Human Research Protection Program and eResearch SubmissionsInformation on submitting research applications to committees (such as the Institutional Biosafety Committee and the Institutional Animal Care and Use Committee) other than the Institutional Review Board can be found on their committee pages. Human subjects regulations decision charts and the HMH Non-Human Subjects Determination Form may be helpful in determining whether your study requires Institutional Review Board (IRB) review and oversight. Information about submitting to internal versus external IRBs can be found here. In order to successfully conduct a research study at HMH, several institutional requirements must be met. Please note that completing them before you submit the study will lead to faster turn-around times on your application. If any of the items below are missing, the application will be returned to the study team, which will lead to delays.
The following must be addressed periodically / as applicable:
- Ensure that CITI training is affiliated with HMH and up to date.
- Annual COI disclosure is required. To update your disclosure profile, navigate to COI tab in eResearch. Please contact firstname.lastname@example.org with any questions.
- Ensure that updated CVs (and licenses, if applicable) are uploaded into the eResearch system for all Investigators . More information about the requirements for the licenses is available here. All documents should be uploaded into eResearch (Profile > Documents > Update Profile > +Add **Please be sure to sign and date your CV**). More information about the credentialing review process can be found here.
The following must be addressed for each study submission:
- Use the correct Protocol and Consent form templates in eResearch (IRB section > Library > Templates).
- Prepare and submit a funding (or “no funding”) letter.
- Add all necessary ancillary reviews including your department chair and as applicable:
- Investigator Initiated Research for all investigator-initiated projects
- Biorepository for all BioR projects
- Local pharmacy for all interventional studies using a drug
- All other necessary departments
- Once submission is ready, Notify Ancillary Reviewers
- Submit the study via eResearch once you have been notified of approval from all the Ancillary Reviewers.
Please note that if you are working within the HMH network, signing in to eResearch will be single sign on. However, you will need your domain ID to sign into eResearch (not your email address) if you are working off network. If you are having difficulty logging into eResearch, please review the instructions here.
It is important to keep in mind that other documents may need to be provided along with the application. For questions, please contact email@example.com or 201-880-3669.
Guides for submitting an application in eResearch can be found here.A memo that includes common research misconceptions can be found here.
When you have a patient with a serious or life threatening condition for which there is no standard of care treatment, there are several courses of action that may be taken. The options available to you will depend on various factors, including whether a relevant clinical trial is enrolling and whether the treatment is needed in an emergent manner.
Please review this decision chart for more information on the processes. If you have any questions at any point, please contact the Research Integrity Office for guidance. They can be reached at 201-880-3669 or firstname.lastname@example.org."