Form 1 Survey

Evaluation of the Impacy of New Conflicts of Interest Regulations

Attachment 2 Potential survey[1]

Evaluation of the Impact of New NIH Conflicts of Interest Regulations

OMB: 0925-0579

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Attachment 2

Instrument: Survey of Potential Applicants






























Hello, my name is ____________. I’m calling from Opinion Research Corporation—ORC—on behalf of the National Institutes of Health. May I please speak with {INSERT NAME FROM SAMPLE}?


ORC is conducting a brief survey on behalf of NIH to gain a better understanding of the health and science community’s views toward NIH. ORC will hold your individual identity and responses confidential and this will not be disclosed to anyone but researchers conducting this study, except as otherwise required by law.


While your participation in this survey is voluntary, your responses to the questions are very important.  There are no penalties should you choose not to participate. This survey will take about 10 minutes to complete. It has been approved by NIH and the U.S. Office of Management and Budget. If you wish, I can read you the full statement of approval. Would you like to continue with the survey or shall I read the whole statement? Reading the statement will take an additional 2 minutes.


1 No, continue directly to survey [GO TO Q1]

2 Yes, please read full statement below [CONTINUE]


The information we collect in this study is in accordance with the clearance requirements of the pPaperwork Reduction Act of 1995. We may not conduct or sponsor, and you are not required to respond to, a collection of information unless it displays a valid control number from the Office of Management and Budget in the Federal Government. We estimate that it will take you approximately 15 minutes to complete the survey, including the time for reviewing instructions, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-xxxx)


[SECTION A: AWARENESS AND UNDERSTANDING OF REGULATIONS]


TIn this survey covers, I would like to talk to you about thea series of new ethics rules that NIH announced in 2005. Changes to the ethics rules—also called the Conflict of Interest rules—applicable to NIH employees were first proposed in February of 2005.  After comments were submitted and considered, the rules were further amended and made final in August of 2005. 


These rules prohibit certain types of outside activities, limit the health-related financial holdings certain NIH employees may hold, and limit the types of awards certain NIH employee receive. Note that these new COI rules evolved from an Interim Final Rule published on February 3, 2005 and include revisions as part of the Final Rule published on August 25, 2005.

For this survey, please base your responses on the Final Rule, which includes the revisions published on August 25, 2005.


For this survey, please base your responses on the Final Rule, which includes the revisions published on August 25, 2005.

A1) Are you aware that NIH announced these new ethicsConflicts of Interest rules, which prohibiting employees from engaging in certain outside activities, limit senior staff’s health-related , financial holdings, , and may limit their acceptance of certain gifts associated with awards for NIH employees—sometimes called the “new ethics rules”?


O Yes

O No [skip to B1]

O Not sure [skip to B1]


A2) Overall, which best describes your understanding of the new COIethics rules?

O [Strong understanding] I could describe every major provision in considerable detail, along with most of the exceptions to the rules.

O [Basic understanding] I could describe many of the provisions in the new rules, along with some of the exceptions.

O [Little understanding] I could describe some of the provisions in the new rules and a few of the exceptions, but I could not provide many specifics.

O [No understanding] I know that the new rules are in place, but I could not provide much information about them.

O [No awareness] I was not aware of the ethics rules before participating in this survey.


O [Strong understanding] I could describe every major restriction or clarification in considerable detail, along with most of the exceptions to the rules.

O [Basic understanding] I could describe many of the restrictions or clarifications in the new rules, along with some of the exceptions.

O [Little understanding] I could describe some of the restrictions or clarifications in the new rules and a few of the exceptions, but I could not provide many specifics.

O [No understanding] I know that the new rules are in place, but I could not provide much information about them.


[SECTION B: OUTSIDE ACTIVITIES]

Whether you were previously aware or not, I would like to get your views about each of the three components of the rules. We’ll start with outside activities.


The new ethics rules prohibit certain types of outside activities, such as consulting with pharmaceutical or biotechnology companies or some compensated speaking engagements with a hospital or other health care provider. These rules do not impact your ability to interact with pharmaceutical or biotechnology companies or hospitals when doing so as part of your official duties.

The new COI rules prohibit certain types of outside activities, such as consulting with pharmaceutical or biotechnology companies and some compensated speaking engagements with a hospital or other health care provider.


B1. Prior to any of the new COIethics rules being announced (i.e., before February 2005), did you believe there was a need for NIH to address the rules governing outside activities of staff?


O Yes

O No


B2. Based on your understanding of the new COIethics rules on outside activities, would you say that the rules are … ?


O Too restrictive

O Appropriate for NIH

O Not restrictive enough


[SECTION C: FINANCIAL HOLDINGS OF STAFF]

Next, I want to discuss the new rules as they relate to financial holdings. The new ethics rules restrict senior-level officials’ ownership of financial interests in pharmaceutical companies, biotechnology companies, medical device manufacturers, and related health-care sector funds over certain amounts except in limited circumstances.

The new COI rules restrict senior-level officials’ ownership of financial interests in pharmaceutical companies, biotechnology companies, medical device manufacturers, and related sector funds over certain amounts except in limited circumstances. These officials may be required to divest themselves of the affected investments.


C1. Prior to any of the new COIethics rules being announced (i.e., before February 2005), did you believe there was a need for NIH to addressaddress the the financial holdings of staff?


O Yes

O No


C2. Based on your understanding of the new ethics rules on financial holdings of senior staff, would you say that the rules are … ?Based on your understanding of the new COI rules on financial holdings of staff, would you say that the rules are … ?


O Too restrictive

O Appropriate for NIH

O Not restrictive enough


[SECTION D: AWARDS]

Lastly, I want to discuss the new rules as they relate to awards. The new ethics rules prohibit NIH employees from accepting gifts associated with an award with an aggregate market value of more than $200 if the award is offered by an organization with matters pending under an employee’s official responsibility. The new rules generally do not prohibit the acceptance of the honor associated with the award.

The new COI rules prohibit NIH employees from accepting gifts with an aggregate market value of more than $200 that are awards offered by an organization with matters pending under and employee’s official responsibility.


D1. Prior to any of the new COIethics rules being announced (i.e., before February 2005), did you believe there was a need for NIH to address the rules governing gifts that employees can accept in association with awards from certain sources?NIH to address the types of awards that staff can accept?


O Yes

O No


D2. Based on your understanding of the new ethics rules covering the gifts that employees can accept in association with awards from certain sources, would you say that the rules are … ?Based on your understanding of the new COI rules on the types of awards that staff can accept, would you say that the rules are … ?


O Too restrictive

O Appropriate for NIH

O Not restrictive enough


D3. Now I would like you think about all three components of the new COIethics rules. Over the past several years, many organizations—not just NIH—have instituted their own rules regarding conflicts of interest. Compared to your current place of employment, do you feel that NIH’s new COIethics rules are…?


O Much more restrictive

O More restrictive

O About the same

O Less restrictive

O Much less restrictive

O My current place of employment does not have rules governing conflicts of interest

O I am not aware if my current place of employment has rules governing conflicts of interest


[SECTION E: POTENTIAL APPLICANT QUESTIONS]

E1. Have you ever worked at NIH in the past?


O Yes

O No


[ask if E1= Yes]

E1a. Would you consider working at NIH again?


O Yes

O No


[ask if E1= No]

E1b. Have you ever considered or would you consider working at NIH at some point in your career?


O Yes

O No

O I used to work at NIH


E2. To what extent would these new COIethics rules impact your desire to work at NIH? Would you say they would have a…


O Very positive impact

O Moderately positive impact

O Slightly positive impact

O No impact [go to E3]

O Slightly negative impact

O Moderately negative impact

O Very negative impact


E2a. Which of the three components would most impact your desire to work at NIH? [read list, select only one]


O Restrictions on outside activities

O Restrictions on financial holdings

O Restrictions on the types of giftsawards employees can accept that are associated with awards

O None


E2b. You said that [insert from above] would most impact your desire to work at NIH. Please describe how this would affect you?


[open end]


E3. To what extent would ethicsCOI rules like these impact your desire to work at any organization that had ethics rules of this kind? Would you say they would have a…


O Very positive impact

O Moderately positive impact

O Slightly positive impact

O No impact [go to E4]

O Slightly negative impact

O Moderately negative impact

O Very negative impact


E3a. Which of the three components would most impact your desire to work at any organization that had ethics rules of this kind? [read list, select only one]


O Restrictions on outside activities

O Restrictions on financial holdings

O Restrictions on the types of awards employees can accept

O None


E4. We've talked mostly about your views on the new ethicsCOI rules at NIH. Other than the new ethicsCOI rules... what aspects of working at NIH make it appealing to you as a place to work?


[open end]


E5. What aspects of working at NIH make it unappealing to you as a place to work?


[open end]


[Probe: If providing generic answers about changing jobs, moving, etc., probe "Anything specifically about NIH?”]


[SECTION F: IMPACT ON NIH]

Now we would like to ask you some questions about how much you personally think the new COIethics rules will impact NIH long-term. Please answer using the same scale:


O Very positive impact

O Moderately positive impact

O Slightly positive impact

O No impact

O Slightly negative impact

O Moderately negative impact

O Very negative impact


F1. How do you think the new ethics rules will impact NIH’s…? [rotate b to f only]


a. Overall ability to complete its mission

b. Credibility with the public

c. Status as a leader in the scientific and health community

d. Ability to recruit the best staff to NIH

e. Ability to retain existing NIH staff

f. Official duty relationships with investigators in universities, associations, and the commercial sector


[SECTION G: IMAGE OF NIH]

Now I would like to ask you some questions about how the new COIethics regulationsrules impact your overall image of NIH. Please answer using the same scale [repeat scale as necessary]:


O Very positive impact

O Moderately positive impact

O Slightly positive impact

O No impact

O Slightly negative impact

O Moderately negative impact

O Very negative impact


G1. How do you think the new COIethics regulationsrules will impact…? [rotate a to d]


a. Your general image of NIH as a workplace

b. Your advocacy of NIH to others as a place to work

c. How you talk about NIH to colleagues

d. Your ability to conduct work with NIH


[SECTION H: DEMOGRAPHICS]

Now, I would like to ask you to provide some information about yourself. Again, ORC emphasizes we will hold your identity and individual responses confidential.


H1. What is your age? I’ll give you a set of ranges…


O 30 or younger

O 31-40

O 41-50

O 51-60

O 61 or older


H2. What position do you currently hold?


[open end]


DRAFT 25/29/06 10

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File Created2007-03-13

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