IC: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ DATE:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ FINAL **11/01/01**

+---------------------------------------------------------------+---+---+
| BIENNIAL INTRAMURAL SELF ASSESSMENT OF MANAGEMENT CONTROLS    |   |   |
|                                                               |   |   |
| PERIOD OF REVIEW : [FY 2001]{.underline} (Information for 1   |   |   |
| year period)                                                  |   |   |
+---------------------------------------------------------------+---+---+
| **I. PROGRAM AND PROJECT PLANNING/MANAGEMENT**                |   |   |
+---------------------------------------------------------------+---+---+
| > **A. PROTECTION OF HUMAN SUBJECTS**                         | Y | N |
|                                                               | E | O |
|                                                               | S |   |
+---------------------------------------------------------------+---+---+
| > 1\. Do you have a duly constituted Institutional Review     |   |   |
| > Board (IRB) or access to a duly constituted IRB,            |   |   |
| > established in accordance with the NIH Multiple Project     |   |   |
| > Assurance (MPA)?                                            |   |   |
+---------------------------------------------------------------+---+---+
| > a\. Are the IRB records maintained in accordance with the   |   |   |
| > MPA? (See MPA, Sec. III.G.6.)                               |   |   |
+---------------------------------------------------------------+---+---+
| > b\. Where? \[ Bldg. \# \_\_\_\_\_\_\_\_\_\_, Room \#        |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_ \]                                   |   |   |
+---------------------------------------------------------------+---+---+
| > c\. Secured by Whom?                                        |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_              |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |   |   |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+---------------------------------------------------------------+---+---+
| > 2\. Has your IC received any allegations of non-compliance  |   |   |
| > with the requirements of the MPA in the past 12 months?     |   |   |
+---------------------------------------------------------------+---+---+
| > If YES, please explain :                                    |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                    |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |   |   |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+---------------------------------------------------------------+---+---+
| > 3a. How many new protocols has your IRB reviewed during the |   |   |
| > period of review?                                           |   |   |
| > \_\_\_\_\_\                                                 |   |   |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+---------------------------------------------------------------+---+---+
| > b\. How many new protocols has your IRB disapproved or      |   |   |
| > deferred/tabled during the period of review?                |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                      |   |   |
+---------------------------------------------------------------+---+---+
| > 4\. How many of the following types of protocols are active |   |   |
| > in your IC?                                                 |   |   |
+---------------------------------------------------------------+---+---+
| > Research: Clinical Trial : \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_   |   |   |
| > Screening : \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                  |   |   |
+---------------------------------------------------------------+---+---+
| > Research: Natural History/Epidemiology :                    |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Training :                   |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                            |   |   |
+---------------------------------------------------------------+---+---+
| > 5\. Were all patients seen in your IC Clinical Program      |   |   |
| > covered by a written, active protocol?                      |   |   |
+---------------------------------------------------------------+---+---+
| > If NO, please describe situations to justify such           |   |   |
| > exceptions :                                                |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\   |   |   |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+---------------------------------------------------------------+---+---+
| > 6\. Who at the NIH has oversight responsibility to assure   |   |   |
| > that patients sign and receive copies of informed consent   |   |   |
| > documents?                                                  |   |   |
+---------------------------------------------------------------+---+---+
| > Name of individual and phone number :                       |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                              |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |   |   |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+---------------------------------------------------------------+---+---+
| > 7\. Were all IRB annual continuing reviews completed within |   |   |
| > 30 days of their scheduled review?                          |   |   |
+---------------------------------------------------------------+---+---+

+--------------------------------------------------------------+---+---+
| > **A. PROTECTION OF HUMAN SUBJECTS (cont.)**                | Y | N |
|                                                              | E | O |
|                                                              | S |   |
+--------------------------------------------------------------+---+---+
| > 8a. Are all new protocols evaluated for suitability of     |   |   |
| > enrollment of minorities, children and women?              |   |   |
+--------------------------------------------------------------+---+---+
| > b\. Has the IRB identified, on continuing reviews, any     |   |   |
| > protocols with unsatisfactory enrollment of minorities,    |   |   |
| > children and women?                                        |   |   |
+--------------------------------------------------------------+---+---+
| > If YES, how many?                                          |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_                               |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+
| > c\. What action was taken?                                 |   |   |
| > \_                                                         |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+
| > \_\_                                                       |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+
| > 9\. Are all clinical protocols including natural history   |   |   |
| > and epidemiology subjected to critical scientific review   |   |   |
| > before being sent to the IRB?                              |   |   |
+--------------------------------------------------------------+---+---+
| > 10a. Do you assure that all scientific staff in your IC    |   |   |
| > complete the OHSR computer-based training program          |   |   |
| > protecting human research subjects at the NIH?             |   |   |
| > (http://ohsr.od.nih.gov/cbt/)                              |   |   |
+--------------------------------------------------------------+---+---+
| > b\. How many staff have not completed this program?        |   |   |
| > \_                                                         |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+
| > Please explain:                                            |   |   |
| > \_                                                         |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+
| > c\. Have all of your IRB taken the Computer-Based Training |   |   |
| > (CBT) for NIH IRB members?                                 |   |   |
| > (http://ohsr.od.nih.gov/irb_cbt/)                          |   |   |
+--------------------------------------------------------------+---+---+
| > 11\. Do you involve your IC Clinical Director in           |   |   |
| > determining and allocating resources for clinical          |   |   |
| > research?                                                  |   |   |
+--------------------------------------------------------------+---+---+
| > 12\. Have you and your clinical director implemented the   |   |   |
| > NIH Standards for Clinical Research within the NIH         |   |   |
| > Intramural Research Program?                               |   |   |
| > (http://www.cc.nih.gov/ccc/clinicalresearch/index.html)    |   |   |
+--------------------------------------------------------------+---+---+
| > **B. RULES COVERING INVOLVEMENT OF INTRAMURAL SCIENTISTS   |   |   |
| > AND USE OF INTRAMURAL FACILITIES IN NIH-FUNDED EXTRAMURAL  |   |   |
| > PROJECTS**                                                 |   |   |
+--------------------------------------------------------------+---+---+
| > 1\. Are intramural scientists in your IC who are listed on |   |   |
| > the grant application as collaborating or serving as       |   |   |
| > consultants on an extramural NIH grant, submitting to you  |   |   |
| > a copy of the letter of collaboration for advanced         |   |   |
| > approval?                                                  |   |   |
| > (http://www1.od.nih.gov/o                                  |   |   |
| ir/sourcebook/ethic-conduct/IRP-ERP-Cover-memo-10-27-99.htm) |   |   |
+--------------------------------------------------------------+---+---+
| > 2\. Are you notifying the grants management office of the  |   |   |
| > appropriate IC about collaborations involving your         |   |   |
| > intramural scientists which are such a substantial part of |   |   |
| > a grant application that it may need to be changed to a    |   |   |
| > cooperative agreement (UO1)?                               |   |   |
+--------------------------------------------------------------+---+---+
| > 3\. Have you approved of any significant use of NIH        |   |   |
| > intramural facilities by guest researchers or special      |   |   |
| > volunteers supported by extramural NIH funds, i.e., SBIR,  |   |   |
| > or other federal granting agency?                          |   |   |
+--------------------------------------------------------------+---+---+
| > IF YES, how often? :                                       |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_\_                                   |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+
| > a\. Was the grants management office of the IC (or other   |   |   |
| > federal granting agency) informed?                         |   |   |
+--------------------------------------------------------------+---+---+
| > 4\. Have you encountered any violation(s) of conflict of   |   |   |
| > interest statutes and Office of Government Ethics          |   |   |
| > regulations involving scientists paid with intramural      |   |   |
| > funds, guest researchers or special volunteers?            |   |   |
+--------------------------------------------------------------+---+---+
| > IF YES, please explain :                                   |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_\_                                   |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+

+--------------------------------------------------------------+---+---+
| > **C. BOARD OF SCIENTIFIC COUNSELOR (BSC) REVIEWS**         | Y | N |
|                                                              | E | O |
|                                                              | S |   |
+--------------------------------------------------------------+---+---+
| > 1\. Has any Principal Investigator/laboratory/branch gone  |   |   |
| > unreviewed for more than four years?                       |   |   |
+--------------------------------------------------------------+---+---+
| > IF YES, please justify non-review:                         |   |   |
| > \_\_\_\_\_\_\_\_                                           |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+
| > 2\. For each laboratory reviewed during the period of      |   |   |
| > review, were all tenured independent investigators and all |   |   |
| > tenure track scientists reviewed?                          |   |   |
+--------------------------------------------------------------+---+---+
| > IF NO, please justify non-review :                         |   |   |
| > \_\_\_\_\_\_\_\_\_\_                                       |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+
| > 3a. Do you report to the BSC your actions in response to   |   |   |
| > their recommendations?                                     |   |   |
+--------------------------------------------------------------+---+---+
| > b\. Were any recommendations by the BSC not addressed by   |   |   |
| > the Scientific Director?                                   |   |   |
+--------------------------------------------------------------+---+---+
| > c\. Does someone from your IC report on the BSC evaluation |   |   |
| > of intramural research to the IC National Advisory Council |   |   |
| > annually?                                                  |   |   |
+--------------------------------------------------------------+---+---+
| > 4a. Is clinical research reviewed by your BSC similarly to |   |   |
| > basic research?                                            |   |   |
+--------------------------------------------------------------+---+---+
| b\. Do you have reviewers with clinical research expertise   |   |   |
| on your BSC?                                                 |   |   |
+--------------------------------------------------------------+---+---+
| > c\. Are clinical protocols reviewed by your BSC or a       |   |   |
| > subgroup of your BSC?                                      |   |   |
+--------------------------------------------------------------+---+---+
| > 5\. Do you provide your BSC with lists of fellows who have |   |   |
| > left your IC since the last review, along with the         |   |   |
| > position that they have taken?                             |   |   |
+--------------------------------------------------------------+---+---+
| > 6\. Is your BSC reviewing and commenting on mentoring?     |   |   |
+--------------------------------------------------------------+---+---+
| > **D. ANIMAL CARE AND USE (answer with assistance of ACUC   |   |   |
| > chair)**                                                   |   |   |
+--------------------------------------------------------------+---+---+
| > 1\. Does your IC have a properly constituted ACUC or       |   |   |
| > access to a properly constituted ACUC (under a formal      |   |   |
| > contractual agreement) that meets regularly to review      |   |   |
| > Animal Study Proposals?                                    |   |   |
+--------------------------------------------------------------+---+---+
| > a\. Is there a nonaffiliated public member appointed to    |   |   |
| > your ACUC (or the ACUC that supports your IC under a       |   |   |
| > formal contractual agreement)?                             |   |   |
+--------------------------------------------------------------+---+---+
| > b\. How many Animal Study Proposals were approved on the   |   |   |
| > first round\_\_\_\_\_\_\_; pending information or changes  |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_?        |   |   |
+--------------------------------------------------------------+---+---+
| > c\. How many Animal Study Proposals were disapproved       |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_; deferred                           |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_?                          |   |   |
+--------------------------------------------------------------+---+---+
| > 2\. Were there any animal-related incidents required to be |   |   |
| > reported to OLAW during the past 12 months?                |   |   |
+--------------------------------------------------------------+---+---+
| > IF YES, please explain :                                   |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_     |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+

+--------------------------------------------------------------+---+---+
| > **D.** **ANIMAL CARE AND USE (answer with assistance of    | Y | N |
| > ACUC chair) (cont.)**                                      | E | O |
|                                                              | S |   |
+--------------------------------------------------------------+---+---+
| > 3\. Does a system exist to verify that all appropriate     |   |   |
| > staff receives training in the care and use of animals     |   |   |
| > (e.g. Animal Users Course)?                                |   |   |
| > (http://oacu.od.nih.gov/training/trainline_2.htm)          |   |   |
+--------------------------------------------------------------+---+---+
| > 4\. Have all projects that require NIH Institutional       |   |   |
| > Biosafety Committee (IBC) approval been reviewed and       |   |   |
| > approved by the IBC prior to the initiation of animal      |   |   |
| > work?                                                      |   |   |
+--------------------------------------------------------------+---+---+
| > 5a. Does a system exist to assure that staff having direct |   |   |
| > contact with animals, their viable tissues, body fluids,   |   |   |
| > wastes, or living quarters are enrolled in the Animal      |   |   |
| > Exposure Surveillance Program?                             |   |   |
+--------------------------------------------------------------+---+---+
| > b\. How many staff are enrolled in this program?           |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                         |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+
| > c\. How many staff remain to be enrolled?                  |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                         |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+
| > 6\. Were any major/significant deficiencies found during   |   |   |
| > the ACUC semi-annual program review of your animal         |   |   |
| > facilities?                                                |   |   |
+--------------------------------------------------------------+---+---+
| > 7\. Were any Animal Study Proposals or investigator        |   |   |
| > privileges revoked or suspended?                           |   |   |
+--------------------------------------------------------------+---+---+
| > 8\. Has the IC veterinarian, or other source, reported to  |   |   |
| > you or the IC ACUC any instances of facility management    |   |   |
| > deficiencies that would threaten AAALAC accreditation?     |   |   |
+--------------------------------------------------------------+---+---+
| > a\. Describe the resolution of these deficiencies:         |   |   |
| > \_\_\_\_\_\_\_\_\_                                         |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+
| > \_\_\_\_\_\_\_\_\_                                         |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+
| > 9\. Do you meet with the ACUC Chair twice a year to review |   |   |
| > your IC Animal Care and Use program?                       |   |   |
+--------------------------------------------------------------+---+---+
| > 10\. Does your ACUC Chair attend meetings of the NIH       |   |   |
| > Animal Research Advisory Committee on a regular basis?     |   |   |
+--------------------------------------------------------------+---+---+
| 11a. Did the ACUC review IC animals/animal activities in     |   |   |
| shared/central facilities?                                   |   |   |
+--------------------------------------------------------------+---+---+
| b\. Were any noted deficiencies corrected to the ACUC's      |   |   |
| satisfaction?                                                |   |   |
+--------------------------------------------------------------+---+---+
| > 12\. Did all new ACUC members receive their required       |   |   |
| > training?                                                  |   |   |
+--------------------------------------------------------------+---+---+
| 13. Were all students, guest workers, etc. properly          |   |   |
|     identified and integrated into the animal care and use   |   |   |
|     program (training, enrollment in AESP, etc.)?            |   |   |
+--------------------------------------------------------------+---+---+
| 14. Have you provided funding for ACUC member training?      |   |   |
+--------------------------------------------------------------+---+---+
| 15. Do you provide support for the ACUC to have coordinator? |   |   |
+--------------------------------------------------------------+---+---+
| 16. Do you provide funding for your ACUC chair to attend     |   |   |
|     ACUC oriented or continuing education, e.g., OLAW        |   |   |
|     Workshops or PRIM & R Meetings?                          |   |   |
+--------------------------------------------------------------+---+---+

+--------------------------------------------------------------+---+---+
| > **E. SCIENTIFIC MISCONDUCT**                               | Y | N |
|                                                              | E | O |
|                                                              | S |   |
+--------------------------------------------------------------+---+---+
| > 1a. Does your organization use approved NIH procedures to  |   |   |
| > define misconduct and specify reporting requirements and   |   |   |
| > procedures?                                                |   |   |
| >                                                            |   |   |
| > (http://w                                                  |   |   |
| ww1.od.nih.gov/oir/sourcebook/ResEthicsCases/sm-booklet.htm) |   |   |
+--------------------------------------------------------------+---+---+
| > b\. Has each member of your scientific staff been provided |   |   |
| > a copy of the publication: "A Guide to the Handling of     |   |   |
| > Scientific Misconduct Allegations in the Intramural        |   |   |
| > Research Program at the NIH"?                              |   |   |
| > (http://                                                   |   |   |
| www1.od.nih.gov/oir/sourcebook/ResEthicsCases/cases-toc.htm) |   |   |
+--------------------------------------------------------------+---+---+
| > 2a. Is research ethics/scientific conduct training         |   |   |
| > provided by the IC yearly?                                 |   |   |
| >                                                            |   |   |
| > (http://www.nih.gov/campus/irnews/guidelines.htm)          |   |   |
+--------------------------------------------------------------+---+---+
| > b\. How many people took the training in the past year?    |   |   |
| >                                                            |   |   |
| > Are you including \_\_\_\_senior investigators;            |   |   |
| > \_\_\_investigators; \_\_\_postdocs; \_\_\_staff           |   |   |
| > scientists; \_\_\_staff clinicians; \_\_\_senior research  |   |   |
| > assistants; \_\_\_research assistants; \_\_\_postbacs;     |   |   |
| > \_\_\_graduate students; \_\_\_technical IRTAS?            |   |   |
+--------------------------------------------------------------+---+---+
| > 3\. Who is the designated official for receiving           |   |   |
| > allegations of scientific misconduct?                      |   |   |
+--------------------------------------------------------------+---+---+
| > Name of individual and phone number :                      |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                             |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+
| > 4\. Did the designee receive any allegations during the    |   |   |
| > period of review?                                          |   |   |
+--------------------------------------------------------------+---+---+
| > a\. Were all of these allegations addressed?               |   |   |
+--------------------------------------------------------------+---+---+
| > b\. Were all such allegations brought to the attention of  |   |   |
| > the Agency Intramural Research Integrity Officer (AIRIO)   |   |   |
| > in the Office of Intramural Research?                      |   |   |
+--------------------------------------------------------------+---+---+
| > 5\. What was the disposition of the allegation(s) :        |   |   |
+--------------------------------------------------------------+---+---+
| > Proceeded to inquiry stage?                                |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+
| > Proceeded to investigation stage?                          |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_         |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+
| > 6\. Were any allegations of inappropriate authorship       |   |   |
| > raised during the period of review?                        |   |   |
+--------------------------------------------------------------+---+---+
| > If YES, how many?                                          |   |   |
| > \_                                                         |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+
| > 7\. Have research resources (equipment, personnel, and     |   |   |
| > space) been diverted to prohibited activities (i.e.,       |   |   |
| > violations of the Antideficiency Act)?                     |   |   |
+--------------------------------------------------------------+---+---+
| > If YES, please describe corrective action taken :          |   |   |
| > \_\_\_\_\_\_\_\_\_                                         |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+
| > \_\_\_\_\_\_\_\_\_                                         |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+

+---+-----------------------------------------------------------+---+---+
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+---+-----------------------------------------------------------+---+---+
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+---+-----------------------------------------------------------+---+---+
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| d |                                                           |   |   |
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|   |                                                           |   |   |
| \ |                                                           |   |   |
| _ |                                                           |   |   |
| \ |                                                           |   |   |
| _ |                                                           |   |   |
| \ |                                                           |   |   |
| _ |                                                           |   |   |
| \ |                                                           |   |   |
| _ |                                                           |   |   |
| \ |                                                           |   |   |
| _ |                                                           |   |   |
| > |                                                           |   |   |
|   |                                                           |   |   |
| t |                                                           |   |   |
| h |                                                           |   |   |
| i |                                                           |   |   |
| s |                                                           |   |   |
| > |                                                           |   |   |
|   |                                                           |   |   |
| c |                                                           |   |   |
| e |                                                           |   |   |
| r |                                                           |   |   |
| t |                                                           |   |   |
| i |                                                           |   |   |
| f |                                                           |   |   |
| i |                                                           |   |   |
| c |                                                           |   |   |
| a |                                                           |   |   |
| t |                                                           |   |   |
| i |                                                           |   |   |
| o |                                                           |   |   |
| n |                                                           |   |   |
| ? |                                                           |   |   |
+---+-----------------------------------------------------------+---+---+
|   | > 7\. Do you inform all new personnel, including          |   |   |
|   | > trainees, about the Government-wide prohibition         |   |   |
|   | > against:                                                |   |   |
+---+-----------------------------------------------------------+---+---+
|   | > \>Cloning human beings?                                 |   |   |
+---+-----------------------------------------------------------+---+---+
|   | > \>Conducting research on human embryos?                 |   |   |
+---+-----------------------------------------------------------+---+---+

+--------------------------------------------------------------+---+---+
| > **F. ADMINISTRATIVE PROCEDURES (cont.)**                   | Y | N |
|                                                              | E | O |
|                                                              | S |   |
+--------------------------------------------------------------+---+---+
| 8\. Do you inform all new personnel, including trainees,     |   |   |
| about the Government-wide restrictions regarding:            |   |   |
+--------------------------------------------------------------+---+---+
| \> Human fetal tissue procurement?                           |   |   |
+--------------------------------------------------------------+---+---+
| > \>Stem cell research?                                      |   |   |
+--------------------------------------------------------------+---+---+
| > 9\. Do you follow the formal NIH checkout procedure?       |   |   |
+--------------------------------------------------------------+---+---+
| > 10\. Are all research staff informed of rules and          |   |   |
| > procedures to avoid conflict of interest (e.g., outside    |   |   |
| > activity, support under NIH extramural grants, etc.)?      |   |   |
| > (http://www1.od.n                                          |   |   |
| ih.gov/oir/sourcebook/ethic-conduct/ethical-conduct-toc.htm) |   |   |
+--------------------------------------------------------------+---+---+
| # **II. HEALTH AND SAFETY OF INTRAMURAL PERSONNEL**          |   |   |
+--------------------------------------------------------------+---+---+
| > 1a. Does the IC have a safety and health committee?        |   |   |
+--------------------------------------------------------------+---+---+
| b.  Who serves as Chair?                                     |   |   |
|                                                              |   |   |
| > Name of individual and phone number:                       |   |   |
| >                                                            |   |   |
| > \_\_\_\_                                                   |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+
| > 2\. Is there an established mechanism for reporting safety |   |   |
| > and health concerns to IC management?                      |   |   |
+--------------------------------------------------------------+---+---+
| > 3\. Is there a mechanism established to track required     |   |   |
| > corrective actions?                                        |   |   |
+--------------------------------------------------------------+---+---+
| > 4a. Have all IC laboratory personnel who work with         |   |   |
| > potentially hazardous materials completed the appropriate  |   |   |
| > training courses required by the NIH, "Laboratory Safety   |   |   |
| > at the NIH" and "Working Safely with HIV or Other          |   |   |
| > Bloodborne Pathogens at the NIH"?                          |   |   |
| >                                                            |   |   |
| > (http://oshbftp.od.nih.gov/labsafety/)                     |   |   |
+--------------------------------------------------------------+---+---+
| > b\. Have personnel who have contact with patients or       |   |   |
| > biological specimens completed the training course         |   |   |
| > "Universal Precautions Training"?                          |   |   |
+--------------------------------------------------------------+---+---+
| > c\. Did personnel with occupational exposure to bloodborne |   |   |
| > pathogens receive annual refresher training (in compliance |   |   |
| > with the OSHA Bloodborne Pathogen Standard)?               |   |   |
| > (http://oshbftp.od.nih.gov/labsafety/#bloodborne)          |   |   |
+--------------------------------------------------------------+---+---+
| > 5\. Have any work- related accident/injury/infectious      |   |   |
| > disease cases occurred during the past 12 months?          |   |   |
+--------------------------------------------------------------+---+---+
| > a\. What steps were taken to resolve the specific (and     |   |   |
| > future) problem(s)?                                        |   |   |
| > \_\_\_\_\_\_\_\_\_                                         |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+
| > 6a. Have all staff in your IC who use radionuclides        |   |   |
| > completed the appropriate Radiation Safety Training?       |   |   |
| > (http://www.nih.gov.od/ors/ds/train.html#rad)              |   |   |
+--------------------------------------------------------------+---+---+
| > b\. Have any users in your IC had their privilege to use   |   |   |
| > radionuclides suspended for failure to take the radiation  |   |   |
| > safety refresher training, security violations, or other   |   |   |
| > violations of rules governing the use of radionuclides?    |   |   |
+--------------------------------------------------------------+---+---+
| > If YES, how many?                                          |   |   |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_     |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |   |
+--------------------------------------------------------------+---+---+

+---+------------------------------------------------------------+---+---+
| # |                                                            |   |   |
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+---+------------------------------------------------------------+---+---+
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+---+------------------------------------------------------------+---+---+
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+---+------------------------------------------------------------+---+---+
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+---+------------------------------------------------------------+---+---+
|   | 2\. Is there a process for competitive selection of the    |   |   |
|   | most highly qualified internal and external candidates     |   |   |
|   | into the tenure track or tenure?                           |   |   |
+---+------------------------------------------------------------+---+---+
|   | > a\. Are Affirmative Action Plan requirements met as a    |   |   |
|   | > part of this process?                                    |   |   |
+---+------------------------------------------------------------+---+---+
|   | > b\. Are positions advertised in scientific journals with |   |   |
|   | > broad circulation?                                       |   |   |
+---+------------------------------------------------------------+---+---+
|   | > c\. Did the selection(s) improve the race or gender      |   |   |
|   | > balance of your tenure track and tenured staff?          |   |   |
+---+------------------------------------------------------------+---+---+

+---+----------------------------------------------------------+---+---+
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+---+----------------------------------------------------------+---+---+
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+---+----------------------------------------------------------+---+---+
| 4 | 2\. On each tenure-track or tenure search committee is   |   |   |
| . | there an:                                                |   |   |
|   |                                                          |   |   |
|   |                                                          |   |   |
+---+----------------------------------------------------------+---+---+
|   | a\. EEO representative?                                  |   |   |
+---+----------------------------------------------------------+---+---+
|   | b\. WSA or designee?                                     |   |   |
+---+----------------------------------------------------------+---+---+
|   | > c\. Under-represented minority scientist?              |   |   |
+---+----------------------------------------------------------+---+---+
| d |                                                          |   |   |
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+---+----------------------------------------------------------+---+---+
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|   |                                                          |   |   |
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| s |                                                          |   |   |
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|   |                                                          |   |   |
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| h |                                                          |   |   |
| > |                                                          |   |   |
|   |                                                          |   |   |
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|   |                                                          |   |   |
| t |                                                          |   |   |
| o |                                                          |   |   |
| > |                                                          |   |   |
|   |                                                          |   |   |
| g |                                                          |   |   |
| e |                                                          |   |   |
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| d |                                                          |   |   |
| e |                                                          |   |   |
| r |                                                          |   |   |
| > |                                                          |   |   |
|   |                                                          |   |   |
| o |                                                          |   |   |
| r |                                                          |   |   |
| > |                                                          |   |   |
|   |                                                          |   |   |
| m |                                                          |   |   |
| i |                                                          |   |   |
| n |                                                          |   |   |
| o |                                                          |   |   |
| r |                                                          |   |   |
| i |                                                          |   |   |
| t |                                                          |   |   |
| y |                                                          |   |   |
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|   |                                                          |   |   |
| s |                                                          |   |   |
| t |                                                          |   |   |
| a |                                                          |   |   |
| t |                                                          |   |   |
| u |                                                          |   |   |
| s |                                                          |   |   |
| ? |                                                          |   |   |
+---+----------------------------------------------------------+---+---+

<table>
<colgroup>
<col style="width: 5%" />
<col style="width: 3%" />
<col style="width: 36%" />
<col style="width: 9%" />
<col style="width: 6%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 7%" />
<col style="width: 6%" />
<col style="width: 6%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="3"><p><strong>Provide the following data :</strong></p>
<p><strong>(Include intent-for-tenure)</strong></p></td>
<td><strong>Women</strong></td>
<td><strong>Men</strong></td>
<td><p><strong>Total</strong></p>
<p><strong>Minority*</strong></p></td>
<td><p><strong>Under-</strong></p>
<p><strong>Represented</strong></p>
<p><strong>Minority**</strong></p></td>
<td><strong>Total</strong></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td rowspan="15"></td>
<td colspan="2"><blockquote>
<p>4. Total number of scientists acquiring tenure in past 12 months?</p>
</blockquote></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td rowspan="2"></td>
<td rowspan="2"></td>
</tr>
<tr class="odd">
<td></td>
<td>a. Outside recruitment</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td></td>
<td>b. Appointed from within NIH</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td rowspan="6"></td>
<td rowspan="6"></td>
</tr>
<tr class="odd">
<td colspan="2"><blockquote>
<p>5. Of the total number of scientists acquiring tenure, how many
were:</p>
</blockquote></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td></td>
<td>a. Approved via Central Tenure Committee</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td><blockquote>
<p>b. Approved via SBRS Policy Board</p>
</blockquote></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="2">6. Total number of scientists appointed to tenure-track
positions in past 12 months?</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td>a. Outside recruitment</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td></td>
<td>b. Appointed from within NIH</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="2"><blockquote>
<p>7. Total number of promotions (or salary increases greater than
$5,000 in Title 42/SBRS) of tenured scientists in past 12 months?</p>
</blockquote></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="2"><blockquote>
<p>8. Total number of tenured scientists on board. ***</p>
</blockquote></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="2"><blockquote>
<p>9. Current total number of tenure-track scientists on board. **</p>
</blockquote></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="2">10. Current total number of Staff Scientists on
board***</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td rowspan="3"></td>
<td rowspan="3"></td>
</tr>
<tr class="odd">
<td colspan="2"><ol start="11" type="1">
<li><p>Current total number of Staff Clinicians on</p></li>
</ol>
<blockquote>
<p>board. ***</p>
</blockquote></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="2"><blockquote>
<p>* African-American; Hispanic: Native American (American Indian/
Alaskan Native); Asian/Pacific Islanders</p>
<p>** African-American; Hispanic: Native American (American Indian/
Alaskan Native)</p>
<p>* ** As of September 30, 2001</p>
</blockquote></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
</tbody>
</table>

+-------------------------------------------------------------+---+----+
| > **C. EVALUATION OF SCIENTIFIC AND TECHNICAL PERSONNEL**   | Y | NO |
|                                                             | E |    |
|                                                             | S |    |
+-------------------------------------------------------------+---+----+
| 1\. Does the Scientific Director review the progress of     |   |    |
| all:                                                        |   |    |
+-------------------------------------------------------------+---+----+
| a\. Pre-doctoral trainees?                                  |   |    |
+-------------------------------------------------------------+---+----+
| > b\. Post-doctoral fellows?                                |   |    |
+-------------------------------------------------------------+---+----+
| > c\. Tenure-track scientists annually in a meeting with    |   |    |
| > the laboratory/branch chief?                              |   |    |
+-------------------------------------------------------------+---+----+
| > d\. Staff scientists prior to renewal or every four       |   |    |
| > years?                                                    |   |    |
+-------------------------------------------------------------+---+----+
| > 2\. Is each fellow informed of his/her progress?          |   |    |
+-------------------------------------------------------------+---+----+
| > 3\. Was each postdoctoral fellow who remained at the NIH  |   |    |
| > for more than five years sent a memorandum from the       |   |    |
| > supervisor describing the proposed career course (in      |   |    |
| > accordance with the 5-yr/8-yr rule)?                      |   |    |
+-------------------------------------------------------------+---+----+
| > 4\. Were copies of all such memoranda provided to the     |   |    |
| > DDIR?                                                     |   |    |
+-------------------------------------------------------------+---+----+
| **IV. TECHNOLOGY TRANSFER (answer with the assistance of    | Y | NO |
| the IC TDC)**                                               | E |    |
|                                                             | S |    |
+-------------------------------------------------------------+---+----+
| > 1\. Do you have a process in place within your IC to      |   |    |
| > assist scientists in the identification of inventions?    |   |    |
+-------------------------------------------------------------+---+----+
| > 2\. Do you have a process in place within your IC to      |   |    |
| > evaluate Employee Invention Reports (EIRs)?               |   |    |
+-------------------------------------------------------------+---+----+
| > 3\. Is there an IC or Intramural budget allocation        |   |    |
| > set-aside for patent filing?                              |   |    |
+-------------------------------------------------------------+---+----+
| > If NO, how is patent filing supported?                    |   |    |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                            |   |    |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |   |    |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |    |
+-------------------------------------------------------------+---+----+
| > 4\. Were any EIRs not forwarded because of lack of funds? |   |    |
+-------------------------------------------------------------+---+----+
| > 5\. Does a documented procedure exist to screen           |   |    |
| > publications for patentable inventions prior to public    |   |    |
| > disclosure?                                               |   |    |
+-------------------------------------------------------------+---+----+
| > 6\. Does a documented procedure exist to reduce potential |   |    |
| > for public disclosure of invention due to a seminar or    |   |    |
| > talk?                                                     |   |    |
+-------------------------------------------------------------+---+----+
| > 7\. Was there any assignment of invention rights to       |   |    |
| > inventors during the period of review?                    |   |    |
+-------------------------------------------------------------+---+----+
| > 8\. Was there any instance where a conflict of interest   |   |    |
| > situation occurred due to assignment of federal rights to |   |    |
| > an inventor or other personal interest in a patent,       |   |    |
| > license, or CRADA?                                        |   |    |
+-------------------------------------------------------------+---+----+
| > 9\. Do you have safeguards in place to assure that no     |   |    |
| > conflict of interest situation will arise from invention  |   |    |
| > assignments to an employee or other personal interest in  |   |    |
| > a patent, license, or CRADA?                              |   |    |
+-------------------------------------------------------------+---+----+
| > If YES, please describe :                                 |   |    |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_    |   |    |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |   |    |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |    |
+-------------------------------------------------------------+---+----+

+-------------------------------------------------------------+---+----+
| **IV. TECHNOLOGY TRANSFER (answer with the assistance of    | Y | NO |
| the IC TDC) (cont.)**                                       | E |    |
|                                                             | S |    |
+-------------------------------------------------------------+---+----+
| > 10\. Has the IC encountered any intellectual property     |   |    |
| > complications or problems that could have been avoided by |   |    |
| > appropriate use of a MTA or CRADA?                        |   |    |
+-------------------------------------------------------------+---+----+
| > If yes, explain:                                          |   |    |
| > \                                                         |   |    |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |    |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |   |    |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |    |
+-------------------------------------------------------------+---+----+
| > 11\. Is there IC policy regarding the use of MTAs and     |   |    |
| > CRADAs?                                                   |   |    |
+-------------------------------------------------------------+---+----+
| > 12\. Are fair access guidelines applied to IC CRADA's?    |   |    |
+-------------------------------------------------------------+---+----+
| > 13\. Is there an IC process in place to ensure that all   |   |    |
| > fellows working on CRADA-related projects are aware of    |   |    |
| > the agreement and possible restrictions related to        |   |    |
| > research collaborations and future employment             |   |    |
| > opportunities?                                            |   |    |
+-------------------------------------------------------------+---+----+
| > 14\. Does your IC have CRADA procedures in place to       |   |    |
| > ensure IC scientists are not being inappropriately        |   |    |
| > limited in publication rights, waiving intellectual       |   |    |
| > property rights or violating confidentiality and/or       |   |    |
| > conflict of interest rules?                               |   |    |
+-------------------------------------------------------------+---+----+
| > 15\. Is an IC process in place to assure that scientific  |   |    |
| > staff is informed of their responsibilities in the        |   |    |
| > technology transfer area?                                 |   |    |
+-------------------------------------------------------------+---+----+
| > 16\. Does your IC have an internal resource person for    |   |    |
| > technology transfer issues?                               |   |    |
+-------------------------------------------------------------+---+----+
| > Name of person and phone number :                         |   |    |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                          |   |    |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |   |    |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |   |    |
+-------------------------------------------------------------+---+----+
| > 17\. Is there an IC process in place to ensure that all   | [ |    |
| > fellows, guest workers, volunteers and other              | ] |    |
| > non-employees working on technology transfer matters do   | { |    |
| > not represent themselves as government employees or       | . |    |
| > engage in negotiations and other matters as if they       | m |    |
| > represented the government?                               | a |    |
|                                                             | r |    |
|                                                             | k |    |
|                                                             | } |    |
+-------------------------------------------------------------+---+----+
| > 18\. Are Postdoctoral Fellows/GR/SV notified of their     |   |    |
| > responsibility to report and assign to the government any |   |    |
| > invention that occurs while working in a NIH facility?    |   |    |
+-------------------------------------------------------------+---+----+