11-5-2014 1 of 5 The purpose of this checklist is to provide support for IRB staff conducting pre-review. This checklist is to be completed by the IRB staff, signed, dated, and retained with the IRB protocol record. IRB Number: Protocol Name: Investigator: Reviewer: Check appropriate box for Submission Type. New Study Amendment Status Change Continuing Review Reportable Event Other (Specify): Regulatory Oversight (Check all that apply) DHHS DOD DOJ EPA FDA DOE ED HUD Items Submitted This submission includes the following: Check the appropriate boxes. Application Sponsor Consent Form Template Scientific Review Documentation Study Protocol Sponsor Assent Form Template Web Sites PH Consent Form(s) Investigators Brochure Questionnaires / Surveys Number of Consent Forms Instructions for Use Patient Diary / Patient Tools 1 2 3 4 5 or Recruitment Materials IND / IDE / HDE FDA Approval PH Assent Form(s) Advertisement Materials Research Authorization Number of Assent Forms Subject Payment / Retention Materials Interview Materials 1 2 3 4 5 or Impacted Services Agreements Data Collection / Assessment Forms Other (Specify): Special Determinations (Check all that apply) Children Not significant risk device (FDA) Waiver/alteration of the consent process Children who are wards Non-viable neonates Waiver of consent documentation Pregnant women Neonates of uncertain viability Waiver of consent for emergency research Prisoners Cognitively impaired adults HIPAA Waiver / alteration Missing Materials Study Closure All Amendments, Continuing Reviews, Reportable Events, and Status Changes are Complete. The Study can be closed. Final Contingencies
11-5-2014 2 of 5 1 ALL REVIEWS (Check when completed.) Determine whether the activity is Human Subject Research or a HUD. Refer to the CHECKLIST: Human Subject Research Determination. Refer to Non-Committee Review for a Human Subject Research determination if you are uncertain or the activity appears to not be Human Subject Research or a HUD. Determine the laws that apply to the Human Subject Research and indicate these in the Regulatory Oversight section. Determine review type. Refer to the CHECKLIST: Exempt Determination, CHECKLIST: Expedited Review or CHECKLIST: Criteria for Approval and Additional Considerations for HUD. The application is completed accurately. 2 INITIAL REVIEW AND AMENDMENTS (Check the box if the answer is Yes or N/A. Do not check the box if the answer is No.) The research involves the use of a drug and meets the criteria in section 7. ( N/A if no drugs.) The research involves the use of a device and meets the criteria in section 8. ( N/A if no devices.) The research involves the use of advertisement and meets the criteria in section 9. ( N/A if no advertisement.) The research involves payment to subjects and meets the criteria in section 10. ( N/A if no payment.) Any special determinations that need to be made are noted in the Special Determinations section. ( N/A if no Special Determinations.) All materials necessary for review are included, i.e.: Completed Submission Documentation Consent / Assent Document(s) or Script(s) Materials Provided to Subjects Protocol and Appendices Data Collection Instruments(s) CITI current for all study staff Qualifications of key research personnel Sample consent / assent document(s) Product information for device Grant application Investigator brochure for investigational drug Department of Energy Checklist Complete sponsor protocol Package insert for marketed drug Department of Education compliance letter Scientific Review Conflict of Interest declaration Impacted Services Agreement(s) The application is complete and questions are accurately answered, i.e.: IRB review history Number of local subjects Subject withdrawal Objectives Total number of subjects study wide Risks to subjects Background Study timeline Potential benefits to subjects Settings Study endpoint(s) Economic burden to subjects Resources available Procedures involved Consent / assent process * Prior approvals Data or specimen banking Consent / assent documentation* Study design Data management Vulnerable populations* Recruitment methods Privacy Drugs or devices Inclusion / exclusion criteria Confidentiality Multi-site research Injury compensation Data safety monitoring plan Sharing results * Refer to CHECKLIST: Full Board Review The Informed Consent document is formatted as required. (Check the box if the answer is Yes or N/A. Do not check the box if the answer is No.) The header includes: 1) Palmetto Health; 2) the complete study title; 3) sponsors name; 4) Informed Consent for Participation in Research; 5) the IRB # The footer includes: 1) Initials line; 2) Page # The signature section includes: 1) Subject; 2) Person Obtaining Consent; 3) Witness; 4) Minor Assent The consent is written in lay language. The consent is written in a question and answer format. The spelling and grammar are correct. The HIPAA waiver / alteration section and questions are complete and accurately answered. ( N/A if no HIPAA waiver/ alteration.) ( N/A if Initial Review.) 3 CONTINUING REVIEW (Check the box if the answer is Yes or N/A. Do not check the box if the answer is No.) CITI training current for listed study personnel. 4 AMENDMENT (Check the box if the answer is Yes or N/A. Do not check the box if the answer is No.) 5 REPORTABLE EVENT (Check the box if the answer is Yes or N/A. Do not check the box if the answer is No. If one is No information is not complete.)
11-5-2014 3 of 5 Date discovered by PI or Research Staff is provided. [PGR requires report within 5 days] Protocol Deviations (Check if Yes. All must be Yes If one is No information is not complete.) Number of similar protocol deviations previously submitted is provided. The measures previously taken to prevent reoccurrence are provided. 6 STATUS CHANGE (Check the box if the answer is Yes or N/A. Do not check the box if the answer is No.) Confirm that the research meets the criteria for closure and note in the Study Closure Section. ( N/A if not Study Closure.) 7 DRUGS (Check if Yes. Both must be Yes If one is No information is not complete. Note: This information is usually in the protocol or the investigators brochure.) IND Requirements (Check if Yes. One must be Yes If all are No IND information is not complete.) The drug has a valid IND. (Check if Yes. Both must be Yes If one is No IND information is not complete.) IND Validation (Check if Yes. At least one must be Yes If all are No IND cannot be validated.) Sponsor protocol imprinted with the IND number. Written communication from the sponsor documenting the IND number. Written communication from the FDA documenting the IND number. (Required if the investigator holds the IND.) Drug Control (Check if Yes. Must be Yes If No information regarding drug control is incomplete.) The plan for storage, control, and dispensing of the drug is adequate to ensure that only authorized investigators will use the drug and that they will use the drug only in subjects who have provided consent. The drug is exempt from the IND requirements (Check if Yes. All criteria for one category must be Yes to be met. If none are met, the drug is not exempt from an IND.) Category # 1 (21 CFR 312.2) The drug is lawfully marketed in the United States. The research is not intended to be reported to the FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug. The research is not intended to support a significant change in the advertising for the product. The research does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product. The research is conducted in compliance with the marketing limitations described in 21 CFR 312.7. (i.e., the investigation is not intended to promote or commercialize the drug product.) Category # 2 (21 CFR 312.2) A clinical investigation involving use of a placebo when the investigation does not otherwise require submission of an IND. Category # 3 (21 CFR 320.31) The active moiety in the drug product is identical to that in an FDA approved drug. (i.e., the drug product does not contain a new chemical entity.) The drug product is not radioactively labeled. The drug product is not cytotoxic. The dose (single or total daily) does not exceed the dose in the labeling of the approved version of the drug product. The sponsor meets the requirements for retention of test article samples in 21 CFR 320.31(d) (1). Category # 4 (21 CFR 361.1) The drug has been approved by a FDA-approved Radioactive Drug Research Committee as a radioactive drugs for certain research use under the criteria in 21 CFR 321.1(b) Category # 5 (21 CFR 361.1) The research is intended to obtain basic information regarding the metabolism (including kinetics, distribution, and localization) of a drug labeled with a cold isotope or regarding human physiology, pathophysiology, or biochemistry. The research is not intended for immediate therapeutic, diagnostic, or preventive benefit to the study subject. The dose to be administered is known not to cause any clinically detectable pharmacologic effect in humans based on clinical data from published literature or other valid human studies. The quality of the cold isotope meets relevant quality standards. IND Oversight for investigators who hold the IND (Check if Yes. One of the following must be Yes ) The investigator does NOT hold the IND. The FDA requirements of a sponsor (including Good Manufacturing Practices (GMP) when applicable) have been assumed by a contract research organization. An audit has documented that the investigator is compliant with FDA sponsor requirements (including GMP when applicable). 8 DEVICES (Check if Yes. Both must be Yes If one is No information is not complete. Note: This information is usually in the protocol.) IDE/HDE Requirements (Check if Yes. One must be Yes If all are No IDE/HDE information is not complete.)
11-5-2014 4 of 5 The device has an IDE or HDE. (Check if Yes If one is No IDE/HDE information is not complete.) IDE/HDE Validation (Check if Yes. At least one must be Yes If all are No, IDE/HDE cannot be validated.) Sponsor protocol imprinted with the IDE/HDE number. Written communication from the sponsor documenting the IDE/HDE number. Written communication from the FDA documenting the IDE/HDE number. (Required if the investigator holds the IDE/HDE.) Device Control (Check if Yes. Must be Yes If No, information regarding device control is incomplete.) The plan for storage, control, and dispensing of the device is adequate to ensure that only authorized investigators will use the device and that they will use the device only in subjects who have provided consent. The device qualifies for an abbreviated IDE. (Check if Yes If one is No, information regarding abbreviated IDE is not complete.) Abbreviated IDE (Check if Yes. All must be Yes ) (21 CFR 812.2) The device is not a significant risk device. The device is not a banned by the FDA. The sponsor will label the device in accordance with FDA regulations. Informed consent will be obtained and documented in accordance with FDA regulation. The investigator will comply with FDA requirements for monitoring investigations. The investigator will comply with FDA requirements for records and reports. The investigator will not market or promote the device. Device Control (Check if Yes. Must be Yes If No, information regarding device control is not complete.) The plan for storage, control, and dispensing of the device is adequate to ensure that only authorized investigators will use the device and that they will use the device only in subjects who have provided consent. The device is exempt from the IDE requirements. (Check if Yes. All criteria under one category must be Yes for a category to be met. If none of the categories is met, the device is not exempt from an IDE.) Category # 1 (21 CFR 812.2) The device was not regulated as a drug before enactment of the Medical Device Amendments. (Transitional device.) The device is FDA-approved/cleared. The device is being used or investigated in accordance with the indications in the FDA approved/cleared labeling. Category # 2 (21 CFR 812.2) The device is a diagnostic device. The sponsor will label the device in accordance with FDA regulations. The testing is noninvasive. i The testing does not require an invasive sampling procedure that presents significant risk. The testing does not by design or intention introduce energy into a subject The testing is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure. Category # 3 (21 CFR 812.2) The device is undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution, and the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk. Category # 4 (21 CFR 812.2) The device is a custom device as defined in 21 CFR 812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution. IDE Oversight for investigators who hold the IDE (Check if Yes. One of the following must be Yes ) The investigator does NOT hold the IDE. The FDA regulatory requirements of a sponsor (including Good Manufacturing Practices (GMP) when applicable) have been assumed by a contract research organization. An audit has been performed which documents that the investigator is compliant with FDA sponsor requirements (including GMP when applicable). 9 ADVERTISEMENT (Check if Yes or N/A. All three must be checked, if one is No the information is incomplete.) The context (Check if Yes or N/A. All must be checked) The application describes the mode of communication For printed advertisements, the final copy is being reviewed For audio/video tape, the tape is the final version The content: (Check if Yes. All must be checked) Does NOT state or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and the
11-5-2014 5 of 5 protocol Does NOT promise free treatment, when the intent is only to say subjects will not be charged for taking part in the research Does NOT include exculpatory language Does NOT emphasize the payment or the amount to be paid, by such means as larger or bold type The advertisement is limited to the information prospective subjects need to determine their eligibility and interest, such as: The name and address of the investigator or research facility The condition under study or the purpose of the research In summary form, the criteria that will be used to determine eligibility for the study A brief list of participation benefits, if any The time or other commitment required of the subjects The location of the research and the person or office to contact for further information For FDA-Regulated research: (Check if Yes. All must be checked) Does NOT make claims, either explicitly or implicitly, that the drug, biologic or device is safe or effective for the purposes under investigation Does NOT make claims, either explicitly or implicitly, that the test article is known to be equivalent or superior to any other drug, biologic or device Does NOT use terms, such as new treatment, new medication or new drug without explaining that the test article is investigational. Does NOT include a coupon good for a discount on the purchase price of the product once it has been approved for marketing. 10 PAYMENT TO SUBJECTS (Check if Yes or N/A. Must be checked, or the information is incomplete.) Requirements for Payments (Check if Yes. All must be checked) All payments are described in the application including: (Check if Yes. All must be checked) Amount Method Timing of disbursement Credit for payment accrues as the study progresses. Payment is not contingent upon completing the entire study. The amount of payment and the proposed method and timing of disbursement is neither coercive nor presented undue influence. Any amount paid as a bonus for completion is reasonable and not so large as to unduly induce subjects to stay in the study when they would otherwise have withdrawn. All information concerning payment, including the amount and schedule of payments, is in the informed consent document. Compensation does not include a coupon good for a discount on the purchase price of the product once it has been approved. i Blood sampling that involves venipuncture is considered non-invasive for purposes of this exemption. The use of surplus samples of body fluids or tissues that are left over from samples taken for non-investigational purposes is also considered non-invasive. http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm071230.pdf