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Consent Form Changes

October 2013

The October 2013, Version 14 version of the HIPAA Combined Informed Consent/Authorization Template  has been posted. All new and revised consent forms are required to be on this template as of December 1, 2013.  Consent forms received after December 1, 2013 on an outdated template will be returned and the application will not be processed until the correct consent forms are submitted.

What’s new?

  • To conform to HIPAA/HITECH Final Rule, any opt-in/opt-out request in the consent form will require the full signature of the research participant.  Initials alone will not be acceptable.
  • Title Page: Information has been added in the patient I.D. Plate to provide instructions for faxing consent documents to Epic.

Section 1: What you should know about this study:

The following bullets have been added:

  • The word biospecimen may be used in this consent form.  Biospecimen may include any of the following: blood, tissue, saliva, urine, bone marrow, cells. Most biospecimens contain DNA, which is the genetic code for each person.
     
  • If you would like to review the information for this study, or a summary of the results, ask the study team doctor for the ClinicalTrials.gov study registration number.
     
  • Information about your research study participation will be included in your medical record, which is used throughout Johns Hopkins and its affiliated institutions.   Doctors outside of Johns Hopkins and its affiliated institutions may not have access to this information.  You can ask the research team to send this information to any of your doctors.
     
  • The Johns Hopkins School of Medicine Institutional Review Board (IRB) sometimes reviews studies that are conducted at other institutions. These other institutions are solely responsible for conducting the study safely and according to the protocol that the Johns Hopkins IRB has approved. Information about how to contact the investigator at the institution that is responsible for the study is included in this form.  When another institution is conducting the study, the word “we” in this consent form may include both Johns Hopkins and the participating institution.

Section 3:
JHMIRB standard language has been provided for permission to collect and store biospecimens for future research.  Please note that participants must provide a full signature.

Section 4:
JHMIRB standard language for research involving genetic material must be included.

Sections 10 and 11:
We have added “and its affiliated institutions

Section 12:
JHMIRB HIPAA privacy language has been revised.

Section 15:
Conflict of Interest language has been revised.

Section 16:
Certificate of Confidentiality language has been revised

Section 17:

  • Subsections a, b, and c: Information for clinical trials network sites has been included
  • Subsection d: Commercial language has been revised
  • Subsection e:  All Children’s Hospital has been added

Signature Page:
Information about EPIC has been added to “NOTE.”


AAHRPP

 

 

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