Harbor:How to get started in research at Harbor
- 1 Do your CITI training
- 2 Complete the patent/copyright agreement form
- 3 Request project number from the Office of Research Administration (ORA) in RB-1 (Walter P. Martin Research Center)
- 4 Complete the Institutional Research Project application
- 5 Get an iMedRIS account
- 6 Fill out the IRB forms on the iMedRIS account
- 7 Documents that will be needed if you are audited
- 8 Other Information
- 9 See Also
Do your CITI training
Forewarned: this will take a long time – probably several days
- Go to https://www.citiprogram.org and create an account
- Use Los Angeles Biomedical Research Institute as your organization affiliation
- We must do: HIPAA, Responsible conduct of research basic course, Conflicts of interest, Export controls, Biomedical researcher – basic/refresher, and Good clinical practices
- When you complete each module, download a copy of the certificate for your files
- For questions contact Tina Yiadom at email@example.com, 222-3624
Complete the patent/copyright agreement form
This only needs to be completed once
- Bring this with you and turn it in during Step 3
- Not yet available online, but available from Luz or in PEM fellowship dropbox
Request project number from the Office of Research Administration (ORA) in RB-1 (Walter P. Martin Research Center)
- Luz Garcia for government/non-profit funded projects, including CTSI activities and institutional/internal projects (firstname.lastname@example.org, x3621)
- Barbara Lee for industry funded projects (email@example.com, x3621)
- Step 3 and 4 may be reversed – ie do the institutional research project form, scan it, and email it to Luz/Barbara to obtain a number
Complete the Institutional Research Project application
- Either abbreviated or full (not yet available online, ask Luz for these forms, or they are available in PEM fellowship dropbox), AND an investigator protocol (use the template) http://intranet.labiomed.org/group/4/forms
Abbreviated Institutional Research Project (Accelerated Review)
- For projects that would fall under the Institutional Review Board’s (Human Subjects Committee’s) Expedited, Exempt categories, or Not Human Research determination. Examples of studies that would be proposed using the *Abbreviated application form include retrospective chart reviews, surveys, basic science research using previously collected de-identified samples, etc. Please see iRIS, Operating Procedures, HRP-319 and HRP-320 for the Exempt and Expedited review categories.
- If you are doing chart review, will need Medical Records Director’s signature: Nanette Jackson. Go to MFI suite 100 with a copy of the completed institutional research project form and protocol template to get her signature.
Institutional Research Project (Full Review)
- For research projects that: (1) propose to use funds from any institutional source including Departmental Funds, PI unrestricted funds, etc. or projects will be conducted without funds; (2) prospective studies proposing to conduct Human Subjects research that is neither Exempt nor Expedited; (3) studies that include animal research.
- Additionally, a PRACC form must be filled out if the research is externally funded
- Submit these forms to Luz Garcia in N-14
Get an iMedRIS account
contact Tina Yiadom (firstname.lastname@example.org, x 3624) to request an iMedRIS account.
Fill out the IRB forms on the iMedRIS account
- Protocol number (that you obtained from Luz Garcia)
- Investigator protocol (that you did in step 4)
- Brief summary of your project written for a lay person
- Institutional Research Project Application
- CV’s of all investigators
- PRACC if applicable
- Consent forms: Need consent, for children 8-17yo assent, PHI authorization
- Templates are available on iMedRIS under My Assistant, Operating Procedures, 2. HRPP - For Investigators, and online http://intranet.labiomed.org/group/4/forms
- Data collection forms
- Any recruitment materials you plan to use (flyers, etc.)
- (There are additional forms if using an investigational drug or device, or CTSI services, or using animals in research – we are unlikely to be using these)
Submit through IMedRIS and await review by compliance
- You will likely need to change some things after they review it; often there are multiple back and forth cycles of you changing things. Submit all responses / changes through Imedris.
- Once your project is approved, you must download Stamped forms and use only those (consent, data collection, etc) from iMedRIS. Do not use unstamped forms and do not use forms beyond their expiration date. Doing either of these things will trigger an audit.
- If you need consent forms translated into Spanish, request that through the compliance office. For PEM fellows: the fellowship funds will be used to pay for the translation.
- Note: consent forms must be signed by the PI within 14 days of execution. Not doing so will trigger an audit.
- Also, once your project is approved, if it involves a clinical patient care unit, you must submit it to Nursing. They will review it and keep it in a binder in the ED for nurses to review.
- Write cover letter briefly describing your study and nursing’s role (if any), and submit it along with a copy of the protocol, consents, IRB approval letter, to Joy Lagrone email@example.com and Dawna Wilsey DWilsey@dhs.lacounty.gov.
- RB1 = Walter P. Martin Research Center
- RB2 = St. John’s Cardiovascular Research Center
- RB3 = Liu Research Center
Documents that will be needed if you are audited
Make a “Regulatory Binder” with the following
- A note to file (see template at http://intranet.labiomed.org/group/4/forms) that says all of the following are available (if they are applicable) on Imedris: IRB Protocol, IRB Protocol amendments, IRB correspondence, PI correspondence, Site Standard Operating Procedures, All versions of IRB approved consent forms, Data Collection Forms, IRB approved recruitment materials. Also determine which Human Subjects Committee (HSC) reviewed your project and add to your Note to File which one it was, and the fact that the membership roster is available on Imedris.
- Collect a copy of the medical (or NP) licenses of all the study investigators. Write a note to file that their CVs are available on Imedris. Make a note to file listing which CITI modules they have completed (they can log onto CITI www.citiprogram.org, click My Reports, and print that out). Make a Staff Designation Signature Log, which lists each investigator, their role in the project, their specific tasks, their start date and stop date (can be left blank until study over) in the project, and their signature AND initials.
- Make and keep a subject screening log and a subject enrollment log. The difference is that the screening log includes patients that were screened but did not enroll.
Also, for each patient’s research folder / documents:
- Make sure there is an inclusion/exclusion eligibility checklist for each patient, either as part of the data collection forms or as a separate sheet of paper in each patient’s research folder.
- There is also supposed to be a statement that says “The subject was given ample time (30-45 minutes) to read the consent form including the bill of rights form, all questions and concerns of the subject were answered, the subject signed the consent form prior to any study related procedures being performed and the subject was given a copy of the signed and dated consent form.” in each research chart.
- Here is additional information http://intranet.labiomed.org/node/512
- You need to be on the LA Biomed network to access the LA Biomed intranet for these links to work (except for the citiprogram link).