Research and Clinical Trials

Resources at HRPP For Researchers

medical researchers

Research, Ethics, and Compliance Training

Collaborative institutional training initiative (CITI) training and education:

CITI Training

Active Research and/or IRB Submissions

Health and Human Services (HHS) Human Research Protection Foundational Training

The Office of Human Research Protection (OHRP) offers comprehensive training on human research protections based on the requirements of the revised Common Rule.

View the training

OHRP Educational Resources for Investigators

A list of general resources at the Office for Human Research Protection.

View resources

IRBNet    

HRP Forms, Worksheet, Checklist    

Find the current list located in IRBNet Library

Project Guidance

Research Risks and Benefits

The assessment of risks and benefits requires a careful array of relevant data, including, in some cases, alternative ways of obtaining the benefits sought in the research. Thus, the assessment presents both an opportunity and a responsibility to gather systematic and comprehensive information about proposed research. For the investigator, it is a means to examine whether the proposed research is properly designed. For a review committee, it is a method for determining whether the risks that will be presented to subjects are justified. For prospective subjects, the assessment will assist the determination whether or not to participate.

Read the Belmont Report on OHRP

  • Benefit- valued or desired outcome; an advantage          
  • Minimal Risk- Minimal Risk to subjects means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical and psychological examinations or tests and that confidentiality is adequately protected.

Subject Selection and Recruitment      

Recruitment and selection of participants must be equitable (fair or just) within the confines of the study. Researchers may not exclude participants on the basis of gender, race, national origin, religion, creed, education, or socioeconomic status. 45 CFR 46.111(a)(3) Selection of subjects is equitable. 

Read the full policy on NIH.gov

IRB Fees

An IRB can charge review fees for commercially funded studies. The fee compensates Lifespan’s IRB for costs of IRB operation and research oversight. The schedule is based on a review of multiple peer institution IRB fee schedules. New Projects, Continuing Reviews and sponsor-initiated revisions to research when Lifespan is the reviewing IRB will be charged. When Lifespan relies on an external IRB, a one-time fee for the administrative Local Context Review will apply. The fee schedule is in line with the median and average rates across peer institutions. The rates will be reviewed annually, and adjustments will be made as necessary.    

Read the IRB Review Fee FAQ