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This page contains information and resources for members of the University of Pennsylvania’s 8 Institutional Review Boards.

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IRB Member Review Materials for Download

These guidance materials and templates have been developed by the IRB support staff to assist the IRB members in compiling organized notes and understanding how to apply regulations consistently while performing reviews.

Click each document to download a copy:

IRB Member Training Archive

As part of the University of Pennsylvania Human Research Protections Program, IRB members are provided with focused training presentations at the monthly convened board meetings. These trainings aim to improve member understanding of their role as an ethical reviewer of research as well as to provide an open forum about newsworthy topics in research and related regulations. The training slides for past presentations are provided here as a resource for member reference.

Click Title to download PDF of presented slides:

September 2016 - Training on NIH Policy for Single IRB of Record

October 2016 - Updates for Members about HSERA Changes and Member Resources

November 2016 - An Overview on Meeting Preparation and Review Presentation

December 2016 - Penn IRB Performance Review

January 2017 - 21st Century Cures Act

February 2017 - Exempt and Expedited IRB Review Process

March 2017 - Sex and Gender in Clinical Research

April 2017 - Article Discussion: Mystery Fungus Sparks NIH Crisis

May 2017 - Changes to the Common Rule

June 2017 - Member Self Evaluations prep

July 2017 - Individual Autonomy

August 2017 - PA Supreme Court Ruling Re: PI Consent

September 2017 - Member Survey Results

October 2017 - Convened Review of Deviations

Novermber 2017 - Exclusion of Pregnant Women

December 2017 - Year In Review

Jan 2018 - Common Rule Update

Feb 2018 - Investigational Drug and Device Regulations

March 2018 - Article Discussion : Gene Therapy and Viral Vectors

April 2018 - Informed Consent

May 2018 - Data Protection

IRB Meeting Dates, Times and Locations for 2018

The table shown below includes the planned meeting dates for 2018 for each board.

Please note that meeting dates, times and locations are subject to change.

Please check the agenda email you receive from your board administrator to confirm each month.

 Click here to download a copy

-IRB 1: Time: 11:45 AM - Location: IRB Conference Room 3800 Spruce Street Suite 151E
-IRB 2: Time: 11:45 AM - Location: 9025 Maloney HUP
-IRB 3: Time: 10:00 AM - Location: 9025 Maloney HUP
-IRB 4: Time: 10:45 AM - Location: IRB Conference Room 3800 Spruce Street Suite 151E
-IRB 5: Time: 11:00 AM - Location: 8030 Maloney HUP
-IRB 6: Time:   4:00 PM - Location: Cheston Conference Room Pennsylvania Hosp.
-IRB 7: Time: 11:00 AM - Location: 8030 Maloney HUP
-IRB 8: Time: 12:00 PM - Location: IRB Conference Room 3800 Spruce Street Suite 151E

Ethical Principles References for Download

The Penn IRB recognizes and references the guiding ethical principles for human subject’s research that have been set forth in the following documents.

Click each document to download a copy:

About IRB Membership at UPenn

 The Institutional Review Boards are federally regulated entities with the mandate to review biomedical and social behavioral research studies that take place within or under the authority of the University of Pennsylvania. The purpose of review is to determine if the proposed research meets certain established regulatory, policy, and ethical criteria to protect the rights and welfare of the human subjects of such research.

As a Committee Member of the IRB, your presence will be used to establish a quorum; therefore you will be expected to attend regularly scheduled meetings, which generally occur once a month. Members will be provided with a copy of the IRB agenda and access to protocols, informed consent forms, and other supporting study documents prior to the convened meeting. In addition, members will receive expedited review information and the minutes from the committee's last convened meeting for final approval.
The term for IRB Member is one year. This term is renewable. Members may be removed at any time if they are unable or unwilling to fulfill their duties as IRB members.

UPenn IRB Members are expected to:

  • Review agenda information prior to each meeting
  • Participate in the review of agenda items and facilitate the discussion
  • Be broadly familiar with each protocol being reviewed at each meeting
  • Participate in continuing training and education provided by the IRB support staff during the term of appointment
  • Hold the contents of reviewed protocols and the discussions that occur during the IRB meetings in strict confidence
  • Recuse/abstain from deliberation or voting on any study submitted to the IRB in which you or your immediate family has any financial interest as defined in policy GA 106A Managing Conflicts of Interest: IRB Members, Consultants and Staff.

If you are interested in becoming a member of the UPenn IRB please contact Megan Bogia (mbogia@upenn.edu) to inquire.

 

Click to download IRB Member Confidentiality Statement

 

Board and Member evaluations

IRB committee composition and IRB membership is evaluated periodically, as appropriate, by IRB chairs and HRPP senior staff to ensure committee composition meets regulatory and organization requirements. IRB staff meets with the IRB executive chair and director of HRPP, typically once per year, to discuss continuation, performance, training needs and other membership concerns. Member self-evaluation is part of that process. De-identified aggregate information from the self-evaluation surveys is shared with the IRB executive chair, committee chairs, and staff. Individual feedback for members, in the form of corrective action, or compliment, is provided by the chair or IRB staff as changes are needed, or as performance warrants. Evaluations are documented in IRB member files.

Criteria for Approval Explained

In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:

  • Risks to subjects are minimized:

      (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and
      (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

  • Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
  • Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
  • Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by §46.116.
  • Informed consent will be appropriately documented, in accordance with, and to the extent required by 46.117.
  • When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
  • When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
  • Additional safeguards have been included in the study to protect the rights and welfare of subjects vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons,

IRB Determinations Explained

The IRB may make one of the following determinations as a result of its review of research submitted for initial review

  • Approval - When an acceptable risk/benefit ratio exists and the criteria required for approval are deemed acceptable, protocol is approved as submitted.
  • Withheld Approval Pending Changes - The IRB determines that the protocol will meet the regulatory criteria for approval provided the investigator agrees to make specific changes to the IRB application including the informed consent document. Only when the convened IRB stipulates specific revisions requiring simple concurrence by the investigator may the IRB Executive Chair, Chair or another designated IRB member subsequently approve the revised research protocol on behalf of the IRB under an expedited review procedure.Research may not be initiated until a letter of IRB approval is received and other applicable committee reviews are satisfied.
  • Tabled - The IRB requires substantive changes that are directly relevant to the determinations required by the IRB under federal regulations at §_.111, the IRB will table the approval of the protocol pending subsequent review by the convened IRB of the responsive material.
  • Disapproved - The IRB determines that the research does not meet the regulatory criteria for approval and cannot provide modifications that may allow the protocol to be approved.

The IRB may make one of the following determinations as a result of its review of research submitted for continuation or modification

  • Approval - When an acceptable risk/benefit ratio exists and the criteria required for approval are deemed acceptable, protocol is approved as submitted.
  • Conditional/Withheld Approval - When the IRB determines requires minor modification to the protocol or accompanying documents.
  • Tabled - The IRB requires substantive changes that are directly relevant to the determinations required by the IRB under federal regulations at §_.111, the IRB will table the approval of the protocol pending subsequent review by the convened IRB of the responsive material.
Withheld Approval vs. Tabled
  • WITHHELD APPROVAL PENDING CHANGES

When the IRB votes to WITHHOLD APPROVAL PENDING CHANGES an IRB chair or experienced IRB reviewer may approve the changes using an expedited mechanism. When the IRB withholds approval, the IRB should have in mind a clearly defined protocol that it is willing to approve. This protocol does not exist in final form, but represents the submitted protocol with specific required modifications. The IRB should document the required modifications so that an IRB chair or experienced IRB member can judge whether the revised protocol matches the one the IRB was willing to approve.
The IRB should provide the investigator specific modifications required to secure approval. For example,
 

  • "Participants must be 18 years or older"
  • "Drop the placebo controlled arm of this study"
  • "Offer psychological counseling to all participants at the study's conclusion”
  • "Include in the consent all side effects listed in the investigator's brochure"

The IRB may be less specific provided the modifications may be reviewed by the expedited procedure. For example, "Rewrite the content of the consent into lay language," or "Modify advertisements according to IRB policy" or "Submit quality of life surveys for review."

  • TABLED

The IRB should not grant withheld approval if the judgments of the convened IRB are required for any of the criteria that the IRB must consider for approval.  Such requests would include:
 

  • "Explain why participants less than 18 years of age will be allowed to participate"
  • "Provide additional justification for the use of placebo"
  • "Clarify whether participants will be offered counseling services at the end of the study"
  • "Indicate how often the data and safety monitoring board will meet"
  • "Provide additional animal data for the study drug"