When talking to a reporter it is important to be aware of terms of the journalistic trade. What does “Off the Record” mean?
a. This means that the a reporter cannot use your information in a story as coming from you; however, the reporter can use it in others ways such as getting another source to respond to your comment
b. This means that the reporter can use the information you give, including direct quotes, but you are not to be named. You may be identified as a NIH scientist or a knowledgeable NIH source
c. This means that a reporter can quote you directly, using your name and title
32. Despite the ground rules, when talking to a reporter it is always best to be?
a. On the record
b. Not for attribution and on background
c. Off the record
33. The United States’ Freedom of Information Act (FOIA) provides individuals with a right to access records in the possession of the federal government. Which item best describes what may be available under the FOIA?
a. Minutes of NIH Institution Review Boards
b. Your computer files
c. Document drafts
d. Your e-mail messages
e. Approved research protocols
f. All of the above
34. Under the United States’ Freedom of Information Act a document stamped “Confidential” may still be released to the requester
35. The best response for you to give when a reporter contacts you directly is?
a. “Sure, I can talk with you right now. What would you like to talk about?”
b. “I’d be happy to talk with you, but I am not allowed”
c. “I’d be happy to talk with you. Would you coordinate this with my Communication Office?”
36. Which of the following is a key component of a good outcome measure?
a. Cohen’s d
b. Sensitivity to change
c. Ratio scale
37. Which of the following characteristics are the most important in determining a good measure?
a. Cost and categorization
b. Feasibility and frequency of publication
c. Scale and specialization
d. Reliability and validity
38. Community-Based Participatory Research (CBPR) is only applicable to descriptive research to identify the social determinants of health.
39. CBPR is only qualitative research methods used to study community health problems.
40. What is the reason NIH requires the inclusion of women and minorities in all clinical research?
a. Legal requirement as a result of the 1993 NIH reauthorization
b. NIH policy
c. Ethical principle of justice
d. All of the above
41. Since the implementation of the inclusion policy:
a. Knowledge has been gained about differences in cardiovascular symptoms between men and women
b. More research participants from minority groups have participated in clinical research
c. More women than men have participated in clinical research
d. All of the above
42. A university scientist has discovered a compound that may be an important new drug, the compound has not yet been disclosed publicly, but a manuscript is being prepared. The scientist needs to conduct certain additional experiments, but is unfamiliar with the technical procedures. Fortunately, the scientist knows a colleague, now working at a company, who is an expert at those techniques. The scientist wants to send a sample to the colleague to conduct those tests on the compound. Which one of the following statements is TRUE?
a. The scientist should send a sample of the compound to the colleague now; any necessary paperwork can be done later, when it is more convenient
b. The scientist likely is not authorized to send a sample to the colleague until a Material Transfer Agreement has been executed by the scientist’s employer and the colleague’s Company
c. The scientist and the colleague should personally execute a Confidential Disclosure Agreement before discussing the compound
d. The colleague, on behalf of the company, must file an Employee Invention Report on the scientist’s compound as quickly as possible
e. The parties must negotiate a full Cooperative Research and Development Agreement (CRADA) to allow the company to pay for the scientist’s efforts
43. A scientist at NIH wants to get a sample of a patented compound from a company. The company is willing to send the compound if the scientist signs a form. The form says that (1) the recipient may not distribute the materials further, (2) the company owns any inventions the recipient develops, and (3) the recipient agrees to indemnify the company. Which one of the following should the scientist do?
a. Send the form to the NIH scientist’s Technology Transfer office or General Counsel’s office, and wait for them and the company’s attorneys to work something out
b. The NIH scientist should sign the company’s form on behalf of the NIH and hope no one at the company realizes the scientist is not authorized to sign to sign the form.
c. Get the sample from a colleague at a nearby university, who signed the company’s form, if the university colleague will not make the scientist sign anything
d. File an Employee Invention Report on the compound as quickly as possible, and attach any relevant background materials
e. Sign a copy of the US Public Health Service (PHS) Model Cooperative Research And Development Agreement (CRADA) and send it to the company for counter-execution
44. A scientist at NIH and a colleague at a company have been working together on a project established under an approved, duly executed CRADA. During the project, the colleague shows the NIH scientist a draft (unfiled) patent application for something the colleague and the NIH scientist both believe they co-invented. The scientist should do which of the following?
a. Post the draft patent application on the Internet immediately, because NIH policy favors publication at the soonest possible opportunity
b. Buy stock in the colleague’s company before the invention has been publicly disclosed
c. Sign a Uniform Biological Material Transfer Agreement immediately to document the transfer rights
d. Forward the draft to the NIH scientist’s Technology Development Coordinator to determine what the NIH wants to do about the invention
e. Do nothing – under a CRADA, the company automatically owns all inventions and NIH no longer has to worry about such inventions
45. In order to strengthen certain literature searches for potential side effects, Johns Hopkins University recommended that investigators collaborate with which two of the following: 1) a board-certified physician with a relevant specialty 2) a pharmacist 3) a senior MD/PhD researcher with a relevant specialty 4) a librarian 5) a PhD chemist with a relevant specialty
a. 1 & 2
b. 1 & 4
c. 2 & 3
d. 2 & 4
e. 2 & 5
46. Which of the following is a key clinical information database that is very similar in subject coverage to PubMed, and is particularly valuable for drug, toxicology, conference and international information coverage?
a. Web of Science
47. Implementation studies focus primarily on:
a. Whether and how an intervention that is known to be efficacious can be implemented in a “real-world” setting
b. Whether an intervention is efficacious in a highly selected samples of research participants
c. Whether a treatment can be implemented in a highly selected sample of research participants
d. Whether and how an intervention that does not have known efficacy can be implemented in a controlled setting
48. The main purpose(s) of establishing exclusionary criteria is:
a. For balancing between-participant variance
b. For safety issues
c. To decrease potential confounding
d. All of the above
e. b and c only
49. The risk of Type I error is most likely to occur when:
a. A researcher has designed a study to maximize control over extraneous factors
b. A researcher is most concerned about various sources of bias
c. A researcher is most concerned with maximizing generalizability
d. A researcher has designed a study to equally balance internal and external validity
50. The name of the conceptual structure of a team made up of people of different disciplines who each report to someone outside the team structure is known as:
a. Project team
b. Matrix model
c. Disconnected team
d. Clinical team
51. Which is NOT true of the recent trends in project management?
a. There is a trend toward the project manager being more involved in timeline management
b. The project manager serves as both a project leader and analyst
c. The project manager may have duties in managing the company’s pipeline portfolio
d. Interpersonal skills may be as important to the project manager than analytical skills
52. Disclosure of which of the following items is necessary for an informed consent document?
a. The diagnosis or identification of a subject’s condition or problem
b. The nature and purpose of the proposed treatment or intervention
c. The foreseeable risks and benefits of the proposed treatment or intervention
d. All of the above
53. An individual enrolled in a protocol at the NIH Clinical Center may appoint a surrogate decision-maker to make medical and/or research decisions in the event s/he becomes incapable through use of a Durable Power of Attorney for Health Care, also known as a DPA?
54. Authorship is based on significant contribution to?
a. The conceptualization and design of the research project
b. The execution of the experiments
c. Writing of the paper
d. Assumption of responsibility for the entire study
e. Any of the above
55. Which of these is NOT considered to be research misconduct?
a. In your manuscript copying verbatim a paragraph from another scientist’s published manuscript with no attribution
b. Submitting a previously published table of data without attribution to the original work
c. Preparing a figure for a paper using only those experiments which had laboratory controls that worked
d. Changing some of the numbers in a table so that the standard error is smaller
56. In evaluating the ethical aspects of a study, it is important to assess scientific validity. Assessing scientific validity includes consideration of:
a. Sample size and study design
b. Costs and budget
c. Informed consent
d. Amount of compensation to participants
57. In the proposed ethical framework for clinical research, the final principle “respect for enrolled subjects” is understood to include:
a. Establishing a contract between the subject and the researcher
b. Monitoring the subject’s welfare and protecting confidentiality of information
c. Keeping the financial costs of participation reasonable
d. Informing the subject of new information only after the study is published
58. If you are conducting clinical research that is funded by the NIH, you are always required to follow the:
a. CIOMS International Guidelines
b. Common Rule
c. Nuremberg Code
d. Belmont Report