CITI Training
Summary 1
The responsibilities associated with administering an IRB will vary, depending
on the type of institution and the institutional, local, national, and
international policies that prevail. However, the following will be common
across borders and institutions:
Use standard operating procedures (SOPs) to ensure the quality
and consistency of review of human research activities.
Communicate effectively with researchers, research coordinators,
and other staff involved in the human research protection
program.
Provide guidance to the IRB staff, IRB members, researchers,
research staff, and the research community, at large.
Respond to research subject and community inquiries.
References
Protection of Human Subjects, 21 CFR § 50 (2016).
Protection of Human Subjects, 45 CFR § 46 (2017).
Additional Resources
Association for the Accreditation of Human Research Protection
Programs (AAHRPP). nd. “Home.” Accessed November 9, 2022.
Office for Human Research Protections (OHRP). 2022. “Reporting
Incidents to OHRP (2022).” September 9.
National Cancer Institute (NCI). nd. "Clinical Trials Information
for Patients and Caregivers." Accessed November 9, 2022.
, U.S. Department of Health and Human Services (HHS), Office for
Human Research Protections (OHRP). 2020. "Regulations, Policy &
Guidance." Accessed November 9, 2022.
U.S. Food and Drug Administration (FDA). 2022. "Clinical Trials
Guidance Documents." Accessed November 9, 2022.
U.S. Food and Drug Administration (FDA). 2018. "Institutional
Review Board (IRB) Written Procedures: Guidance for
Institutions and IRBs.” Accessed August 7, 2017.
Module 1 Quiz- Question 1
Question The IRB Administrator would be responsible for which of the
following tasks:
Your Professional development for IRB members and supporting staff
Answer
Result Correct
Comment The IRB administrator helps provide development for IRB
members and supporting staff through training and supporting
proposals for funds to help members and staff attend regional
and national meetings.
Budgets for research departments would be prepared by the
personnel in those individual departments. Institutional and
national scientific review committees would be responsible for
assessing the scientific design of proposed research. Either
institutional or private legal counsel would provide legal advice.
Question 2
Question Which one of the following statements is true?
,Your The IRB administrator is responsible for ensuring the
Answer development and maintenance of policies or standard operating
procedures that provide consistency and structure to the human
research protection program.
Result Correct
Comment The IRB administrator helps to ensure that policies and standard
operating procedures are developed and maintained. Some IRB
administrators may be members of the IRB, but this is not
required or even allowed at all organizations.
The IRB administrator may assist the individuals responsible for
budget preparations, but the actual finalization of the proposed
budget more generally is the responsibility of a higher
organizational administration official. Site visitors usually will
request to speak with multiple individuals from within the
organization during a site visit.
Question 3
Question A television news reporter contacts the IRB Administrator after
reading a press release describing a federally funded breast
cancer prevention study coordinated by an institutional
researcher. Study findings might lead to the identification of new
genes that might predispose an individual or their family
members to breast cancer. The reporter would like to interview
the study subjects and their family members who are enrolled in
this new study.
Which of the following best describes the IRB administrator’s
action in response to this request?
Your Refer the inquiry to the media spokesperson
, Answer
Result Correct
Comment Most organizations have a designated media spokesperson who
is responsible for responding to media inquiries. Informing the
chair and notifying a federal funding agency is recommended,
but is not required. Any details or study background are best
presented by the media spokesperson and if needed, the media
spokesperson could consult the researcher for more details that
might be requested when there is a media inquiry.
Question 4
Question A staff member approaches the IRB administrator about a
researcher submitting a new HIV prevention study that involves
multiple performance sites in different countries. The researcher
also proposes to be the coordinating center for this multisite
trial. The staff member asks for help with preparing the IRB for
review of this more than minimal risk, intervention study. Which
of the following best describes the IRB administrator’s action to
prepare the study for IRB review?
Your Determine if an IRB consulting reviewer is required
Answer
Result Correct
Comment Policies and procedures should describe when a consulting
reviewer is required to assist the IRB during review of the study.
A consulting reviewer could provide local context or scientific
expertise.
While media or FDA might find the study of interest, it is not
necessary to contact them. SOPs would be developed by the
research team or sponsor for the study. Some participating sites
may have local SOPs already in place.
Summary 1
The responsibilities associated with administering an IRB will vary, depending
on the type of institution and the institutional, local, national, and
international policies that prevail. However, the following will be common
across borders and institutions:
Use standard operating procedures (SOPs) to ensure the quality
and consistency of review of human research activities.
Communicate effectively with researchers, research coordinators,
and other staff involved in the human research protection
program.
Provide guidance to the IRB staff, IRB members, researchers,
research staff, and the research community, at large.
Respond to research subject and community inquiries.
References
Protection of Human Subjects, 21 CFR § 50 (2016).
Protection of Human Subjects, 45 CFR § 46 (2017).
Additional Resources
Association for the Accreditation of Human Research Protection
Programs (AAHRPP). nd. “Home.” Accessed November 9, 2022.
Office for Human Research Protections (OHRP). 2022. “Reporting
Incidents to OHRP (2022).” September 9.
National Cancer Institute (NCI). nd. "Clinical Trials Information
for Patients and Caregivers." Accessed November 9, 2022.
, U.S. Department of Health and Human Services (HHS), Office for
Human Research Protections (OHRP). 2020. "Regulations, Policy &
Guidance." Accessed November 9, 2022.
U.S. Food and Drug Administration (FDA). 2022. "Clinical Trials
Guidance Documents." Accessed November 9, 2022.
U.S. Food and Drug Administration (FDA). 2018. "Institutional
Review Board (IRB) Written Procedures: Guidance for
Institutions and IRBs.” Accessed August 7, 2017.
Module 1 Quiz- Question 1
Question The IRB Administrator would be responsible for which of the
following tasks:
Your Professional development for IRB members and supporting staff
Answer
Result Correct
Comment The IRB administrator helps provide development for IRB
members and supporting staff through training and supporting
proposals for funds to help members and staff attend regional
and national meetings.
Budgets for research departments would be prepared by the
personnel in those individual departments. Institutional and
national scientific review committees would be responsible for
assessing the scientific design of proposed research. Either
institutional or private legal counsel would provide legal advice.
Question 2
Question Which one of the following statements is true?
,Your The IRB administrator is responsible for ensuring the
Answer development and maintenance of policies or standard operating
procedures that provide consistency and structure to the human
research protection program.
Result Correct
Comment The IRB administrator helps to ensure that policies and standard
operating procedures are developed and maintained. Some IRB
administrators may be members of the IRB, but this is not
required or even allowed at all organizations.
The IRB administrator may assist the individuals responsible for
budget preparations, but the actual finalization of the proposed
budget more generally is the responsibility of a higher
organizational administration official. Site visitors usually will
request to speak with multiple individuals from within the
organization during a site visit.
Question 3
Question A television news reporter contacts the IRB Administrator after
reading a press release describing a federally funded breast
cancer prevention study coordinated by an institutional
researcher. Study findings might lead to the identification of new
genes that might predispose an individual or their family
members to breast cancer. The reporter would like to interview
the study subjects and their family members who are enrolled in
this new study.
Which of the following best describes the IRB administrator’s
action in response to this request?
Your Refer the inquiry to the media spokesperson
, Answer
Result Correct
Comment Most organizations have a designated media spokesperson who
is responsible for responding to media inquiries. Informing the
chair and notifying a federal funding agency is recommended,
but is not required. Any details or study background are best
presented by the media spokesperson and if needed, the media
spokesperson could consult the researcher for more details that
might be requested when there is a media inquiry.
Question 4
Question A staff member approaches the IRB administrator about a
researcher submitting a new HIV prevention study that involves
multiple performance sites in different countries. The researcher
also proposes to be the coordinating center for this multisite
trial. The staff member asks for help with preparing the IRB for
review of this more than minimal risk, intervention study. Which
of the following best describes the IRB administrator’s action to
prepare the study for IRB review?
Your Determine if an IRB consulting reviewer is required
Answer
Result Correct
Comment Policies and procedures should describe when a consulting
reviewer is required to assist the IRB during review of the study.
A consulting reviewer could provide local context or scientific
expertise.
While media or FDA might find the study of interest, it is not
necessary to contact them. SOPs would be developed by the
research team or sponsor for the study. Some participating sites
may have local SOPs already in place.
