eirb Review Checklist

Transcription

1 Start an eirb On-Line Submission Analysis Form Section Review Details Section 1: Study Identification & Personnel Study Identification Look for spelling in both Full and Short title. Make sure dates match dates in the protocol and that they make sense / format. End dates for study should match what is stated in the study protocol. This can be left blank, if it is clear in the Protocol or lay summary that there is no specified end date. If not specified, an end date must be provided. Ensure that staff is only listed once. Ensure that only Non-Emory Staff are listed in Question 9 Check for current CITI Certification for all study staff Required Reviews Studies using radiation must go to Full Committee. If Radiation Safety is checked as a Required Review ensure that Radiation Exposure is selected under Biomedical Research Q-2 Medical procedures and considerations. Also, ensure that the questions are answered in the EHSO-RAD section Ensure that appropriate additional reviews are listed, CTRC, COI, Biosafety Study Sites Ensure that Q-1 is answered and if Q-1 has the response Other that Q-2 has a response. Ensure that study sites match the sites listed in the Consent(s) e.g., Emory Healthcare, VA, Grady, CHOA, Winship, etc If VA is a site have the VA liaison review consents Funding Q-1, a funding source must be selected even if funding is pending. If any funding is Federal the grant is REQUIRED all others N/A Grant documents to be uploaded on the pop-up page; multiple documents can be uploaded budget documentation is not required Section 2: Research Design & Methods Research Design Q-1, Read summary and make sure it is a summary and is not too technical or scientific Q-2, Ensure that the study protocol is attached and contains the required sections outlined on the eirb Website (e.g., references). If the protocol is password protected ask that the password be removed. If not, ensure that the password is EmoryeIRB and is included in the document title. Research Type Q-1, Yes will direct to IRB Biomedical Research ; No will direct to IRB Social Research Within Q-2, If your research involves human specimens, you may be doing human subjects research. Federal requirements to protect human subjects apply to a much broader range of research than many investigators realize, including research that uses human specimens (such as cells, blood, and urine), residual diagnostic specimens and medical information. See: Q-2, ensure this matches protocol; a Yes response will eliminate questions/pages regarding human subjects Section 3 (i.e. recruitment, population, ICD, etc.) Social Research If questionnaires/surveys are used, they must be uploaded under Q-2 If Q-3 or 4 are Yes, needs Full committee review Page 1 of 6 Review Form v3.0, 9/19/2007

2 Biomedical Research Banking Clinical Trials Device Clinical Trials Drug Section 3: Study Population Study Population Recruitment Population - Normal Volunteers Q-1, if an item is checked using an IND, IDE, or HDE a corresponding item should be checked in Q-2. For example: Q-1 has Humanitarian Device Exemption checked so Q-2 should have Investigational Use of Approved Device checked. This is the only way it will take them to the Drug or Device questions. Q-2, if it is a drug study ensure that Investigational Drug or Investigational Use of Approved Drug is selected. This will require the Clinical Trials Drug section to be completed Q-2, if it is a device study ensure that Investigational Device or Investigational Use of Approved Device is selected. This will require the Clinical Trials Device section to be completed Compare Q-2 & 3 (procedures, considerations, and data collection types) to procedures in protocol and consent. Make sure all appropriate categories are marked. Q-2, if blood draws are part of the study procedures ensure Blood Test Q-2, if Radiation exposure is selected ensure that under Required Reviews, EHSO - Radiation Safety is selected. Ensure that the questions are answered in the EHSO-RAD section A separate consent must be obtained for specimen banking this information may be included in the main consent. If so, a statement of banking must be presented after consent to the main study with the subject initialing Yes or No. These studies must go to Full Committee If a Clinical Investigator s Brochure or Operating Manual is available, it should be uploaded under Q-8 If the CIB or Operating Manual is password protected ask that the password be removed. If not, ensure that the password is EmoryeIRB and is included in the document title. These studies must go to Full Committee If it is a Phase I III study a Clinical Investigator s Brochure must be uploaded under Q-6. If it is a Phase IV study a package insert should be uploaded under Q-6. If the CIB or Package Insert is password protected ask that the password be removed. If not, ensure that the password is EmoryeIRB and is included in the document title. Q-5, Adults and/or Minors, must be checked; plus at least one additional population type Q-5, Pregnant women and/or fetuses, Lactating women, Women of child-bearing potential this population should be selected for most studies check the ICF to see if this population is specifically excluded. If checked the Population Pregnant Women section must be completed. If Q-1 indicates medical records will be reviewed to identify potential subjects, a Partial HIPAA Waiver must be requested if investigators will have access to PHI Q-3, Physician referral Yes, a Partial HIPAA Waiver must be requested Recruitment materials used need to be uploaded under Q-4 Page 2 of 6 Review Form v3.0, 9/19/2007

3 Population - Minors Population - Students Population - Patients Population - Emory Employees Population Pregnant Women Population - Prisoners Population - Cognitively Impaired Population Non-English Section 4: HIPAA and PHI HIPAA Determination PHI HIPAA part 1 HIPAA part 2 Section 5: Informed Consent If the study involves children and is more than observational, it must go to Full Committee Determine if an Assent is required, < 6 no assent required, 6-10 a verbal assent is required, written assent required, and 17 year old assent signature line in the main consent. If an Assent is required it must be uploaded as a separate document and have an Assent Cover page. These studies must go to Full Committee and a Prisoner Representative must be present at the review. Q-2 will always be Yes for PIs in School of Medicine and School of Public Health Q-1, If the study is retrospective a date in the past must be provided Q-6, For Biomedical Studies that are being conducted at an Emory Healthcare site Other should be selected and the Clinical Trial Office (CTO) needs to be listed. Q-7, The date or event must match the date or event listed in the HIPAA Authorization form Q-3, for most studies a partial or complete HIPAA waiver needs to be requested Page 3 of 6 Review Form v3.0, 9/19/2007

4 Informed Consent Process (Q1 Q12) Do the forms have version dates? Each document that is uploaded that will be stamped MUST and have a version date. Is a revocation letter attached, separately - if applicable Q-1, if the study has no subjects, check Waiver of written/signed consent (i.e., information sheet, telephone consent, verbal script) these documents must be uploaded and on the document stamping template Q-11, if a copy of the consent form will be placed in medical records, this must be stated in the consent form Study Populations Students if enrolled, provide assurance that no coercion will be used in enrollment, statement included that their grade, graduation status, etc. will not be affected due to participation Employees if enrolled, provide assurance that no coercion will be used in enrollment, statement included that employment status will not be affected due to participation Non-English the consent must be translated into the appropriate language. The translation should be submitted for approval along with a copy of the translator s certification after the English version is approved. Pregnant Women if ineligible to participate will a pregnancy test be administered? If so, must be stated in the consent Cognitively Impaired Need signature line for guardian Q-11, For Biomedical Studies that are being conducted at an Emory Healthcare site the response should be Yes unless a request for exception is submitted (see DSMP Q-5) Attached Documents (Q-13, consent forms, assent forms, HIPAA forms, revocation letters scripts and/or information sheets uploaded separately) eirb Consent Template Informed Consent Process Introduction/Purpose Procedures Risks Benefits Alternatives Consent(s), HIPAA, etc., if applicable, MUST be on the Document Stamping Template All uploaded documents that are required to be on the Document Stamping Template MUST have a version date Q-13, Upload Certificate of Confidentiality if applicable Should begin with a first statement of research (e.g., You are being asked to volunteer for a research study to ) If randomizing subjects analogy for 2 groups is like flipping a coin ; for more than 2 groups analogy should be like drawing straws Frequency of risks need to be quantified; use percentages and descriptors.; so they do not appear to have the incidence Should begin with You may not benefit directly from your participation in this study Must be included if a treatment and/or intervention study. If not, a statement should be included that the alternative is not to participate. Page 4 of 6 Review Form v3.0, 9/19/2007

5 Confidentiality If a separate HIPAA Authorization form is being used, a Confidentiality section must be in the consent Must include Emory as having access to study records The following language must be included in ALL consents: If you are or have been a patient at an Emory Healthcare facility, then you will have an Emory Healthcare medical record. If you are not and have never been a patient at an Emory Healthcare facility then no Emory Healthcare medical record will be created for you just because you are participating in a research study. Results from study tests and procedures that are performed, analyzed and/or read at or for Emory Healthcare facilities that can be used for healthcare purposes will be placed in any medical record that you have with Emory Healthcare facilities. In addition, a copy of the informed consent form and HIPAA authorization form that you sign will be placed in any Emory Healthcare medical record you may have. Persons who have access to your medical record will be able to have access to all results and documents that are placed there, and the results/documents may be used by Emory Healthcare facilities to help provide you with medical care. Any results and documents that are kept as part of your medical record are not covered by certain state and federal laws and regulations that may prevent the disclosure of, research data. However, the confidentiality of the results and other documents in the medical record will be governed by laws such as HIPAA that concern medical records. does not have any control over results from tests and procedures performed and/or analyzed or read at non-emory Healthcare facilities. These results are NOT routinely included in medical records at Emory Healthcare facilities, and they will not necessarily be available to Emory Healthcare providers. Emory University also does not have control over any other medical records that you may have with other healthcare providers and will not send any test or procedure results from the study to these providers. It is up to you to let these healthcare providers know that you are participating in a clinical trial. Some tests and procedures that may be performed during this study by Emory Healthcare or other facilities or persons MAY NOT BE LOOKED AT OR READ FOR ANY HEALTHCARE TREATMENT OR DIAGNOSTIC PURPOSES. THESE TESTS AND PROCEDURES WILL ONLY BE LOOKED AT FOR RESEARCH PURPOSES AND THE RESULTS WILL NOT BE REVIEWED TO MAKE DECISIONS ABOUT YOUR PERSONAL HEALTH OR TREATMENT. The specific types of tests or procedures, if any, that fall within this category are listed below: [Insert names of any specific tests and procedures that fall into this category; if there aren t any insert none. ] UNLESS VOTED DIFFERENTLY BY IRB COMMITTEE or STUDY STAFF REQUEST (i.e., CoC or request for exception) If an exception is granted ensure that the correct confidentiality language is added (i.e., Section B or Section C) and that the corresponding submission form questions are answered appropriately. Ensure that if the exception has been granted any language in the consent that states this consent will appear in your medical record is removed. Tel: Fax: irb@emory.edu - Web: Page 5 of 6 Review Form v3.0, 9/19/2007

6 Compensation/Costs (Emory Disclaimer) The Emory disclaimer must be included If the Atlanta VA is a site the VA disclaimer/text must be included Voluntary Participation/Withdrawal Contact Persons Ensure statement: Call Dr. Colleen DiIorio, Chair of the Institutional Review Board An Identifiable contact MUST be listed on Consents and HIPAA Authorizations Check the IRB phone number (404) If Grady is a site, include Grady contact information. New Findings Entitlement Statement Must include a statement that they will be given a copy of the consent for their records. It should not state given a signed copy as this is coercive HIPAA Authorization Form Use the Guidelines listed on the IRB Website Ensure that ALL required sections are completed The following language must be included in all stand-alone forms: We will put a copy of your signed informed consent form for the Research Study and your signed HIPAA Authorization form into any medical record that you may have with Emory Healthcare facilities. Laboratory and medical procedure results received from Emory Healthcare facilities may also be placed in any medical record that you have with Emory Healthcare facilities. Assent Use the Guidelines listed on the IRB Website Ensure that the proper Assent Coversheet is included Section 6: Data Safety & Monitoring Plan (DSMB/DMC) DSMB DSMP Q-4, For Biomedical Studies that are being conducted at an Emory Healthcare site the response should be Yes unless a request for exception is submitted (see DSMP Question 5) Question 5, if there is a request for exception the letter of request needs to be uploaded here. Section 7: Ancillary Committee HESC (Human Embryonic Stem Cell) EHSO-BIO EHSO-RAD Conflict of Interest Miscellaneous Documents If any questions are answered, make sure the committee is also marked in the Required Reviews section. If any questions are answered, make sure the committee is also marked in the Required Reviews section. If any questions are answered, make sure the committee is also marked in the Required Reviews section. If any COI questions are answered yes, make sure COI is listed in the Required Reviews section. This section is used for attached CITI Certifications and Recertification s Page 6 of 6 Review Form v3.0, 9/19/2007