All human research conducted by UNM Health Sciences faculty, students, and staff must be reviewed by the UNM Health Sciences Institutional Review Board - IRB (aka Human Research Review Committee - HRRC) and approved for compliance with regulatory and ethical requirements before it may be undertaken (unless the IRB determines that the activity is exempt from IRB review).
General PI Eligibility
Principal Investigators must possess the appropriate training, experience, and professional qualifications (e.g., degrees, licenses, credentials) to safely conduct and oversee a human research study. Individuals who are debarred, disqualified, or otherwise restricted from participation in research or as a recipient of grant funds for research by a federal, state, or other agency may not serve as PI.
To serve as a Principal Investigator (PI) on a human research study submitted to the HSC IRB you must be a contract (paid) UNM faculty member who is:
Examples of positions not generally eligible to serve as PI at UNM HSC unless an exception is granted:
Only properly credentialed individuals may engage in any “Greater-than-minimal risk” study activity or any activity that requires credentialing, unless or until the individual becomes properly licensed and credentialed.
Exceptions to General PI Eligibility
In special instances and with support from the relevant UNM dean, Health System CEO, UNM Hospital CEO, or department chair, other members of the UNM community may request approval to serve as PI. The request should be specific to a study and contain information about the qualifications and capabilities of the individual that would allow the person to perform the duties of a PI. The PI must complete the PI Eligibility Request Form.
The completed request should be sent to HSC-HRPO@salud.unm.edu and will be reviewed by the IRB staff, IRB Chair, and the Vice Chancellor of Research.
HSC IRB Approval of Principal Investigators
Investigators who meet the General PI Eligibility or who are granted an exception criteria are not automatically approved to act as PI for a particular study. The HSC IRB is charged by federal regulation with approving PIs who are qualified to oversee and take responsibility for the conduct of every aspect of a particular study, which includes overall participant safety, consideration of pre-existing conditions, careful monitoring and consideration of a participants evolving health status, and management of adverse events and unanticipated problems.
Clinical trials and studies often have additional approval processes depending on the nature of the study or the patient population. Examples include Protocol Review and Monitoring Committee (PRMC) review for studies conducted at the UNM Comprehensive Cancer Center or Data Safety and Monitoring Board (DSMB) ongoing review and monitoring for emergency research or as otherwise required for clinical trials sponsored by Veteran Affairs and NIH. These approvals are distinct from IRB approval, and help address other issues such as ensuring participants aren’t enrolling in multiple conflicting or contraindicative studies, that special participant populations are protected, or that rare tissues are used in a responsible manner. Investigators with a Conflict of Interest may serve as the Principal Investigator if the Conflict of Interest is managed under a management plan approved by the IRB.
The Principal Investigator bears the ultimate responsibility for assuring that the conduct of the study complies with all applicable regulations, policies and procedures for the protection of human subjects.
When the Principal Investigator for clinical studies involving medical/clinical interventions or investigational agents does not have a medical degree, there must be at least one co-investigator on the project who is a qualified, licensed healthcare provider and is readily available to provide medical oversight and decision-making. When the research involves the administration of a drug or use of a device for research purposes, the PI must be a licensed physician. When the research involves an intervention that is greater than minimal risk, then the PI must be a licensed healthcare provider. Rare exceptions to this requirement are made by the IRB on a case-by-case basis. Exceptions require a licensed physician coinvestigator and approval of the department chair.
The Principal Investigator is responsible for ensuring that all investigators and research personnel participating in the study possess the necessary licenses and credentials to perform their study responsibilities. Only properly credentialed individuals may engage in any “Greater-than-minimal risk” study activity or any activity that requires credentialing, unless or until the individual becomes properly credentialed.
The HHS regulations at 45 CFR part 46 use the term “investigator” to refer to an individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB. For the purposes of the HHS regulations, OHRP interprets an “investigator” to be any individual who is involved in conducting human subjects research studies. Such involvement would include:
Investigators can include physicians, scientists, nurses, administrative staff, teachers, and students, among others. Some research studies are conducted by more than one investigator, and usually one investigator is designated the “principal investigator” with overall responsibilities for the study. In every human subjects research study, investigators have certain responsibilities regarding the ethical treatment of human subjects.
CITI training
The UNM HSC requires initial and continuing education (every 3 years) in the protection of human research participants for individuals involved in the conduct or oversight of human research. UNM HSC subscribes to the Collaborative Institutional Training Initiative (CITI) founded and managed by the University of Miami for human subjects protections training.
All members of the research team involved in the design, conduct or reporting of the research must complete training. Members of the research team who have not completed human research protections training may not take part in aspects of the research that involve human subjects.
For each new research submission received, verification will be made during the HRRC Administrative & Pre-Review that the applicable educational requirements have been met and are current for all members of the research study staff. If the educational requirements are incomplete or not current for any member of the study staff, the submission will be returned and must be re-submitted once the requirements are met. HRRC approval will not be granted for proposed research in which investigators have not completed human research protections training.
View list of people who have completed CITI training
Huron IRB system training and IRB account request
To gain access to the Huron IRB submission system, you will need to complete the self-guided training and submit an IRB account request. You may access the training and account request in UNM LearningCentral, HSC 115-001 or use the links provided below:
If you will be listed as the principal investigator on a study and you meet the criteria to be PI at the UNM Health Sciences, contact the HRPO to request the “Principal Investigator” role to be added to your account.
Allow 1-2 business days for your account request to be processed. An IRB account manager will send you an email that will contain your login information, the website address, and instructions.
COI training and COI account request
Two courses are required to be completed in order to activate a Click COI account: Electronic Research Administration:
The courses are located:
View list of people who have completed the FCOI training (HSC 104-002)
General PI Eligibility
Principal Investigators must possess the appropriate training, experience, and professional qualifications (e.g., degrees, licenses, credentials) to safely conduct and oversee a human research study. Individuals who are debarred, disqualified, or otherwise restricted from participation in research or as a recipient of grant funds for research by a federal, state, or other agency may not serve as PI.
To serve as a Principal Investigator (PI) on a human research study submitted to the HSC IRB you must be a contract (paid) UNM faculty member who is:
Examples of positions not generally eligible to serve as PI at UNM HSC unless an exception is granted:
Only properly credentialed individuals may engage in any “Greater-than-minimal risk” study activity or any activity that requires credentialing, unless or until the individual becomes properly licensed and credentialed.
Exceptions to General PI Eligibility
In special instances and with support from the relevant UNM dean, Health System CEO, UNM Hospital CEO, or department chair, other members of the UNM community may request approval to serve as PI. The request should be specific to a study and contain information about the qualifications and capabilities of the individual that would allow the person to perform the duties of a PI. The PI must complete the PI Eligibility Request Form.
The completed request should be sent to HSC-HRPO@salud.unm.edu and will be reviewed by the IRB staff, IRB Chair, and the Vice Chancellor of Research.
HSC IRB Approval of Principal Investigators
Investigators who meet the General PI Eligibility or who are granted an exception criteria are not automatically approved to act as PI for a particular study. The HSC IRB is charged by federal regulation with approving PIs who are qualified to oversee and take responsibility for the conduct of every aspect of a particular study, which includes overall participant safety, consideration of pre-existing conditions, careful monitoring and consideration of a participants evolving health status, and management of adverse events and unanticipated problems.
Clinical trials and studies often have additional approval processes depending on the nature of the study or the patient population. Examples include Protocol Review and Monitoring Committee (PRMC) review for studies conducted at the UNM Comprehensive Cancer Center or Data Safety and Monitoring Board (DSMB) ongoing review and monitoring for emergency research or as otherwise required for clinical trials sponsored by Veteran Affairs and NIH. These approvals are distinct from IRB approval, and help address other issues such as ensuring participants aren’t enrolling in multiple conflicting or contraindicative studies, that special participant populations are protected, or that rare tissues are used in a responsible manner. Investigators with a Conflict of Interest may serve as the Principal Investigator if the Conflict of Interest is managed under a management plan approved by the IRB.
The Principal Investigator bears the ultimate responsibility for assuring that the conduct of the study complies with all applicable regulations, policies and procedures for the protection of human subjects.
When the Principal Investigator for clinical studies involving medical/clinical interventions or investigational agents does not have a medical degree, there must be at least one co-investigator on the project who is a qualified, licensed healthcare provider and is readily available to provide medical oversight and decision-making. When the research involves the administration of a drug or use of a device for research purposes, the PI must be a licensed physician. When the research involves an intervention that is greater than minimal risk, then the PI must be a licensed healthcare provider. Rare exceptions to this requirement are made by the IRB on a case-by-case basis. Exceptions require a licensed physician coinvestigator and approval of the department chair.
The Principal Investigator is responsible for ensuring that all investigators and research personnel participating in the study possess the necessary licenses and credentials to perform their study responsibilities. Only properly credentialed individuals may engage in any “Greater-than-minimal risk” study activity or any activity that requires credentialing, unless or until the individual becomes properly credentialed.
The HHS regulations at 45 CFR part 46 use the term “investigator” to refer to an individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB. For the purposes of the HHS regulations, OHRP interprets an “investigator” to be any individual who is involved in conducting human subjects research studies. Such involvement would include:
Investigators can include physicians, scientists, nurses, administrative staff, teachers, and students, among others. Some research studies are conducted by more than one investigator, and usually one investigator is designated the “principal investigator” with overall responsibilities for the study. In every human subjects research study, investigators have certain responsibilities regarding the ethical treatment of human subjects.
CITI training
The UNM HSC requires initial and continuing education (every 3 years) in the protection of human research participants for individuals involved in the conduct or oversight of human research. UNM HSC subscribes to the Collaborative Institutional Training Initiative (CITI) founded and managed by the University of Miami for human subjects protections training.
All members of the research team involved in the design, conduct or reporting of the research must complete training. Members of the research team who have not completed human research protections training may not take part in aspects of the research that involve human subjects.
For each new research submission received, verification will be made during the HRRC Administrative & Pre-Review that the applicable educational requirements have been met and are current for all members of the research study staff. If the educational requirements are incomplete or not current for any member of the study staff, the submission will be returned and must be re-submitted once the requirements are met. HRRC approval will not be granted for proposed research in which investigators have not completed human research protections training.
View list of people who have completed CITI training
Huron IRB system training and IRB account request
To gain access to the Huron IRB submission system, you will need to complete the self-guided training and submit an IRB account request. You may access the training and account request in UNM LearningCentral, HSC 115-001 or use the links provided below:
If you will be listed as the principal investigator on a study and you meet the criteria to be PI at the UNM Health Sciences, contact the HRPO to request the “Principal Investigator” role to be added to your account.
Allow 1-2 business days for your account request to be processed. An IRB account manager will send you an email that will contain your login information, the website address, and instructions.
COI training and COI account request
Two courses are required to be completed in order to activate a Click COI account: Electronic Research Administration:
The courses are located:
View list of people who have completed the FCOI training (HSC 104-002)
Huron IRB submission system
The UNM Health Sciences uses Huron IRB to process applications for IRB review (e.g., new studies, modifications, continuing reviews, and reportable new information). Review the Huron IRB self-guided training for investigators for:
Levels of review
Determinations
The HRPO charges fees to review research unless the PI is a UNM HSC faculty member AND any of the following apply:
Investigators must complete the IRB Fees Determination Form with each submission. This will guide the investigator in determining if fees are due.
IRB fees for Pharmaceutical Clinical Trials
In an effort to reduce the time it takes to process IRB payments and improve efficiencies in IRB payment collections, UNMHSC is instituting a new policy regarding the invoicing of IRB fees for pharmaceutical clinical trials. Effective January 1, 2018 , all pharmaceutical clinical trial budgets must include all applicable IRB fees in their direct costs.
Review Fees for Non-UNM HSC Research
The UNM Health Sciences IRB does not routinely provide IRB review for studies conducted by non-UNM HSC entities or investigators. On occasion, the UNM Health Sciences IRB will serve as the IRB for a non-UNM HSC project when there is a clear collaborative arrangement with UNM HSC, involvement of an UNM HSC faculty member and the study is conducted in accordance with the Investigator’s Manual – “Serving as the IRB for an Unaffiliated Entity.”
Review fees for non-UNM HSC studies/investigators follow the fee schedule shown above.
Waiver of Fees for Review
On occasion the UNM Health Science IRB will waive required fees.
In order to request a waiver, attach the following to your submission (new study or continuing review):
Please be aware that it is the investigator's responsibility to include IRB review fees within their budget when requesting funds from a sponsor.
Any questions regarding fees can be directed to the HRPO. Please have the PI's name, study title and IRB number if one has been generated.
Refund of Review Fees
If you submit a study that requires a fee and it is withdrawn by the PI or sponsor:
Huron IRB submission system
The UNM Health Sciences uses Huron IRB to process applications for IRB review (e.g., new studies, modifications, continuing reviews, and reportable new information). Review the Huron IRB self-guided training for investigators for:
Levels of review
Determinations
The HRPO charges fees to review research unless the PI is a UNM HSC faculty member AND any of the following apply:
Investigators must complete the IRB Fees Determination Form with each submission. This will guide the investigator in determining if fees are due.
IRB fees for Pharmaceutical Clinical Trials
In an effort to reduce the time it takes to process IRB payments and improve efficiencies in IRB payment collections, UNMHSC is instituting a new policy regarding the invoicing of IRB fees for pharmaceutical clinical trials. Effective January 1, 2018 , all pharmaceutical clinical trial budgets must include all applicable IRB fees in their direct costs.
Review Fees for Non-UNM HSC Research
The UNM Health Sciences IRB does not routinely provide IRB review for studies conducted by non-UNM HSC entities or investigators. On occasion, the UNM Health Sciences IRB will serve as the IRB for a non-UNM HSC project when there is a clear collaborative arrangement with UNM HSC, involvement of an UNM HSC faculty member and the study is conducted in accordance with the Investigator’s Manual – “Serving as the IRB for an Unaffiliated Entity.”
Review fees for non-UNM HSC studies/investigators follow the fee schedule shown above.
Waiver of Fees for Review
On occasion the UNM Health Science IRB will waive required fees.
In order to request a waiver, attach the following to your submission (new study or continuing review):
Please be aware that it is the investigator's responsibility to include IRB review fees within their budget when requesting funds from a sponsor.
Any questions regarding fees can be directed to the HRPO. Please have the PI's name, study title and IRB number if one has been generated.
Refund of Review Fees
If you submit a study that requires a fee and it is withdrawn by the PI or sponsor:
