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Examples for IRB Forms Table of Contents Examples for IRB Forms ................................................................................................................ 1 Table of Contents ............................................................................................................................ 1 FORM A - 1 – Multipurpose Signature Assurance Sheet............................................................... 3 FORM A – Signature Assurance Sheet .......................................................................................... 4 FORM B – General Information ..................................................................................................... 5 FORM B-2 – Study Personnel List ................................................................................................. 6 FORM C – Research Description ................................................................................................. 10 FORM C-1 – Local Repository Description ................................................................................. 13 FORM D – - Consent Documents ................................................................................................. 14 FORM F – Waiver or Alteration of Consent ................................................................................ 16 FORM H-1 – Translation Certificate ............................................................................................ 17 FORM I – Application for Access to De-identified Data (or Specimens) .................................... 18 FORM J-1 – Assurance for Research on Decedent Information .................................................. 19 FORM J – HIPAA Waiver of Authorization ................................................................................ 20 FORM K – Pre-Notification Intent to Conduct Research at Another Institution ......................... 21 FORM N – Off-site_Research ...................................................................................................... 22 FORM O – Investigational New Drug .......................................................................................... 23 FORM O-1 – Approved Drug Unapproved Use ........................................................................... 24 FORM O-2 – Placebo ................................................................................................................... 25 FORM P – Investigational Device ................................................................................................ 26 FORM P-1 – Investigational Device............................................................................................. 27 FORM Q – Radiation Exposure Worksheet ................................................................................. 28 FORM R – Monitoring Participant Safety and Data Integrity ...................................................... 29 FORM T – Decisionally Impaired ................................................................................................ 30 FORM U – PregWomen Neonates Fetuses .................................................................................. 31 FORM V – Prisoners .................................................................................................................... 32 FORM W – Children .................................................................................................................... 33 FORM X – COI Report................................................................................................................. 34 FORM Y – Monitoring Plan - Lead PI ......................................................................................... 35 FORM A - 1 – Multipurpose Signature Assurance Sheet FORM A – Signature Assurance Sheet Example #1 - PI will conduct research on UTHSCSA official time, no Co-PI needed Example #2 - PI will conduct research on VA official time and is requesting IRB approval of a Co-PI FORM B – General Information FORM B-2 – Study Personnel List Examples of when individuals are “engaged” in human research In general, individuals are considered engaged in a non-exempt human research study (and therefore would need their institution’s designated IRB approval) when their involvement in the human subject’s research includes any of the following activities: Individual receives support from HHS (e.g., PI on an NIH grant) to conduct human subjects research, even where all activities involving human subjects are carried out by individuals. Individual intervenes for research purposes with any human subjects of the research by performing invasive or noninvasive procedures (e.g., drawing blood; collecting buccal mucosa cells using a cotton swab; administering individual or group psychotherapy; administering drugs or other treatments; surgically implanting medical devices; utilizing physical sensors; and utilizing other measurement procedures). Individual intervenes for research purposes with any human subject of the research by manipulating the environment (e.g., controlling environmental light, sound, or temperature; presenting sensory stimuli; and orchestrating environmental events or social interactions). Individual obtains for research purposes identifiable private information or identifiable biological specimens from any source. Obtaining includes, but is not limited to: (a) observing and/or recording private behavior; and (b) using, studying, or analyzing for research purposes identifiable private information or identifiable specimens already in the possession of the employees or agents of the institution. Private information or specimens is considered to be individually identifiable when they can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems. Examples of individuals who may have limited involvement in the research and are Not Engaged in Research (1) The individual performs commercial or other services for investigators provided that all of the following conditions also are met: (a) the services performed do not merit professional recognition or publication privileges; (b) the services performed are typically performed by the individual for non-research purposes; and (c) the individual will not administer any study intervention being tested or evaluated under the protocol. The following are some examples, assuming the individual is not part of the research team and the services described would not merit professional recognition or publication privileges: • an appropriately qualified laboratory technician from UHS performs routine serum chemistry analyses of blood samples for investigators as part of a commercial service. • an individual transcribes research study interviews as a commercial service. • a CTRC employee who obtains blood through a blood draw or collects urine and provides such specimens to investigators as a service. • a radiology technician from the Dental School performs bite-wing x-rays and sends the results to investigators as a service. _____________________________________________________________________________ (2) The individual is an employee of another Institution (including private practice) that is not a research site who provides clinical trial-related medical services that are dictated by the protocol and would typically be performed as part of routine clinical monitoring and/or follow-up of subjects enrolled at a study site by clinical trial investigators (e.g., medical history, physical examination, assessment of adverse events, blood test, chest X-ray, or CT scan) provided that all of the following conditions also are met: (a) the individual will not administer the study interventions being tested or evaluated under the protocol; (b) the clinical trial-related medical services are typically provided by the individual’s institution for clinical purposes; (c) the individual does not enroll subjects or obtain the informed consent of any subject for participation in the research; and (d) when appropriate, investigators from an institution engaged in the research retain responsibility for: (i) overseeing protocol-related activities; and (ii) ensuring appropriate arrangements are made for reporting protocol-related data to investigators at an engaged institution, including the reporting of safety monitoring data and adverse events as required under the IRB-approved protocol. **Note that institutions (including private practices) not initially selected as research sites whose employees or agents administer the interventions being tested or evaluated in the study—such as administering either of two chemotherapy regimens as part of an oncology clinical trial evaluating the safety and effectiveness of the two regimens—generally would be engaged in human subjects research (see scenario (3) below for a limited exception). If such an institution does not have an FWA, its employees or agents may be covered by the FWA of another institution that is engaged in the research through an Individual Investigator Agreement. ____________________________________________________________________________________ (3) The individual is an employee of another Institution (including private practices) not initially selected as a research site who administers the study interventions being tested or evaluated under the protocol limited to a one-time or short-term basis (e.g., an oncologist at the institution administers chemotherapy to a research subject as part of a clinical trial because the subject unexpectedly goes out of town, or is unexpectedly hospitalized), provided that all of the following conditions also are met: (a) an investigator from an institution engaged in the research determines that it would be in the subject’s best interest to receive the study interventions being tested or evaluated under the protocol; (b) the individual will not enroll subjects or obtain the informed consent of any subject for participation in the research; (c) investigators from the institution engaged in the research retain responsibility for: (i) overseeing protocol-related activities; (ii) ensuring the study interventions are administered in accordance with the IRB-approved protocol; and (iii) ensuring appropriate arrangements are made for reporting protocol-related data to investigators at the engaged institution, including the reporting of safety monitoring data and adverse events as required under the IRB-approved protocol; and (d) an IRB designated on the engaged institution’s FWA is informed that study interventions being tested or evaluated under the protocol have been administered at an institution not selected as a research site. ____________________________________________________________________________________ (4) The individual who only function is to: (a) inform prospective subjects about the availability of the research; (b) provide prospective subjects with information about the research (which may include a copy of the relevant informed consent document and other IRB-approved materials) but do not obtain subjects’ consent for the research or act as representatives of the investigators; (c) provide prospective subjects with information about contacting investigators for information or enrollment; and/or (d) seek or obtain the prospective subjects’ permission for investigators to contact them. An example of this would be a private practice clinician who provides patients with literature about a research study at the HSC, including a copy of the informed consent document, and obtains permission from the patient to provide the patient’s name and telephone number to investigators. ____________________________________________________________________________________ (5) An individual employed by an institution (e.g., schools, nursing homes, businesses) that permits use of their facilities for intervention or interaction with subjects by investigators from another institution. An example would be a teacher from a Southside ISD school that had permitted HSC investigators to conduct or distribute a research survey in the classroom; or recruit children and parents in a diabetes prevention study, provided the teacher did not perform any activities that would be considered engaged in research. ____________________________________________________________________________________ (6) Individuals from one institution who release to investigators at another institution identifiable private information or identifiable biological specimens pertaining to the subjects of the research. **Note that in some cases the institution releasing identifiable private information or identifiable biological specimens may have institutional requirements that would need to be satisfied before the information or specimens may be released, and/or may need to comply with other applicable regulations or laws. In addition, if the identifiable private information or identifiable biological specimens to be released were collected for another research study covered by 45 CFR part 46, then the institution releasing such information or specimens should: (a) ensure that the release would not violate the informed consent provided by the subjects to whom the information or biological specimens pertain (under 45 CFR 46.116), or (b) if informed consent was waived by the IRB, ensure that the release would be consistent with the IRB’s determinations that permitted a waiver of informed consent under 45 CFR 46.116 (c) or (d). Examples of institutions that might release identifiable private information or identifiable biological specimens to investigators at another institution include: (a) schools that release identifiable student test scores; (b) an HHS agency that releases identifiable records about its beneficiaries; and (c) medical centers that release identifiable human biological specimens. **Note that, in general, the institutions whose employees or agents obtain the identifiable private information or identifiable biological specimens from the releasing institution would be engaged in human subjects research. ____________________________________________________________________________________ (7) Individuals who: (a) obtain coded private information or human biological specimens from another institution involved in the research that retains a link to individually identifying information (such as name or social security number); and (b) are unable to readily ascertain the identity of the subjects to whom the coded information or specimens pertain because, for example: •the individual and the holder of the key enter into an agreement prohibiting the release of the key to the individual under any circumstances; •the releasing institution has IRB-approved written policies and operating procedures applicable to the research project that prohibit the release of the key to the individual under any circumstances; or •there are other legal requirements prohibiting the release of the key to the individual. For purposes of this document, coded means that: (a) identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, and/or combination thereof (i.e., the code); and (b) a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens. ____________________________________________________________________________________ (8) Individuals who access or utilize individually identifiable private information only while visiting an institution that is engaged in the research, provided their research activities are overseen by the IRB of the institution that is engaged in the research. **The individual is engaged however the individual’s home institution is not. An example would be a HSC researcher conducts a records review study at BAMC and the individual’s research activities are approved/overseen by the BAMC IRB. ____________________________________________________________________________________ (9) Individuals who access or review identifiable private information for purposes of study auditing (e.g. a government agency or private company will have access to individually identifiable study data for auditing purposes). ____________________________________________________________________________________ (10) Individuals who receive identifiable private information for purposes of satisfying U.S. Food and Drug Administration reporting requirements. ____________________________________________________________________________________ (11) Individuals who author a paper, journal article, or presentation describing a human subjects research study. Note: the VA does not use engaged in research to determine whether a study falls under VA research regulations. Examples of when a study is considered “VA Research” sponsored by the VA being conducted by or under the direction of any salaried or without compensation (WOC) employee of the STVHC during her/his official duty time or in connection with her/his STVHCS responsibilities being conducted at a STVHCS facility recruiting subjects at the STVHCS or using the STVHCS’s records (CPRS) to identify or contact subjects for research being funded or managed by the STVHCS or the Biomedical Research Foundation of South Texas FORM C – Research Description 6.c. Study Intervention Item 4.c.9 Describe measures taken to minimize coercion or undue influence Coercion occurs when an overt threat of harm is intentionally presented to an individual (i.e., subject or legally authorized representative). The threat proposes to make the individual worse off than if he or she would have been if never asked or where the threat would violate the individual’s rights. Examples of coercion include: Telling a prospective subject that continued medical care is dependent upon participation in the research. Telling students that participation in a survey for the instructor’s research is a required to complete an academic course. The IRB will not approve research where coercion is a possibility. For that reason, all sources of coercion must be eliminated. Undue influence is likely through the offer of excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. Examples of undue influence include: “unjustifiable pressures” occur when “persons in positions of authority … urge a course of action for a subject.” manipulating a prospective subject’s choice by utilizing the “influence of a close relative.” when judgment may be compromised by financial incentives especially when the subject is not the recipient of the financial incentive. The IRB will not approve research unless undue influence is minimized. Example of study interventions being tested – Protocol will compare a new investigational drug (drug E) to two other standard care drugs ( drug S1 and S2) 6.b. List of the study intervention(s) being tested or evaluated under this protocol N/A - this study does not test or evaluate an intervention. # Study intervention(s) being tested or evaluated under the protocol Add or delete rows as needed 1 Drug E (100mg by mouth, four times a day) 2 Drug S1 (50 mg by mouth, four times a day) 3 Drug S2 (75 mg by mouth, daily) Skip to item 6.d. Local Standard Practice Indicate whether the intervention is considered acceptable practice locally Delete one of the words, if you are using a table for each procedure for example vs. deleting the word procedure if you are listing several procedures for one component. [Insert short label] This label should be the same terms or terms used to describe the component in the component list. It is allowed to add a truncated list of procedures in the component if you prefer to remind the reader when many procedures are involved especially when you find yourself needing to list specific procedures separately in the risks section below with a component. List each group exposed to this For each group, list the benefits of this procedure (either the procedure procedure on a separate line. or a monitoring procedure likely to contribute to the subject’s well being). (e.g., experimental, control, Arm A, Arm If there are no benefits, state “none”. B, etc Or state All Groups/Subjects List benefits for each component, you can list them separately on each of these lines if you have many different components with different benefits but the intent is that you group procedures with like benefits and like levels of risk so hopefully this will not be necessary Examples of benefit might include: increased monitoring if several safety labs are performed as research only in the components list indicating they would not have been performed if the subject was not participating in the study. It is allowed to list a potential benefit “Particular research protocols may hold out the prospect of direct medical benefit to the subjects themselves, even though such benefit can never be assured. The potential direct medical benefits to the subjects include health improvements which may or may not be related to the disorder responsible for the subject's incapacity” Payments or Free medical care should not be portrayed as a benefit of research participation or considered in the assessment of the risk:benefit ratio. Receipt of procedures and study items may be listed as benefits to the subject if they would not have otherwise received them as part of standard care, but not in conjunction with their being "free" or at reduced cost. Group: 1 Direct Benefit: [State "None" (or insert direct benefit, secondary benefit, or monitoring benefit)] All Groups Benefit to the community (or specify population especially if same population being recruited) / Knowledge gained benefit (philanthropic on behalf of the individual). For this procedure or component, list the reasonably foreseeable risks List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious). (include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms) Likely These risks are expected to occur in more than 20 out of 100 subjects. The Board considers the definition of likelihood should be relatively consistent across all components in order to allow subjects to clearly understand the likelihood of those risks. If it is absolutely necessary to change the numbers, ensure the numbers in each of the three levels add up and do not overlap. Less likely These risks are expected to occur in 5-20 subjects or less out of 100 subjects. Rare These risks are expected to occur in less than 5 subjects out of 100 Not serious Venipunture: Pain Bleeding Bruising It is ok to list one of the procedures in the component separately when it is appropriate to single it out Serious If you list a risk without a header the assumption is that the risk applies to all procedures in the component if the table is used to describe several procedures as one component. Not serious Serious Vomiting (though not frequently when it occurs it is most often self limiting) Serious This block is not to be Vomiting (dehydration) (rarely vomiting can be used. severe enough to lead to dehydration and hospitalization) Do not delete frequency. Make an effort to estimate. See detailed instructions above on previous page Occasionally it is necessary to list the same risk in two different boxes. When you do this it is necessary to offer some explanation as to why you believe it is appropriate to do so. Click here for other examples which include examples of risk:benefit tables: Example 1, Example 2, Example 3 (specific for randomization as a risk) 6.d. List of ALL other research procedures or components not listed in table 6.b. All of the research procedures for this study should be listed in either table 6.b. or 6.d. Consider grouping similar procedures under a single component. E.g., blood work, CT = safety assessments) (Click here for example) # Research component individual procedures example: Eligibility Assessments History and physical Questionnaire Laboratory tests Add or delete rows as needed 1 2 3 4 Eligibility Assessments Obtain consent Medical hx, inclusion/exclusion review Physical exam Safety Assessments Venipuncture for blood tests EKG Efficacy Assessments CT scan Column A Local Standard Practice Indicate the number of times each procedure will be performed as stipulated in the research plan that would be done as part of standard practice. Column B Research Only Indicate the number of times each procedure will be performed solely for research purposes (any performed outside frequency or timing for acceptable local practice) Column C Risks List the reasonably expected risks under the following categories as appropriate: Serious and likely; Serious and less likely; Serious and rare; Not serious and likely; Not serious and less likely 0 0 1 1 None None 4 1 None 4 8 2 2 Not serious and likely - Momentary pain/discomfort None 4 2 Insert procedure here Insert procedure here Insert component 4 here Insert procedure here Insert procedure here Insert procedure here FORM C-1 – Local Repository Description Serious and rare - cancer FORM D – - Consent Documents Examples of risk tables categorizing risk by probably (likelihood) and magnitude (seriousness) Likely (10 or more subjects out of 100) Not Serious Serious Cough Headache Nausea Tiredness (fatigue) None Less Likely (Between 2-9 subjects out of 100) Not Serious Chest discomfort Chest pain Shortness of breath Chills Fever Serious Low red blood cells (anemia), which may make you feel tired Low platelets (cells that help blood clot) (thrombocytopenia), which may increase your chance of bleeding Rare (Less than 2 subjects out of 100) Not Serious Serious Likely (21-100 subjects out of 100) Likely and Not Serious Nausea and vomiting Abnormal levels of certain salts in the body like sodium and potassium Likely and Serious Fewer red blood cells and white blood cells and platelets in the blood o A low number of red blood cells can make you feel tired and weak. o A low number of white blood cells can make it easier to get infections. o A low number of platelets causes you to bruise and bleed more easily. Allergic reaction, which may be mild or could be potentially life-threatening (could cause death) Less Likely (5-20 subjects out of 100) Less Likely and Not Serious Rash Metallic taste Numbness and tingling in the fingers and toes Hair loss Constipation or diarrhea Pain in your abdomen Temporary changes in vision Damage to the ear causing hearing and balance problems Less Likely and Serious Allergic reactions (can be severe and life-threatening (could cause death), causing difficulty in breathing and/or a drop in blood pressure) Rare but Serious (Less than 5 subjects out of 100) Damage to the liver Damage to the kidney Leukemia later in life FORM F – Waiver or Alteration of Consent FORM H-1 – Translation Certificate FORM I – Application for Access to De-identified Data (or Specimens) FORM J-1 – Assurance for Research on Decedent Information FORM J – HIPAA Waiver of Authorization FORM K – Pre-Notification Intent to Conduct Research at Another Institution FORM N – Off-site_Research FORM O – Investigational New Drug FORM O-1 – Approved Drug Unapproved Use FORM O-2 – Placebo FORM P – Investigational Device FORM P-1 – Investigational Device FORM Q – Radiation Exposure Worksheet FORM R – Monitoring Participant Safety and Data Integrity FORM T – Decisionally Impaired FORM U – PregWomen Neonates Fetuses FORM V – Prisoners FORM W – Children FORM X – COI Report FORM Y – Monitoring Plan - Lead PI Progress Report Example of how to complete the detailed description of the reason for withdrawal Detailed Description of the Reason for Withdrawal Screening – fasting blood sugar was not within the stated inclusion parameters AE – experienced nausea & vomiting that was expected, however was unable to continue with oral medications and was withdrawn AE – experienced nausea & vomiting that lead to unexpected dehydration and hospitalization (UPIRSO reported) and was withdrawn Personal reasons – did not like the expected side effects of the study drug and opted out of the study Death – natural causes, not related to study Death – disease progression, not related to study Death – serious adverse event, related to study (UPIRSO reported) Total number per reason 5 3 3 1 1 1 1