Does HIPAA prohibit physicians from discussing recruitment into studies with
patients for whom involvement might be appropriate? correct answer -
Physicians can continue to discuss such options with their own patients, since
this would be part of treatment.
Does HIPAA permit research authorizations to be combined with other
documents? correct answer -Yes, research authorizations for may be
combined with any other legal permission related to the research study,
including another authorization or consent to participate.
These three action must be taken after a breach: correct answer -1.) Take
Immediate action to stop the activity causing the breach, if applicable
2.) Conduct a detailed analysis to determine threshold of financial,
reputational, or other harm that may have occurred.
3.) Notify the Privacy Official
True or False: After a breach, patients should be notified. correct answer -
False
True or False: HIPAA permits a verbal authorization for research in certain
circumstances. correct answer -False
True or False: An authorization or waiver of authorization is not necessary if
the researcher is only looking at records of his or her own patients in a
retrospective chart review and is only recording de-identified information for
research purposes. correct answer -False
To obtain a complete waiver of authorization for a research project, the
researcher must provide the Privacy Board evidence of these three things:
correct answer -1.) The use and disclosure of PHI involves no more than the
minimal risk to the subject's privacy rights
2.) The reason the information being sought is necessary
3.) The reason it is not practicable to obtain an authorization
To obtain a complete waiver of authorization for a research project, the
researcher must provide the Privacy Board evidence that the use and
, disclosure only involves information on deceased individuals. correct
answer -False. This is not one of the criteria that must be met in order for the
IRB or Privacy Board to approve the waiver or alteration of authorization.
All of the following are examples of new enforcement rules under HITECH,
EXCEPT: correct answer -Revocation of medical licensing by the
Department of Health and Human Services
True or False: Encryption is an effective deterrent against breaches of PHI
maintained electronically. correct answer -True
True or False: A researcher must provide a copy of the research authorization
to the covered entity where he/she wants to look at or obtain PHI about the
subject. correct answer -True
True or False: Quality of care of an IVF patient will not be affected by their
decision to donate or not. correct answer -True. IVF patients who donate
embryos for use in research are not considered human subjects under the
Common Rule unless the investigator obtains data through interaction or
intervention with the donor or obtains identifiable private information. In
most cases, the identity of IVF patients who donate embryos for research
purposes will not be known to the investigator. The investigator and the
physician caring for the IVF patient should not be the same person to prevent
conflict of interest. Consent should be obtained at the time of donation.
In general, ESCRO Committees specifically include this type of person:
correct answer -A member of the lay public.
True or False: One major responsibility of ESCRO/SCRO/SCRO Committee is
to review and approve the scientific merit of hESC research. correct answer
-True. The NAS Guidelines do not specifically require annual re-review and re-
approval of hES cell research. However, many ESCRO Committees perform
continuing review similar to the reviews performed by IRBs. ESCRO
Committees are responsible for facilitating the education of hESC research
investigators.
What does appropriate provenance mean with regards to the embryo?
correct answer -The embryo is no longer required for reproductive purposes
and the donor of the embryo consented to the use of the derived hESCs.