IUPUI AND CLARIAN INSTITUTIONAL REVIEW BOARDS ...



Indiana University Southeast Institutional Review Board (IRB)Expedited Research Checklist and Review ApplicationIRB Study Number: FORMTEXT ?????Principal Investigator: FORMTEXT ?????Study Title: FORMTEXT ?????Document Date: FORMTEXT ????? Anticipated End Date: FORMTEXT ?????DIRECTIONS: This form is to be neatly typed and submitted to the IRB when the investigator is contemplating the initiation of a research project which, in the investigator’s judgment, qualifies for expedited review by the IRB. Consultation with the Chair IRB during the study’s planning stages will help ensure the appropriate level of review. Items 1-7 are the categories that qualify for expedited review. APPLICABILITY:Research activities that: (1) present no more than minimal privacy, psychological and/or physical risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.The categories in this list apply regardless of the age of the subjects, except as noted.The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.The expedited categories outlined below do not apply to research involving prisoners or to classified research involving human subjects.The standard requirements for informed consent and authorization (or their waiver, alteration, or exception) apply regardless of the type of review.Section I: Expedited CategoryCheck the appropriate category(ies) that applies to your research project: FORMCHECKBOX Clinical studies of drugs and medical devices only when condition (a) or (b) is met.Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review).orResearch on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared / approved for marketing and the medical device is being used in accordance with its cleared / approved labeling. FORMCHECKBOX Collection of blood samples by finger stick, heel stick, ear stick or venipuncture, as follows:From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts withdrawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; orFrom other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week. FORMCHECKBOX Prospective collection of biological specimens for research purposes by noninvasive means. Examples:Hair and nail clippings in a nondisfiguring manner;Deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; Permanent teeth if routine patient care indicates a need for extraction;Excreta and external secretions (including sweat);Uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax by applying a dilute citric solution to the tongue;Placenta removed at delivery;Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;Supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;Sputum collected after saline mist nebulization. FORMCHECKBOX Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared / approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications). Examples:physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; weighing or testing sensory acuity;magnetic resonance imaging;electrocardiography; electroencephalography, thermography detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;moderate exercise, muscular strength testing, body composition assessment and flexibility testing where appropriate given the age, weight and health of the individual FORMCHECKBOX Research involving materials (data, documents, records or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt. Check below, as appropriate.Provide a list of all data points that will be collected below or attach a data collection sheet. FORMTEXT ????? FORMCHECKBOX Collection of data from voice, video, digital or image recordings made for research purposes. If the data collected is considered individually identifiable health information, the data must be protected from inappropriate use and disclosure. Either an authorization must be obtained from the subject or a waiver of authorization must be obtained from the IRB. FORMCHECKBOX Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects (45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is exempt.If the data collected is considered individually identifiable health information, the data must be protected from inappropriate use and disclosure. Either an authorization must be obtained from the subject or a waiver of authorization must be obtained from the IRB.Section II: Performance SiteCheck all locations where research is conducted, and/or where data is stored and analyzed. FORMCHECKBOX Indiana University Southeast Campus; state location(s): FORMTEXT ????? FORMCHECKBOX School of Arts & Letters FORMCHECKBOX School of Business FORMCHECKBOX School of Education FORMCHECKBOX School of Natural Sciences FORMCHECKBOX School of Nursing FORMCHECKBOX School of Social Sciences FORMCHECKBOX Other (state location (s)): FORMTEXT ?????Section III: Research DescriptionProvide a brief description, in lay terms, of the purpose of the proposed project. FORMTEXT ?????Please state the eligibility criteria for qualification as a research subject, record, or specimen in your study (examples could be age range, sex, language spoken, etc.). FORMTEXT ?????List all methods by which information or data about or from subjects will be obtained. Describe the frequency and duration of the procedures. NOTE: Please SUBMIT all surveys, instruments, interview questions, etc. that will be used for this research. FORMTEXT ?????Are you conducting any part of your research in a language other than English? FORMCHECKBOX No. Proceed to next question. FORMCHECKBOX Yes. Please only submit English versions (study information sheets, recruitment, instruments etc) and keep a copy of all non-English documents so they may be provided to the Human Subjects Office, upon request for audit or other purposes.a. Provide the process by which potential subjects will be identified and recruited (introduced to the investigator(s) and the research study). Note: Please SUBMIT a copy of all information to be shared with or intended to be seen by potential subjects to inform them of this research and ask for their participation. FORMTEXT ?????b. Explain how it will be ensured that recruitment or selection will not unfairly target a particular population or will target the population that will benefit from the project/research. FORMTEXT ?????Explain how subjects will be fully informed of this research prior to their participation (through the use of a study information sheet, letter, etc.). Note: Please SUBMIT a copy. FORMTEXT ?????I am requesting a waiver of written documentation of informed consent (i.e. a consent process will occur, but no signature will be obtained from the subject). FORMCHECKBOX No. Proceed to next question. FORMCHECKBOX Yes. For the IRB to grant a waiver of written documentation of informed consent, EITHER of the following criteria must be met. Please indicate which criterion is met and provide an appropriate response below. FORMCHECKBOX 1.The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality, and the research is not FDA-regulated. Each subject will be asked whether the subject wants documentation linking the subject with the research and the subject’s wishes will govern. Please explain: FORMTEXT ?????OR FORMCHECKBOX 2.The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. Please explain: FORMTEXT ?????Please only submit English versions (study information sheets, recruitment, instruments etc) and keep a copy of all non-English documents so they may be provided to the Human Subjects Office, upon request for audit or other purposes.NOTE: You must submit a written statement regarding the research, which must be provided to subjects upon their request. Will you be audio or video recording? FORMCHECKBOX No. Proceed to next question. FORMCHECKBOX Yes. Complete items a. and b. below.a. How do you plan to protect the confidentiality of the audio or video recordings: will they contain subject names or images, where will they be kept, who will have access, will they be destroyed or archived and when? FORMTEXT ????? FORMTEXT ?????b. Could the information obtained or recorded about subjects place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, or reputation? FORMCHECKBOX No. Proceed to next question. FORMCHECKBOX Yes. Please explain: FORMTEXT ?????Will subjects be paid for participation in the study (e.g. monetary, meals, free services, gifts, course credit, including extra credit)? FORMCHECKBOX No. Proceed to next question. FORMCHECKBOX Yes. Complete items a. and b. below.Explain the payment arrangements (e.g. amount and timing of payment and the proposed method of disbursement). NOTE: Payments must accrue and not be contingent upon completion of the study. However, a small payment (bonus) for completion of the study may be acceptable if it is found to not be persuasive for the subjects to remain in the study. FORMTEXT ?????Justify the proposed payment arrangements described in section B. (e.g., how this proposed payment arrangement is not considered to be coercive). FORMTEXT ?????Will you include any individuals with diminished autonomy (e.g. children, people with limited ability to make decisions) in your research? FORMCHECKBOX No. Proceed to next question. FORMCHECKBOX Yes. Please explain how they will be protected: FORMTEXT ?????Explain how subject privacy will be protected while data is being collected. For example, if interviewing, where will that be conducted? FORMTEXT ?????Explain how the data will be kept confidential after it has been collected. FORMTEXT ?????How will you help to minimize potential risks that individuals may be exposed to while participating in the research? Potentials risks may include psychological, social, legal, physical, etc. FORMTEXT ?????Are you conducting research outside the United States (excluding internet research which may incidentally enroll non-US research subjects)? FORMCHECKBOX No. FORMCHECKBOX Yes. Please describe your familiarity with local languages spoken, customs, culture, and local ethical review requirements: FORMTEXT ????? Section IV: Co-Investigators1.Co-investigators: Provide the name and department of other individual(s) assisting with the study who 1) will be responsible for the design, conduct, or reporting of the study, 2) have access to subjects (i.e. will consent subjects, conduct parts of the study), 3) will be making independent decisions about the inclusion or exclusion of participants, or 4) have access to identifying and confidential information. List individuals from affiliated institutions who are directly interacting or intervening with subjects:NameDepartment FORMTEXT ????? FORMTEXT ?????The Primary Researcher along with individuals listed above are required to:Pass the CITI training required of IU Southeast Researchers found at Instructions for accessing and completing the training are found on the Research Compliance webpage. Provide the IRB with documentation of their agreement to participate in the research. This can be accomplished by having the individual provide his/her signature next to his/her name above or including a memo (or email) from the individual documenting agreement to participate in this specific protocol.Have a Conflict of Interest (COI) disclosure form on file with IU. Complete the form at . Provide the IRB a copy of the email confirmation from IU to document that you have completed this requirement. For more information about COI, please go to List individuals from affiliated institutions who are not directly interacting or intervening with subjects:NameDepartment FORMTEXT ????? FORMTEXT ?????2.Collaborating Co-investigators. List any co-investigators from nonaffiliated institutions for which the IU Southeast IRB is providing the review and approval for their role in the study.Note: For each nonaffiliated investigator, a nonaffiliated investigator agreement may be required. Nonaffiliated investigators actively involved with and/or interviewing subjects (including obtaining consent) must pass the CITI Researcher education.Name of Co-investigatorInstitutionRoleProcedures performed FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????Statement of Principal Investigator: I have personally reviewed this application and agree with its contents and am aware of my responsibility to provide supervision and guidance during its execution (in the case of a student project).Principal Investigator Signature:Date:Note: As an alternative to providing original signatures on the form, the PI should simply e-mail the completed form to tandrews@ius.edu. This e-mail serves as the PI’s signature. For the faculty sponsor’s signature, please forward an e-mail from the individual acknowledging his/her oversight responsibilities for the student research project. This will serve as the faculty sponsor’s signature.Section IV: Expedited Review Determination FORMCHECKBOX Accepted, Expedited Category (ies): FORMTEXT ????? FORMCHECKBOX Denied, Reason: FORMTEXT ?????Authorized Signature:Date: ................
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