When evaluating risks of harm, IRBs must determine that:
Risks are reasonable in relation to anticipated benefits.
When the primary potential harm is the breach of individually identifiable data to protect against such disclosure researchers should?
When the primary potential harm is the breach of individually identifiable data, to protect against such disclosures researchers should:
Encrypt the data and store it in password protected files on institutionally maintained servers with limited access
.
Which of the following is a measure researchers can use to protect?
Which of the following is a measure researchers can use to protect the confidentiality of subject data?
Keep sensitive and identifiable data in encrypted files on a password protected hard drive
.
What three questions must an IRB include in its Ferpa checklist?
What three questions must an IRB include in its FERPA checklist? Is there
written permission to collect the data
? Will the use of the data be for a legitimate educational interest? Will the disclosure be to another educational institution?
What statement about risks in social and behavioral sciences research is most accurate:
Risks are specific to time, situation, and culture
. The primary purpose of a Certificate of Confidentiality is to: Protect identifiable research information from compelled disclosure.
What procedures must be described in an agreement called an?
What procedures must be described in an agreement called an “
assurance of compliance
” with a U.S. federal agency? Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB.
When required the information provided to the data subject in a Hipaa disclosure?
When required, the information provided to the data subject in a HIPAA disclosure accounting …
must be more detailed for disclosures that involve fewer than 50 subject records
. Can qualify as an activity “preparatory to research,” at least for the initial contact, but data should not leave the covered entity.
How do you protect participants anonymously?
Researchers employ a number of methods to keep their subjects’ identity confidential. Foremost, they keep their
records secure through the use of password protected files
, encryption when sending information over the internet, and even old-fashioned locked doors and drawers.
How can you protect research information?
- Remain Current with Cybersecurity Practices. …
- Install Anti-virus Software. …
- Install a Firewall.
- Update and Patch Operating System. …
- Data Classification. …
- System Authentication and Security. …
- Data Backup Options. …
- Data Encryption.
How do you protect participants in research?
To protect participants’ confidentiality, you should
encrypt computer-based files, store documents (i.e., signed consent forms) in a locked file cabinet and remove personal identifiers from study documents
as soon as possible.
What must be included in a FERPA compliant consent form?
FERPA requires that a
consent for disclosure of education records be signed and dated, specify the records that may be disclosed, state the purpose of the disclosure, and identify the party or class of parties to whom the disclosure may be made
.
Which of the following is a reason that prisoners need special protection?
Which of the following is a reason that prisoners need special protection?
Prisoners have limited free choice because their autonomy is restricted
.
Which statement best describes information that must be included in a consent form?
Respect for Persons, Beneficence, Justice. Which statement best describes information that must be included in a consent form:
A description of the research’s potential benefits and risks.
Which is the best statement regarding research risks of harm?
Which is the best statement regarding research risks of harm?
Both the mothers and children are subjects of the research, and they are each exposed to research risks of harm
. The risks of harm are different for mother and child.
What is the primary purpose of a certificate of confidentiality?
Certificates of Confidentiality are issued by the National Institutes of Health (NIH) and other HHS agencies
to protect identifiable research information from forced or compelled disclosure
.
What brought increased public attention to the problems with the IRB system?
Which of the following brought increased public attention to the problems with the IRB system?
Death of Jesse Gelsinger
(Although all of these are related to the problems with the IRB system, the death of Jesse Gelsinger was what received public attention.)
