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.

PLEASE NOTE: Changes to the Common Rule regulations for human subjects research (45 CFR 46) – further delay until January 21, 2019
Common Rule regulations are separate from FDA regulations. The FDA regulations have NOT changed.
OHRP announced on June 19, 2018, a final rule that delays by an additional six months the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149). The effective date is now January 21, 2019. The final rule can be found at gpo.gov/fdsys/pkg/FR-2018-06-19/pdf/2018-13187.pdf.

Additional policy resources:


IRB forms

This page contains the current MLH IRB forms that are required with each type of submission. This page also contains information sheets to assist you in completing the necessary submission forms. Always use the most current version of the IRB forms. Incomplete forms or forms with inaccurate information will cause a delay in processing your submission.

HOW TO APPLY FOR IRB REVIEW

Flow diagram (Revised 11/01/17)

IRB EDUCATION REQUIREMENTS FOR RESEARCHERS

Main Line Health education and training

REQUIREMENTS FOR IRB SUBMISSIONS/APPLICATIONS

  1. New protocols – full board review and expedited review (Revised 11/01/17)
  2. Retrospective chart reviews (Revised 11/01/17)
  3. Continuing review for an ongoing study – full board review and expedited review (Revised 11/01/17)
  4. Amendments to an ongoing study – full board review and expedited review (Revised 11/01/17)
  5. Addition of research personnel to an ongoing study (Revised 11/01/17)
  6. Requirements for use of a central IRB (Revised 10/8/18)

FORM ID

NAME OF FORM

USE WHEN SUBMITTING

ADDITIONAL INFORMATION

MLH IRB Form 001 (Revised 11/01/17)

Protocol Submission Form

  • New research studies
  • Any submissions to ORA (except with Continuing Review/Final Reports)

MLH IRB Form 002 (Revised 11/01/17)

Initial Submission Form

  • New research studies

MLH IRB Form 003 (Revised 11/01/17)

Continuing Review/Final Report Form

  • Renewal for an ongoing study
  • Final Report/Termination
  • Renewals should be submitted a minimum of six to eight weeks before expiration date of study. IRB approval must be maintained in order to conduct research.
  • Final Report/Termination requests must be submitted when all research activities are completed and must include a summary of the research activities.

MLH IRB Form 004A

Unanticipated Problems Reporting for SAEs/UADEs

  • An anticipated problem in a study which is a Serious Adverse Event or Unanticipated Adverse Device Effect
  • Flow Chart for Determining Which Adverse Events ARE Unanticipated Problems that must be reported to the IRB.
  • Information Sheet for Reporting Unanticipated Problems that ARE Serious Adverse Events or Unanticipated Adverse Device Effects

MLH IRB Form 004B

Unanticipated Problems Reporting for NON-SAEs/UADEs

  • An anticipated problem in a study which is NOT a Serious Adverse Event or Unanticipated Adverse Device Effect
  • Flow Chart for Determining Which Adverse Events ARE Unanticipated Problems that must be reported to the IRB.
  • Information Sheet for Reporting Unanticipated Problems that ARE NOT Serious Adverse Events or Unanticipated Adverse Device Effects

MLH IRB Form 005 (Revised 11/01/17)

Grant Application Information Form

  • A new grant or a change in an existing grant

Should be submitted with all grant funded research at time of new study submission or whenever a grant is awarded or changed

MLH IRB Form 006 (Revised 06/20/16)

HIPAA Authorization Form

  • New research studies involving the use of protected health information (PHI)

MLH IRB Form 007

HIPAA Revocation Form

N/A

Use when a currently enrolled research subject wishes to withdraw their consent for use of their protected health information from a study

COI Form (Revised 04/09/14)

COI Disclosure Form for Researchers and Research Staff

  • New research studies
  • Annual renewal for an ongoing study

Required by all personnel involved in the conduct of the study

Budget (Revised 10/22/15)

Clinical Trial Budget Submission Template

  • New research studies

Use with ALL funded/sponsored study types

MLH Transmittal Form (Revised 11/01/17)

MLH New Research Proposal Transmittal Form

  • New research studies

Use with all study types (funded or un-funded). ORA will not accept a new study without all required signatures

IRB guides

Informed Consent Guide

HIPPA Authorization Template and Revocation Template

Research Guides

Short-form Consent Template and Guide for Use with Non-English Speaking Research Subjects

Registering Investigator-Initiated Clinical Trials on ClinicalTrials.gov

Guidelines for Investigators and Research Staff

Use of a Central IRB