Humans

What’s essential

Federal regulation (Common Rule 45 CFR 46) and UNH policy require that all UNH research activities proposing to involve human subjects must be reviewed and receive written, unconditional approval from the UNH Institutional Review Board (IRB) for the Protection of Human Subjects in Research before commencing.  This applies to all research conducted under the auspices or by an agent of UNH, including research in the humanities, health, behavioral, and social sciences, and engineering, regardless of whether the research is internally or externally funded.

The human subjects protection program is administered by Research Integrity Services (RIS).  RIS staff can assist in the interpretation and application of UNH policy and procedures.

Why it’s important

UNH has legal and ethical obligations to ensure the protection of the rights and welfare of individuals who are subjects of UNH research activities.

How to comply

Prior to beginning the study: 

• Complete the UNH Web-based human subjects protections training module (https://www.unh.edu/rcr/HumSubj-Title.htm).  This requirement applies to only IRB project directors (applicants); other study personnel are encouraged, but not required, to complete the training.
• Submit an application to RIS for review by the UNH IRB (materials and resources available at http://unh.edu/research/human-subjects).

Applications that meet federally-determined standards for Exempt or Expedited review are considered on a rolling basis; all other applications undergo Full Board review at a convened meeting of the IRB.  The full IRB meets to review protocols every other week during the academic year, and once each month during the summer.

During the semester, allow a minimum of two weeks for review of applications qualifying for Exempt or Expedited review, and one month for applications requiring Full Board review; reviews during breaks and the summer may require additional time. 

Vertebrate Animals

What’s essential 

Federal regulations and UNH policy require that all research, teaching/instruction, and testing activities involving the care and/or use of vertebrate animals must be reviewed by and receive approval from the UNH Institutional Animal Care and Use Committee (IACUC) before commencing. This applies to all research, teaching/instruction, and testing, including field studies, training in research methodologies, or standard husbandry courses, conducted under the auspices or by an agent of UNH, regardless of whether the activity is internally or externally funded.   

The vertebrate animal care and use program is administered by Research Integrity Services (RIS) and the Animal Resources Office (ARO).  RIS staff or ARO staff can assist in the interpretation and application of UNH policy and procedures.  The ARO also provides veterinary services, technical support, and training, in addition to purchasing animals and overseeing all UNH animal facilities.

Why it’s important

UNH has legal and ethical obligations to ensure the humane care and use of vertebrate animals used in research, teaching/instruction, and testing.

How to comply

Prior to beginning the study, testing, or instruction:

• All personnel handling/working with live vertebrate animals at UNH must participate in the UNH Occupational Health Program for Animal Care Personnel.  Prior to handling or working with live vertebrate animals at UNH, applicable individuals need to (1) complete a Medical History and Risk Assessment Questionnaire for Persons Handling or Working with Live Vertebrate Animals (available at http://unh.edu/research/occupational-health-program-animal-handlers); (2) submit the completed form to UNH Health Services, and (3) wait for notification of approval from RIS to the applicable project investigator/instructor or animal facility manager.
• All UNH faculty, staff, and graduate and undergraduate students involved in vertebrate animal care and use are required to attend (only once) a general training session about the humane care and use of animals conducted each Fall and Spring semester (see http://unh.edu/research/training-animal-care-and-use-personnel).
• Submit an application for review by the UNH IACUC (materials and resources available at http://unh.edu/research/animal-care-use) to RIS.

At UNH, all animal use protocols undergo review by the full IACUC at a convened meeting.  The IACUC meets once a month throughout the year. Allow a minimum of one month for review of protocols by the IACUC.

Biological Materials

What’s essential

Biohazardous materials used in research, teaching and service operations at the University must be registered with the Institutional Biosafety Committee (IBC).   UNH defines these materials as infectious agents, or biological materials which are known to be, or are suspected to be hazardous to humans, animals, plants and other forms of life. They include known pathogens such as bacteria and their plasmids and phages, viruses, fungi, mycoplasmas, and parasites; human and non-human primate tissues, body fluids, blood, blood products and cell lines; animal remains and laboratory animals, including insects that may harbor zoonotic pathogens.  Recombinant DNA, materials that have been genetically manipulated and biologically active toxins are also included. 

Why it’s important

It is UNH policy to comply with all federal, state and local regulations and guidelines applicable to biohazardous materials.  (e.g., OSHA’s Bloodborne Pathogens Standard, NIH Guidelines for Research Involving Recombinant DNA Molecules, DOT Shipment of Hazardous Materials , and NH DES Infectious Waste regulations).  The Office of Environmental Health and Safety (OEHS) works with individuals who use biohazardous materials to explain applicable regulations and design compliance programs for each situation.

How to comply

Prior to beginning work with biohazardous materials: 

• Review the IBC Charter and Procedures Document and complete the Biological Materials Registration Form on the OEHS website. 
• Complete the rDNA Registration application if you plan to work with recombinant materials.
• Complete the Infectious Agents Registration form if you plan to work with infectious agents, Select Agents, or biological toxins.  

Forms should be sent to the Biological Safety Officer who will perform a risk assessment.   

Those using biohazardous material in research, teaching, and service are encouraged to submit their forms as soon as possible so that training, lab set-up, and risk assessment can be addressed. 

The IBC reviews registration applications on a quarterly basis.  Registrations are approved for a maximum of three years.  The biological safety officer requests annual updates for approved registrations and performs annual inspections of laboratories approved for biohazardous materials use.