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Email: s.murthy@drexel.edu
Phone: 215.255.7857
Fax: 215.255.7874

Address:
Drexel University College of Medicine
Office of Regulatory Research Compliance
1601 Cherry Street, 3 Parkway Bldg.,
Mail Stop 10-444
Philadelphia, PA 19102
IRB Full Review Procedure Updates

Effective immediately all new Investigator Initiated Full Board review applications for Medical IRB #1 and Non-Medical IRB #3 will now be submitted and reviewed by the Drexel IRBs.  The Drexel IRBs are now reviewing Full review applications using the current Drexel IRB application materials found at the ORRC website.

The IRB application forms home page is: http://www.research.drexel.edu/compliance/IRB/default.aspx   

Applications to the WIRB are ONLY for sponsored/industry protocols as had been our past practice.  Applicants to the Drexel IRBs will follow the links for Medical or Non-Medical IRB from the link above.

Please note: As the IRB transitions into the AAHRPP accreditation model to manage the Drexel University Human Subjects Protection Program, applicants to the IRB may notice changes in the format and style of forms used for both NEW INITIAL applications as well as continuing communications with the IRB for currently approved protocols.  A final roll out date for the new application format has not been finalized.  The ORRC will make every attempt to communicate these changes as they are implemented.

Please check the ORRC home web page frequently for announcements regarding these changes.  You may also contact the ORRC at 215-255-7857 in advance of completing and submitting new documents electronically to the ORRC.

ORRC home page: http://www.research.drexel.edu/compliance/default.aspx  
New Human Research Training Program and Website

The Office of Regulatory Research Compliance announces the implementation of the Collaborative Institutional Training Initiative (CITI) program now available to all DUCoM and DU Investigators and Key Personnel. Guidance and FAQs regarding the changes in Human Subjects Research training may be found on the Human Research Training website.
Human Subjects Research, Genetic Studies and Mandatory Consent Language

April 22, 2009

There is a recent change in the OHRP guidance concerning changes to the consent form language for clinical trials involving genetic testing.

This guidance is based on the act, which takes effect between May 22, 2009 and May 21, 2010. The act prohibits discrimination in health coverage and employment based on an individual’s genetic information. Many of the key provisions of this act are retroactive.

Based on this act, on April 7, 2009 OHRP finalized this guidance entitled, “Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards.” The guidance document provides OHRP’s first formal guidance on this topic. The document, which is available on the OHRP website at: http://www.hhs.gov/ohrp/humansubjects/guidance/gina.html and http://www.hhs.gov/ohrp/humansubjects/guidance/gina.pdf, is intended primarily for investigators who conduct, and institutional review boards (IRBs) that review, non-exempt human subjects research involving genetic testing or collection of genetic information. The guidance document provides background on protections provided by the Genetic Information Nondiscrimination Act of 2008 (GINA) and discusses some of the implications of GINA for investigators who conduct, and IRBs that review, genetic research, particularly with respect to the criteria for IRB approval of research and the requirements for obtaining informed consent under the Department of Health and Human Services regulations for the protection of human subjects (45 CFR part 46).

Currently when IRBs review clinical trials seeking to collect genetic information through informed consent; there is a potential risk that during the course of the study the genetic information collected may run into theoretical risks of finding it harder to get health insurance and employment due to potential unfavorable genetic information about the participant.

The required language to be included in the consent forms of all human research studies involving the collection of specimens for ANY genetic evaluation is listed below. This language is to be included in all currently approved IRB applications as well as future new applications. Your currently approved applications must be submitted to the IRB with an official request for amendment.

The required language is to be inserted immediately following your consent form’s specific section which details and describes collection or evaluation of the subject's specimen(s) for genetic evaluation. This section typically follows your consent form’s HIPAA language in section 19.

In this specific circumstance, Principal Investigators are not required to re-consent their subjects, they are however required to amend their currently approved protocols to describe how they will inform ALL consented subjects in each affected IRB protocol that currently has IRB approval.

The required language is as follows:

A new Federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law generally will protect you in the following ways:
  • Health insurance companies and group health plans may not request your genetic information that we get from this research.
  • Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums.
  • Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.

However, GINA will not protect you if you already have a genetic disease or disorder and does not prohibit discrimination on the basis of an existing genetic disease or disorder. In addition, this new Federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.

All health insurance companies and group health plans must follow this law by May 21, 2010. All employers with 15 or more employees must follow this law as of November 21, 2009.

Please note that despite these safeguards, our IRBs when reviewing clinical trials must take into account whether risks are minimized and reasonable in terms of benefit and whether adequate provisions are in place to protect the privacy of the research participant. This privacy protection will be additional to HIPAA-mandated privacy and confidentiality.

If you have additional questions on this guidance please go to the website cited above or contact me.

Sincerely,

Sreekant Murthy, Ph.D.
Vice Provost for Research Compliance
CLINICAL TRIALS REGISTRATION

Dear Faculty and Research Coordinators:

On September 27, 2007, a new law was enacted that expands the type of clinical trials that MUST be registered in Clinical Trials.Gov. There are penalties for non-compliance with the law. Publishers do not accept for publication and report the submission to the clinical trials monitoring agencies. A description of the law and the requirements for registration is attached. Please read the description of the law to meet the requirements. A simple trifold brochure of the registration information can also be downloaded from http://prsinfo.clinicaltrials.gov/registering.pdf

Clinical trials that must be Registered by December 26, 2007

1. Trials of Drugs and Biologics, controlled clinical investigations EXCEPT Phase 1investigations of a product subject to FDA regulations*.

2. Trials of Devices: Controlled trials with health outcomes of devices subject to FDA regulation, other than studies and pediatric postmarket surveillance*.

*This includes all ongoing trials including those trials which are in the stages of “follow up” or open for “data analysis”. If the trial is designed to contain more than one arm, you are required to register separately each arm of the trial.

Exceptions or Extended Registration Date*

Extended Time: Data for clinical trials “ongoing” as of 9/27/2007 that do NOT involve a “serious or life threatening disease or condition” must be reported by 9/27/2008.

Trials NOT subject to reporting per this Law: Trials that involve a “serious or life threatening disease of condition”, are initiated by before 9/27/2007, and have a “completion” date prior to 12/26/2007 are not subject to these new requirements.

*Investigators conducting research such as chart reviews, data mining and, clinical specimen analysis unrelated to a clinical trial or not required to register.

Who Should Register

If the project is an internally initiated clinical trial including those funded by the NIH or other funding agencies, Individual PIs are responsible for registering the trial.

If it is a sponsored study such as those being reviewed by WIRB, sponsors are responsible for registering the trail. It is important that you contact your sponsor to ensure that the sponsor has registered the trial and has secured

“CTA #”. A data providers list is posted on the website: http://prsinfo.clinicaltrials.gov/gettingIndivAccount.html.

You can also search at http://clinicaltrials.gov/ct/screen/SimpleSearch whether your trial has already been registered by your sponsor including those registered by NCI, COG, POG, GOG, ECOG and similar research cooperative groups.

DO NOT REGISTER INDIVIDUALLY IF YOUR SPONSOR OR THE RESEARCH COPERATIVE GROUPS HAVE ALREADY REGISTERED THE TRIAL.

Please obtain the CTA # from the sponsor, record the CTA number in your CRF and send an e-mail to the Office of Research Compliance (Cls69@drexel.edu) providing the title of the study and the corresponding CTA#.

How to register

To begin the registration process, go to the ClinicalTrials.gov registration website (https://register.clinicaltrials.gov/). You need the following information to login (case sensitive):

A password and username are required in order to register and are available from the Office of Regulatory Research Compliance by contacting Jack Medendorp at:
JCM29@DREXEL.EDU

In the event you have difficulty at login, you can also obtain your own password by sending an e-mail to register@clinicaltrails.gov . When you request for the login, please give the organization name as “DrexelU”, your name, telephone number and e-mail address, they will send you a password within 24 hours. Again, please make sure that you give the organization name as “DrexelU”. It takes approximately about 30 minutes to register a trial.



Questions on Registering

If you have any questions on registering, please contact Jack Medendorp (jcm29@drexel.edu) or Sree Murthy (sm53@drexel.edu) or call 215 255 7859.