Human Subjects Protection
In addition to our IRB services we provide customized training for companies and organizations interested in learning more about social research ethics, HIPAA and institutional review board policies and procedures.
We offer online training in research ethics through Solutions Institute. Created by researchers, for researchers, this new high-quality, media-rich training is designed to meet the needs of both novice and experienced investigators. With engaging content, excellent client support, optional facilitated discussions and CE credit, Solutions Institute is the answer for your individual, small research group or institutional training needs. Click here to see more!
Recruitment and Consent
Ethical recruitment and the informed consent process for vulnerable populations – recruitment and consent documents for these populations may present additional challenges. Our team can provide training on topics related to informed consent with those individuals or populations unable to provide written or oral consent, individuals with cognitive impairment, individuals who are homeless, prisoners, Native American and indigenous populations, and children.
IRB Board Consultation
We can also assist organizations in the development and formation of their own institutional review board. National and international inquiries are welcome.
Online Training and Education Resources
There are existing online resources available for new researchers and those who need to update human subjects training.
Office of Human Research Protection (OHRP)
OHRP educational videos were developed by the OHRP Division of Education and Development and are intended to provide information regarding the requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR part 46. The videos represent OHRP’s current thinking on these topics and should be viewed as recommendations unless specific regulatory requirements are cited.
When the Regs Come a’ Knockin’: Nuts and Bolts of 45 CFR part 46
Preparing for an OHRP Compliance Evaluation
IRB Records (Two separate presentations)
Research involving Vulnerable Populations
General Informed Consent Requirements
Research Use of Human Biological Specimens and Other Private Information
Reviewing and Reporting Unanticipated Problems and Events
Office of Research Integrity (ORI)
This site contains links to other resources mentioned on this page and also one on Ethics and Research in the Community
MIT Good Clinical Practice in Research (This is an older presentation but still has good information)
NIH Protecting Human Research Participants
University of California Irvine
UCI Health Insurance Portability and Accountability Act (HIPAA) Research Tutorial website. This tutorial reviews core concepts and requirements for accessing, collecting, creating and/or providing Protected (Personal) Health Information (PHI) in the conduct of research involving human research participants.
University of California Television (UCTV) has several video presentations on research ethics topics.
Exploring Ethics: Can The Community Help Overcome Barriers to Medical Research?
Exploring Ethics: Henrietta Lacks and Human Subject Research: A Look at Past, Present, and Future
Exploring Ethics: Science Literacy and Underserved Populations
Ethical research does not only apply to the study design and participants, it also includes academic honesty. The Office of Research Integrity (ORI) has created guidelines to help students and researchers understand these issues.