Prior to 2023, in order to complete the research process at Geisel or DH, it was critical that students completed a necessary (although somewhat lengthy) on boarding process. The process was designed to ensure that all research training, indemnity and compliance requirements were in place before students begin a research project. For further clarification, please see the Research On Boarding tab.
Below are the historical important components to the research process at DHMC.
The first step is to complete basic coursework about research methods, ethics and compliance. This coursework is completed via the CITI training link (weblink www.citiprogram.org) at the institution at which the research is being performed. Also please see the CITI training FAQ document included on this website. This training is required for research at both Geisel and Dartmouth Health and the requirements for each institution are slightly different. Beginning with the Geisel Class of 2027, completion of CITI training at both Geisel and Dartmouth Health prior to matriculation will be required.
IRB ENROLLMENT AND ENGAGEMENT
All human research performed at Geisel and Dartmouth Health must be enrolled in a human research protection program – essentially known as the Institutional Review Board or IRB. The IRB is an essential component of any human research program and it is critical that all human research (clinical trials, survey studies, chart reviews, interventional trials, etc) be enrolled via the IRB.
There are two separate IRBs for Geisel and Dartmouth Health. Human research performed under the Geisel research umbrella is supervised by the Dartmouth Committee for the Protection of Human Subjects or CPHS (https://www.dartmouth.edu/cphs/). In order to participate in a study that is managed by Geisel, you must be enrolled on the study team that is managed in CPHS. If you are starting a new study and are responsible for on-boarding the study into CPHS, please reach out to the Assistant Dean For Medical Student Research so we can help assist you in the process. Of note the RAPPORT system is the web-based management system used by CPHS to manage human studies at Geisel.
If you are participating in a study at Dartmouth Health, the IRB of record is called Dartmouth Health Human Research Protection Program or DHRPP (https://www.dartmouth-hitchcock.org/research/hrpp-irb). Any human research performed at DH is overseen by the DHRRP. If you are joining an ongoing clinical study, it is imperative that you be included on the study by the study primary investigator in the DHRRP. DH investigators submit their protocols and supporting documents at the following website: (http://dhirb.huronresearchsuite.com). If new to the system you will need to create an account and profile. If you are starting a new study and are responsible for on-boarding the study into DHRRP, please reach out to the Assistant Dean.
DH CLINICAL TRIALS OFFICE
If you are completing human research at DH, the Clinical Trials Office or CTO must also be contacted prior to study enrollment (https://www.dartmouth-hitchcock.org/research/clinical-trials-office). The CTO is responsible for ensuring the business of research is protected. They are the office ensuring billing compliance with federal guidance as well as executing research agreements such as data use agreement (DUA), MTA, CDA/NDA etc. Enrollment with the CTO is a completely separate process from the DHRRP that is required prior to study activation for any clinical research being performed at Dartmouth Health. However, if you are performing research only at Geisel the CTO does not need to be involved. In order for a study to begin, the CTO must complete their review process and approval prior to study initiation. This process typically takes longer than the DHRRP review.
DATA ANALYTICS INSTITUTE
The Data Analytics Institute or DAI is the data management team that should be contacted if interested in performing an EPIC chart review. (http://one.hitchcock.org/intranet/departments/the-analytics-institute). Not all chart review can be done exclusively through the DAI because the DAI can only obtain information from EPIC data such as medications, diagnoses ICD-9 codes, CPT codes, patient demographics etc. The DAI is not able to pull more complex narrative or multifactorial information such as outcomes and complications. As such, the use of the DAI is optional, although encouraged, by the DHRRP depending on the type of data being evaluated. Of note, processing through the DAI can take several months so it is strongly encouraged that if you are interested in using the DAI, please start early.
It is critically important that if obtaining protected patient data, it be stored in a secure location. Using an encrypted, password-protected Dartmouth Health issues computer acceptable, but many researchers use the REDCAP data management system. This is a free web-based program that allows one to collect and manage research data securely through easy project creation and sample data entry. Access can be gained via the following address (https://synergy.dartmouth.edu/tools/redcap).