Before you begin...

PI Eligibility

To serve as a Principal Investigator (PI) on a human research study submitted to the Human Research Review Committee (HRRC) you must be a contract (paid) UNM HSC faculty member who is:

• .50 FTE or greater
• Tenure track or non-tenure track
• Researcher, clinical educator or lecturer

Examples of positions not eligible to serve as Principal Investigator at UNM HSC:

• Adjunct faculty
• Visiting faculty
• Volunteer faculty
• Postdoctoral fellows
• Students without a letter of academic title

In special instances (not indicated above) and with support from the dean or department chair, other members of the HSC community may request approval to serve as Principal Investigator with the support of a dean or department chair. The PI must complete the PI Eligibility Request Form. The completed request should be sent to HRPO@salud.unm.edu and will be reviewed by the Vice Chancellor of Research.

The HRRC recognizes one Principal Investigator for each project.  The Principal Investigator bears the ultimate responsibility for assuring that the conduct of the study complies with all of UNM HSC HRPP 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.

Responsibilities

• Design and implement ethical research, consistent with the three ethical principles delineated in The Belmont Report.
• Comply with all applicable Federal Regulations impacting the protection of human subjects.
• Ensure that all research involving human subjects is submitted and approved by the appropriate HRRC.
• Comply with all applicable HRRC policies, procedures, decisions, conditions, and requirements. Implement research as approved and obtain HRRC approval for changes.
• Obtain informed consent and assent in accordance with Federal Regulations and as approved by the HRRC.
• Document informed consent and assent in accordance with Federal Regulations and as approved by the HRRC.
• Report progress of approved research to the HRRC as often and in the manner prescribed by the HRRC.
• Report to the HRRC any injuries, adverse events, or other unanticipated problems involving risks to subjects and to others.
• Retain signed consent documents and HRRC research records for at least three years past completion of the research activity.

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:

• obtaining information about living individuals by intervening or interacting with them for research purposes;
• obtaining identifiable private information about living individuals for research purposes;
• obtaining the voluntary informed consent of individuals to be subjects in research; and
• studying, interpreting, or analyzing identifiable private information or data for research purposes.

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.

• Step 1. Create an account at citiprogram.org and affiliate your account with the University of New Mexico Health Sciences Center.
• Step 2. Select one of the following groups: Group 1 Biomedical Research Investigator or Group 2 Social & Behavioral Research Investigators
• Step 3. Complete the course

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:

• Step 1. Go through the Huron IRB 8.2 self-guided training for investigators
• Step 2: Submit the IRB account management request form

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:

1. COI Disclosures (HSC 001)
2. HSC Financial Conflict of Interest training (HSC 104-002)
   • Must be renewed every 4 years

The courses are located:

• UNM (HSC, main campus, UNMH &UNMMG) faculty , staff and students take the courses in Learning Central
• Non-UNM disclosers and those without a Learning Central account take the courses in Moodle under the course category, HSC Financial Conflicts of Interest.

View list of people who have completed the FCOI training (HSC 104-002)

Huron IRB submission system 

The UNM Heath 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 8.2 self-guided training for investigators for:

• Overview of Huron IRB at the UNM Health Sciences
• Basic activities, navigation and workspaces
• Walk-through a new study submission
• IRB submission help and Huron IRB support

Levels of review 

• Committee
• Expedited
• Exempt

Determinations 

• Approved
• Modifications Required
• Deferred
• Disapproved
• Suspend/Terminate

The HRPO charges fees to review research unless the PI is a UNM HSC faculty member AND any of the following apply:

1. The project is receiving no monetary support from any external entity.
2. The project is supported by a federal or state grant or contract awarded directly to UNM HSC and the grant or contract includes facilities and administration (FandA) costs.
3. The project is a sub-award to UNM HSC and the sub-award includes flow-through of facilities and administration (F&A) costs from a federal or state agency.
4. The project is receiving monetary support from a non-profit agency, such as a foundation, and is receiving no other form of industry support.
5. The project is receiving support from an industry sponsor that is limited to supplying a drug or device (no monetary support).

Investigators must complete the IRB Fees Determination Form with each submission. This will guide the investigator in determining if fees are due.

• New Study Review: $2,500
• Continuing Review: $1000
• Modification: $500

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.  

Read memo  

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):

• Memo requesting waiver - in the memo specify why you are requesting the waiver.
• Detailed budget that provides support to your memo that there are no funds available for review fees.

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:

• If the submission has gone through the pre-review process we can only refund 50% ($1,000 administrative fee).
• Once IRB approval is issued, no refunds will be granted.