The Lankenau Institute for Medical Research
What's New
January 2010 - Update #1
Institutional Review Board News
1. Updated Procedure for New Research Proposal Transmittal Form
Prior to submitting a new research proposal/protocol to the Office of Research Affairs (ORA), obtain all signatures on the MLH Transmittal Form. Please factor in extra time when planning your submission.
In addition, when circulating the MLH Transmittal Form for signature, the following items must be attached:
- Protocol Synopsis/Summary
- Clinical Trial Budget Submission Template
- Clinical Trial Agreement (when applicable)
This requirement applies to ALL types of research (funded or unfunded). ORA will not accept new research protocols without all required signatures.
The New Research Proposal Transmittal Form and the Clinical Trial Budget Submission Template is available on the ORA website at: http://www.limr.org/oth/Page.asp?PageID=OTH003889
2. Updated Informed Consent Form Preparation Guide
The “Informed Consent Form Preparation Guide” has been updated to include template language for disclosing Investigator Conflict of Interest. In addition the Guide has been revised to delete the requirement to include a signature for “Physically Not Able to Sign Consent Form”. This signature is no longer required to be on the form.
Additionally, the policy has been revised to allow provisions, on a case by case basis, for the use of facsimile, mail or telephone to document informed consent and included a statement that the reading level of the informed consent should be no higher than an 8th grade level.
The Guide is located on the ORA website at: http://www.limr.org/oth/Page.asp?PageID=OTH003890
3. Updated Informed Consent Documentation Policy
The “Informed Consent Documentation” Policy (Part 1, No. XIII) has been revised to include “short form written consent” procedures for use with potential subjects who do not speak English., The short form can be used when English is not understandable to a potential research subject when considering whether to participate in a research study and the investigator does not have an IRB-approved consent document translated into a language understandable to the potential subject.
The English version of the short form, the updated policy, guidance document and the January 28, 2010 Inservice on “Short Form Consent Process” is available on the ORA website.
The approved translations of the short forms are available via Johns Hopkins IRB website at: http://irb.jhmi.edu/Forms/ShortFormTranslation.html. The MLH IRB gratefully acknowledges permission from the Johns Hopkins IRB for the use of these forms.
