U.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board (IRB)

Transcription

1 IORG #: IORG Institution: U of Kentucky Expires: 08/28/2021 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 Name of Institution or Organization Operating the IRB(s) *Name of Institution or Organization: U of Kentucky

2 *Mailing Address: 315 Kinkead Hall *treet Address (if different from the Mailing Address above): *City: Lexington *tate/province: KENTUCK *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: Lisa Middle Initial: A *Last Name: Cassis Earned Degree(s): Ph.D. Title or Position: Interim Vice President for Research *Mailing Address (if different from the Mailing Address in section 3): 311 Main Building *City: Lexington *tate/province: KENTUCK *Zip/Postal Code: *Country (if outside the U..): *Phone: *FA: * lcassis@uky.edu 5. Contact Person Providing this Registration Information *First Name: Pamela Middle Initial: A *Last Name: tafford Earned Degree(s): MA Title or Position: Associate Director, Office of Research Integrity Name of Institution or Organization (if different from the Name in section 3): *Mailing Address (if different from the Mailing Address in section 3): 316 Kinkead Hall *City: Lexington *tate/province: KENTUCK *Zip/Postal Code: *Country (if outside the *Phone: *FA: * pastaf3@uky.edu 6. IRB Registration Information (to be completed separately for each IRB being renewed/updated or newly registered)

3 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 Kentucky IRB #1 - Med Monday C. Location of the IRB *Mailing Address (if different from the Mailing Address in section 3): 315 Kinkead Hall *treet Address of the IRB (if different from the Mailing Address of the IRB): *City: Lexington *tate/province: KENTUCK *Zip/Postal Code: *Country (if outside the U..): *Phone: *FA: * pastaf3@uky.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):

4 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): 80 human drugs medical devices biological food additives color additives other pecify H. IRB Chairperson *First Name: Roger Middle Initial: *Last Name: Humphries Earned Degree(s): MD Title or Position: IRB Chairperson Mailing Address (if different from the Mailing Address in section 3): c/o Office of Research Integrity City: Lexington tate/province: KENTUCK Zip/Postal Code: Country (if outside the U..): *Phone: FA: * roger.humphries@uky.edu

5 I. IRB Roster Form: Completion of the IRB Roster Form is required if your IRB is designated on a Federalwide assurance submitted to OHRP. Otherwise, it is optional. Member Name (Last, First) ex M/F Earned Degree(s) cientist () Non-scientist (N) Primary cientific or Non-cientific pecialty Affiliation with Institution(s) /N Comments Physician cientist, exp Humphries, Roger M MD Emergency Medicine till, Alicia F JD N Legal N Nonscientist, Community Member, exp Thompson, John M MD Internal Medicine Physician cientist, exp Jicha, Gregory M MD, PhD Neurology Physician cientist, Impaired Consent Capacity, exp Lile, Joshua M PhD Behavioral cience ocial cientist, exp Hardy, Peter M PhD Radiology, Biomed Other cientist, exp Engineering Duke, Mary F MD Geriatrics, Physician cientist, Impaired Pediatrics, Consent Cap., Child Advocate, exp Pathology Rush, Craig M PhD Behavioral cience Vice Chair, ocial cientist, exp 8/31/21 Bush, Matthew M MD Otolaryngology and Physician cientist, Child Advocate, Neurotology CBPR, Parental Perspective, exp Jordan Courtney, Tosia F RN, B, Clinical Other cientist, exp CCRP Nursing/Oncology Blyth, Julie F B N Japanese culture and N Nonscientist, Community member, communications exp Alternative Members Logan, T. K. F PhD Applied Psychology ocial cientist, Prisoner Rep, Parental Perspective, exp taton, Michelle F PhD ocial Work ocial cientist, Prisoner Rep, exp Frazier, usan F PhD, RN Nursing Instruction Other cientist, exp Howard, Patricia F PhD, RN, CEN, CPEN, Clasey, Jody F PhD, FACM Miller-pillman, Kimberly Nursing Other cientist, Child Advocate, Parental Perspective, exp Exercise Physiology/Bone Densitometry F PhD Environmental ciences Andreatta, Richard M PhD Rehabilitation ciences Other cientist, Child Advocate, MED, exp Other cientist, urvey Research, exp Other cientist, MED & NMED, exp 8/31/21

6 Hughes, Michele F BA Oncology, Psychology Other cientist, exp, MED & NMED Brown, Joe M MH N Business Nonscientist, MED & NMED, exp Hartsfield, James M DMD, M, MMc, PhD Oral/Genetics/Geno mics Physician cientist, P& reviewer, exp Fillmore, Mark M PhD Psychology ocial cientist, NMED, exp Field, Marilyn F PhD Political cience N Other cientist, Community Member, MED & NMED, exp Flaherty, Chris M PhD ocial Work ocial cientist, NMED, exp Noonan, Jacqueline F MD Pediatrics Physician cientist, Child Advocate, exp Lodder, Robert M PhD Pharmacy/Chemistr y Other cientist, exp Oyler, Douglas M PharmD Pharmacy Other cientist, exp DiLorenzo, Amy F M Anesthesiology Education Page, Judith F PhD peech-language Pathology Other cientist, Child Advocate, Impaired Consent Capacity, exp Other cientist, Child Advocate, Impaired Consent Capacity, exp Wang, iaoqin Jennifer F MD Radiology Physician cientist, exp Harper, Tamela F MHA Biomedical Informatics Burgess, Karl M M N Information ystems Other cientist, exp, MED & NMED Nonscientist, exp, MED & NMED Marcum, Michelle F M Cancer Research Other cientist, exp, MED Oltmann, hannon F PhD Information cience Other cientist, MED & NMED, exp Wallace, Thomas M MD, JD, MBA Pulmonary & Critical Care, Health Law Heald, Ashlie F JD, MBA N Healthcare Compliance & Law Physician cientist, exp Nonscientist, Community Member, exp Vazsonyi, Alexander M PhD Family tudies Child Advocate, ocial cientist, NMED, exp

7 Mahuwala, Zabeen F MD Neurology Physician scientist, exp Chavan, Niraj M MD, MPH OB/GN-Maternal Fetal Medicine El Khouli, Riham F MD, PhD Radiology-Nuclear Med/Molecular Imaging Qasem, hadi M MD Pathology & Laboratory Medicine Physician scientist, exp Physician scientist, exp Physician scientist, exp van Horne, Craig M MD, PhD Neurosurgery Physician scientist, exp Whiteman, Gregory M ME, MA, BA N Education N Nonscientist, Community Member, exp Hartman, Ellen F M Fitness Management Other cientist, exp Grisham-Brown, Jennifer F EdD Early Childhood Development ocial cientist, Child Advocate, exp 8/31/21 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 Kentucky IRB #2 - Med Tuesday C. Location of the IRB *Mailing Address (if different from the Mailing Address in section 3): 315 Kinkead Hall *treet Address of the IRB (if different from the Mailing Address of the IRB): *City: Lexington *tate/province: KENTUCK *Zip/Postal Code: *Country (if outside the U..): *Phone: *FA: * pastaf3@uky.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): 80 human drugs medical devices biological food additives color additives other pecify H. IRB Chairperson *First Name: Larry Middle Initial: *Last Name: Cunningham, Jr. Earned Degree(s): MD, DD Title or Position: Professor Mailing Address (if different from the Mailing Address in section 3): c/o Office of Reseaarch Integrity City: Lexington tate/province: KENTUCK Zip/Postal Code: Country (if outside the U..): *Phone: FA: * llcunn2@ .uky.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 Affiliation with Institution(s) /N Comments Physician cientist, exp Cunningham, Jr., Larry M MD, DD Oral & Maxillofacial urgery Hirschowitz, Edward M MD Pulmonary Physician cientist, exp Oncology White, Carol F MPH Epidemiology Other cientist, CBPR, exp piker, James M M N Colonel U Army N Nonscientist, Community Member, (Retired) exp kaff, Karen F PhD Higher Education ocial cientist, Parental Perspective, exp 8/31/21 Kiessling, tefan M MD, FAN Pediatrics Physician cientist, Child Advocate, exp 8/31/21 Dawson, Dolph M DMD, M, Oral Health Practice Vice Chair, Other cientist, exp MPH 8/31/21 chwarze, teven M PhD, ML Cellular Vice Chair, Other cientist, exp Biochemistry & Pathology Bhakta, Avinash M MD Colon & Rectal Physician cientist, exp urgery Dillon, Johanne F MD, FAAP Pediatric Radiology Physician cientist, exp Cunningham, Emily F MD OB/GN Physician scientist, pregnant women, exp Thompson, Jeffrey M BA N Insurance Agent N Nonscientist, Community Member, exp

12 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 Kentucky IRB #3 - Med Thursday C. Location of the IRB *Mailing Address (if different from the Mailing Address in section 3): 315 Kinkead Hall *treet Address of the IRB (if different from the Mailing Address of the IRB): *City: Lexington *tate/province: KENTUCK *Zip/Postal Code: *Country (if outside the U..): *Phone: *FA: * pastaf3@uky.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

13 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): 80 human drugs medical devices biological food additives color additives other pecify H. IRB Chairperson *First Name: Terry Middle Initial: *Last Name: Malone Earned Degree(s): Ed.D. Title or Position: Professor Mailing Address (if different from the Mailing Address in section 3): C/o Office of Research Integrity City: Lexington tate/province: KENTUCK Zip/Postal Code: Country (if outside the U..): *Phone: FA: * trmalo1@ .uky.edu

14 I. IRB Roster Form: Completion of the IRB Roster Form is required if your IRB is designated on a Federalwide assurance submitted to OHRP. Otherwise, it is optional. Member Name (Last, First) ex M/F Earned Degree(s) cientist () Non-scientist (N) Primary cientific or Non-cientific pecialty Affiliation with Institution(s) /N Comments Malone, Terry M Ed.D. PT Assessment Other cientist, CBPR, exp Rice, Linda F RN Nursing Other cientist, ocial cientist, Parental Perspective, exp Tran, Tuyen M MD Emergency N Physician cientist, exp Medicine Davis, George M PharmD, Pharmacy Vice Chair, Other cientist, exp BCP Ziada, Ali M MD Pediatrics/Urology Physician cientist, Child Advocate, exp Wallace, Adrian M B N None N Nonscientist, Community Member, exp annelli, John M PhD Immunotherapy Other cientist, exp Hahn, Ellen F PhD, RN, Drug Prevention ocial cientist, CBPR, Parental FAAN Perspective, exp Hendrix, Nancy F MD Obstetrics/Gynocolo Physician scientist, exp gy Lightner, Donita F MD Neurology- Physician scientist, Child Advocate, Pediatrics exp McMullen, Colleen F MA Physiology other cientist, Parental Perspective, MED & NMED, exp 8/31/21

15 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 Kentucky IRB #6 - Med Wednesday C. Location of the IRB *Mailing Address (if different from the Mailing Address in section 3): 315 Kinkead Hall *treet Address of the IRB (if different from the Mailing Address of the IRB): *City: Lexington *tate/province: KENTUCK *Zip/Postal Code: *Country (if outside the U..): *Phone: *FA: * pastaf3@uky.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

16 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): 80 human drugs medical devices biological food additives color additives other pecify H. IRB Chairperson *First Name: Terry Middle Initial: *Last Name: Malone Earned Degree(s): Ed.D. Title or Position: Professor Mailing Address (if different from the Mailing Address in section 3): c\o Office of Research Integrity City: Lexington tate/province: KENTUCK Zip/Postal Code: Country (if outside the U..): *Phone: FA: * trmalo1@ .uky.edu

17 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 Affiliation with Institution(s) /N Comments Malone, Terry M Ed.D. PT Assessment Other cientist, exp Perrine, William M B Chemical Engineer N Nonscientist, Community Member, (Retired) exp Fleischman, Roger M MD Hematology/Oncolo Physician cientist, exp gy Chishti, Aftab M MD, FAAP, Pediatrics Physician cientist, Child Advocate, CT exp hook, Lori F MD Pediatrics Vice Chair, Physician cientist, Child Advocate,Pregnant Women,exp Hatton-Kolpek, Jimmi F PharmD Pharmacy Practice Vice Chair, Other cientist, exp & cience 8/31/21 chumacher, Mitzi F PhD Behavioral cience Other cientist, exp Oliva, Frank M B N Risk Management N Nonscientist, Community Member, exp Isaacs, Kathy F PhD, MN Neonatal Nursing Other cientist, Child Advocate, exp