------------------------------+---+
| Thyroid                       |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Urinary Bladder Wall ^3^      |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| Uterus                        |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| ** EFFECTIVE DOSE**           |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| NOTES:                        |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+
| DOSIMETRY SOURCE:             |                               |   |
+-------------------------------+-------------------------------+---+
|                               |                               |   |
+-------------------------------+-------------------------------+---+

NOTES:

A. If more than one agent or radiation source is to be used, fill out
[additional]{.underline} copies of this tabulation (see attachment B).

B. If radiographic studies are involved, indicate primary site(s) or
organs to be irradiated and include skin or \"entrance\" dose.

C. Estimates of doses for the organs and tissues listed in the table
should be as accurate as possible. If this is inappropriate for some
sites, e.g., for those that are distant from the irradiated site in
radiographic studies, note the basis for dose estimates in the protocol
or leave blank, as appropriate.