U.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board (IRB)
|
|
- Muriel Tate
- 6 years ago
- Views:
Transcription
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 Hieber Building *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: * miklosm@upmc.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 Manders, Ernest M MD plastic & reconstructive surgery Deantes, Lisa F B, CIP N IRB regulations, study coordination 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 Handen, Benjamin M PhD child psychology, autism Affiliation with Institution(s) /N Comments Alternative Members Orndoff, Patricia F RN, MEd Nursing any other scientific member Valenti, hannon F B, MBA N Research regulations any non-scientific member Lee, Ann F MN, CRNP, CIP cardiology, heart/lung transplant any other scientific member Holloway, Melanie F RN, BN pediatric nursing any other scientific member McKaveney, Theresa F B N IRB regulations any non-scientific member Gerger, Allison F MPH research coordinator, international any other scientific member DiVirgilio, Dana F MPH community health, study any other scientist
7 coordination 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 any other scientific member Ansari, Nena F BA N IRB regulations any non-scientific member Quillen, Deane M MPH psycho-social research any other scientific member Carella, Beth F DO pediatric hem/onc, stem cell tx Carey, Thomas M MW, CIP ocial Work, IRB regulations any physician member any other scientific member Miklos, Melissa F B, CIP N IRB regulations any non-scientific member 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 Wenzel, ally F MD Pulmonary, Allergy & Critical Care Medic any non-scientific member any physician member Moss, Deborah F MD pediatrics any physician member LeMenager, Michelle F B N IRB regulations any non-scientific member Navratil, Judith F BA N IRB regulations any non-scientific 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.
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 Hieber Building *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: * miklosm@upmc.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 Michel, Ian M JD N legal piess, Alex M MD orthopedics, plastic surgery, hand Bunge, Katherine F MD OB/Gyn, reproductive services Mancino, Juliet F M, RDN, nutrition, diabetes CDE, CCRC management 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 Lee, Ann F MN, RN, CRNP, CIP Alternative Members Deantes, Lisa F B, CIP N IRB regulations, study coordination cardiology, heart/lung tx any other scientific member any non-scientific member Engh, Johnathan M MD Neurological surgery any other physician member Libman, Ingrid F MD, PhD pediatric endocrinology any physician member Holloway, Melanie F RN, BN, CIP pediatric nursing any other scientific member Carey, Tom M MW, CIP ocial work, IRB regulations Pischke, Jack M MW N incarceration, social work, advocacy any other scientific member prisoner representative, any non scientist Jackson Graves, Carlyn F B N study coordination, GCP any non-scientific member Chen, Beatrice F MD OB/Gyn, reproductive services any physician member Miklos, Melissa F B, CIP N IRB regulations any non-scientific member
12 Brandom, Barbara F MD pediatric anesthesia any other 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. 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 Hieber Building *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: * miklosm@upmc.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 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 anowitz, Toby F MD neonatology, pediatrics Cipkala-Gaffin, Jan F DrPh, MN, nursing, PCO, RN mental health George, Betsy F RN, PhD tertiary, critical care 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 Gerger, Allison F MPH IRB regulations Phillips, Brandi F MPPM N health care N administration Finder, Jonathan M MD pediatric pulmonology Affiliation with Institution(s) /N Comments Alternative Members Gildengers, Ariel M MD psychiatry any physician member Holloway, Melanie F RN, BN, CIP pediatric nursing, IRB regulations any other scientific member Irrgang, James M PhD, PT, ATC orthopaedics, PT, rehab any other scientific member Hoffman, Paul M B, RPh pharmacy any other scientific member 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 any other scientific member Venkataraman, hekhar M MD pediatric critical care any physician member
16 Holliman, Jennifer F MPA N community outreach N any non-scientific member Miklos, Melissa F B, CIP N IRB regulations any non-scientific member Barone, Jean F CIP N IRB regulations any non-scientist Deantes, Lisa F B, CIP N IRB regulations any non-scientific member Lee, Ann F MN, CRNP, CIP cardiology, heart/lung transplant any other scientific 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. 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 Hieber Building *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: * miklosm@upmc.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) N Primary cientific or Non-cientific pecialty Guido, Richard M M.D. OB/GN Oliver, D. Lamar M B electrical N engineering, non-scientist Zeh, Herbert M MD surgical oncology 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 Affiliation with Institution(s) /N Comments Alternative Members Horwitz, Mara F MD medicine, endocrinology any physician member Zelazny, Jamie F MPH, RN psychiatric nursing any other scientific 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 Hieber Building *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: * miklosm@upmc.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: Richard Middle Initial: *Last Name: Guido Earned Degree(s): M.D. 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: * rguido@mail.magee.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 Guido, Richard M MD OB/GN Ho, Ken M MD, MPH Infectious Diseases Howrie, Denise F PharmD Pharmacy Wang, Norman M MD cardiology, electrophysiology Holloway, Melanie F RN, BN pediatric nursing Olawaiye, Alexander M MD OB/GN, oncology Holliman, Jennifer F MPA N community outreach N Becker, tacey F B cognitive N psychology pillane, usan F RN, CCRP nursing, research coordination Lynch, Andrew M PhD, PT physical therapy chwartz, Miriam F none N support groups N Affiliation with Institution(s) /N Comments Lee, Ann F MN, CRNP, CIP Alternative Members cardiology, heart/lung transplant Deantes, Lisa F B N IRB regulations, study coordination Carey, Tom M MW, CIP social work, IRB regulations any other scientific member any non-scientific member any other scientific member Barone, Jean F CIP N regulatory affiars any non-scientific member Mancino, Juliet F M, RDN, CDE, CCRC nutrition, diabetes management Jack, Pischke M MW N incarceration, prisoner representative Gerger, Allison F MPH IRB regulations, public health any other scientific member prisoner rep any other scientific 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.
24 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 Hieber Building *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: * miklosm@upmc.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 Pingpank, James M MD surgical oncology Johnson, Bruce M MD pulmonary, critical care medicine Brandom, Barbara F MD Pediatric Anesthesiology Rubin, Joshua M MD surgical oncology Dick, Natalie F MHA N healthcare ethics Lieberman, Frank M MD neuro-oncology, oncology Ensor, Christopher M PharmD, pharmacy, BCP-CV pharmacology, lung disease, Tx Liang, Rui F MD, M OB/Gyn, urogynecology zanto, Katalin F MD psychiatry Olawaiye, Alexander M MD OB/GN, oncology Carey, Tom M MW, CIP social work, IRB regulations Popchak, Adam M DPT, PhD, physical therapy PT Conner, Ian M MD, PhD ophthalmology Affiliation with Institution(s) /N Comments Alternative Members Barone, Jean F CIP N IRB regulations any non-scientific member Knapp, Beth F M N Non-scientific N any non-scientific member Lee, Ann F MN, CRNP, CIP cardiology, heart/lung transplant any other scientific member Venkataraman, hekhar M MD pediatric critical care any physician member Gerger, Allison F MPH IRB regulations any other scientific member Reiche, Teri F B, CIP N IRB regulations any non-scientific member Watchko, Jon M MD Newborn Medicine any physician member Holloway, Melanie F RN, BN, CIP pediatric nursing any other scientific member Deantes, Lisa F B, CIP N IRB regulations any non-scientific member
28 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.
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 Hieber Building *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: * miklosm@upmc.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 Beers, ue F PhD pediatric neuropsychology haikh, Nader M MD Pediatrics Choudry, M. Haroon M MD surgical oncology Drappatz, Jan M MD neuro-oncology, oncology Pasek, Tracy F RN, MN Pediatric ICU nursing Ryan, Robert M EdD N education administration 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 Baker, Nancy F cd, MPH, occupational OTR/L therapy Gerger, Allison F MPH research regulations, public health Maranchie, Jodi F MD urology chneider, Michael M PhD, DC physical therapy, health & rehab science Affiliation with Institution(s) /N Comments Lee, Ann F MN, CRNP, CIP Alternative Members cardiology, heart/lung transplant Deantes, Lisa F B N IRB regulations, study coordination Carey, Thomas M MW social work, IRB regulations any other scientific member any non-scientific member any other scientific member Pischke, Jack M MW N incarceration prisoner representative Barone, Jean F none N regulatory compliance any non-scientific member Holloway, Melanie F RN, BN, CIP pediatric nursing, IRB regulations any other scientific member
U.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board (IRB)
ubmission#: 363262 IORG#: IORG0000196 Institution: U of Pittsburgh OMB No. 0990-0279 Approved for use through October 31, 2018 U.. Department of Health and Human ervices (HH) Registration of an Institutional
More informationU.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board (IRB)
ubmission#: 230537 IORG#: IORG0000196 Institution: U of Pittsburgh OMB No. 0990-0279 Approved for use through October 31, 2018 U.. Department of Health and Human ervices (HH) Registration of an Institutional
More informationU.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board (IRB)
Submission#: 189584 IORG#: IORG0000196 Institution: U of Pittsburgh OMB No. 0990-0279 Approved for use through October 31, 2018 U.S. Department of Health and Human Services (HHS) Registration of an Institutional
More informationU.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board (IRB)
Submission#: 138373 IORG#: IORG0000196 Institution: U of Pittsburgh OMB No. 0990-0279 Approved for use through October 31, 2018 U.S. Department of Health and Human Services (HHS) Registration of an Institutional
More informationU.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board (IRB)
Submission#: 116937 IORG#: IORG0000196 Institution: U of Pittsburgh OMB No. 0990-0279 Approved for use through October 31, 2018 U.S. Department of Health and Human Services (HHS) Registration of an Institutional
More informationU.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board (IRB)
IORG #: IORG0009047 Institution: Morsel Research and Development Pvt Ltd Expires: 11/17/2019 OMB No. 0990-0279 Approved for use through October 31, 2018 U.S. Department of Health and Human Services (HHS)
More informationU.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board (IRB)
IORG #: IORG0000177 Institution: University of Arizona Expires: 07/26/2020 OMB No. 0990-0279 Approved for use through October 31, 2018 U.S. Department of Health and Human Services (HHS) Registration of
More informationU.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board (IRB)
IORG #: IORG0000250 Institution: U of Kentucky Expires: 08/28/2021 OMB No. 0990-0279 Approved for use through October 31, 2018 U.. Department of Health and Human ervices (HH) Registration of an Institutional
More informationU.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board (IRB)
IORG #: IORG0001492 Institution: U of Cape Town Expires: 11/25/2018 OMB No. 0990-0279 Approved for use through October 31, 2018 U.S. Department of Health and Human Services (HHS) Registration of an Institutional
More informationU.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board (IRB)
Submission#: 363274 IORG#: IORG0000124 Institution: Icahn School of Medicine at Mount Sinai OMB No. 0990-0279 Approved for use through October 31, 2018 U.S. Department of Health and Human Services (HHS)
More informationU.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board (IRB)
IORG #: IORG0000147 Institution: U of Louisville Expires: 04/02/2021 OMB No. 0990-0279 Approved for use through October 31, 2018 U.S. Department of Health and Human Services (HHS) Registration of an Institutional
More informationU.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board (IRB)
Submission#: 64805 IORG#: IORG0000247 Institution: Northwestern University Date: March 3, 2016 U.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board (IRB) This
More informationSpecialty Y/N. Internal Medicine Y PS-Physician Scientist; Vice-Chair. Alternative Members
Ochsner IRB Panel A 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. Scientist (S) Primary
More informationU.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board (IRB)
IORG #: IORG0000177 Institution: University of Arizona Expires: 11/09/2015 OMB No. 0990-0279 Approved for use through August 31, 2015 U.S. Department of Health and Human Services (HHS) Registration of
More informationU.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board (IRB)
IORG #: IORG0000267 Institution: Emory U Expires: 11/09/2021 OMB No. 0990-0279 Approved for use through October 31, 2018 U.S. Department of Health and Human Services (HHS) Registration of an Institutional
More informationThis policy defines the composition and requirements of the North Shore Medical Center (NSMC) Institutional Review Board (IRB) membership.
THE NORTH SHORE MEDICAL CENTER Institutional Review Board (IRB) POLICIES AND PROCEDURES Title: IRB Composition and Roster Page: 1 of 6 Written by: Laura W. Knight, MPH; Sr. IRB Administrator IRB Policy
More informationOTM Patent Coordinator. Biomedical and Health Information Sciences Lauren Segal Anne Burkhart Architecture, School of Mark Krivchenia Anne Burkhart
College of Applied Health Science College of Architecture, Design, and the Arts Biomedical and Health Information Sciences Lauren Segal Anne Burkhart Architecture, School of Mark Krivchenia Anne Burkhart
More informationIRB COMPOSITION AND IRB MEMBER ROLES AND RESPONSIBILITIES
IRB COMPOSITION AND IRB MEMBER ROLES AND RESPONSIBILITIES 1. Overview Each IRB must be appropriately constituted for the volume and types of human research to be reviewed, in accordance with federal regulations.
More informationIRB MEMBERSHIP COMPOSITION, ROLES AND RESPONSIBILIES
Approved by: Vice Chancellor for Academic Affairs Approved by: Chair of the IRB INSTITUTIONAL REVIEW BOARD Date: Date: SOP # IRB-001 Revision: 1.0 Page #: Page 1 of 7 Date Effective: 01/15/2018 Date of
More informationSOP Institutional Review Board (IRB) Appointments and Membership
Office of Research Integrity - Human Subjects SOP #: ORI(HS)-3.06 Page #: Page 1 of 5 Approved By: ORI Executive Director Approved by: Biomedical Chair *Signature on File Date: Date First Effective: 01/25/2017
More information2 Institutional Review Board
2 Institutional Review Board 2.1 Policy The University has established two Institutional Review Boards ( IRBs ) to ensure the protection of Human Subjects in Research Under the Auspices of the Institution.
More informationHuman Research Protections Program Medical College of Wisconsin and Froedtert Memorial Lutheran Hospital
Human Research Protections Program Medical College of Wisconsin and Froedtert Memorial Lutheran Hospital To Whom It May Concern: The Medical College of Wisconsin (MCW) has an approved Federal Wide Assurance
More informationCOMPARISON GUIDE TO MARYLAND MEDICAL PROFESSIONAL LIABILITY INSURANCE RATES
COMPARISON GUIDE TO MARYLAND MEDICAL PROFESSIONAL LIABILITY INSURANCE RATES l~m-$! J INSURANCE ADMINISTRATION Comparison Guide to Maryland Medical Professional Liability Insurance Rates How to Shop for
More informationCCTS Lunch and Learn. December 19, 2017
CCTS Lunch and Learn December 19, 2017 Agenda Introduction Penny Jester IRB Update - Vanessa Champigny CTAO Update Mark Marchant CBR Update Dawn Matthews OnCore Update - Lisa Williams/John Sandefur Powertrials
More informationUSC Institutional Review Boards (IRBs)
Chapter 6: Chapter Contents 6.1 Description of USC IRBs USC Institutional Review Boards (IRBs) 6.2 The Membership of the IRB Committees 6.3 IRB Member Requirements 6.4 IRB Use of Consultants 6.5 IRB Support
More informationAdvance Data Tables 2008 Main Residency Match
Advance Data Tables 2008 Main Residency Match Table 1. Match Summary, 2008...1 Table 3. Positions Offered in the Matching Program, 2004-2008...2 Table 4. Applicants in the Matching Program, 2004-2008...3
More informationCONTINUING REVIEW 3/7/2016
DUKE UNIVERSITY HEALTH SYSTEM Human Research Protection Program Introduction CONTINUING REVIEW 3/7/2016 Federal regulations require that DUHS has written procedures which the IRB will follow for (a) conducting
More information2.0 Institutional Review Board
2.0 Institutional Review Board 2.1 Policy Pennington Biomedical Research Center has one IRB to ensure the protection of human subjects in research. IRB Biomedical (IRB 00000708) (IORG00006218) The IRB
More informationIndependent Ethics Committees
GCP Independent Ethics Committees 1 GCP What is an Ethics Committee? An ethics committee is a committee formally designated to review and approve the initiation of a clinical research study involving human
More informationUNIVERSITY OF TENNESSEE GRADUATE SCHOOL OF MEDICINE INSTITUTIONAL REVIEW BOARD PROCEDURES FOR FULL BOARD REVIEW
UNIVERSITY OF TENNESSEE GRADUATE SCHOOL OF MEDICINE INSTITUTIONAL REVIEW BOARD PROCEDURES FOR FULL BOARD REVIEW I. PURPOSE This document outlines the required elements of Institutional Review Board (IRB)
More informationUniversity of Kentucky Office of Research Integrity and Institutional Review Board Standard Operating Procedures SOP #4-1 Revision #6
TITLE: Minutes of IRB Meetings Page 1 of 5 ORI Director Signature Date Date First Effective: 06-30-05 Nonmedical IRB Chair Signature Date Medical IRB Chair Signature Date Revision Date: 07/29/2011 OBJECTIVE
More informationIssue in IRB Approvals:
Issue in IRB Approvals: What are the obligations of investigators and the IRB in maintaining IRB approval? What are the consequences of a lapse in IRB approval? How does the IRB evaluate lapses in approval?
More informationWayne State University Institutional Review Board
Wayne State University Institutional Review Board Subject Approvals, Serious & Continuing Non-Compliance and the Institutional Official s Responsibilities Administrative Approval: 07/2011; Office of the
More informationUNIVERSITY OF TENNESSEE GRADUATE SCHOOL OF MEDICINE INSTITUTIONAL REVIEW BOARD CONTINUING REVIEW AND REAPPROVAL OF RESEARCH
UNIVERSITY OF TENNESSEE GRADUATE SCHOOL OF MEDICINE INSTITUTIONAL REVIEW BOARD CONTINUING REVIEW AND REAPPROVAL OF RESEARCH I. PURPOSE This document outlines the required elements of University of Tennessee
More informationCategory Description This policy and procedure applies to the Sparrow research community.
Title: OR 203 Duties of IRB Members Department: Sparrow Institutional Review Board 1.0 Policy: 2.0 Scope: Each member's primary duty is the protection of the rights and welfare of the individual human
More informationInstitutional Responsibilities Under A Federalwide Assurance
Institutional Responsibilities Under A Federalwide Assurance Lisa A. Rooney, JD Director Aegis Compliance & Ethics Center, LLP June 6, 2013 1 Questions There will be a q&a session at the end of the program.
More informationPercent of All Positions Filled % Percent of PGY-1 Positions Filled %
2121 K Street NW, Suite 1000, Washington, DC 20037 www.nrmp.org Email: support@nrmp.org Toll Free: (866) 653-NRMP Phone: (202) 400-2233 2017 Main Residency Match By the Numbers** Complete data here: http://www.nrmp.org/match-data/main-residency-match-data/
More informationIV. Basic Procedures for Human Research Protections
Human Research Protection Program Procedures IV. Basic Procedures for Human Research Protections D. IRB Membership [45CFR46.107] (21CFR56.107) (1) General considerations The IRB shall have at least twelve
More informationWhat s New in GCP? FDA, OHRP Issue Harmonized Guidance on Transferring IRB Oversight of Clinical Studies
Vol. 8, No. 8, August 2012 Happy Trials to You What s New in GCP? FDA, OHRP Issue Harmonized Guidance on Transferring IRB Oversight of Clinical Studies Reprinted from the Guide to Good Clinical Practice
More informationIRB Minutes Quality Improvement Assessment
IRB Panel Name Date of Meeting Name of Person Completing Checklist Date Completed Length of Meeting: Time Meeting Started: Time Meeting Ended: OHRP & FDA General Minutes Requirements 1. Yes No Do the minutes
More informationSOP 5.06 Full Committee Review: Initial IRB Review
Office of Research Integrity - Human Subjects SOP #: ORI-HS(HS)- Page #: Page 1 of 5 Approved By: ORI-HS Executive Director *Signature on file Date: Date First Effective: 10/13/2016 Approved by: Biomedical
More informationYale University Institutional Review Boards
Yale University Institutional Review Boards 100 PR.1 Review by a Convened Institutional Review Board (IRB) Overview... 1 Meeting Dates and Distribution of Materials... 1 Materials Provided to Members for
More informationOklahoma State University Institutional Review Board Standard Operating Procedures
Oklahoma State University Institutional Review Board Standard Operating Procedures Duties of IRB Members SOP # OR 203 Effective Date 1/1/2012 Revision Date 08/12/2015 Revision # 1 Approval: IRB 08/12/2015
More informationDOCUMENTATION OF IRB DISCUSSIONS AND DECISIONS ( IRB MINUTES)
POLICY # RESEARCH POLICY & PROCEDURE Approval Date: 12-19-2008 CTM Review Cycle: 1 2 3 Revision Dates: AAHRPP DOC # 54 Responsible Office: Research Compliance DOCUMENTATION OF IRB DISCUSSIONS AND DECISIONS
More informationAdvance Data Tables 2018 Main Residency Match
Advance Data Tables 2018 Main Residency Match Definitions...1 Table 1. Match Summary, 2018...2 Table 3. Positions Offered in the Matching Program, 2014-2018...4 Table 4. Applicants in the Matching Program,
More informationReview of Research by the Convened IRB
Office for the Protection of Research Subjects (OPRS) Institutional Review Board FWA# 00000083 Review of Research by the Convened IRB 201 AOB (MC 672) 1737 West Polk Street Chicago, IL 60612-7227 Phone:
More informationHarford Community College. Institutional Review Board Charter and Standard Operating Procedures
Institutional Review Board Charter and Standard Operating Procedures March 5, 2010 Institutional Review Board Charter and Standard Operating Procedures TABLE OF CONTENTS INTRODUCTION...1 I. INSTITUTIONAL
More informationJeffrey A. Cooper, MD, MMM Huron Consulting Group
Jeffrey A. Cooper, MD, MMM jcooper@huronconsultinggroup.com Huron Consulting Group Stuart Horowitz, PhD, MBA shorowitz@huronconsultinggroup.com Huron Consulting Group. 1 Huron Consulting Group Inc. All
More informationEffective Date Revisions Date Review by the Convened Institutional Review Board
Review by the Convened Institutional Review Board Effective Date Revisions Date 8.1.2018 1.0 Purpose: The purpose of this standard operating practice (SOP) is to define and describe the process of review
More informationTo assure knowledge and compliance by documenting the continuing review procedure of approved projects for the IRB.
Institutional Review Board.... University of Missouri-Columbia.. Standard Operating Procedure Continuing Review Report (CRR) Continuing Review Report (CRR) Effective Date: July 1, 2004 Original Approval
More informationAnesthesia FL, Starke. Cardiology (Interventional) GA, Statesboro FL, Crystal River TN, Tullahoma. Cardiology (Invasive) GA, Statesboro SC, Hartsville
Anesthesia FL, Starke Cardiology (Interventional) FL, Crystal River Cardiology (Invasive) SC, Hartsville Cardiology (Non-Invasive) FL, Lehigh Acres FL, Melbourne GA, Winder Dermatology PA, Carlisle Emergency
More informationInstitutional Review Board (IRB) Policies and Procedures Manual
The University of Chicago Division of Biological Sciences The Pritzker School of Medicine and The University of Chicago Medical Center Institutional Review Board (IRB) Policies and Procedures Manual Office
More informationOHRP Guidance on Written IRB Procedures
Office for Human Research Protections (OHRP) Department of Health and Human Services Date: OHRP Guidance on Written IRB Procedures Scope: This document outlines the required elements of written Institutional
More informationJUN L WARNING LETTER VIA FEDERAL EXPRESS
DEPARTMENT OF HEALTH, & HUMAINi SEF.'`viLES JUN L 2 2006., WARNING LETTER VIA FEDERAL EXPRESS Patricia Hardenbergh, MD Chairperson, Vail Valley Medical Center IRB 181 West Meadow Drive, Suite 100 Vail,
More informationCeded IRB Review. The University of Arizona has standing agreements in place for the following entities regarding ceded IRB review:
Investigators working at multiple institutions and with multiple IRBs may choose to have one IRB become the IRB of record over some or all participating sites (commonly referred to as ceded review, reliance
More informationSubmitting Continuing Reviews and/or Amendments to the IRB
Submitting Continuing Reviews and/or Amendments to the IRB Tufts-New England Medical Center Tufts University Health Sciences IRB Education Series 2006 Presentation may only be reused or reprinted with
More informationHSPP Standard Operating Procedures
HSPP Standard Operating Procedures General HRP 001 Definitions HRP 012 Observation of Consent Process HRP 013 Legally Authorized Representatives, Children, and Guardians Management of Incoming Information
More informationIRB Chair Responsibilities
IRB Chair Responsibilities Introduction: The Saint Luke s Health System (SLHS) Institutional Review Board (IRB) Human Research Protection Program (HRPP) is guided by the ethical principles regarding research
More informationTexas Tech University Protection of Human Subjects Institutional Review Board Annual Report
Texas Tech University Protection of Human Subjects Institutional Review Board 2010 Annual Report Total of 1,602 proposals in 2010 including 396 terminated proposals but not including 110 amendments to
More information(y9. &i?r, JUL t Certified-Return Receipt Requested WARNING LE7TER
... (y9 &i?r, DEPARTMENT OF HEALTH a HUMAN SERVICES Public Health Service Food and Drug Admini~ation Center for Biologics Evaluation and Rem 1401 Rockville Pike Rockville MD 20852-1448 JUL t 71997 Certified-Return
More informationTo assure knowledge and compliance by documenting the annual administrative review and continuing IRB review of non-exempt projects for the IRB.
Institutional Review Board.... University of Missouri-Columbia.. Standard Operating Procedure Annual Review of Research Annual Review of Research Effective Date: January 21, 2019 Original Approval Date:
More informationTitle: EXPEDITED IRB REVIEW OF HUMAN SUBJECTS RESEARCH
SYRACUSE UNIVERSITY HUMAN RESEARCH PROTECTION PROGRAM STANDARD OPERATING PROCEDURES TITLE: EXPEDITED IRB REVIEW OF HUMAN SUBJECTS RESEARCH DOCUMENT NUMBER: 012 REVISION NUMBER REVISION DATE (SUPERSEDES
More informationConferences. Conferences
Conferences Conferences 2018 2 0 1 8 C o n f e r e n c e s Fostering Collaborative Efforts of the Scientific Community to Promote Life Science Research Communication Henderson, UK: Established in the year
More informationUNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER INSTITUTIONAL REVIEW BOARD CONTINUING REVIEW OF RESEARCH
UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER INSTITUTIONAL REVIEW BOARD CONTINUING REVIEW OF RESEARCH I. PURPOSE This document outlines the University of Tennessee Health Science Center Institutional
More informationChoose the quarter in which the submission was reviewed and approved: Please provide the following information about the minutes being reivewed:
Default Question Block HRP-431 - CHECKLIST - Minutes Quality Assurance Assessment - Qualtrics Survey Welcome to the Audit Tool Checklist - Minutes Quality Improvement Assessment. The purpose of this online
More informationResearch and IRB Review FAQs
Research and IRB Review FAQs Who sits on the Institutional Review Board (IRB)? The Chair of the IRB is Dr. Ronald Blonder, D.O., and he can be reached via email at: ron1doc@aol.com or by calling: 719-337-2599.
More informationEMERGENCY USE 03/02/2016
DUKE UNIVERSITY HEALTH SYSTEM Human Research Protection Program EMERGENCY USE 03/02/2016 Emergency Exemption for an Investigational Drug or Biologic or Unapproved Device Emergency use of an investigational
More informationCONTINUING REVIEW OF APPROVED IRB PROTOCOLS
POLICY # RESEARCH POLICY & PROCEDURE Approval Date: 4-13-2012 CTM c Review Cycle: 1 2 3 Revision Dates: AAHRPP DOC # 64 Responsible Office: CONTINUING REVIEW OF APPROVED IRB PROTOCOLS Research Compliance
More informationHumanitarian Use Devices Made Simple
May 25, 2017 Humanitarian Use Devices Made Simple Robert Romanchuk, BSHS, CIP, CCRC, CHRC, CCRCP IRB Vice Chairperson, Schulman IRB About Schulman IRB Established in 1983 Superior audit history with FDA
More informationPolicies & Standard Operating Procedures
Policies & Standard Operating Procedures December 2016 SPRINGFIELD COMMITTEE FOR RESEARCH INVOLVING HUMAN SUBJECTS (SCRIHS) For more information about SCRIHS Policies and Procedures, visit: http://www.siumed.edu/adrfa/scrihs.html
More informationStudy Management SM STANDARD OPERATING PROCEDURE FOR Interactions with the Institutional Review Board (IRB)
Study Management SM 302.00 STANDARD OPERATING PROCEDURE FOR Interactions with the Institutional Review Board (IRB) Approval: Nancy Paris, MS, FACHE President and CEO 24 May 2017 (Signature and Date) Approval:
More informationSOP 801: Investigator Qualifications and Responsibilities
1. POLICY University of Oklahoma : Investigator Qualifications and Responsibilities The purpose of this policy is to outline the qualifications and responsibilities of the principal investigator and key
More informationOffice of the Vice President for Research
Contents Introduction... 9 Overview of the Human Research Protection Program... 9 Reporting Structure... 9 Ethical Principles Governing Research... 9 Authority from the Institution... 10 Policy Implementation...
More informationThe Top 10 Human Research Protection Compliance Risks
The Top 10 Human Research Protection Compliance Risks Health Care Compliance Association Research Compliance Conference Kristina Borror, Ph.D. Director, Division of Compliance Oversight June 2, 2015 1
More informationIRB Policy Number: 202 Version Number: 6.0 Effective Date: October 16, 2017 Title: Initial Review of Research Involving Human Participants
IRB Number: 202 Version Number: 6.0 Effective Date: October 16, 2017 Title: Initial Review of Research Involving Human Participants Purpose This document describes the policy used when performing an initial
More informationEffective Date: January 16, 2012 Policy Number: MHC_RP0107. Revised Date: November 2, 2015 Oversight Level: Corporate
Policy Title: Initial Review of Human Subject Research Effective Date: January 16, 2012 Policy Number: Review Date: November 20, 2015 Section: Revised Date: November 2, 2015 Oversight Level: Corporate
More informationSupersedes Document Dated: 7/7/11. SOP: RR 401 Version No.: 07 Version Date: 9/8/15 EXPEDITED REVIEW 1. POLICY
1. POLICY Steering Committee approved / Effective Date: 9/9/15 An expedited review procedure consists of a review of research involving human subjects by an IRB Chair or by one or more experienced reviewers
More informationUniversity of Cincinnati. Radiation Safety Committee Operations Guidelines Statement of Policy (RSC Guidelines) RSC Guidelines (revision 5)
University of Cincinnati Radiation Safety Committee Operations Guidelines Statement of Policy (RSC Guidelines) Table of Contents 1 Purpose of the Guidelines 1 2 Committee 1 3 Meetings 4 4 Committee Purpose,
More informationCABARRUS COLLEGE OF HEALTH SCIENCES COURSE SECTION SCHEDULE Fall 2017
CABARRUS COLLEGE OF HEALTH SCIENCES COURSE SECTION SCHEDULE Fall 2017 Course Sect Creds Description Instructor Seat Room Day/Time BIO100 91 1.00 Medical Terminology Phillips, Billie Anne 35 Online BIO100
More informationChapter 4 Institutional Review Board (IRB) Roles and Authorities
Chapter 4 Institutional Review Board (IRB) Roles and Authorities HSS Institutional Review Board Guidance An Institutional Review Board (IRB) is an appropriately constituted group that has been formally
More informationInvestigator Manual. If you have questions about whether an activity requires IRB review, contact the IRB Office.
CM-999 001 1 May 2015 Page 1 of 5 What is the purpose of this manual? This document is designed to guide you through policies and procedures related to the conduct of human research that are specific to
More informationCONTINUING REVIEW CRITERIA FOR RENEWAL
1. POLICY Steering Committee approved / Effective Date: 9/2/15 The IRB conducts continuing review of research taking place within its jurisdiction at intervals appropriate to the degree of risk, but not
More informationFood and Drug Administration Center for Devices an d * 1Ya I a Radiological Health WARNING LETTE R
H yeavicts L r e DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Servic e 0r- 'ryj Food and Drug Administration Center for Devices an d * 1Ya I a Radiological Health 9200 Corporate Blvd Rockville,
More informationBoard Report. Prevent Cardiovascular Disease by learning how to lower your risks. Cardiovascular. July 2013 FREE EVENT
Board Report July 2013 1 Cardiovascular Health Presentation Cardio July 13, 15, 18 and 19 Prevent Cardiovascular Disease by learning how to lower your risks. FREE EVENT Health Presentation Friday, July
More informationGUIDE TO DAILY OPERATIONS
Institutional Review Board 3624 Market St., Suite 301 S Philadelphia, PA 19104-6006 Phone: 215-573-2540 GUIDE TO DAILY OPERATIONS Version 8.1 2, May 2016 Introduction, Table of Contents, and Format INTRODUCTION
More informationNONCOMPLIANCE. 1. Overview
NONCOMPLIANCE 1. Overview Investigators, research staff, the IRBs, (ORRP), and the organization share responsibility for the ethical conduct of human subjects research and for compliance with federal regulations,
More informationReporting an Unanticipated Problem Involving Risks to Subjects or Others (UPIRTSO) to the IRB
INSTITUTIONAL REVIEW BOARD (IRB) OFFICE FOR HUMAN RESEARCH PROTECTION Reporting an Unanticipated Problem Involving Risks to Subjects or Others (UPIRTSO) to the IRB UPIRTSO Flowchart Content Applies To
More informationSTRUCTURE, MANAGEMENT AND COMPOSITION OF IRBS Chapter 6
In this chapter: 6.1 Authority of the Institution and Authority of the IRB -Authority of Institution -Authority of IRB -Purpose of the IRB -Prohibition against Others Usurping IRB Approval Authority or
More informationInstitutional Review Board Policies and Procedures
Institutional Review Board Policies and Procedures September 2009 Rev 3 TABLE OF CONTENTS Introduction 4 Institutional Policy and IRB Authority.. 5 Laws, Regulations, Guiding Principles.. 7 Management
More informationFDA Violation 1: 1. The IRB failed to fulfill membership requirements [21 CFR ]
Christine J. Drabick Division of Inspections and Surveillance (HFM-664) Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research 1401 Rockville, Maryland, 20852-1448 March
More informationINSTITUTIONAL REVIEW BOARD (IRB) PROCEDURES
INSTITUTIONAL REVIEW BOARD (IRB) PROCEDURES July 2016 Table of Contents National American University Mission...2 Purposes...2 Core Values...3 Institutional Review Board Policy...4 IRB Membership...6 Training...7
More information21 CFR Part 56 - Institutional Review Boards
INFORMATION SHEETS Guidance for Institutional Review Boards and Clinical Investigators 1998 Update Appendix C 21 CFR Part 56 - Institutional Review Boards Subpart A General Provisions 56.101 Scope. 56.102
More informationHuman Research Protection Program. Institutional Review Board
Human Research Protection Program Institutional Review Board Standard Operating Procedures (SOPs) Updated December 5, 2017 January 18, 2018 Update TABLE OF CONTENTS Statement of Purpose, Authority and
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Inspections, Compliance, Enforcement, and Criminal Investigations Burzynski Research Institute / IRB Department of Health and Human Services Public Health Service Food and Drug Administration Silver Spring,
More informationInstitutional Review Board - Restriction s Impo sed
('/(.s~ ll $L'P.VIC' s '0 ~t: 'o
More informationInfo Sheet - Operations Office for Human Research Studies
Guidance on Single IRB Review Process This document outlines how the DFCI IRB may rely on an external IRB to serve as the IRB of record for a DF/HCC site or Investigator. The Dana-Farber Cancer Institute
More informationChildren s Hospital of Philadelphia Committees for the Protection of Human Subjects Policies and Procedures. IRB Review Processes
Page: 1 of 8 I. PURPOSE II. III. IV. The purpose of this standard operating procedure is to describe IRB review processes, including pre-review, review, and post-review procedures. POLICY STATEMENT The
More informationIRB Reliance Models: Workshop for OSU Researchers Collaborating with External Partners
IRB Reliance Models: Workshop for OSU Researchers Collaborating with External Partners Jessica Evans, MHA, CHRC, CIP Office of Responsible Research Practices August 8, 2017 Workshop Overview Regulatory
More informationthe HRPP Director will prepare a draft report within three (3) workdays after the IRB meeting at which the determination occurred.
IRB Policy 34: Reporting Policy Revision Date: March 27, 2009, revised June 11, 2010, revised January 27, 2011, revised 9/23/13, revised 9/17/15, revised 4/2/18, revised 9/14/18 INSTITUTIONAL REVIEW BOARD
More informationMISSISSIPPI STATE UNIVERSITY HUMAN RESEARCH PROTECTION PROGRAM. Collaborative Research and Performance Sites (01-23) Approved
MISSISSIPPI STATE UNIVERSITY HUMAN RESEARCH PROTECTION PROGRAM Collaborative Research and Performance Sites (01-23) Approved 02-04-2013 Policy It is the policy of the MSU HRPP that all human subjects research
More information