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).
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.
View list of users that have completed CITI training below:
FCOI training
Required for all COI disclosers:
The courses are located:
View list of users that have completed FCOI training below:
HSC Learning Central FCOI training Lookup
Moodle FCOI Training Lookup (NON-UNM)
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.
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 research study submitted to the HSC IRB or IACUC you must be a UNM faculty member (any campus, rank, or track) with .50 FTE or greater. Otherwise, an exemption must be submitted and approved.
Examples of positions not generally eligible to serve as PI at UNMHSC unless an exception is granted:
Exceptions to General PI Eligibility
In special circumstances and with support from the relevant supervisor, other members of the research 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 President for Research.
Graduate students applying for fellowships that require the trainee to be the PI of the proposal may fall under special circumstances. They may not need to complete the PI Eligibility Request form. The students must satisfy the applicable PI eligibility requirements, including possessing appropriate training, experience, and professional qualifications to safely conduct a human research study in a mentored setting during the fellowship period.
While the extramural awards may introduce particular requirements for PI eligibility, the above guidelines continue to apply for conducting human subjects research at UNMHSC. In the particular case of graduate student fellowships, it is typical for the mentoring faculty to serve as the PI on the human research study related to the trainee's fellowship project/grant/award.
Additional Oversight and Special Circumstances
In addition to what is listed above, there are other considerations when considering PI eligibility to serve as PI. Investigators who meet the General PI Eligibility or who are granted an exception to the general PI eligibility requirements 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 participant's evolving health status, and management of adverse events and unanticipated problems.
Examples include:
| Study Special Circumstances | Additional PI Requirements |
|---|---|
| Clinical trials involving a drug or device intervention. | PI must be a licensed healthcare provider at HSC. |
| Research involving PHI or access to UNM patients or patient data. | All access to patients or patient data must be through a qualified UNMHSC PI or Co-I. |
| Research that does not engage UNMHSC in research, but for which UNMHSC HRRC will act as the IRB of record. | PI eligibility should at least be consistent with the requirements of the PI’s local institution. All eligibility questions will be reviewed individually. |
| Research involving HSC facilities or equipment, without a UNMHSC faculty member serving as PI, Co-Investigator, or Key Personnel. | Research involving HSC facilities or equipment must be reviewed by the HSC IRB and include at least one team member familiar with the facility or equipment. Appropriate permission to use the facility or equipment is also required. |
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.
View list of users that have completed CITI training below:
FCOI training
Required for all COI disclosers:
The courses are located:
View list of users that have completed FCOI training below:
HSC Learning Central FCOI training Lookup
Moodle FCOI Training Lookup (NON-UNM)
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.
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 research study submitted to the HSC IRB or IACUC you must be a UNM faculty member (any campus, rank, or track) with .50 FTE or greater. Otherwise, an exemption must be submitted and approved.
Examples of positions not generally eligible to serve as PI at UNMHSC unless an exception is granted:
Exceptions to General PI Eligibility
In special circumstances and with support from the relevant supervisor, other members of the research 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 President for Research.
Graduate students applying for fellowships that require the trainee to be the PI of the proposal may fall under special circumstances. They may not need to complete the PI Eligibility Request form. The students must satisfy the applicable PI eligibility requirements, including possessing appropriate training, experience, and professional qualifications to safely conduct a human research study in a mentored setting during the fellowship period.
While the extramural awards may introduce particular requirements for PI eligibility, the above guidelines continue to apply for conducting human subjects research at UNMHSC. In the particular case of graduate student fellowships, it is typical for the mentoring faculty to serve as the PI on the human research study related to the trainee's fellowship project/grant/award.
Additional Oversight and Special Circumstances
In addition to what is listed above, there are other considerations when considering PI eligibility to serve as PI. Investigators who meet the General PI Eligibility or who are granted an exception to the general PI eligibility requirements 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 participant's evolving health status, and management of adverse events and unanticipated problems.
Examples include:
| Study Special Circumstances | Additional PI Requirements |
|---|---|
| Clinical trials involving a drug or device intervention. | PI must be a licensed healthcare provider at HSC. |
| Research involving PHI or access to UNM patients or patient data. | All access to patients or patient data must be through a qualified UNMHSC PI or Co-I. |
| Research that does not engage UNMHSC in research, but for which UNMHSC HRRC will act as the IRB of record. | PI eligibility should at least be consistent with the requirements of the PI’s local institution. All eligibility questions will be reviewed individually. |
| Research involving HSC facilities or equipment, without a UNMHSC faculty member serving as PI, Co-Investigator, or Key Personnel. | Research involving HSC facilities or equipment must be reviewed by the HSC IRB and include at least one team member familiar with the facility or equipment. Appropriate permission to use the facility or equipment is also required. |
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).
Huron IRB Training Materials:
Obtain Access to the Huron IRB System:
To obtain Huron IRB access you must have a Huron IRB account. Please submit the Account Management Request form to obtain an account or to revise an existing account.
Click COI Disclosure System
The UNM Health Sciences uses Click COI to process COI disclosures. Each study team member is required to complete a COI disclosure in the COI system for each IRB study or grant they are affiliated with. Completing COI disclosures requires each member to have a Click COI account. Request a COI account below:
Account Management Request Form
For more information on COI disclosures, please click here.
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:
Administrative and Compliance Review Fee
Effective March 1, 2023, all pharmaceutical clinical trial budgets must include a fee for initial and
ongoing administrative and ancillary compliance reviews for studies that are reviewed by an
external IRB. These fees will then be charged directly to the contract or grant index to which
these fees pertain. These fees will cover the cost of the significant administrative costs incurred
by the research compliance offices for studies deferred to an external IRB.
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).
Huron IRB Training Materials:
Obtain Access to the Huron IRB System:
To obtain Huron IRB access you must have a Huron IRB account. Please submit the Account Management Request form to obtain an account or to revise an existing account.
Click COI Disclosure System
The UNM Health Sciences uses Click COI to process COI disclosures. Each study team member is required to complete a COI disclosure in the COI system for each IRB study or grant they are affiliated with. Completing COI disclosures requires each member to have a Click COI account. Request a COI account below:
Account Management Request Form
For more information on COI disclosures, please click here.
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:
Administrative and Compliance Review Fee
Effective March 1, 2023, all pharmaceutical clinical trial budgets must include a fee for initial and
ongoing administrative and ancillary compliance reviews for studies that are reviewed by an
external IRB. These fees will then be charged directly to the contract or grant index to which
these fees pertain. These fees will cover the cost of the significant administrative costs incurred
by the research compliance offices for studies deferred to an external IRB.
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: