Drexel University Office of Research - Regulatory Committees Home

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

Welcome from the Vice Provost of Research

Welcome Message from Dr. Murthy

Educational In-Service on Laboratory Training, HIPAA Oversight and Human Specimen Collection

November 3, 2009

The Office of Regulatory Research Compliance (ORRC), in collaboration with the Department of Safety and Health and Compliance and Privacy Office are presenting an educational in-service on the requirements for laboratory safety training, HIPAA oversight and the research process, and human tissue/specimen collection registration.

This multi-topic presentation is scheduled for Thursday, November 12, 2009 from 1:00 - 2:00 PM. The presentation will be held the 1601 Cherry Street Building, 3 Parkway, room 840A and each presentation should last no more than 20 minutes. Live web streaming for those who cannot attend in person will be available at http://webcampus.drexelmed.edu/webcast.

1:00 - 1:20 PM
Jon Chase, Director of Department of Safety and Health, Drexel University
"Introduction to Regulations and Training Applicable to Research Personnel"

1:20 - 1:40 PM
Ed Longazel, Chief Compliance and Privacy Officer, Drexel University College of Medicine
"HIPAA Privacy and Research"

1:40 - 2:00 PM
Jack Medendorp, Assistant Director for Research Compliance, Drexel University
"Human Tissue/Specimen Collection Registration with the ORRC"

Any additional questions may be directed to the Office of Regulatory Compliance at 215-255-7857 or jcm29@drexel.edu.

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

IRB NEW APPLICATION FORMS VERSION 2008 ARE NOW AVAILABLE

The Office of Regulatory Research Compliance is pleased to announce the newly revised and released IRB application forms available from our website. Our new 2008 Version forms may be found in the usual fashion via our web link: http://www.research.drexel.edu/compliance/

Whether you apply to our Medical or Non-Medical IRB you will initiate the process in the usual format by choosing the appropriate IRB and then selecting the requested level of review; Exempt, Expedited, or Full. Please take note that the next page will default to the currently available forms and in order to proceed to our new applications you will check the circle next to New Forms, after which the 2008 Version forms will appear.

Please note that our new forms are more inclusive with respect to responses required to fulfill our responsibility of a thorough and complete review, now inclusive of Conflict of Interest attestation, while limiting the necessity of the applicant to download additional supporting application documents. Directions for completion accompany each IRB review application form however if you are in need of additional clarity do not hesitate to contact your respective IRB Coordinator.

Medical Adult IRB #1:	Cheryl Storino	215-255-7868
Non-Medical IRB #3:	Danyelle Greene	215-255-7864
Medical Pediatric IRB #4:	Jessica Crujeiras	215-255-7863

The Office of Regulatory Research Compliance will continue to accept new applications completed with our current forms until August 29, 2008 after which only the 2008 Version forms will be accepted.

OFFICE OF REGULATORY RESEARCH COMPLIANCE: UPDATING OUR CONTACT INFORMATION UPDATING YOUR CONSENT AND RESEARCH DOCUMENTS

Greetings to all Investigators and Research Staff,

The Office of Regulatory Research Compliance has resumed operations in our new location:

1601 Cherry Street, 3 Parkway Bldg., Suite 10-444,
Philadelphia, PA. 19102

Our contact phone numbers have changed, our main number is 215-255-7857, our Fax number is 215-255-7874, and the specific contact numbers for our staff is available upon request at cls69@drexel.edu

An additional task at hand is maintaining our standards of compliance which require our research subjects and volunteers to be properly informed of the appropriate contact information in case of injury or emergency. The consent templates for all IRB applications on line will be updated with the new contact phone number; however, we request all of our investigators and support staff to assist with the following:

1. We ask that all NEW applications/consent forms, requests for amendment consent forms and documents, as well as annual renewals currently under development be amended PRIOR to IRB submission to include the appropriate Office of Regulatory Research Compliance contact number 215-255-7857.

2. For all on going research activities where a consent form(s) is used, please email to the appropriate IRB coordinator a copy of each of your currently approved consents forms with the Office of Regulatory Research Compliance contact number updated as 215-255-7857. Our office will make the administrative changes and provide you with a revised stamped version of the updated consent form without delay. If an electronic version is not available, a hard copy of the consent form with the new contact number 215-255-7857, may be mailed to the following address:

Drexel University College of Medicine
Office of Regulatory Research Compliance
1601 Cherry Street, 3 Parkway Bldg., Suite 10-444
Philadelphia, PA. 19102

We appreciate all of your efforts to assist in our goal to maintain our compliance standards.

Thank you for your assistance

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.

New OHRP Frequently Asked Questions and Answers on Informed Consent

(June 18, 2007) - New OHRP Frequently Asked Questions and Answers on Informed Consent

OHRP posted on its website a new set of Frequently Asked Questions and Answers (FAQs) on informed consent. These FAQs provide guidance on OHRP’s current thinking on this topic and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word must in OHRP guidance means that something is required under HHS regulations at 45 CFR Part 46. The use of the word should in OHRP guidance means that something is recommended or suggested, but not required. The informed consent FAQs can be accessed at: http://www.hhs.gov/ohrp/faq.html.

OHRP (Office for Human Research Protections) ANNOUNCES NEW GUIDANCE ON ADVERSE EVENTS REPORTING AND REVIEW

1. The Office for Human Research Protection has provided guidance on how to report adverse events and unanticipated problems to IRBs and OHRP. The aim of this report is to clarify and assist the investigators on what kinds of information are needed to be submitted to the IRB and help minimize the amount of information needs to be submitted to the IRB and OHRP. The key component of the guidance is "Unanticipated" that meets the following Criteria:

a. Unexpected (in terms of nature, severity, or frequency) given (i) the research procedures are described in the protocol-related documents, such as the the IRB-approved protocol and informed consent document; and (ii) the characteristics of the subject population being studied;

b. Related or possible related to participation in the research ("related" means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and

c. Suggests that the research places subjects or others at great risk for risk of harm (including physical, psychological, economic, or social (harm) that was previously know or recognized.

The OHRP recognizes that sometimes there may be problems in interpreting "unexpected", "related", or "possibly related"; however, any incident, experience or outcome that meets the three criteria listed above warrants substantial changes in the research protocol or informed consent process/document.

For further information on adverse event reporting, please contact the Office of Regulatory Research Compliance at 215-255-7857 or visit http://www.hhs.gov/ohrp/policy/AdvEvntGuid.htm.

Please note that the procedures for such reporting for procedures regulated by the FDA are somewhat different. The draft guidance for FDA is given below.

FDA ANNOUNCES NEW DRAFT GUIDANCE FOR ADVERSE EVENT REPORTING

This draft guidance issued by the FDA assists the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events to the IRB. The draft guidance can be downloaded from http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0106-gdl0001.pdf.

The draft guidance is applicable to sponsors, investigators and IRBs. These are non-binding recommendations at the present time.

This draft guidance describes the current situation for reporting to IRBs and problems associated with current reporting process. There are specific guidelines for reporting adverse effects for"Clinical Investigations of Drugs and Biological Products Under Investigational New Drug (IND) Regulations: and "Clinical Investigations of Devices Under Investigational Device Exemption (IDE) Regulations".

Under these draft guidelines, investigators using drugs and biological products will be required to report adverse events promptly to the sponsor. If the adverse effect is "alarming", the investigator must report the event immediately to the sponsor.

For drugs and biological products, investigators are required to report promptly unanticipated problems to the IRB along with all previous safety reportings concerning similar adverse experiences.

If the adverse event involves a device, sponsors must immediately conduct an evaluation of an averse device effect and must report results of the evaluation to FDA, all reviewing IRBs and participating investigators within ten (10) working days after sponsor receives the first notice of effect.