HRPP (IRB) Toolkit and submission requirements
- What is the HRPP Toolkit?
- What forms do I use?
- Will the Dartmouth Health IRB accept CPHS forms?
- When do I need to start using Dartmouth Health forms and templates?
- What are my responsibilities as a Dartmouth Health Investigator?
- Where can I find additional information?
Dartmouth Health HRPP (IRB) system
- What electronic system will the Dartmouth Health IRB use?
- What is the transition plan for active studies?
- Can I still use RAPPORT?
- When do I have to start using the Dartmouth Health IRB system?
- How do I log in the Dartmouth Health eIRB system?
- I cannot log in to the Dartmouth Health eIRB system. What should I do?
- What if I do not see some (or any) of my studies when I log into Dartmouth Health
Dartmouth Health / CPHS transition
By housing all clinical trial research administration services under Dartmouth Health, researchers will have a more streamlined approach to clinical trial submission and activation. Additionally, the creation of the Dartmouth Health HRPP (IRB) enhances our ability to:
- Increase transparency of research activities
- Oversee and manage compliance risks
- Manage compliance and efficiency metrics for accurate reporting
- Manage industry sponsor relationships with Dartmouth Health
- Utilize the sponsor’s IRB of record to decrease time to study activation
- Build stronger sponsor relationships to increase research volume
- Become AAHRPP (Association for the Accreditation of Human Research Protection Programs) accredited to demonstrate the effectiveness and compliance of the Dartmouth Health HRPP (IRB)
Studies should be submitted to the Dartmouth Health HRPP (IRB) if ANY of the following statements are true:
- The principal investigator is employed by Dartmouth Health.
- The study utilizes any Dartmouth Health data or specimens. Examples include:
- Data from the Dartmouth Health EDH (electronic medical record), Clinical Trials Management System (CTMS), PeopleSoft, and/or the pathology system
- Specimens from the Dartmouth Health pathology, biorepositories or clinical labs
- Dartmouth Health data that is part of a national dataset
- Dartmouth Health health care/clinical data included in registries
- Oncology Research Information Exchange Network (ORIEN)
- The study enrolls any patients from Dartmouth Health or is recruiting from Dartmouth Health sites.
- The study utilizes any Dartmouth Health resources (includes study procedures taking place at a Dartmouth Health location, using Dartmouth Health equipment or shared resources).
HRPP (IRB) Toolkit and submission requirements
The HRPP (IRB) Toolkit is a comprehensive set of workflows, standard operating procedures (SOPs), checklists, worksheets and templates. All Toolkit documents will be available from the Policies and Procedures page to foster transparency throughout the review process.
The Dartmouth Health HRPP (IRB) is in the process of developing templates, including protocols and consent forms, for submission to the Dartmouth Health HRPP (IRB). Templates included in the HRPP (IRB) Toolkit will be adapted for use at Dartmouth Health and will incorporate much of the information you are use to providing to CPHS.
The HRPP (IRB) Toolkit also includes an Investigator Manual (coming soon) that provides an overview on how to prepare and submit to the Dartmouth Health HRPP (IRB).
Currently approved studies that transition to the Dartmouth Health HRPP (IRB) will be assessed at the time of continuing review to determine what updates are needed to align with Dartmouth Health HRPP (IRB) requirements. You will not need to submit a new study to the Dartmouth Health HRPP (IRB) for currently approved research.
Starting July 1, 2019, all initial submissions to the Dartmouth Health HRPP (IRB) should use templates available on the Dartmouth Health HRPP (IRB) website. The Dartmouth Health HRPP (IRB) Intranet site will house these materials as they are published and until the Dartmouth Health HRPP (IRB) website is live.
Starting July 1, 2019, all initial submissions to the Dartmouth Health HRPP (IRB) should use templates available on the HRPP (IRB) Toolkit Overview and Library page. The Dartmouth Health HRPP (IRB) Intranet site will house these materials as they are published and until the Dartmouth Health HRPP (IRB) website is live.
For multi-site studies, where the study sponsor/funding agency already has a multi-site study protocol, you will supplement their protocol with a Site Supplement Template, which is like the Protocol Plus used by CPHS.
A detailed list of investigator responsibilities can be found in the Investigator Manual (coming soon):
- Do not start Human Research activities until you have the final HRPP (IRB) approval letter.
- Do not start Human Research activities until you have obtained all other required institutional approvals, including approvals of departments or divisions that require approval prior to commencing research that involves their resources.
- Ensure that there are adequate resources to carry out the research safely. This includes, but is not limited to, sufficient investigator time, appropriately qualified research team members, equipment, and space.
- Ensure that Research Staff are qualified (e.g., including but not limited to appropriate training, education, expertise, credentials, protocol requirements and, when relevant, privileges) to perform procedures and duties assigned to them during the study.
- Update the HRPP (IRB) office with any changes to the list of study personnel.
- Personally conduct or supervise the Human Research. Recognize that the investigator is accountable for the failures of any study team member.
- Conduct the Human Research in accordance with the relevant current protocol as approved by the HRPP (IRB), and in accordance with applicable federal regulations and local laws.
- When required by the HRPP (IRB) ensure that consent or permission is obtained in accordance with the relevant current protocol as approved by the HRPP (IRB).
- Do not modify the Human Research without prior HRPP (IRB) review and approval unless necessary to eliminate apparent immediate hazards to subjects.
- Protect the rights, safety, and welfare of subjects involved in the research.
- Submit to the HRPP (IRB):
- Proposed modifications as described in this manual. (See “How do I submit a modification?”)
- A continuing review application as requested in the approval letter. (See “How do I submit continuing review?”)
- A continuing review application when the Human Research is closed. (See “How Do I Close Out a Study?”)
- Complete the Report New Information SmartForm within five business days.
- Submit an updated disclosure of financial interests within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new financial interest.
- Do not accept or provide payments to professionals in exchange for referrals of potential subjects (“finder’s fees”).
- Do not accept payments designed to accelerate recruitment that were tied to the rate or timing of enrollment (“bonus payments”)
- Federal agencies outline additional investigator requirements and do no override the baseline requirements of this section.
If the study is a clinical trial and supported by a Common Rule agency, one HRPP (IRB)-approved version of a consent form that has been used to enroll participants must be posted on a public federal website designated for posting such consent forms. The form must be posted after recruitment closes, and no later than 60 days after the last study visit. Please contact the study sponsor with any questions.
The Dartmouth Health HRPP (IRB) will use the following channels to make resources and information available:
- The HRPP (IRB) News and Events page
- The Dartmouth Health HRPP (IRB) Intranet site
- Broad email communications
- ORO meetings
- Workshop sessions
You can also contact the Dartmouth Health HRPP IRB Office with questions!
Dartmouth Health HRPP (IRB) system
The Dartmouth Health HRPP (IRB) is using an updated version of the RAPPORT system that you are familiar with. The submission process is virtually the same and we will offer trainings and publish user guides to assist you through new questions in the system forms that might be unfamiliar to you.
We will make a copy of studies in RAPPORT at the end of June and make these studies available in the Dartmouth Health HRPP (IRB) system as of July 1, 2019 so you will have access to the entire study history and there will not be a need for you to re-enter information. The first time you access the system and submit to the Dartmouth Health HRPP (IRB) you may have to complete new questions in the Dartmouth Health HRPP (IRB) system that are not in RAPPORT.
Your study will fall into one of three categories:
- Transitioned to the Dartmouth Health HRPP (IRB) system as of July 1, 2019
- Eligible for transition but not yet moved to the Dartmouth Health HRPP (IRB)
- Studies in this category may be in the IRB review process, have pending actions or other housekeeping items that need to be resolved before they can transition to Dartmouth Health’s HRPP (IRB).
- Eligible for transition but remaining with CPHS
- Studies in this category may be nearing completion and/or limited to data analysis activities.
We are currently assessing studies in RAPPORT and will share details of the transition plan as studies are identified for transition. Investigators will receive a targeted email communication explaining the submission process if they have active studies or submissions in process that may be impacted during the transition period.
- We will coordinate with CPHS to ensure that any studies identified for transition that have follow-on submissions in process with CPHS are completed prior to the system transition.
- We are also working with CPHS to develop timelines and a submission strategy for studies that have expiration dates in June and July to avoid any lapses in IRB approval.
REMINDER: If you are planning a new initial submission, please visit the HRPP (IRB) Submission Decision Questions page to determine which IRB is responsible for oversight as of July 1, 2019. If you will be submitting to the Dartmouth Health HRPP (IRB) on or after July 1, 2019 and you are working on compiling your study submission materials in June, it is recommended that you access the Dartmouth Health HRPP (IRB) in order to use applicable Dartmouth Health templates as you prepare your submission.
RAPPORT will remain active for studies under CPHS oversight after July 1, 2019. If you have a study that was identified as staying with CPHS, or identified for a future transition date, you will continue to use RAPPORT for the management of those studies.
If you attempt to access transitioned studies in the RAPPORT system after July 1, 2019 you will receive a message that links you to the Dartmouth Health HRPP (IRB) site. The Dartmouth Health HRPP (IRB) system will include a full history of your studies, including CPHS review records. You will not need to access both IRB systems to manage a single study.
REMINDER: If you are planning a new initial submission, please visit the HRPP (IRB) Submission Decision Questions page to determine to which IRB is responsible for oversight as of July 1, 2019.
The Dartmouth Health HRPP (IRB) system will go-live on July 1, 2019. All new initial submissions as well as follow-on submissions (modifications, continuing reviews, reportable new information) for previously approved studies that were transitioned should use the Dartmouth Health HRPP (IRB) system as of July 1, 2019.
Not sure if your study is eligible for oversight by the Dartmouth Health HRPP (IRB)? Visit the HRPP (IRB) Submission Decision Questions page.
Existing RAPPORT users should continue to use their RAPPORT credentials to log-in to the Dartmouth Health eIRB system. The table below includes login instructions for existing and new users.
Within the application home page, you will see an option to login with Dartmouth Health or Dartmouth College (DC) credentials. Click one of the options based on which user group you fit into.
|eIRB User Group||Dartmouth Health eIRB Log-In Instructions|
|Dartmouth Health users with active protocols that transitioned to the Dartmouth Health IRB||On the eIRB homepage, click “Dartmouth College” and use RAPPORT username and password.
NOTE: Studies will NOT be viewable by using your Dartmouth Health credentials. Please avoid using your Dartmouth Health credentials until told otherwise by the Dartmouth Health IRB.
|DC users with RAPPORT credentials issued before 7/1/2019||On the eIRB homepage, click "Dartmouth College" and use RAPPORT username and password.|
|New Dartmouth Health users or Dartmouth Health users with no active protocols that transitioned to the Dartmouth Health IRB||On the eIRB homepage, click "D-H" and use Dartmouth Health username and password.
NOTE: Do NOT use RAPPORT credentials to log-in.
|DC users that do not have RAPPORT credentials by 7/1/19||Contact the Dartmouth Health IRB to receive a username and password.|
During the transition to Dartmouth Health eIRB, we are allowing both Dartmouth Health and Dartmouth College credentials to access the site. As a result, some Dartmouth Health users may have 2 profiles in the eIRB system. In order to avoid errors, existing RAPPORT users please continue to use your RAPPORT credentials to log-in to the system.
Users may not be able to log in to the eIRB system for the following reasons:
- Dartmouth Health credentials are disabled
- DC RAPPORT credentials are disabled
- DC user with no active RAPPORT credentials by 7/1/19
Please contact the Dartmouth Health IRB if you require access to the system.
There may be a few reasons for this:
- You used Dartmouth Health credentials to log-in to the system but your study is linked to your RAPPORT credentials. Log-in to the Dartmouth Health eIRB system using your RAPPORT credentials to see if your study is in the Dartmouth Health eIRB system.
- Your study did not transition to the Dartmouth Health IRB as of 7/1/19 but will transition during Phase II of the project this Fall. Please log-in to the RAPPORT system to manage your study.
- Your study will not be transitioned to the Dartmouth Health IRB. Please log-in to the RAPPORT system to manage your study.
If you received notification from the Dartmouth Health IRB and/or the RAPPORT site shows a message on the workspace that the protocol was transitioned, please contact the Dartmouth Health IRB.