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 Scientific Affiliation with Member Name Sex Earned Non-scientist or Non-Scientific Institution(s) (Last, First) M/F Degree(s) (N) Specialty Y/N Comments Breault, Joseph M MD,ScD S Family Medicine Y PS=Physician Scientist Gilyot, Merlin M BS S Pharmacist N OS=Other Scientist Servay, Chris F BA S Biology Y OS, Other Scientist Bazzano, Lydia F MD,PhD S Internal Medicine Y PS-Physician Scientist; Vice-Chair Metzinger, Barbara F MBA N Chaplain Y NS, non-scientist Sanders, Cheryl F MSN S Nursing Y OS, Other Scientist Graber, Cindy F M.Div. N Chaplain Y NS, non-scientist Effron, Mark M MD S Cardiology Y PS. physician scientist Campbell, Bob M BS S Phamacy N OS, other scientist Alternative Members Pankey, George M MD S Infectious Diseases Y PS Physician Scientist Latsis, Maria F BS S Speech Pathology Y OS=Other Scientist Green, Heather F MS S BioMed Y OS=Other Scientist Engineering Hand, Linda F BS N Business N NS=Non-scientist Gloth, Maria F BS S BioMed Y OS - Other Scientist Engineering Muery, Susan F BS N Education N NS, Non-scientist Anderson, Eric M BS N Music Y NS=Non-scientist Bencaz, Angelle F MSPH S Biostatistics N OS, Other Scientist Pratt, Kelly F BSN S Nursing Y OS=other scientist Williams, Shannon F N/A N Radiology Tech Y NS=Non Scientist Warrier, Raj M MD S Peds Oncology Y PS=Physician Scientist Smith, Taylor M MD S Vascular SUrgery Y PS=Physician Scientist Marques, Carol F BSN,RN S Nursing Y OS=Other Scientist Bober, Robert M MD S Cardiology Y PS=Physician Scientist Catha, Connie F - N Administration Y NS-non-scientist Zhang, Xin F MD, MPH S Immunology Y OS - Other Scientist Walch-Patterson, F BS, MPH S Public Health Y OS, Other Scientist Amelia Ahia, Chad M MD, MPH S physician Y OS, Other Scientist Smith-Martell, Donna F BSN S Nursing N OS, other scientist Segner, Jeffery M MSPH S Public Health N OS, Other Scientist
Hoffman, Ross M MBBS S Physician N PS, Physician scientist McKinney, Don M JD,PhD N Legal, Ethics Y NS - Nonscientist Becker, Arlene F RN S Nursing Y OS, other scientist Gupta, Tripti F MBBS S Physician Y PS, physician scientist Birdsong-Williams, F BS S Biology Y OS/other scientist Elisa Goodrow, Erin F MSW S Nursing Y OS, other scientist Ascani, Jeannine F MS S Pathology Y OS, Other Scientist Cruz, Brian M MD S Internal Medicine Y PS, Physician Scientist Hussain, Azad M MPH S Epidemiology Y OS, Other Scientist Larned, Zoe F MD S Oncology Y PS, Physician Scientist Tang, Wendell M MD S Pathology Y PS, Physician Scientist Meyers, Charles M PhD S Clinical Psychology N OS, other scientist Tutberidze, Maia F MD S medicine N OS, other scientist Mukerjee, Kimberly F MD S Pediatrics Y PS, physician scientist Fontenelle, Cindy F RN S Nursing Y OS, other scientist Munley, Benjamin M MPH S Public Health N OS, other scientist LaCoste, Nicole F PharmD S Pharmacology Y OS, other scientist Henry, Jessica F BSN S Nursing Y OS, other scientist Neal, Monica F DPT S Physical Therapy Y os, other scientist Deveny, Robert M BS S medical student Y OS, other scientist Nguyen, Doan M PhD S cell biology Y OS, other scientist Albataineh, M PhD S immuniology Y OS, Other scientist Mohammad Ramirez, Robert M DO S oncology Y PS, Physician scientist Young, Sylvia F MA N Pastoral Care Y NS, non-scientist Helms, Stefan M BA S medical student Y OS, other scientist Wright, Mathew M BS,MPH S medical student Y OS, Other Scientist Kolomensky, Andrew M BS S medical student Y OS, Other Scientist Mikolowsky, Jessica F BS S medical student Y OS, Other Scientist Abi-Samra, Freddy M MD S Cardiology Y PS. physician scientist Liles, Lindsay F AB S medicals tudent Y OS, other scientist Pyakurel, Kusma F PhD S Pharmacology Y OS, other scientist Smith, Dawn F MA S Bioethics Y OS, other scientist Slattery, Lauren F BS S medical student Y OS, other scientist Goldman, Daryl F BS S medical student Y OS, other scientist
NOTES: 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. Yes = 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 46.107(a) and 46.108(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.
A. *Is this a renewal or update of a registration for an IRB already registered with HHS? [X] Yes. Provide the IRB registration number previously assigned to this IRB by OHRP: IRB00002435 (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 http://ohrp.cit.nih.gov/search/search.aspx or contact OHRP using the contact information at http://www.hhs.gov/ohrp/daqi-staff.html or by telephone at 1-866-447-4777) [ ] No, this is a new IRB registration. B. Provide the IRB name, if any, used by the institution or organization (e.g., State University Behavioral IRB, University Healthcare Biomedical IRB, or XYZ Hospital IRB #1): Ochsner Clinic Foundation Panel B C. Location of the IRB *Mailing Address (if different from the Mailing Address in section 3): 1514 Jefferson Highway Brent House 425 *Street Address of the IRB (if different from the Mailing Address of the IRB): *City: New Orleans *State/Province: LOUISIANA *Zip/Postal Code: 70121 *Country (if outside the U.S.): *Phone: 504 842-3535 *FAX: 504 842-3899 *E-Mail: irb@ochsner.org 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 HHS (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): 1 200 50
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): 150 X X X human drugs medical devices biological food additives color additives other Specify H. IRB Chairperson *First Name: Joseph Middle Initial: *Last Name: Breault Earned Degree(s): M.D., Sc.D Title or Position: Chairman, IRB Mailing Address (if different from the Mailing Address in section 3): 1514 Jefferson Highway, BH514 City: New Orleans State/Province: LOUISIANA Zip/Postal Code: 70121 Country (if outside the U.S.): *Phone: 504 842-3535 FAX: 504 842-3648 *E-Mail: jbreault@ochsner.org
Ochsner IRB Panel B 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 Scientific Affiliation with Member Name Sex Earned Non-scientist or Non-Scientific Institution(s) (Last, First) M/F Degree(s) (N) Specialty Y/N Comments Breault, Joseph M MD,ScD S Family Medicine Y PS=Physician Scientist Rice, Karen F DSN S Nurse Y OS, Other Scientist Thibeau, Shelley F PhD S Nursing Y OS, Other Scientist Butcher, Brian M PhD S Microbiology N OS Other Scientist Therapondos, George M MD,PhD S Transplant Surgery Y PS-Physician Scientist; Vice-Chair McNeal, Kerrie F BA N IT N NS - nonscientist Lawton, Andrew M MD S Neuro- Y PS/physician scientist Ophthalmology Innocent-Ituah, Ijeoma F MD, MPH S Family Medicine Y PS, Physician Scientist Green, David M MA N Education Y NS, non-scientist Alternative Members NOTES: 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. Yes = 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 46.107(a) and 46.108(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.
A. *Is this a renewal or update of a registration for an IRB already registered with HHS? [X] Yes. Provide the IRB registration number previously assigned to this IRB by OHRP: IRB00002595 (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 http://ohrp.cit.nih.gov/search/search.aspx or contact OHRP using the contact information at http://www.hhs.gov/ohrp/daqi-staff.html or by telephone at 1-866-447-4777) [ ] No, this is a new IRB registration. B. Provide the IRB name, if any, used by the institution or organization (e.g., State University Behavioral IRB, University Healthcare Biomedical IRB, or XYZ Hospital IRB #1): Ochsner Clinic Foundation Panel C C. Location of the IRB *Mailing Address (if different from the Mailing Address in section 3): 1514 Jefferson Highway Brent House 425 *Street Address of the IRB (if different from the Mailing Address of the IRB): *City: New Orleans *State/Province: LOUISIANA *Zip/Postal Code: 70121 *Country (if outside the U.S.): *Phone: 504 842-3535 *FAX: 504 842-3899 *E-Mail: irb@ochsner.org 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 HHS (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 1 200 50
the IRB conducted an initial review or continuing review at a convened meeting or under an expedited review 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): 150 X X X human drugs medical devices biological food additives color additives other Specify H. IRB Chairperson *First Name: Michael Middle Initial: *Last Name: White Earned Degree(s): M.D., Ph.D. Title or Position: Chairman - Panel C Mailing Address (if different from the Mailing Address in section 3): 1514 Jefferson Highway, BH425 City: New Orleans State/Province: LOUISIANA Zip/Postal Code: 70121 Country (if outside the U.S.): *Phone: 504 842-3535 FAX: 504 842-3648 *E-Mail: irb@ochsner.org
Ochsner IRB Panel C 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) Sex M/F Earned Degree(s) Scientist (S) Non-scientist (N) S S N S S S Primary Scientific or Non-Scientific Specialty Affiliation with Institution(s) Y/N Comments White, Michael M MD,ScD Family Medicine Y PS=Physician Scientist Garbee, Deborah F PhD Nurse N OS=Other Scientist Rowntree, Stephen M PhD Priest, Ethics N NS=Non Scientist LeCompte, Leah F LOTR Physical Therapist Y OS=Other Scientist Elnaggar, Mini F MD Radiation Oncology Y PS - Physician Scientist Piazza, Janice F MSN, MBA Nursing, Y OS - Other Scientist Administration Vashistha, Himanshu M PhD S Microbiology Y OS, Other Scientist Adams, Joanna F BS N Management Y NS, Non-scientist Collins, Sean M MD S Urology Y PS, physician scientist Alternative Members NOTES: 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. Yes = 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 46.107(a) and 46.108(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.
Public burden for this collection of information is estimated to average one hour for an initial IRB registration, and thirty minutes for updating or renewing the registration of a previously registered IRB. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: OS Reports Clearance Officer, Room 503, 200 Independence Avenue, SW., Washington, DC 20201. Do not return the completed form to this address.