Getting Started: Human Subjects Research
In addition to the links below, be sure to browse through everything on VCU’s Human Subjects Research Guide website geared specifically to investigators.
Investigators should also review the SOM Clinical Research Administration page for step-by-step information on performing clinical research in the School of Medicine.
Required training: CITI modules
All researchers involved in human subjects research at VCU must complete initial and continuing education using the Collaborative IRB Training Initiative (CITI) modules. There are two tracks: Social and Behavioral Research and Biomedical Research (faculty and residents in clinical departments will most often use the Biomedical Research module).
- VCU’s CITI Requirements Main Page – most information you need is here.
- If you have never taken CITI training before, start here: Initial CITI Training Requirement
- If you need to renew your CITI training (every two years), go here: CITI Continuing Education Requirement
- CITI Frequently Asked Questions
Once you have taken the training and passed the quizzes, remember to print off/PDF a copy of the completion verification to maintain in your records.
Required training: Good Clinical Practice (GCP)
Is your study a clinical trial? Additional training is needed. All study personnel listed on a new or continuing review IRB protocol involved in executing a drug, device, biologic and/or behavioral intervention that meets the NIH definition of clinical trial are required to complete the Good Clinical Practice (GCP) module through the Collaborative Institute Training Initiative (CITI) course. Currently this training will be required every 3 years.
RAMS-IRB online system for submitting studies
RAMS-IRB (login here with VCU eID and password: https://irb.research.vcu.edu/) is the system VCU uses to build and submit human subjects research protocols for IRB approval. There are all kinds of videos that walk you through the RAMS-IRB protocol submission and review process. The best way to get a feel for the system, though, is to create a new study protocol.
- The RAMS-IRB Research Content Guide has lots of information about each required section of your protocol.
Chart review studies and the different levels of IRB review
If your research project only involves chart reviews (as opposed to direct contact with or involvement of human subjects), then it will either qualify as Category 4 EXEMPT from IRB review (if it is a retrospective only chart review) or Category 5 EXPEDITED IRB review (if both retrospective and prospective data will be collected from chart review).
Because Exempt and Expedited reviews do not go to the full IRB panel for review – they are reviewed by a single IRB member – they take significantly less time to get approved (assuming they are not recommended for full IRB review).
- Category 4 Exempt from IRB Review: You still must submit an IRB exemption request – the IRB gives final determination of whether a project is Exempt from their review. Exempt projects are different from Expedited or Full Board review in that they are not assigned an expiration date, do not have to undergo continuing review and are able to be modified in most cases without IRB approval.
- Category 5 Expedited IRB Review: You still must submit a protocol for IRB review. Expedited review means that the review can be done by a single qualified IRB member rather than at a convened IRB meeting. Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not disapprove a study. When reviewers cannot approve the research under expedited review, the study is referred for full board review.
- Full IRB Review:Full board review is conducted by the convened IRB. Studies that require full board review are those that are greater than minimal risk and/or do not qualify for an exempt or expedited research category.
REDCap web application for online surveys and databases
REDCap is a system often used when working with research at VCU. It is a secure web application used to build and manage online surveys and databases. REDCap can collect any type of data and is specifically geared to support research studies.
- All VCU faculty, staff, and students automatically have login access to REDCap. You don’t need to request access. Just use your VCU eID and password at this link: https://redcap.vcu.edu/redcap_sensitive/redcap/ (be aware that if off campus, RAMSVPN is required to access).
For access to CERNER, contact the VCUHS Service desk at 804-828-6447.
Submitting a grant proposal for research funding
If you are thinking about submitting a grant proposal, check out the School of Medicine’s Office of Research Administration website for more information!
Additional questions – find your department research administrator
Contact your department research administrator for assistance with submitting IRB studies and grant proposals. Find your department RA here: Research Administrator Contact List