The Institutional Review Board (IRB) is dedicated to the highest standards of patient care in research and upholds the principles of the Belmont Report and guidelines for the protection of human subjects participating in research under its jurisdiction.
The Main Line Health IRB Policy and Procedures Manual is the primary reference for research studies involving human subjects and contains policies and procedures for conducting research activities under its jurisdiction as defined by Federal and State law. Please remember use the IRB web site as your source for the most recent policies and procedures.
The Main Line Hospitals IRB accepts submissions for review through iMedRis, an electronic IRB management system.
IRB submission types
Below, you will find information sheets to assist you in completing the various types of submissions.
- Getting started – login instructions (PDF)
- Submitting a new study (PDF)
- Note: A MLH Transmittal Form (Word) is required for all new Expedited and Full review study submissions. This form will have to be completed and uploaded into iMedRis.
- PLEASE NOTE: The Transmittal form is only required for Exempt applications that receive funding from any source.
- PI signoff (PDF)
- Note: Submission will not be delivered to the IRB until the PI has signed off.
- Accessing study documents (PDF)
- Submitting a continuing review/final report (PDF)
- Submitting an amendment (PDF)
- Responding to request revisions (PDF)
IRB education requirements for researchers
Main Line Health has adopted a mandatory initial and on-going educational training program in the ethical principles and guidelines for the protection of human subjects research for all investigators and research personnel involved in research involving human subjects. Research personnel are defined as anyone who has contact with human participants and/or access to research data.
Collaborative Institutional Training Initiative (CITI) is a subscription online service providing research ethics education to all members of the research community. Main Line Hospitals is one of over 800 institutions participating in the program. There are several groups to choose from as outlined below.
- Group 1: biomedical research – for research personnel who engage in biomedical research.
- Group 2: social and behavioral research – for research personnel who engage in social and behavioral research which does not involve biomedical procedures.
Research personnel who engage in biomedical research must also complete the Group 1 Module.
- Group 3: data or specimen ONLY research – for research personnel who engage exclusively in secondary data analysis of data, human tissues and/or samples. This group does NOT satisfy the educational requirements for biomedical or social and behavioral research. If you are planning to conduct biomedical or social and behavioral research you are required to take Group 1 and/or Group 2.
- Group 4: IRB members – for IRB members and staff. This group does not satisfy the educational requirements for Groups 1, 2 or 3.
- Group 5: Good clinical practices (ICH-GCP) – For research personnel who engage in NIH Funded Research and greater than minimal risk investigator initiated protocols. This group does NOT satisfy the educational requirements for Groups 1, 2 3 or 4. Recertification of the training must be completed every three years.
- Group 6: exempt research – For research personnel who engage in Exempt research. This group does not satisfy the educational requirements for Groups 1-5. Note: Recertification of the training must be completed every three years. Groups 1-3 will satisfy the training requirements of Group 6.
Research personnel at the Main Line Health hospitals are required to take one of the BASIC courses. The BASIC training courses are valid for three years. After three years have passed, you are required to re-certify by taking a REFRESHER Course that corresponds with the appropriate Group listed above. Please note that the REFRESHER Courses are for those who wish to continue research upon expiration of the three-year certification period. Refresher courses are also valid for three years.
Financial COI training
All researchers and research staff are required to complete financial conflict of interest training at least every four years online through the Collaborative Institutional Training Initiative (CITI). Please select the course “Financial Conflict of Interest” when you log into CITI using your previously established user name and password. This training is required every four years.
Print a copy of the completion report for your records. You will not receive a certification from Main Line Hospitals.
The IRB requires all individuals listed on the protocol complete and remain current with the training requirements before approval will be granted.
Please contact the Office of Research Protections if you need assistance in determining which group is appropriate.
Good clinical practice (US FDA focus)
All NIH-funded investigators and staff involved in the conduct, oversight, or management of clinical trials must be trained in Good Clinical Practice (GCP). This training requirement applies to all new and existing NIH clinical trials. The policy requires basic GCP training and refresher GCP training every three years. In order to satisfy the federal training requirement, all research investigators and staff who are involved in an NIH-funded study meeting the definition of a clinical trial (as defined by NIH) will be required to complete GCP training. To meet these requirements, a Good Clinical Practice (GCP) Module and refresher course has been added to CITI and is required for all research personnel involved in an NIH-funded clinical trial.
IRB guidance documents
Financial Conflict of Interest (FCOI) Form
Informed Consent Guide
- Informed Consent Form Preparation Guide (PDF) (Revised 10/4/22)
HIPAA Authorization Template and Revocation Template
Short-form Consent Template and Guide for Use with Non-English Speaking Research Subjects
- Short Form Consent Guide (PDF) (Revised 11/11/22)
- Short Form Consent Template (PDF) (Revised 11/11/22)
Registering Investigator-Initiated Clinical Trials on ClinicalTrials.gov
Guidelines for Investigators and Research Staff
- IRB Review Decision Charts
- Responsibilities of Investigators and Research Staff Conducting Human Subjects Research (PDF) (Revised 11/14/22)
Use of a single IRB
- Final NIH Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research (PDF) - Effective on January 25, 2018