Training Resources

https://phrptraining.com/

Human Participant Protections Education for Research Teams - a web-based course that presents information about the rights and welfare of human participants in research. The two-hour tutorial is designed for those involved in conducting research involving human participants. It satisfies the NIH human subjects training requirement for obtaining Federal Funds. This is offered through the NIH Office of Extramural Research.

https://www.hhs.gov/ohrp/education-and-outreach/online-education/videos/index.html (Including, but not limited to, the topics below)

• Research Use of Human Biological Specimens & Other Private Information
• Reviewing and Reporting Unanticipated Problems and Adverse Events
• General Informed Consent Requirements
• IRB Membership; Complex Issues with Research Involving Vulnerable Populations
• IRB Records, Part I
• IRB Records, Part II

https://ocr.od.nih.gov/clinical_research_training.html

Clinical Research Training - a free course offered through NIH that provides a standard knowledge base for principal investigators by providing practical information and guidance to enhance the quality of research conducted at the NIH. Users must register and the course takes 3-4 hours to complete. You do not need to be an NIH intramural investigator to take this course, but the content focuses on research being conducted at the NIH. Course topics include:

• Introduction to the Principles and Practice of Clinical Research
• Principles of Clinical Pharmacology
• Ethical and Regulatory Aspects of Clinical Research
• NIH-Duke Clinical Research Training Program (CRTP)
• NIH Summer Course in Clinical and Translational Research
• Sabbatical in Clinical Research Management

Education | OLAW (nih.gov)

• Working Safely with Nonhuman Primates - Produced by the NIH Office of Animal Care and Use in 1999 for training staff in the NIH intramural research program. This video has a strong emphasis on proper use of personal protective equipment combined with understanding nonhuman primate behavior, and the general principals are applicable to any program that houses nonhuman primates.
• Working with the Laboratory Dog - Helps meet the training mandates for research staff using dogs in biomedical research. This video presents basic techniques and background information that are appropriate for all who work with laboratory dogs in a research setting. The training was produced by the Department of Veterans Affairs (VA) in 2000 with funding support by a charitable organization and with the cooperation of the American Association for Laboratory Animal Science (AALAS).
• Mouse & Rat Humane Restraint and Experimental Techniques - The NIH Office of Animal Care and Use developed this training CD on “Mouse & Rat Humane Restraint and Experimental Techniques.” The CD illustrates the most common procedures used within the NIH intramural research program and was developed to promote proficiency in performing common techniques with rodents. Techniques illustrated include restraint, ear punch, tail biopsy, common injection techniques, oral gavage, common blood collection techniques, and euthanasia.
• Training in Survival Rodent Surgery - Training resources on Rodent Survival Surgery are available from the NIH Office of Intramural Research page. Extramural investigators should consult with their institutional veterinarian to ensure that they are following any specific requirements of their IACUC.
• Training in Basic Biomethodology for Laboratory Mice - The National Human Genome Research Institute Office of Laboratory Animal Medicine has developed a training CD in Basic Methodology for Laboratory Mice. The CD illustrates the most common practices used in the NIH intramural research program and was developed to promote proficiency in performing common techniques in the mouse. It consists of eight training modules, table of contents, list of definitions and help and reference sections.
• Training in Basic Biomethodology for Laboratory Rats - The National Human Genome Research Institute Office of Laboratory Animal Medicine, with support from the NIH Office of Animal Care and Use and the AALAS Foundation, has developed this training CD. The CD compliments the training CDs in “Training in Survival Rodent Surgery” and “Training in Basic Biomethodology for Laboratory Mice”. It illustrates the most common practices used in the NIH intramural research program and was developed to promote proficiency in performing common techniques in the rat. It consists of nine training modules, table of contents, list of definitions and help and reference sections.
• Other Training Resources - The training videos, multimedia resources, and guidelines on this site were developed by the NIH Office of Animal Care and Use (OACU) for training staff in the NIH Intramural Research Program and do not reflect OLAW guidance. They are provided here as resources that may be useful to IACUCs and investigators.

https://www.fda.gov/vaccines-blood-biologics/news-events-biologics/otp-learn

These free educational videos are offered through the Office of Therapeutic Products (OTP). Partial list of courses:

• IND Decisions: Safe to Proceed, Clinical Hold, and Partial Hold
• Overview of Office of Therapeutic Products (OTP) Regulated Products
• Original Investigational New Drug (IND) Content and Format
• Regenerative Medicine Advanced Therapy (RMAT) Designation
• Breakthrough Therapy (BT) Designation
• OTP Processing of Formal Meeting Requests
• Regulatory Obligations for Investigator-Sponsored Research
• Early-Phase Trials of Cellular and Gene Therapies
• Fast Track (FT) for Products Regulated in OCTGT
• The Chemistry, Manufacturing and Controls (CMC) Section of a Gene Therapy IND