Research HIPAA Exam 
This exam which accompanies the "HIPAA Training Handbook for Researchers: HIPAA and Clinical Trials"  is an education requirement for all MRI employees who conduct research.   This includes primary investigators, co-investigators and clinical coordinators. 

In order to certify electronically that you completed HIPAA training requirements, you must complete the following exam.  Please answer the following questions and then press the submit button on the bottom of the page. Please print a copy of the subsequent confirmation page and save it for your records. Failure to print the confirmation page may require you to retake the exam.  The Office of Research Programs will not be able to retrieve your certification.

Back to the Research HIPAA training page.

 
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1.

The criminal penalties for improperly disclosing PHI can be as high as fines of $250,000 and sentences of up to 10 years in prison.

True

False
2.

What type of information does the HIPAA privacy rule protect?

a. patient information in electronic form

b. patient information spoken out loud

c. patient information on paper

d. all of the above
3.

Which of the following are common ways researchers protect patient privacy?

a. not speaking about patient conditions in public areas

b. remembering to turn off unattended laptops that contain patient information

c. keeping labeled tissue samples in a private place

d. all of the above
4.

In September 2002, 30 subjects signed valid consents for research, which did not contain HIPAA language.  Your study continues into the summer of 2003.  These subjects must sign a new consent containing HIPAA authorization language?

True

False
5.

What research is covered by HIPAA? (Choose the best answer.)

a. any research done by a covered entity

b. research involving patients funded by the federal government

c. all research on people, living or dead

d. FDA Phase III trials
6.

Who can see the general medical record for research with the patient's authorization?  (Choose the best answer.)

a. the study nurse only

b. the study nurse, the PI, monitor, IRB and oversight organizations

c. the study nurse and PI only

d. It depends on the wording of the informed consent/authorization form
7.

Which of the following features of a consent for research are completely new with the HIPAA requirements?  (Choose all that apply.)

a. the purpose of the use or disclosure

b. expiration date or event

c. right to refuse to participate

d. re-disclosure by the recipient of the data
8.

How long must you retain a consent/authorization for research?

a. until the end of the study

b. for at least six years or the minimum amount of time required under
        state law, whichever is longer

c. at least 10 years or the minimum amount of time required under
        state law, whichever is longer

d. at least 14 years or the minimum amount of time required under
        state law, whichever is longer
9.

How long can a study site use or disclose PHI for research?

a. forever

b. six years

c. as long as described in the research authorization or waiver request

d. until the end of the study
10.

How can you perform pre-screening for research under HIPAA?

a. under a waiver of authorization from an IRB

b. using a notice of review preparatory to research

c. with no changes from current practices

d. a or b, depending on the study needs
11.

How should you pre-screen patients if you want to call them on the phone?

a. under a waiver of authorization by an IRB

b. with a notice of review preparatory to research, provided no PHI
        leaves the covered entity

c. with no changes from current practices

d. either a or b
12.

If you want to send pre-screening logs to the sponsor for research, what steps should you take?

a. obtain a waiver of authorization from an IRB

b. send de-identified data

c. send a limited data set with data use agreement

d. any of the above
13.

Which of the following is true about PHI you obtain in pre-screening performed under reviews preparatory to research?

a. The sponsor's monitor can review it for subject recruitment purposes.

b. The investigator can send the PHI, as is, to the sponsor.

c. The PHI must stay at the health care facility.

d. both a and c
14.

How much PHI are you permitted to obtain during pre-screening?

a. the entire medical record

b. only the patient's name and admission date

c. the minimum amount you need for your study, which is stated in the
        notice of reviews preparatory to research or in the request for
        waiver of authorization

15.

You conduct pre-screening using the review preparatory to research.  Now, the study sponsor would like a copy of some of the items on the pre-screening log for research purposes.  What can you do?  (Choose all that apply.)

a. nothing

b. de-identify the data and send it

c. create a limited data set and obtain a data use agreement with the sponsor

d. go back to the IRB and request a waiver of authorization for the
        information you have in the log
16.

You are a clinical trials coordinator employed by a doctor who is conducting research at a nearby hospital.  You have been reviewing hospital logs to pre-screen 40 subjects for a study.  You must keep track of the patients you've reviewed in case the hospital needs to inform the patients about your activities.

True

False
17.

You must obtain a business associate agreement with the sponsor in pharmaceutical company-sponsored studies for which you've obtained authorization from subjects.

True

False