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Human Research Protection Program Institutional Review Board Office of Research Integrity B308 Kerr Administration Building, Corvallis, Oregon 97331-2140 (541) 737-8008 [email protected] | http://research.oregonstate.edu/irb Pre-Review Supplemental Worksheet: DRUGS, BIOLOGICS, FOODS, DIETARY SUPPLEMENTS, DEVICES, & BIOEQUIVALENCE Study ID Study Title Principal Investigator Submission Type Pre-Reviewer Date of Pre-Review INTERVENTION TYPE The study involves which of the following intervention(s): ☐ Drugs or Biologics ☐ Dietary Supplements ☐ Foods or related ☐ Devices ☐ Bioequivalence & Bioavailability Complete only the relevant sections below and the final determination section FINAL DETERMINATION YES NO a) Is the study FDA-regulated? ☐ ☐ b) Does the study require an IND or IDE? ☐ ☐ N/A COMMENTS Complete this section after completing the sections below. (Note to Staff: if yes, Database checkbox/FDA Approval Notice) ☐ c) If “yes” what is the IND/IDE Status? ☐ IND # ______________ ☐ IND Application Pending* ☐ Exempt from IND requirements ☐ IDE # _____________ (Significant Risk) ☐ IDE Application Pending* ☐ NSR Determination Recommended ☐ Exempt from IDE requirements *IRB approval should not be granted until the IND or IDE #’s are received and validated. 1. DRUGS OR BIOLOGICS YES NO a) Does the study involve administering a drug or biological product to subjects? If no, skip this section If yes, the study is FDA-regulated: ☐ ☐ ☐ ☐ i. Is the drug or biological product already lawfully marketed in the U.S.? OSU IRB FWA000003920 1 N/A COMMENTS NOTE: If FDA-regulated, 21 CFR 50 & 56 apply. HRPP Form | v. date May 2016 ii. Is the route of administration, dosage level and use in a subject population consistent with the approved indications and labeling? iii. Is the study intended to support a significant change in labeling, advertising, or to support a new indication? If “no” to (i) or (ii) and/or “yes” to (iii) - an IND may be required. For more information see the IND Decision ☐ ☐ ☐ ☐ ☐ ☐ ☐ Rationale: ____________ ☐ ☐ ☐ Number: ___________ Tree If “yes” to (i) and (ii) and “no” to (iii) – the intervention may be exempt from the IND requirements. For more information see the IND Decision Tree b) Is the intervention exempt from IND requirements? c) If not exempt, has the FDA issued an IND number? If no, IRB approval cannot be granted until the PI has a valid IND number i. If no, is the IND application pending? If no, the PI must submit an IND application to the FDA ☐ ☐ ☐ ii. If yes, has the validity of the IND number been confirmed? ☐ ☐ ☐ d) Is there an adequate plan for the storage, dispensing, labelling, handling, and disposal of all investigational and FDA-approved drugs and/or biologics? ☐ ☐ ☐ 2. FOODS YES NO N/A a) Does the study involve giving or providing food or a food ingredient to subjects? If no, skip this section. ☐ ☐ b) Is there an adequate plan for the storage, preparation, handling, and distribution of all foods? ☐ ☐ c) Does the study adequately address the potential for allergic reactions? ☐ ☐ d) Does the study involve alcohol? ☐ ☐ ☐ ☐ Acceptable documentation of the IND number includes: Sponsor protocol imprinted with the IND number; written communication from sponsor documenting the IND number; or written communication from the FDA documenting the IND number. i. Are subjects expectorating all alcohol? May be eligible for exemption if it meet all criteria under category 6 2 COMMENTS ☐ HRPP Form | v. June 2016 ii. Are subjects ingesting alcohol? If yes, may be expedited category 7 or Full Board e) Does the study involve giving food or food ingredients as an intervention (as opposed to compensation)? If no, skip the rest of this section. i. Is the food used as only a food (i.e. primarily for taste, aroma or nutritive value)? ii. Is the food store-bought or does it have a GMP or USP/Food Grade certificate provided by the manufacturer? iii. Is the food used for therapeutic purposes or to cure, mitigate, or prevent disease (outside of providing nutrition)? iv. Is the food used to affect or measure structure or function of the body other than providing nutrition v. Will the study be used to support a new health claim related to the food? ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ Rationale: ___________ ☐ ☐ ☐ NOTE: If FDA-regulated, 21 CFR 50 & 56 apply. ☐ ☐ ☐ Number: ___________ See also: 2015 FDA stay related to health claims If “yes” to (i) and (ii) and “no” to (iii), (iv) and (v) – The food is not considered a drug and no IND would be required. For more information see the FAQs on the IND Decision Tree. Skip the rest of this section. f) If “no” to (i) or (ii) and/or “yes” to (iii), (iv) or (v) – The food may be considered a drug and an IND may be required. For more information see the FAQs on the IND Decision Tree Is the food being used as a drug? i. Is the food already lawfully marketed (as a drug) in the U.S.? ii. Is the route of administration, dosage level and in a subject population consistent with the approved indications and labeling? iii. Is the study intended to support a significant change in labeling, advertising, or to support a new indication (such as a health claim)? If “no” to (i) or (ii) and/or “yes” to (iii) - an IND may be required. For more information see the IND Decision Tree If “yes” to (i) and (ii) and “no” to (iii) – the intervention may be exempt from the IND requirements. For more information see the IND Decision Tree g) Is the intervention exempt from IND requirements? h) Is an IND needed for the drug/food? If yes, the study is FDA-regulated i. If yes, has the FDA issued an IND number? 3 ☐ HRPP Form | v. June 2016 If no, IRB approval cannot be granted until the PI has a valid IND number ii. i. If no, is the IND application pending? If no, the PI must submit an IND application to the FDA Has the validity of the IND number been confirmed? ☐ ☐ ☐ ☐ ☐ ☐ YES NO N/A ☐ ☐ Acceptable documentation of the IND number includes: Sponsor protocol imprinted with the IND number; written communication from sponsor documenting the IND number; or written communication from the FDA documenting the IND number. 3. DIETARY SUPPLEMENTS a) Does the study involve administering dietary supplements to subjects? If no, skip this section. i. Is the dietary supplement being used for therapeutic purposes or to cure, mitigate, or prevent disease? ☐ ☐ ii. Is the dietary supplement being used to affect structure or function of the body other than providing nutrients? Will the study be used to support a new health claim related to the dietary supplement? ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ iii. COMMENTS See also: 2015 FDA stay related to health claims If “no” to (i), (ii) and (iii) – The dietary supplement is not considered a drug and no IND would be required. For more information see the FAQs on the IND Decision Tree. Skip to 3e. If “yes” to (i), (ii) or (iii) – The dietary supplement may be considered a drug and an IND may be required. For more information see the FAQs on the IND Decision Tree b) Is the dietary supplement being used as a drug? i. Is the dietary supplement already lawfully marketed (as a drug) in the U.S.? ii. Is the route of administration, dosage level and use in a subject population consistent with the approved indications and labeling? iii. Is the study intended to support a significant change in labeling, advertising, or to support a new indication? If “no” to (i) or (ii) and/or “yes” to (iii) - an IND may be required. For more information see the IND Decision Tree 4 ☐ HRPP Form | v. June 2016 If “yes” to (i) and (ii) and “no” to (iii) – the intervention may be exempt from the IND requirements. For more information see the IND Decision Tree c) Is the intervention exempt from IND requirements? ☐ ☐ ☐ Rationale: __________ ☐ ☐ ☐ NOTE: If FDA-regulated, 21 CFR 50 & 56 apply. If yes, has the FDA issued an IND number? If no, IRB approval cannot be granted until the PI has a valid IND number ☐ ☐ ☐ Number: ___________ i. If no, is the IND application pending? If no, the PI must submit an IND application to the FDA Has the validity of the IND number been confirmed? ☐ ☐ ☐ ☐ ☐ ☐ e) Is there an adequate plan for the storage, dispensing, labeling, handling, and disposal of all dietary supplements? 4. DEVICES ☐ ☐ YES NO a) Does the study involve a medical device? Refer to the “Is it a Medical Device” decision tree. If “no”, skip this section. b) Does the study collect safety or efficacy data related to the medical device? If “no”, it is not a clinical investigation of a device, and an IDE is not required. Skip to 4h. If “yes”, even if exempt from IDE requirements, the study is FDA-regulated. c) Is the device exempt from IDE requirements? Refer to the “Is my medical device exempt” decision tree. If the intervention is not exempt, an IDE is required. ☐ ☐ ☐ ☐ NOTE: If FDA-regulated, 21 CFR 50 & 56 apply. ☐ ☐ Rationale: ____________ d) Is the device an in vitro diagnostic (IVD) device? ☐ ☐ d) Is an IND needed for the drug/dietary supplement? If yes, the study is FDA-regulated iii. iv. Acceptable documentation of the IND number includes: Sponsor protocol imprinted with the IND number; written communication from sponsor documenting the IND number; or written communication from the FDA documenting the IND number. If “yes” and exempt from IDE requirements, consent can be waived if all of the following criteria are met: i. Specimens are left over from routine clinical care or a specimen repository or are leftover specimens that were previously collected for other research purposes. ii. Identity of the individual from whom the specimen was originally obtained is not readily 5 N/A COMMENTS For more information, see: FDA Guidance for informed consent for IVD device studies using leftover specimens that are not individually identifiable HRPP Form | v. June 2016 ascertainable (deidentified or coded with an agreement) iii. Researchers are not otherwise involved with the subjects’ clinical care iv. Test results will not be reported to subjects’ health care providers. If “no” to IVD device, or device is not exempt from IDE requirements, or criteria above are not met, consent is required (even if only deidentified specimen will be used). e) Are the consent procedures in compliance with FDA requirements? If exempt from IDE requirements, skip to 4h. f) If the device is NOT exempt, indicate the risk level: Refer to “Significant risk versus nonsignificant risk device” decision tree. ☐ Non- Significant Risk (NSR) device Investigator should provide documentation from the sponsor, if sponsored. If no sponsor, the determination must be made by the IRB at a convened meeting. ☐ Significant Risk (SR) device IDE is required. g) Is there an IDE for the device? ☐ ☐ ☐ Risk Determination Rationale: _____________ ☐ ☐ ☐ If “yes”, has the validity of the IDE number been confirmed? Acceptable documentation of the IDE number includes: Sponsor protocol imprinted with the IDE number; written communication from sponsor documenting the IDE number; or written communication from the FDA documenting the IDE number. h) Is there an adequate plan for the storage, dispensing, labeling, handling, and disposal of all investigational and/or FDA-approved devices? ☐ ☐ ☐ ☐ ☐ ☐ 5. BIOEQUIVALENCE & BIOAVAILABILITY YES NO N/A a) Does the study involve bioavailability or bioequivalence ? ☐ ☐ b) Is the intervention exempt from IND requirements? Refer to IND decision tree for additional information. f) Is an IND needed for the drug product? If yes, the study is FDA-regulated g) If non-exempt, has the FDA issued an IND number? ☐ ☐ ☐ ☐ ☐ ☐ NOTE: If FDA-regulated, 21 CFR 50 & 56 apply. ☐ ☐ ☐ Number: ___________ ☐ ☐ ☐ i. i. Has the validity of the IND number been confirmed? Number: _____________ COMMENTS Acceptable documentation of the IND number includes: Sponsor protocol imprinted with the IND number; written communication from sponsor documenting the IND 6 HRPP Form | v. June 2016 number; or written communication from the FDA documenting the IND number. h) Is there an adequate plan for the storage, dispensing, labeling, handling, and disposal of the drug product? 7 ☐ ☐ HRPP Form | v. June 2016