CIP CORE MAIN QUESTIONS AND ANSWERS SET A+
✔✔Beneficence - ✔✔The doing of good, obligates the researcher to secure the
individual's well-being by maximizing benefits and minimizing harms to the individual
research subject. Requires that the researcher perform a risk/benefit analysis. Requires
that competent investigators design ethical research, protect human subjects from risk,
and make continuing assessments of the risk/benefit ratio.
✔✔Factors that may determine when a DSMB is necessary - ✔✔A large study
population, multiple study sites, highly toxic therapies or dangerous procedures, high
expected rates of morbidity or mortality in the study population, high chance of early
termination.
✔✔Reasons a DSMB may stop a study - ✔✔efficacy, futility, or safety
✔✔Serious or Continuing Non-compliance - ✔✔A problem that indicates noncompliance
that is serious or continuing, OHRP will be notified within 48 hours, regardless of the
funding source. If applicable the FDA will be notified.
✔✔Renewal Interval - ✔✔No more than 365 days and is determined by the risk to
subjects.
✔✔Main Goals of HIPAA - ✔✔To make health insurance portable and increase
accountability in Medicare billing.
✔✔Protected Health Information (PHI) - ✔✔Individually identifiable health information
held by a covered entity.
✔✔Authorization - ✔✔Written permission from an individual allowing a CE to use or
disclose specified PHI for a particular purpose.
✔✔Designated Record Set - ✔✔The part of medical records that must be disclosed to
the individual--research information that is specifically for research is not typically part of
this.
,✔✔Data Use Agreement - ✔✔An agreement in which the data recipient promises not to
attempt to re-identify or contact the individuals.
✔✔Limited Data Set (LDS) - ✔✔Allows more identifiers than a de-identified data set--in
particular allows all dates and ZIP codes , but street addresses are not allowed--this set
is still considered PHI and is subject to the minimum necessary requirements of the
Privacy Rule.
✔✔Business Associate Contracts (BACs) - ✔✔For activities related to treatment,
payment, or operations--the only research activities for which this might be pertinent are
obtaining authorizations and creating a limited or de-identified data set.
✔✔Federalwide Assurance (FWA) - ✔✔A type of contract established by OHRP that
specifies when and how an institution will comply with DHHS research regulations.
Written documentation of an institution's commitment to comply with federal regulations
governing human subjects research--covers all federally supported or conducted
research involving human subjects.
✔✔Human Protections Administrator - ✔✔An employee or agent of the FWA institution
who exercises day-to-day operational responsibility for the institution's program for
protecting human subjects. AKA IRB Administrator/Director.
✔✔International Conference on Harmonization (ICH) - ✔✔Designed to streamline the
process for developing and marketing new drugs internationally, composed of
representatives from the pharmaceutical industry and the regulatory bodies of the US,
Japan, and the EU, and has established several international standards of good clinical
practice (GCP) for the development of pharmaceutical products.
✔✔Differences Between ICH guidelines and US Regulations - ✔✔Definition of
vulnerable subject, Confidentiality of Medical Records, Signature by Person Conducting
the Consent Discussion, Subject Receipt of a Signed and Dated Copy of the Consent
Form, Assent for Children and Mentally Incapacitated Adults, Impartial Witness for
Illiterate Subjects, and Prior Approval for Minor Amendments
✔✔Off-label Use - ✔✔A treating physician administers a drug for an indication other
than the approved ones.
✔✔Form 483 "Statement of Findings" - ✔✔Essentially a blank page that the deficiencies
found during an FDA audit are written on.
✔✔Establishment Inspection Report (EIR) - ✔✔A report which contains positive and
negative observations from the FDA's audit of an IRB.
, ✔✔Voluntary Action Indicated (VAI) Letter - ✔✔Letters that simply ask for a correction
of minor deficiencies found during an FDA audit.
✔✔Official Action Indicated (OAI) Letter - ✔✔Letter that demands correction for what
the FDA believes to be serious deficiencies and/or violations of the regulations--these
are called warning letters and often carry some type of sanction for the instituion and its
investigators.
✔✔Study-oriented Inspections - ✔✔Inspections that are done at study sites that have
participated in pivotal clinical trials (trials that the FDA uses to approve drugs and
devices for marketing).
✔✔Investigator-oriented Inspections - ✔✔Inspections that are usually the result of one
or more reports of questionable behavior or of questions that have been raised.
✔✔The 3 Statutory Responsibilities of OHRP - ✔✔Administration of assurances,
education, and compliance oversight.
✔✔Five Basic Categories of Harm as noted in The Belmont Report - ✔✔social harm,
economic harm, legal harm, psychological harm, and physical harm
✔✔Vulnerable Persons - ✔✔Persons who are relatively (or absolutely) incapable of
protecting their own interest.
✔✔Peer contagion - ✔✔May be caused by grouping high-risk adolescents for
behavioral interventions in which negative behaviors are enforced. This is of particular
risk in school-based research.
✔✔Activities with schoolchildren that DO NOT qualify for exemption under Subpart D -
✔✔1. Research involving surveys
2. Research involving interviews
3. Observation of public behavior when the researcher participates in the activities being
observed
✔✔Fetus - ✔✔The product of conception from the time of implantation until delivery.
✔✔Pregnancy - ✔✔Encompassing the period of time from confirmation of implantation
until expulsion or extraction of the fetus.
✔✔Viable - ✔✔Able to survive if given the benefit of available medical therapy to the
point of independently maintaining heartbeat and respiration.
✔✔Non-Viable - ✔✔A fetus that has not attained a gestational age of 20 weeks and
does not exceed 400 grams in weight.
✔✔Beneficence - ✔✔The doing of good, obligates the researcher to secure the
individual's well-being by maximizing benefits and minimizing harms to the individual
research subject. Requires that the researcher perform a risk/benefit analysis. Requires
that competent investigators design ethical research, protect human subjects from risk,
and make continuing assessments of the risk/benefit ratio.
✔✔Factors that may determine when a DSMB is necessary - ✔✔A large study
population, multiple study sites, highly toxic therapies or dangerous procedures, high
expected rates of morbidity or mortality in the study population, high chance of early
termination.
✔✔Reasons a DSMB may stop a study - ✔✔efficacy, futility, or safety
✔✔Serious or Continuing Non-compliance - ✔✔A problem that indicates noncompliance
that is serious or continuing, OHRP will be notified within 48 hours, regardless of the
funding source. If applicable the FDA will be notified.
✔✔Renewal Interval - ✔✔No more than 365 days and is determined by the risk to
subjects.
✔✔Main Goals of HIPAA - ✔✔To make health insurance portable and increase
accountability in Medicare billing.
✔✔Protected Health Information (PHI) - ✔✔Individually identifiable health information
held by a covered entity.
✔✔Authorization - ✔✔Written permission from an individual allowing a CE to use or
disclose specified PHI for a particular purpose.
✔✔Designated Record Set - ✔✔The part of medical records that must be disclosed to
the individual--research information that is specifically for research is not typically part of
this.
,✔✔Data Use Agreement - ✔✔An agreement in which the data recipient promises not to
attempt to re-identify or contact the individuals.
✔✔Limited Data Set (LDS) - ✔✔Allows more identifiers than a de-identified data set--in
particular allows all dates and ZIP codes , but street addresses are not allowed--this set
is still considered PHI and is subject to the minimum necessary requirements of the
Privacy Rule.
✔✔Business Associate Contracts (BACs) - ✔✔For activities related to treatment,
payment, or operations--the only research activities for which this might be pertinent are
obtaining authorizations and creating a limited or de-identified data set.
✔✔Federalwide Assurance (FWA) - ✔✔A type of contract established by OHRP that
specifies when and how an institution will comply with DHHS research regulations.
Written documentation of an institution's commitment to comply with federal regulations
governing human subjects research--covers all federally supported or conducted
research involving human subjects.
✔✔Human Protections Administrator - ✔✔An employee or agent of the FWA institution
who exercises day-to-day operational responsibility for the institution's program for
protecting human subjects. AKA IRB Administrator/Director.
✔✔International Conference on Harmonization (ICH) - ✔✔Designed to streamline the
process for developing and marketing new drugs internationally, composed of
representatives from the pharmaceutical industry and the regulatory bodies of the US,
Japan, and the EU, and has established several international standards of good clinical
practice (GCP) for the development of pharmaceutical products.
✔✔Differences Between ICH guidelines and US Regulations - ✔✔Definition of
vulnerable subject, Confidentiality of Medical Records, Signature by Person Conducting
the Consent Discussion, Subject Receipt of a Signed and Dated Copy of the Consent
Form, Assent for Children and Mentally Incapacitated Adults, Impartial Witness for
Illiterate Subjects, and Prior Approval for Minor Amendments
✔✔Off-label Use - ✔✔A treating physician administers a drug for an indication other
than the approved ones.
✔✔Form 483 "Statement of Findings" - ✔✔Essentially a blank page that the deficiencies
found during an FDA audit are written on.
✔✔Establishment Inspection Report (EIR) - ✔✔A report which contains positive and
negative observations from the FDA's audit of an IRB.
, ✔✔Voluntary Action Indicated (VAI) Letter - ✔✔Letters that simply ask for a correction
of minor deficiencies found during an FDA audit.
✔✔Official Action Indicated (OAI) Letter - ✔✔Letter that demands correction for what
the FDA believes to be serious deficiencies and/or violations of the regulations--these
are called warning letters and often carry some type of sanction for the instituion and its
investigators.
✔✔Study-oriented Inspections - ✔✔Inspections that are done at study sites that have
participated in pivotal clinical trials (trials that the FDA uses to approve drugs and
devices for marketing).
✔✔Investigator-oriented Inspections - ✔✔Inspections that are usually the result of one
or more reports of questionable behavior or of questions that have been raised.
✔✔The 3 Statutory Responsibilities of OHRP - ✔✔Administration of assurances,
education, and compliance oversight.
✔✔Five Basic Categories of Harm as noted in The Belmont Report - ✔✔social harm,
economic harm, legal harm, psychological harm, and physical harm
✔✔Vulnerable Persons - ✔✔Persons who are relatively (or absolutely) incapable of
protecting their own interest.
✔✔Peer contagion - ✔✔May be caused by grouping high-risk adolescents for
behavioral interventions in which negative behaviors are enforced. This is of particular
risk in school-based research.
✔✔Activities with schoolchildren that DO NOT qualify for exemption under Subpart D -
✔✔1. Research involving surveys
2. Research involving interviews
3. Observation of public behavior when the researcher participates in the activities being
observed
✔✔Fetus - ✔✔The product of conception from the time of implantation until delivery.
✔✔Pregnancy - ✔✔Encompassing the period of time from confirmation of implantation
until expulsion or extraction of the fetus.
✔✔Viable - ✔✔Able to survive if given the benefit of available medical therapy to the
point of independently maintaining heartbeat and respiration.
✔✔Non-Viable - ✔✔A fetus that has not attained a gestational age of 20 weeks and
does not exceed 400 grams in weight.
