U.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board (IRB)
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- Antonia George
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1 ubmission#: IORG#: IORG Institution: U of Pittsburgh OMB No Approved for use through October 31, 2018 U.. Department of Health and Human ervices (HH) Registration of an Institutional Review Board (IRB) This form is used by institutions or organizations operating IRBs that review: a) Research involving human subjects conducted or supported by the Department of Health and Human ervices, or other federal departments or agencies that apply the Federal Policy for the Protection of Human ubjects to such research; and/or b) Clinical investigations regulated by the Food and Drug Administration (FDA) of the Department of Health and Human ervices This form is to be used for the following purposes: a. To register an IRB if your institution or organization has not previously registered an IRB b. To update or renew the registration of an IRB previously registered by your institution or organization c. To add another IRB to those previously registered by your institution or organization Fields with an * are required for OHRP IRBs and FDA IRBs Fields with an are required for OHRP IRBs but are optional for FDA IRBs Fields with an are required for FDA IRBs but are optional for OHRP IRBs Fields with no symbol are optional for both OHRP IRBs and FDA IRBs 1. *Has your institution or organization previously registered an IRB with the Office for Human Research Protections (OHRP)? [] es, proceed to section 2 [ ] No, proceed to section 3 2. *What is your institution or organization (IORG) number? IORG This number was provided by OHRP the first time your institution or organization registered an IRB. If you do not know your IORG number, search for your institution or organization on the OHRP website at or contact OHRP using the contact information at or by telephone at
2 3. Name of Institution or Organization Operating the IRB(s) *Name of Institution or Organization: U of Pittsburgh *Mailing Address: 3500 Fifth Avenue Hieber Building *treet Address (if different from the Mailing Address above): *City: Pittsburgh *tate/province: PENNLVANIA *Zip/Postal Code: *Country (if outside the U..): 4. enior Officer or Head Official of Institution or Organization Responsible for Overseeing the Activities Performed by the IRB(s) *First Name: George Middle Initial: A *Last Name: Huber Earned Degree(s): JD Title or Position: Vice Provost for Research Conduct & Compliance *Mailing Address (if different from the Mailing Address in section 3): Cathedral of Learning 4200 Fifth Avenue *City: Pittsburgh *tate/province: PENNLVANI *Zip/Postal Code: A *Country (if outside the U..): *Phone: *FA: * ghuber@pitt.edu 5. Contact Person Providing this Registration Information *First Name: Melissa Middle Initial: *Last Name: Miklos Earned Degree(s): ML, CIP Title or Position: Associate Director Name of Institution or Organization (if different from the Name in section 3): University of Pittsburgh IRB *Mailing Address (if different from the Mailing Address in section 3): 3500 Fifth Avenue 105 Hieber Building *City: Pittsburgh *tate/province: PENNLVANIA *Zip/Postal Code: *Country (if outside the U..): *Phone: *FA: * mgm12@pitt.edu
3 6. IRB Registration Information (to be completed separately for each IRB being renewed/updated or newly registered)
4 A. *Is this a renewal or update of a registration for an IRB already registered with HH? [ ] es. Provide the IRB registration number previously assigned to this IRB by OHRP: IRB (This number was provided by OHRP the first time the IRB was registered with OHRP. If you do not know the IRB registration number, search for the IRB on the OHRP website at or contact OHRP using the contact information at or by telephone at ) [ ] No, this is a new IRB registration. B. Provide the IRB name, if any, used by the institution or organization (e.g., tate University Behavioral IRB, University Healthcare Biomedical IRB, or Z Hospital IRB #1): U of Pittsburgh IRB #1 - A C. Location of the IRB *Mailing Address (if different from the Mailing Address in section 3): 3500 Fifth Avenue uite 106 *treet Address of the IRB (if different from the Mailing Address of the IRB): *City: Pittsburgh *tate/province: PENNLVANIA *Zip/Postal Code: *Country (if outside the U..): *Phone: *FA: * mgm12@pitt.edu D. Approximate number of full time equivalent positions devoted to the IRB s administrative activities: E. Approximate number of all active protocols (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months): F. Approximate number of active protocols conducted or supported by HH (e.g., the National Institutes of Health, Centers for Disease Control and Prevention, etc.) (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months):
5 G. For IRBs that review, or intend to review, protocols involving products regulated by the Food and Drug Administration (FDA) (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months): i) Approximate number of active protocols involving FDA-regulated products: ii) Types of FDA-regulated products involved in FDA protocols include (check all that apply): 40 human drugs medical devices biological food additives color additives other pecify: H. IRB Chairperson *First Name: Judith Middle Initial: *Last Name: Martin Earned Degree(s): M.D. Title or Position: Vice Chair Mailing Address (if different from the Mailing Address in section 3): 3500 Fifth Avenue, uite 106 City: Pittsburgh tate/province: PENNLVANIA Zip/Postal Code: Country (if outside the U..): *Phone: FA: * judy.martin@chp.edu
6 I. IRB Roster Form: Completion of the IRB Roster Form is required if your IRB is designated on a Federalwide assurance submitted to OHRP. Otherwise, it is optional. Member Name (Last, First) ex M/F Earned Degree(s) cientist () Non-scientist (N) Primary cientific or Non-cientific pecialty Martin, Judith M MD pediatric infectious disease Dilts, Robert M PhD N Mathematics Howland, Robert M MD Psychiatry Mitchell-O'Brien, F JD N Health and Hospital N Leeann Law oran, Ozlem F MD Cardiology Irrgang, James M PhD, PT, Orthopedics, PT, ATC Rehabilitation Miklos, Melissa F B, CIP N IRB regulations Manders, Ernest M MD plastic & reconstructive surgery ummersgill, Kurt M DD, PhD dental medicine, pathology Raman, M PhD pharmacy Venkataramanan ip, Lin F MD surgical oncology, endocrine surgery Corcoran, Timothy M PhD drug development, nuclear imaging Hoffman, Rose F PhD, RN nursing, acute and tertiary care Fowler, John M MD orthopedic surgery Benedict, Neal M PharmD Pharmacy & therapeutics, Critical Care Affiliation with Institution(s) /N Comments Alternative Members Orndoff, Patricia F RN, MEd Nursing McKaveney, Theresa F B N IRB regulations any non-scientific member Valenti, hannon F B, MBA N Research regulations any non-scientific member Carey, Thomas M MW, CIP ocial Work, IRB regulations Hurst, Kathleen F N/A N administrative any non-scientific member Ivanusic, Carolyn F B, MW N IRB regulations any non-scientific member Grabowski, Erin F B, CIP N IRB regulations, psychology Lee, Ann F MN, CRNP, CIP cardiology, heart/lung transplant any non-scientific member Holloway, Melanie F RN, BN pediatric nursing
7 LeMenager, Michelle F B N IRB regulations any non-scientific member Navratil, Judith F MA, CIP N IRB regulations, bioethics Wenzel, ally F MD Pulmonary, Allergy & Critical Care Medic Deantes, Lisa F B, CIP N IRB regulations, study coordination Gerger, Allison F MPH research coordinator, international DiVirgilio, Dana F MPH community health, study coordination any non-scientific member any physician member any non-scientific member any other scientist Fuhrman, Amy F MPA N research coordination any non-scientific member Pischke, Jack M MW N incarceration, social work, advocacy prisoner representative, Any non-scientific member Barone, Jean F CIP IRB regulations any non-scientific member Ivanco, Larry M MW social work, mental health Ansari, Nena F BA N IRB regulations any non-scientific member Quillen, Deane M MPH psycho-social research Carella, Beth F DO pediatric hem/onc, stem cell tx Mancino, Juliet F M, RDN, CDE, CCRC nutrition, diabetes management any physician member any other scientist NOTE: Members whose training, background, and occupation would incline them to view scientific activities from the standpoint of someone within a behavioral or biomedical research discipline should be considered a scientist, while members whose training, background, and occupation would incline them to view research activities from a standpoint outside of any biomedical or behavioral scientific discipline should be considered a nonscientist. In addition, the IRB must have members with sufficient knowledge of the specific scientific discipline(s) relevant to the research that it reviews. Affiliation: Please indicate whether or not each individual (or a member of that person s immediate family) is affiliated (other than as an IRB member) with the institution or organization operating the IRB. es = The IRB member is affiliated with the institution or organization operating the IRB. No = The individual is not affiliated with the institution or organization operating the IRB. Alternate Members: An alternate member(s) may be designated, as needed, for a regular voting member(s). An alternate member may vote only when the regular voting member is not voting.
8 When an institution or organization registers two or more IRBs, all alternate members for all IRBs may be listed on the roster of one IRB, or they may be listed separately with each IRB roster. A primary member of any IRB registered under the same IORG number may serve as an alternate for any comparably qualified member on any other IRB of that institution or organization. Primary members on registered IRBs serving as alternate members do not need to be listed as an alternate on any roster. Each alternate IRB member who replaces a primary member at any given meeting should have experience, expertise, background, professional competence, and knowledge comparable to that of the primary IRB member whom the alternate will replace. Whenever an alternate member substitutes for a primary member of the IRB, the combined requirements of (a) and (b) shall remain satisfied. Whenever this occurs, the minutes of the IRB meeting should indicate clearly that the alternate IRB member has replaced the designated primary IRB member, and include the identity of the replaced primary and the alternate members. If multiple alternate members serve at an IRB meeting, the pairing of primary and alternate members should be indicated.
9 A. *Is this a renewal or update of a registration for an IRB already registered with HH? [ ] es. Provide the IRB registration number previously assigned to this IRB by OHRP: IRB (This number was provided by OHRP the first time the IRB was registered with OHRP. If you do not know the IRB registration number, search for the IRB on the OHRP website at or contact OHRP using the contact information at or by telephone at ) [ ] No, this is a new IRB registration. B. Provide the IRB name, if any, used by the institution or organization (e.g., tate University Behavioral IRB, University Healthcare Biomedical IRB, or Z Hospital IRB #1): U of Pittsburgh IRB #2 - B C. Location of the IRB *Mailing Address (if different from the Mailing Address in section 3): 3500 Fifth Avenue uite 106 *treet Address of the IRB (if different from the Mailing Address of the IRB): *City: Pittsburgh *tate/province: PENNLVANIA *Zip/Postal Code: *Country (if outside the U..): *Phone: *FA: * mgm12@pitt.edu D. Approximate number of full time equivalent positions devoted to the IRB s administrative activities: E. Approximate number of all active protocols (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months): F. Approximate number of active protocols conducted or supported by HH (e.g., the National Institutes of Health, Centers for Disease Control and Prevention, etc.) (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months):
10 G. For IRBs that review, or intend to review, protocols involving products regulated by the Food and Drug Administration (FDA) (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months): i) Approximate number of active protocols involving FDA-regulated products: ii) Types of FDA-regulated products involved in FDA protocols include (check all that apply): 40 human drugs medical devices biological food additives color additives other pecify: H. IRB Chairperson *First Name: Margaret Middle Initial: *Last Name: Hsieh Earned Degree(s): MD Title or Position: IRB Chairperson Mailing Address (if different from the Mailing Address in section 3): 3500 Fifth Avenue, Ground Level City: Pittsburgh tate/province: PENNLVANIA Zip/Postal Code: Country (if outside the U..): *Phone: FA: * hsiehm@upmc.edu
11 I. IRB Roster Form: Completion of the IRB Roster Form is required if your IRB is designated on a Federalwide assurance submitted to OHRP. Otherwise, it is optional. Member Name (Last, First) ex M/F Earned Degree(s) cientist () Non-scientist (N) Primary cientific or Non-cientific pecialty Hsieh, Margaret F MD Emergency Medicine Palmer, Catherine F PhD Audiology chraut, Wolfgang M MD urgery Weyant, Donna F MN, RN, pediatric nursing CPN Hathaway, Bridget F MD otolaryngology Vanwearingen, Jessie F PhD physical therapy Hrynkiw, Nancy F B N non-scientific N community member Holloway, Melanie F RN, BN, pediatric nursing CIP piess, Alex M MD orthopedics, plastic surgery, hand Michel, Ian M JD N legal Bunge, Katherine F MD OB/Gyn, reproductive services Ziccardi, arah F MN, medical, surgical RN-BC nursing Johnson, Heather F PharmD Pharmacy, transplant, hepatology Ziobert, taci F PharmD pharmacy Affiliation with Institution(s) /N Comments Alternative Members Chen, Beatrice F MD OB/Gyn, reproductive services any physician member Miklos, Melissa F B, CIP N IRB regulations any non-scientific member Brandom, Barbara F MD pediatric anesthesia any other physician member Mancino, Juliet F M, RDN, CDE, CCRC nutrition, diabetes management Carey, Tom M MW, CIP ocial work, IRB regulations Pischke, Jack M MW N incarceration, social work, advocacy Lee, Ann F MN, RN, CRNP, CIP Deantes, Lisa F B, CIP N IRB regulations, study coordination prisoner representative cardiology, heart/lung tx any non-scientific member Libman, Ingrid F MD, PhD pediatric endocrinology any physician member
12 NOTE: Members whose training, background, and occupation would incline them to view scientific activities from the standpoint of someone within a behavioral or biomedical research discipline should be considered a scientist, while members whose training, background, and occupation would incline them to view research activities from a standpoint outside of any biomedical or behavioral scientific discipline should be considered a nonscientist. In addition, the IRB must have members with sufficient knowledge of the specific scientific discipline(s) relevant to the research that it reviews. Affiliation: Please indicate whether or not each individual (or a member of that person s immediate family) is affiliated (other than as an IRB member) with the institution or organization operating the IRB. es = The IRB member is affiliated with the institution or organization operating the IRB. No = The individual is not affiliated with the institution or organization operating the IRB. Alternate Members: An alternate member(s) may be designated, as needed, for a regular voting member(s). An alternate member may vote only when the regular voting member is not voting. When an institution or organization registers two or more IRBs, all alternate members for all IRBs may be listed on the roster of one IRB, or they may be listed separately with each IRB roster. A primary member of any IRB registered under the same IORG number may serve as an alternate for any comparably qualified member on any other IRB of that institution or organization. Primary members on registered IRBs serving as alternate members do not need to be listed as an alternate on any roster. Each alternate IRB member who replaces a primary member at any given meeting should have experience, expertise, background, professional competence, and knowledge comparable to that of the primary IRB member whom the alternate will replace. Whenever an alternate member substitutes for a primary member of the IRB, the combined requirements of (a) and (b) shall remain satisfied. Whenever this occurs, the minutes of the IRB meeting should indicate clearly that the alternate IRB member has replaced the designated primary IRB member, and include the identity of the replaced primary and the alternate members. If multiple alternate members serve at an IRB meeting, the pairing of primary and alternate members should be indicated.
13 A. *Is this a renewal or update of a registration for an IRB already registered with HH? [ ] es. Provide the IRB registration number previously assigned to this IRB by OHRP: IRB (This number was provided by OHRP the first time the IRB was registered with OHRP. If you do not know the IRB registration number, search for the IRB on the OHRP website at or contact OHRP using the contact information at or by telephone at ) [ ] No, this is a new IRB registration. B. Provide the IRB name, if any, used by the institution or organization (e.g., tate University Behavioral IRB, University Healthcare Biomedical IRB, or Z Hospital IRB #1): U of Pittsburgh IRB #3 - C C. Location of the IRB *Mailing Address (if different from the Mailing Address in section 3): 3500 Fifth Avenue uite 106 *treet Address of the IRB (if different from the Mailing Address of the IRB): *City: Pittsburgh *tate/province: PENNLVANIA *Zip/Postal Code: *Country (if outside the U..): *Phone: *FA: * mgm12@pitt.edu D. Approximate number of full time equivalent positions devoted to the IRB s administrative activities: E. Approximate number of all active protocols (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months): F. Approximate number of active protocols conducted or supported by HH (e.g., the National Institutes of Health, Centers for Disease Control and Prevention, etc.) (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months):
14 G. For IRBs that review, or intend to review, protocols involving products regulated by the Food and Drug Administration (FDA) (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months): i) Approximate number of active protocols involving FDA-regulated products: ii) Types of FDA-regulated products involved in FDA protocols include (check all that apply): 40 human drugs medical devices biological food additives color additives other pecify: H. IRB Chairperson *First Name: Judith Middle Initial: *Last Name: Martin Earned Degree(s): MD Title or Position: Vice Chair Mailing Address (if different from the Mailing Address in section 3): 3500 Fifth Avenue City: Pittsburgh tate/province: PENNLVANIA Zip/Postal Code: Country (if outside the U..): *Phone: FA: * judy.martin@chp.edu
15 I. IRB Roster Form: Completion of the IRB Roster Form is required if your IRB is designated on a Federalwide assurance submitted to OHRP. Otherwise, it is optional. Member Name (Last, First) ex M/F Earned Degree(s) cientist () Non-scientist (N) Primary cientific or Non-cientific pecialty Martin, Judith M MD pediatric infectious disease George, Betsy F RN, PhD tertiary, critical care Gildengers, Ariel M MD psychiatry Doi, ohei M MD, PhD infectious diseases Harter, Nancy F n/a N research administration Miller, Barbara F B, M ophthalmology research Hilmi, Ibtesam F MBCHB, anesthesia FRCA Deantes, Lisa F B, CIP N IRB regulations anowitz, Toby F MD neonatology, pediatrics Cipkala-Gaffin, Jan F DrPh, MN, nursing, PCO, RN mental health Prasad, Konasale M MD psychiatry, genetics Johnson, Amy F RPh pharmacy, ID uryawanshi, wati F PhD cellular biology, microbiology, uro-gyn Brufsky, Adam M MD, PhD hematology/oncolog y Mohan, Niveditha F MD internal medicine, rheumatology Phillips, Brandi F MPPM N health care N administration Finder, Jonathan M MD pediatric pulmonology Handen, Benjamin M PhD child psychology, autism Affiliation with Institution(s) /N Comments Alternative Members Miklos, Melissa F B, CIP N IRB regulations any non-scientific member Barone, Jean F CIP N IRB regulations any non-scientist Gerger, Allison F MPH IRB regulations Holliman, Jennifer F MPA N community outreach N any non-scientific member Mancino, Juliet F M, RDN, CDE, CCRC nutrition,, diabetes management Lee, Ann F MN, CRNP, CIP cardiology, heart/lung transplant
16 Holloway, Melanie F RN, BN, CIP pediatric nursing, IRB regulations Irrgang, James M PhD, PT, ATC orthopaedics, PT, rehab Pischke, Jack M MW N incarceration prisoner representative, any non-scientist Hsieh, Margaret F MD Emergency Medicine any physician member Carey, Thomas M MW social work, IRB regulations NOTE: Members whose training, background, and occupation would incline them to view scientific activities from the standpoint of someone within a behavioral or biomedical research discipline should be considered a scientist, while members whose training, background, and occupation would incline them to view research activities from a standpoint outside of any biomedical or behavioral scientific discipline should be considered a nonscientist. In addition, the IRB must have members with sufficient knowledge of the specific scientific discipline(s) relevant to the research that it reviews. Affiliation: Please indicate whether or not each individual (or a member of that person s immediate family) is affiliated (other than as an IRB member) with the institution or organization operating the IRB. es = The IRB member is affiliated with the institution or organization operating the IRB. No = The individual is not affiliated with the institution or organization operating the IRB. Alternate Members: An alternate member(s) may be designated, as needed, for a regular voting member(s). An alternate member may vote only when the regular voting member is not voting. When an institution or organization registers two or more IRBs, all alternate members for all IRBs may be listed on the roster of one IRB, or they may be listed separately with each IRB roster. A primary member of any IRB registered under the same IORG number may serve as an alternate for any comparably qualified member on any other IRB of that institution or organization. Primary members on registered IRBs serving as alternate members do not need to be listed as an alternate on any roster. Each alternate IRB member who replaces a primary member at any given meeting should have experience, expertise, background, professional competence, and knowledge comparable to that of the primary IRB member whom the alternate will replace. Whenever an alternate member substitutes for a primary member of the IRB, the combined requirements of (a) and (b) shall remain satisfied. Whenever this occurs, the minutes of the IRB meeting should indicate clearly that the alternate IRB member has replaced the designated primary IRB member, and include the identity of the replaced primary and the alternate members. If multiple alternate members serve at an IRB meeting, the pairing of primary and alternate members should be indicated.
17 A. *Is this a renewal or update of a registration for an IRB already registered with HH? [ ] es. Provide the IRB registration number previously assigned to this IRB by OHRP: IRB (This number was provided by OHRP the first time the IRB was registered with OHRP. If you do not know the IRB registration number, search for the IRB on the OHRP website at or contact OHRP using the contact information at or by telephone at ) [ ] No, this is a new IRB registration. B. Provide the IRB name, if any, used by the institution or organization (e.g., tate University Behavioral IRB, University Healthcare Biomedical IRB, or Z Hospital IRB #1): U of Pittsburgh IRB #6 - F C. Location of the IRB *Mailing Address (if different from the Mailing Address in section 3): 3500 Fifth Avenue uite 106 *treet Address of the IRB (if different from the Mailing Address of the IRB): *City: Pittsburgh *tate/province: PENNLVANIA *Zip/Postal Code: *Country (if outside the U..): *Phone: *FA: * mgm12@pitt.edu D. Approximate number of full time equivalent positions devoted to the IRB s administrative activities: E. Approximate number of all active protocols (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months): F. Approximate number of active protocols conducted or supported by HH (e.g., the National Institutes of Health, Centers for Disease Control and Prevention, etc.) (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months):
18 G. For IRBs that review, or intend to review, protocols involving products regulated by the Food and Drug Administration (FDA) (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months): i) Approximate number of active protocols involving FDA-regulated products: ii) Types of FDA-regulated products involved in FDA protocols include (check all that apply): 40 human drugs medical devices biological food additives color additives other pecify: H. IRB Chairperson *First Name: Richard Middle Initial: *Last Name: Guido Earned Degree(s): M.D. Title or Position: Chairman, IRB Mailing Address (if different from the Mailing Address in section 3): 3500 Fifth Avenue, Ground Level City: Pittsburgh tate/province: PENNLVANIA Zip/Postal Code: Country (if outside the U..): *Phone: FA: * Guido@mail.magee.edu
19 I. IRB Roster Form: Completion of the IRB Roster Form is required if your IRB is designated on a Federalwide assurance submitted to OHRP. Otherwise, it is optional. Member Name (Last, First) ex M/F Earned Degree(s) cientist () Non-scientist (N) Primary cientific or Non-cientific pecialty Guido, Richard M M.D. OB/GN Zelazny, Jamie F PhD, MPH, child/adolescent RN psych, suicide Martin, Judith F MD pediatric infectious disease Knapp, Beth F M N non-scientific, N community Barone, Jean F CIP N IRB regulations Beers, ue F PhD Pediatric neuropsychology weet, Robert M MD psychiatry Hsieh, Margaret F MD Emergency Medicine Lee, Ann F MN, CRNP, cardiology, CIP heart/lung transplant Brufsky, Adam M MD, PhD hematology/oncolog y Affiliation with Institution(s) /N Comments Alternative Members Oliver, D. Lamar M B N electrical engineering, non-scientist N any non-scientific member Horwitz, Mara F MD medicine, endocrinology any physician member NOTE: Members whose training, background, and occupation would incline them to view scientific activities from the standpoint of someone within a behavioral or biomedical research discipline should be considered a scientist, while members whose training, background, and occupation would incline them to view research activities from a standpoint outside of any biomedical or behavioral scientific discipline should be considered a nonscientist. In addition, the IRB must have members with sufficient knowledge of the specific scientific discipline(s) relevant to the research that it reviews. Affiliation: Please indicate whether or not each individual (or a member of that person s immediate family) is affiliated (other than as an IRB member) with the institution or organization operating the IRB. es = The IRB member is affiliated with the institution or organization operating the IRB. No = The individual is not affiliated with the institution or organization operating the IRB. Alternate Members: An alternate member(s) may be designated, as needed, for a regular voting member(s). An alternate member may vote only when the regular voting member is not voting.
20 When an institution or organization registers two or more IRBs, all alternate members for all IRBs may be listed on the roster of one IRB, or they may be listed separately with each IRB roster. A primary member of any IRB registered under the same IORG number may serve as an alternate for any comparably qualified member on any other IRB of that institution or organization. Primary members on registered IRBs serving as alternate members do not need to be listed as an alternate on any roster. Each alternate IRB member who replaces a primary member at any given meeting should have experience, expertise, background, professional competence, and knowledge comparable to that of the primary IRB member whom the alternate will replace. Whenever an alternate member substitutes for a primary member of the IRB, the combined requirements of (a) and (b) shall remain satisfied. Whenever this occurs, the minutes of the IRB meeting should indicate clearly that the alternate IRB member has replaced the designated primary IRB member, and include the identity of the replaced primary and the alternate members. If multiple alternate members serve at an IRB meeting, the pairing of primary and alternate members should be indicated.
21 A. *Is this a renewal or update of a registration for an IRB already registered with HH? [ ] es. Provide the IRB registration number previously assigned to this IRB by OHRP: IRB (This number was provided by OHRP the first time the IRB was registered with OHRP. If you do not know the IRB registration number, search for the IRB on the OHRP website at or contact OHRP using the contact information at or by telephone at ) [ ] No, this is a new IRB registration. B. Provide the IRB name, if any, used by the institution or organization (e.g., tate University Behavioral IRB, University Healthcare Biomedical IRB, or Z Hospital IRB #1): U of Pittsburgh IRB #7 - G C. Location of the IRB *Mailing Address (if different from the Mailing Address in section 3): 3500 Fifth Avenue uite 106 *treet Address of the IRB (if different from the Mailing Address of the IRB): *City: Pittsburgh *tate/province: PENNLVANIA *Zip/Postal Code: *Country (if outside the U..): *Phone: *FA: * mgm12@pitt.edu D. Approximate number of full time equivalent positions devoted to the IRB s administrative activities: E. Approximate number of all active protocols (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months): F. Approximate number of active protocols conducted or supported by HH (e.g., the National Institutes of Health, Centers for Disease Control and Prevention, etc.) (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months):
22 procedure during the preceding 12 months): G. For IRBs that review, or intend to review, protocols involving products regulated by the Food and Drug Administration (FDA) (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months): i) Approximate number of active protocols involving FDA-regulated products: ii) Types of FDA-regulated products involved in FDA protocols include (check all that apply): 40 human drugs medical devices biological food additives color additives other pecify: H. IRB Chairperson *First Name: Jamie Middle Initial: *Last Name: Zelazny Earned Degree(s): PhD, MPH, RN Title or Position: Vice Chairman Mailing Address (if different from the Mailing Address in section 3): 3500 Fifth Avenue City: Pittsburgh tate/province: PENNLVANIA Zip/Postal Code: Country (if outside the U..): *Phone: FA: * jmz22@pitt.edu
23 I. IRB Roster Form: Completion of the IRB Roster Form is required if your IRB is designated on a Federalwide assurance submitted to OHRP. Otherwise, it is optional. Member Name (Last, First) ex M/F Earned Degree(s) cientist () Non-scientist (N) Primary cientific or Non-cientific pecialty Zelazny, Jamie F PhD, MPH, RN child/adolescent psych, suicide Howrie, Denise F PharmD Pharmacy Ho, Ken M MD, MPH Infectious Diseases Olawaiye, Alexander M MD OB/GN, oncology Lynch, Andrew M PhD, PT physical therapy Becker, tacey F B cognitive N psychology Wang, Norman M MD cardiology, electrophysiology chwartz, Miriam F none N support groups N pillane, usan F RN, CCRP nursing, research coordination Navratil, Judith F MA, CIP N IRB regulations, Bioethics Huppert, Theodore M PhD radiology, MR research Affiliation with Institution(s) /N Comments Alternative Members Barone, Jean F CIP N regulatory affiars any non-scientific member Mancino, Juliet F M, RDN, CDE, CCRC nutrition, diabetes management Deantes, Lisa F B N IRB regulations, study coordination Carey, Tom M MW, CIP social work, IRB regulations Lee, Ann F MN, CRNP, CIP cardiology, heart/lung transplant any non-scientific member Holloway, Melanie F RN, BN pediatric nursing Jack, Pischke M MW N incarceration, prisoner representative Gerger, Allison F MPH IRB regulations, public health prisoner rep NOTE:
24 Members whose training, background, and occupation would incline them to view scientific activities from the standpoint of someone within a behavioral or biomedical research discipline should be considered a scientist, while members whose training, background, and occupation would incline them to view research activities from a standpoint outside of any biomedical or behavioral scientific discipline should be considered a nonscientist. In addition, the IRB must have members with sufficient knowledge of the specific scientific discipline(s) relevant to the research that it reviews. Affiliation: Please indicate whether or not each individual (or a member of that person s immediate family) is affiliated (other than as an IRB member) with the institution or organization operating the IRB. es = The IRB member is affiliated with the institution or organization operating the IRB. No = The individual is not affiliated with the institution or organization operating the IRB. Alternate Members: An alternate member(s) may be designated, as needed, for a regular voting member(s). An alternate member may vote only when the regular voting member is not voting. When an institution or organization registers two or more IRBs, all alternate members for all IRBs may be listed on the roster of one IRB, or they may be listed separately with each IRB roster. A primary member of any IRB registered under the same IORG number may serve as an alternate for any comparably qualified member on any other IRB of that institution or organization. Primary members on registered IRBs serving as alternate members do not need to be listed as an alternate on any roster. Each alternate IRB member who replaces a primary member at any given meeting should have experience, expertise, background, professional competence, and knowledge comparable to that of the primary IRB member whom the alternate will replace. Whenever an alternate member substitutes for a primary member of the IRB, the combined requirements of (a) and (b) shall remain satisfied. Whenever this occurs, the minutes of the IRB meeting should indicate clearly that the alternate IRB member has replaced the designated primary IRB member, and include the identity of the replaced primary and the alternate members. If multiple alternate members serve at an IRB meeting, the pairing of primary and alternate members should be indicated.
25 A. *Is this a renewal or update of a registration for an IRB already registered with HH? [ ] es. Provide the IRB registration number previously assigned to this IRB by OHRP: IRB (This number was provided by OHRP the first time the IRB was registered with OHRP. If you do not know the IRB registration number, search for the IRB on the OHRP website at or contact OHRP using the contact information at or by telephone at ) [ ] No, this is a new IRB registration. B. Provide the IRB name, if any, used by the institution or organization (e.g., tate University Behavioral IRB, University Healthcare Biomedical IRB, or Z Hospital IRB #1): U of Pittsburgh IRB #8 - H C. Location of the IRB *Mailing Address (if different from the Mailing Address in section 3): 3500 Fifth Avenue uite 106 *treet Address of the IRB (if different from the Mailing Address of the IRB): *City: Pittsburgh *tate/province: PENNLVANIA *Zip/Postal Code: *Country (if outside the U..): *Phone: *FA: * mgm12@pitt.edu D. Approximate number of full time equivalent positions devoted to the IRB s administrative activities: E. Approximate number of all active protocols (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months): F. Approximate number of active protocols conducted or supported by HH (e.g., the National Institutes of Health, Centers for Disease Control and Prevention, etc.) (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months):
26 G. For IRBs that review, or intend to review, protocols involving products regulated by the Food and Drug Administration (FDA) (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months): i) Approximate number of active protocols involving FDA-regulated products: ii) Types of FDA-regulated products involved in FDA protocols include (check all that apply): 41 human drugs medical devices biological food additives color additives other pecify: H. IRB Chairperson *First Name: Margaret Middle Initial: *Last Name: Hsieh Earned Degree(s): MD Title or Position: Chairman Mailing Address (if different from the Mailing Address in section 3): 3500 Fifth Avenue City: Pittsburgh tate/province: PENNLVANIA Zip/Postal Code: Country (if outside the U..): *Phone: FA: * hsiehm@upmc.edu
27 I. IRB Roster Form: Completion of the IRB Roster Form is required if your IRB is designated on a Federalwide assurance submitted to OHRP. Otherwise, it is optional. Member Name (Last, First) ex M/F Earned Degree(s) cientist () Non-scientist (N) Primary cientific or Non-cientific pecialty Hsieh, Margaret F MD Emergency Medicine Phillips, Brandi F MPPM N non-scientist; N healthcare administration Johnson, Bruce M MD pulmonary, critical care medicine Brandom, Barbara F MD Pediatric Anesthesiology Watchko, Jon M MD Newborn Medicine Mancino, Juliet F M, RDN, nutrition, diabetes CDE, CCRC management Dick, Natalie F MHA N healthcare ethics Rubin, Joshua M MD surgical oncology Liang, Rui F MD, M OB/Gyn, urogynecology Popchak, Adam M DPT, PhD, physical therapy PT zanto, Katalin F MD psychiatry Lieberman, Frank M MD neuro-oncology, oncology Conner, Ian M MD, PhD ophthalmology Affiliation with Institution(s) /N Comments Alternative Members Knapp, Beth F M N Non-scientific N any non-scientific member Holloway, Melanie F RN, BN, CIP pediatric nursing Deantes, Lisa F B, CIP N IRB regulations any non-scientific member Barone, Jean F CIP N IRB regulations any no-scientific member Lee, Ann F MN, CRNP, CIP cardiology, heart/lung transplant Carey, Tom M MW, CIP social work, IRB regulations any other scientist Gerger, Allison F MPH IRB regulations NOTE:
28 Members whose training, background, and occupation would incline them to view scientific activities from the standpoint of someone within a behavioral or biomedical research discipline should be considered a scientist, while members whose training, background, and occupation would incline them to view research activities from a standpoint outside of any biomedical or behavioral scientific discipline should be considered a nonscientist. In addition, the IRB must have members with sufficient knowledge of the specific scientific discipline(s) relevant to the research that it reviews. Affiliation: Please indicate whether or not each individual (or a member of that person s immediate family) is affiliated (other than as an IRB member) with the institution or organization operating the IRB. es = The IRB member is affiliated with the institution or organization operating the IRB. No = The individual is not affiliated with the institution or organization operating the IRB. Alternate Members: An alternate member(s) may be designated, as needed, for a regular voting member(s). An alternate member may vote only when the regular voting member is not voting. When an institution or organization registers two or more IRBs, all alternate members for all IRBs may be listed on the roster of one IRB, or they may be listed separately with each IRB roster. A primary member of any IRB registered under the same IORG number may serve as an alternate for any comparably qualified member on any other IRB of that institution or organization. Primary members on registered IRBs serving as alternate members do not need to be listed as an alternate on any roster. Each alternate IRB member who replaces a primary member at any given meeting should have experience, expertise, background, professional competence, and knowledge comparable to that of the primary IRB member whom the alternate will replace. Whenever an alternate member substitutes for a primary member of the IRB, the combined requirements of (a) and (b) shall remain satisfied. Whenever this occurs, the minutes of the IRB meeting should indicate clearly that the alternate IRB member has replaced the designated primary IRB member, and include the identity of the replaced primary and the alternate members. If multiple alternate members serve at an IRB meeting, the pairing of primary and alternate members should be indicated.
29 A. *Is this a renewal or update of a registration for an IRB already registered with HH? [ ] es. Provide the IRB registration number previously assigned to this IRB by OHRP: IRB (This number was provided by OHRP the first time the IRB was registered with OHRP. If you do not know the IRB registration number, search for the IRB on the OHRP website at or contact OHRP using the contact information at or by telephone at ) [ ] No, this is a new IRB registration. B. Provide the IRB name, if any, used by the institution or organization (e.g., tate University Behavioral IRB, University Healthcare Biomedical IRB, or Z Hospital IRB #1): IRB U of Pittsburgh IRB #9 D C. Location of the IRB *Mailing Address (if different from the Mailing Address in section 3): 3500 Fifth Avenue uite 106 *treet Address of the IRB (if different from the Mailing Address of the IRB): *City: Pittsburgh *tate/province: PENNLVANIA *Zip/Postal Code: *Country (if outside the U..): *Phone: *FA: * mgm12@pitt.edu D. Approximate number of full time equivalent positions devoted to the IRB s administrative activities: E. Approximate number of all active protocols (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months): F. Approximate number of active protocols conducted or supported by HH (e.g., the National Institutes of Health, Centers for Disease Control and Prevention, etc.) (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months):
30 G. For IRBs that review, or intend to review, protocols involving products regulated by the Food and Drug Administration (FDA) (for purposes of completing this registration, an active protocol is any protocol for which the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months): i) Approximate number of active protocols involving FDA-regulated products: ii) Types of FDA-regulated products involved in FDA protocols include (check all that apply): 41 human drugs medical devices biological food additives color additives other pecify: H. IRB Chairperson *First Name: ue Middle Initial: *Last Name: Beers Earned Degree(s): PhD Title or Position: Chairman Mailing Address (if different from the Mailing Address in section 3): 3500 Fifth Avenue City: Pittsburgh tate/province: PENNLVANIA Zip/Postal Code: Country (if outside the U..): *Phone: FA: * beerssr@upmc.edu
31 I. IRB Roster Form: Completion of the IRB Roster Form is required if your IRB is designated on a Federalwide assurance submitted to OHRP. Otherwise, it is optional. Member Name (Last, First) ex M/F Earned Degree(s) cientist () Non-scientist (N) Primary cientific or Non-cientific pecialty Affiliation with Institution(s) /N Comments Beers, ue F PhD pediatric neuropsychology Choudry, M. Haroon M MD surgical oncology Drappatz, Jan M MD neuro-oncology, oncology Pasek, Tracy F RN, MN Pediatric ICU nursing Carey, Thomas M MW social work, IRB regulations Pischke, Jack M MW N incarceration prisoner representative Imes, Christopher M PhD, RN nursing, genetics Vieira, Alexandre M DD, M, genetics, dentistry PhD Kolko, David M PhD child & adolescent psychiatry Kumer, Connie F MEd N non-scientist; public N assistance Mandel, Ellen F MD pediatric otolaryngology Howrie, Denise F PharmD pharmacy chneider, Michael M PhD, DC physical therapy, health & rehab science Maranchie, Jodi F MD urology Moss, Deborah F MD pediatrics Narendran, Rajesh M MD Radiology, PET, Addiction Psych Alternative Members Holloway, Melanie F RN, BN, CIP pediatric nursing, IRB regulations haikh, Nader M MD Pediatrics any other physician member Lee, Ann F MN, CRNP, CIP cardiology, heart/lung transplant Deantes, Lisa F B N IRB regulations, study coordination Gerger, Allison F MPH research regulations, public health any non-scientific member Navratil, Judith F MA, CIP N bioethics, IRB regulation any non-scientific member Barone, Jean F none N regulatory compliance any non-scientific member
32 NOTE: Members whose training, background, and occupation would incline them to view scientific activities from the standpoint of someone within a behavioral or biomedical research discipline should be considered a scientist, while members whose training, background, and occupation would incline them to view research activities from a standpoint outside of any biomedical or behavioral scientific discipline should be considered a nonscientist. In addition, the IRB must have members with sufficient knowledge of the specific scientific discipline(s) relevant to the research that it reviews. Affiliation: Please indicate whether or not each individual (or a member of that person s immediate family) is affiliated (other than as an IRB member) with the institution or organization operating the IRB. es = The IRB member is affiliated with the institution or organization operating the IRB. No = The individual is not affiliated with the institution or organization operating the IRB. Alternate Members: An alternate member(s) may be designated, as needed, for a regular voting member(s). An alternate member may vote only when the regular voting member is not voting. When an institution or organization registers two or more IRBs, all alternate members for all IRBs may be listed on the roster of one IRB, or they may be listed separately with each IRB roster. A primary member of any IRB registered under the same IORG number may serve as an alternate for any comparably qualified member on any other IRB of that institution or organization. Primary members on registered IRBs serving as alternate members do not need to be listed as an alternate on any roster. Each alternate IRB member who replaces a primary member at any given meeting should have experience, expertise, background, professional competence, and knowledge comparable to that of the primary IRB member whom the alternate will replace. Whenever an alternate member substitutes for a primary member of the IRB, the combined requirements of (a) and (b) shall remain satisfied. Whenever this occurs, the minutes of the IRB meeting should indicate clearly that the alternate IRB member has replaced the designated primary IRB member, and include the identity of the replaced primary and the alternate members. If multiple alternate members serve at an IRB meeting, the pairing of primary and alternate members should be indicated.
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