zilongwang/ReadingBank huggingface dataset:
PURPOSE This procedure establishes the process to prepare for a Non-Committee Review. The process begins when an IRB Office staff member identifies an application as being possibly eligible for Non-Committee Review. The process ends when the IRB Office staff member provides the materials to the Designated Reviewer. REVISIONS FROM PREVIOUS VERSION None. POLICY IRB rosters are maintained using “DATABASE: IRB Roster (HRP-601).” For individuals who access materials through an electronic system or are provided all submitted materials, those individuals are expected to review the materials listed in the “WORKSHEET: Review Materials (HRP-301)” according to their role: “Documents Provided to All IRB Members and Alternate IRB Members,” “Additional Items Provided to Primary Reviewer,” and “Additional Items Provided to Scientific/Scholarly Reviewer.” RESPONSIBILITIES IRB Office staff members carry out these procedures. PROCEDURE Refer to “DATABASE: IRB Roster (HRP-601)” and select a Designated Reviewer. If a Designated Reviewer is not available, schedule the protocol to be reviewed by the convened IRB. Use the “Assign Designated Reviewer” activity and select a Designated Reviewer. If a Designated Reviewer is not available, schedule the protocol to be reviewed by the convened IRB. Execute the “Assign Designated Reviewer” activity For individuals who are provided materials to review, prepare the review materials using the “WORKSHEET: Review Materials (HRP-301)” and include all materials listed under the columns according to the individual’s role. Execute the “Assign Designated Reviewer” activity to send to the Designated Reviewer when Pre-review is complete. MATERIALS SOP: Designated Reviewer (HRP-030) WORKSHEET: Review Materials (HRP-301) DATABASE: IRB Roster (HRP-601) REFERENCES 21 CFR §56.110(b) 45 CFR §46.110(b)
Dr Marc Sarossy Chairperson Category A Mr Alf Hawken Layman Category B Mr James Legge Layman Category B Ms Penelope Cottrill Laywoman Category B Ms Brenda Nowlan Laywoman Category B Ms Jenni Bliss A person with knowledge of, and current experience in the professional care , counselling or treatment of people Category C Ms Lesley Sosa-Ritchie A person with knowledge of, and current experience in the professional care , counselling or treatment of people Category C Assoc Prof Anne Brooks A person with knowledge of, and current experience in the professional care , counselling or treatment of people Category C Prof Stephen O’Leary A person with knowledge of, and current experience in the professional care , counselling or treatment of people Category C Dr Elvis Ojaimi A person with knowledge of, and current experience in the professional care , counselling or treatment of people Category C Rev Douglas Robertson A person who performs a pastoral care role in the community Category D Ms Catherine Debreceny A lawyer Category E Ms Jenny Taing A lawyer Category E Prof Paul Baird A person with current research experience Category F Prof Robert Cowan A person with current research experience Category F Prof Richard Dowell A person with current research experience Category F Dr Sanj Wickremasinghe A person with current research experience Category F Ms Kerryn Baker HREC Secretary Attendee
Why and how many of the device have been returned to the sponsor, repaired, or otherwise disposed of. Records of each subject's case history and exposure to the device. Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual's hospital charts, and the nurses' notes. Such records must include: Documents evidencing informed consent and, for any use of a device by the investigator without informed consent, any written concurrence of a licensed physician and a brief description of the circumstances justifying the failure to obtain informed consent. Documentation that informed consent was obtained to participation in the study. All relevant observations, including records concerning adverse device effects (whether anticipated or unanticipated), information and data on the condition of each subject upon entering, and during the course of, the investigation, including information relevant previous medical history and the results of all diagnostic tests. A record of the exposure of each subject to the investigational device, including the date and time of each use, and any therapy. The protocol, with documents showing the dates of and reasons for each deviation from the protocol. Any other records that FDA requires to be maintained by regulation or by specific requirement for a category of investigations or a particular investigation. Inspections Entry and inspection: A sponsor or an investigator who has authority to grant access must permit authorized FDA employees, at reasonable times and in a reasonable manner, to enter and inspect any establishment where devices are held (including any establishment where devices are manufactured, processed, packed, installed, used, or implanted or where records of results from use of devices are kept). Records inspection: A sponsor, IRB, or investigator, or any other person acting on behalf of such a person with respect to an investigation, must permit authorized FDA employees, at reasonable times and in a reasonable manner, to inspect and copy all records relating to an investigation. Records identifying subjects: An investigator must permit authorized FDA employees to inspect and copy records that identify subjects, upon notice that FDA has reason to suspect that adequate informed consent was not obtained, or that reports required to be submitted by the investigator to the sponsor or IRB have not been submitted or are incomplete, inaccurate, false, or misleading. Prepare and submit the following complete, accurate, and timely reports trial trial trial
consent. Emergency use of an unapproved device without prior IRB review is not “research” as defined by FDA and the individual getting the test article is not a “subject” as defined by FDA. However, FDA guidance recommends following similar rules as for emergency use of an unapproved drug or biologic. Individuals getting an unapproved drug, biologic, or device without IRB review cannot be considered a “subject” as defined by DHHS and their results cannot be included in prospective “research” as that term is defined by DHHS. How do I get additional information and answers to questions? This document and the policies and procedures for the Human Research Protection Program are available on the IRB Web Site at . If you have any questions or concerns, about the Human Research Protection Program, contact the IRB Office at: Michelle Van Director, Office of Research Compliance, HRPP Director 875 Ellicott Street Buffalo, NY 14203 716-888-4881 mavanghe@buffalo.edu If you have questions, concerns, complaints, allegations of influence, allegations or findings of non-compliance, or input regarding the Human Research Protection Program that cannot be addressed by contact the IRB Office, follow the directions in the “HUMAN RESEARCH PROTECTION PROGRAM PLAN (HRP-101)” under “Reporting and Management of Concerns.” trial trial
The criteria in “WORKSHEET: Exemption or. The criteria in “WORKSHEET: Expedited “WORKSHEET: Criteria for Approval and other applicable worksheets and checklists as determined by the Regulatory Review. “Conditionally Determine Not Human Research”: The submission with changes can be determined “Not Human Research.” “Conditionally Determine Human Research Not Engaged” The submission with changes can be determined “Human Research Not Engaged.” “Conditionally Approve”: The submission with changes can be granted the action of “Approve.” “Close”: The submission meets “WORKSHEET: Closure Criteria (HRP-413)”. Refer to the HRPP staff member handling the submission for Review. Document using “FORM: Non-Committee Review (HRP-211)” or equivalent: The action If the action is “Approve” or “Conditionally Approve,” document whether the approval level was “Exempt” or “Expedited.” For “Exempt,” document the category or categories allowing the exemption in “WORKSHEET: Exemption (HRP-423).” For “Expedited,” document the category or categories allowing review using the expedited procedure in “WORKSHEET: Expedited (HRP-424)” and document the period of approval (not to exceed one year for regulated research, and not to exceed three years for all others). Update Regulatory Review findings as needed. Notify the HRPP staff member handling the submission when done. Return any materials that are part of the permanent record. Destroy or return any temporary copies of materials. REFERENCES None
PURPOSE This procedure establishes the process to remove a member of an IRB. This procedure begins when the [Organizational Official] has decided to remove an IRB member. This procedure ends when the member has been removed and the IRB’s registration has been updated. POLICY The [Organizational Official] is responsible for deciding whether to remove an IRB member. RESPONSIBILITY A designee of the [Organizational Official] carries out these procedures. PROCEDURE Update the IRB roster. Use “WORKSHEET: IRB Composition (HRP-430)” to evaluate whether the IRB is appropriately constituted. Revise the membership as needed. Notify the IRB member. If the IRB member will no longer as an IRB member prepare and send a thank you letter signed by the [Organizational Official]. If the removed member was a chair, update the IRB’s registration at within 90 days REFERENCES 21 CFR §56.106 and §56.107 45 CFR §46.107 and 45 CFR §46 Subpart E
Indicate where the research will be undertaken. Please specify all location(s) and venues (including the URL for web-based studies). 4.3 Does recruitment involve a direct personal approach from the researchers to the potential participants? Yes No If you answered ‘Yes’, what precautions will be taken to minimise any pressure (real or perceived) on individuals to enrol? 4.4 Does recruitment involve the circulation/publication of an advertisement? Yes No If you answered ‘Yes’, provide a copy of the advertisement and indicate where and how often it will be published. 4.5 Will participants receive any financial or other benefits as a result of participation? Yes No If you answered ‘Yes’, what is the amount/benefit and the justification for this? Please note it is University policy that this amount is limited to $100 per participant. If you exceed this limit, you must provide a detailed justification. (See National Statement 2.2.9 Coercion and pressure and 2.2.10 Reimbursing participants) If the proposed research activity involves Aboriginal and Torres Strait Islander people, refer to Principle 11 of the Australian Institute of Aboriginal and Torres Strait Islander Studies (AIATSIS) Guidelines for Ethical Research in Australian Indigenous Studies () and Q12 of APPENDIX A of the Macquarie University ethics application form.
4.6 Is the research targeting any particular ethnic or community group? Yes No (See National Statement 4 – Ethical consideration specific to participants, 4.7 – Aboriginal and Torres Strait Islander Peoples, 4.8 – People in countries) If you answered ‘No’, proceed to SECTION 5 If you answered ‘Yes’, which group is being targeted? 4.7 Will recruitment be conducted in consultation with a representative of this group? Yes No (a) If you have not consulted a representative of this group, please provide your reasons for not undertaking any consultation. (b) If you have consulted a representative, with whom have you consulted? How do they represent this SECTION 5: AND BENEFITS (See National Statement chapter 2.1) 5.1 What expected benefits (if any) will this research have for the wider community? 5.2 What expected benefits (if any) will this research have for participants?
7.5 How will the confidentiality of data collected/disseminated, including the identity of participants, be ensured (this includes data referred to in 6.2 7.6 How will the results of the study be disseminated (publication and presentation of the research results)? Yes No (See National Statement 1.3 - Guidelines) 7.7 Will feedback or results be made available to participants? (See National Statement 1.5 – Justice.) Give details of how feedback or results will be made available to individual participants or, if relevant, to groups. If no feedback is planned, a justification for this must be provided. 7.8 Are you planning to retain data for the minimum period of five (5) years from the most recent publication of the research? Yes No (See The Code 2.1.1) If you answered ‘Yes’, please indicate how long you intend to retain data for. If you answered ‘No’, please explain why not. 7.9 Do you intend to retain the data for use in future research? Yes No
D11b Will the information be identified or Yes Go to then No Go to Information should be considered identified or re-identifiable if the researcher can identify individual respondents directly or via a code. Identifiable: the data/tissue is held with the individual’s identity which may include name, image, date of birth or address. Re-identifiable or potentially re-identifiable: identifiers have been removed and replaced with a code from which it remains possible to re-identify the individual, eg by using the code or linking different data sets. D12 D12a Will prior warning be given to potential participants? Yes Go to No Go to then Is information any risks – in plain language – included in the Information/Consent materials)? D13 D13a Will prior warning be given to potential participants? Yes Go to No Go to then Is information any risks – in plain language – included in the Information/Consent materials)? D14 D14a Is the observed activity something which would generally occur in public? Yes Go to D14b No Go to then D14b Is the activity something which generally occurs in public and that a reasonable person is unlikely to be concerned about having observed? D14b Will ‘participants’ be identifiable? Yes Go to then No Go to Will the information recorded have the potential to identify individuals, eg of people/places/events? If so, it represents a breach of the participants’ privacy. D15 D15a Is the deception or limited disclosure likely to harm the participants or compound the associated with this research? Yes Go to No Go to D15b D15b Have any alternatives involving full disclosure been considered? Yes Go to D15c No Go to Have alternatives to the deception or limited disclosure been considered, and rejected because they would compromise the scientific validity of the research? D15c Will the participants be given a full and prompt debriefing after their participation? Yes Go to D15d No Go to Prompt disclosure is as soon as possible after the participants complete the research procedures. D15d Do participants have the option of withdrawing their data once the deception has been disclosed? Yes Go to No Go to Can it be reasonably anticipated that, following debriefing, the research participants will regard the research as justified and acceptable conduct and not risk corrupting the relationship between the community and researchers and research in general?
The purpose of this worksheet is to provide support for IRB staff members who send communications after an IRB review where the letter needs to include approval and Expiration Dates. This worksheet describes how to make these calculations. TYPE OF REVIEW APPROVAL DATE EFFECTIVE DATE END APPROVAL DATE Initial Review Convened IRB granted approval Date of convened IRB meeting Date of convened IRB meeting Date of the convened meeting plus the approval interval minus one day Convened IRB required modifications to secure approval; subsequently verified by Non-Committee Review Date of convened IRB meeting Date the IRB Office verified that the required modifications had been made Designated Reviewer granted approval Date the Designated Reviewer granted approval Date the Designated Reviewer granted approval APPROVAL DATE plus the approval interval minus one day. None for exempt research. Designated Reviewer required modifications to secure approval; subsequently verified by Non-Committee Review Date the Designated Reviewer required modifications to secure approval Date the IRB Office verified that the required modifications had been made Continuing Review Convened IRB granted approval Date of convened IRB meeting Date of convened IRB meeting Date of the convened meeting plus the approval interval minus one day Convened IRB required modifications to secure approval; subsequently verified by Non-Committee Review Date of convened IRB meeting Date the IRB Office verified that the required modifications had been made Designated Reviewer granted approval Date the Designated Reviewer granted approval Date the Designated Reviewer granted approval APPROVAL DATE plus the approval interval minus one day Designated Reviewer required modifications to secure approval; subsequently verified by Non-Committee Review Date the Designated Reviewer required modifications to secure approval Date the IRB Office verified that the required modifications had been made Modifications Convened IRB granted approval to modifications to previously approved research. Date of convened IRB meeting Date of convened IRB meeting Previous END APPROVAL DATE, except no end date for exempt research. Convened IRB required modifications to secure approval of modifications to previously approved research; subsequently verified by Non-Committee Review Date of convened IRB meeting Date the IRB Office verified that the required modifications had been made Designated Reviewer granted approval to modifications to previously approved research Date the Designated Reviewer granted approval Date the Designated Reviewer granted approval Designated Reviewer required modifications to secure initial approval of modifications to previously approved research; subsequently verified by Review Date the Designated Reviewer required modifications to secure approval Date the IRB Office verified that the required modifications had been made
Are there changes envisaged to: Study personnel at Calvary HCACT Yes □ No □ If yes, please provide brief summary Quality control Yes □ No □ Date informed: ...../..../..... Monitoring /audit of project Yes □ No □ changes: Insurance Yes □ No □ State changes: Compensation Yes □ No □ changes: Supporting documents (brochures, survey questionnaire etc) Yes □ No □ If yes, please provide the clean and tracked versions of the same New aims and / or substantial changes in the protocol If yes, please provide a brief summary and a clean and tracked versions of the documents
Yes □ No □ For the single-site studies - In the continued research, will it develop into a multi-site study? Yes □ No □ If yes, name the sites and mention if ethics approval has been granted to undertake research in these sites Have you submitted all progress and annual reports so far Yes □ No □ Applicant Signature Applicant Name Date ......./........../..........
HREC Reference Number Allocation Request This form is required only if you wish to be allocated a HREC reference number prior to submission. Please fill out ALL sections and return to HREC Committee: TQEH – Research Ethics Committee (TQEH/LMH/MH) RAH – Royal Adelaide Hospital Research Ethics Committee Study type: Other Study Type FTIH/FTIP Clinical Trial – Drug Clinical Trial - Drug Clinical Trial (Other) Other(Please state) FTIH/FTIP Clinical Trial – Device Clinical Trial - Device Clinical Research FTIH/FTIP Clinical Trial – Drug & Device Clinical Trial - Drug & Device Health Research/Social Science Application Type: Single Site Multi Site Short Title: (max 70 characters) Long Title: CPI/PI Name: Study Coordinator Name: Study Coordinator Phone: HREC Ref: (to be completed by Ethics Officer) HREC/ / /
HREC Reference Number Allocation Request This form is required only if you wish to be allocated a HREC reference number prior to submission. Please fill out ALL sections and return to Study type: Other Study Type FTIH/FTIP Clinical Trial – Drug Clinical Trial - Drug Clinical Trial (Other) Other(Please state) FTIH/FTIP Clinical Trial – Device Clinical Trial - Device Clinical Research FTIH/FTIP Clinical Trial – Drug & Device Clinical Trial - Drug & Device Health Research/Social Science Application Type: Single Site Multi Site Short Title: (max 70 characters) Long Title: CPI/PI Name: Study Coordinator Name: Study Coordinator Phone: HREC Ref: (to be completed by Ethics Officer) HREC/ / /
HREC REQUEST FOR REVIEW OF UPDATED DOCUMENTATION STUDY MONITORING REPORTING (RRUD) This RRUD is to be completed for submission of all documentation and information which requires HREC review. The completed form is to be submitted with accompanying documentation to the CALHN HREC via HREC review is mandatory for all of the outlined below in accordance with the , the , and as directed by the CALHN HREC STUDY DETAIL HREC Reference Number: CALHN Reference Number: Site Name Study Title Site Principal Investigator Name: Email: Department: Employer: Trial Coordinator Name: Email: Department: Employer: Status of the study Recruitment pending Recruiting No active participants Participants on active treatments Participants on the same drug in other studies Participants in follow up List documents requiring review *Documents will appear in approval as documented Name Version Date Does the PICF(s) require amendment? Yes ► Attach updated documentation No Do you believe these changes raise ethical concerns? Yes ► Provide detail below No REPORT INTENT – *Mark all boxes that apply Amendments to Protocols Amendments to Investigator Brochures (IBs) Amendments to Participant Information Consent Forms (PICFs) Amendments to other supporting documents Protocol Deviations/Violations Serious Adverse Event (SAEs) Notifications Safety Reports including: Suspected Unexpected Serious Adverse Reactions (SUSAR), Development Safety Update Reports (DSUR), Data Safety Monitoring Board (DSMB) Reports, Dear Investigator letters Notifications – includes site visits, site closures, file notes NOTIFICATION OF PROTOCOL DEVIATION/VIOLATION Deviation: any change, divergence or departure from the project design or procedures defined in the Protocol. Selected Protocol Deviations are only required to be reported to CALHN HREC annually with the Annual Review Report. Refer to Protocol Violation: a more serious non-compliance that may significantly affect the completeness, accuracy or reliability of research data, or that might significantly affect a participant’s rights, safety or wellbeing.
Adequate assurance exists that parole boards will not take into account a Prisoner’s participation in the research in making decisions regarding parole, and each Prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole. Provide protocol specific findings justifying this determination: If the IRB finds there may be a need for follow-up examination or care of subjects after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual Prisoners’ sentences, and for informing subjects of this fact. Provide protocol specific findings justifying this determination: A prisoner representative reviewed the research focusing on the requirements of this checklist. The prisoner representative received all materials pertaining to the research. For convened IRB review, the prisoner representative presented either orally or in writing at the meeting or for review using the expedited procedure the prisoner representative concurred that the research involves no more than Minimal Riski to the prisoner subjects
Protocol Title: Principal Investigator: Faculty Advisor (if PI is a student): Description of Study Population: Version Date: Debriefing Statement Thank you for taking part in this research study. There was some information about the study that we did not share with you at the beginning of your participation. In order for the study to work, it was necessary to leave out some information so that your response/reaction would be real. We would now like to fully inform you of the nature of this research and provide some additional details about the study. What was the study about? Earlier in our consent form we told you that the purpose of the was [insert brief sentence about original stated purpose of study]. In actuality, our study is about [insert statement(s) describing what the true purpose of the study is and the results/findings you were/are looking for]. What information was not shared with you before the study? [Explain in plain language what information was withheld, any manipulations performed, and the rationale behind this use of deception/incomplete disclosure. Disclose any additional information (e.g., risks) not previously shared with participants.] Why couldn’t we this information with you? In to gather authentic and spontaneous responses in a study, researchers sometimes need to withhold or manipulate information from participants. If participants know in advance what the researchers want to find out, it can bias their responses and this can compromise the outcome of the study. We regret withholding the study’s true purpose, but we hope you understand the reason for it. Was any of the information included in the consent form accurate? Yes. Although the true purpose of this was not fully disclosed to you at the beginning of the study, everything else on the consent form is correct. This includes the ways in which we will keep your data confidential. [Insert sentence reiterating how study data is secured and maintained]. [If applicable include the following:] Please do not disclose research procedures and/or this new information to anyone who participate in this study in the future, as this could impact the results of our study. What is the value of my participation? Your time and responses are very much appreciated by our team, thank you!
University of California at Davis Consent to Participate in Research This document includes directions in red type. You must delete the red type after you follow the directions. It also includes yellow-highlighted type. Yellow-highlighted type indicates language that you should look at carefully and choose whether to leave it in or delete it. Please remove all red type and yellow highlight before submitting this consent document to the IRB. of study: Principal Investigator: [Include only if the research includes skin penetration such as a blood draw] (Experimental Subject's Bill of Rights) Someone will explain this research study to you, including: The nature and purpose of the research study. The procedures to be followed. Any common or important discomforts and risks. Any benefits you might expect. Whether or not you take part is up to you. You can choose without force, fraud, deceit, duress, coercion, or undue influence. You can choose not to take part. You can agree to take part now and later change your mind. Whatever you decide it will not be held against you. You can ask all the questions you want before you decide. [Delete if the consent process will not include obtaining signatures on the consent document.]If you to take part, you will be given a signed and dated copy of this document. [Delete if the consent process includes obtaining signatures on the consent document.] If you agree to take part, you will be given a copy of this document. <Delete if the consent process is not electronic> What are my rights when providing electronic consent? California law provides specific rights when you are asked to provide electronic consent: You have the right to obtain a copy of the consent document in non-electronic format You have the right to provide consent in a non-electronic format. If you change your mind electronic consent, you have the right to request your electronic consent to be withdrawn and you can then provide consent in a non-electronic format; however a copy of your electronic consent will be maintained for regulatory purposes. If you wish to withdraw your electronic consent please tell the study team This agreement for electronic consent applies only to your consent to participate in this research study.
Describe the relevant experience and gaps in current knowledge. Describe any relevant preliminary data. Provide the scientific or scholarly background for, rationale for, and significance of the research based on the existing literature and how it will add to existing knowledge. Describe the resources available to accomplish this research. Specifically include a summary of the qualifications (e.g., training, experience, oversight) of you and your as required to perform their role. When applicable describe your knowledge of the local study sites, culture, language, and society. Subject Population Describe the eligibility criteria that define who will be included and/or excluded in your study sample. If you will include or exclude any of the following special populations, this should be clearly stated: adults unable to consent; children (< 18 years of age); pregnant women; and/or prisoners or individuals likely to become prisoners during the research. Clearly state the total number of subjects to be accrued in this study. If this study is part of a larger multi-site project, clarify the total number of subjects to be accrued locally. Procedures Involved Describe and explain the study design. Provide a description of all research procedures being performed and how, when, and where they are performed. Use bullet points or simple step-by-step language to describe procedures in the order in which they will occur. Include, when applicable: A list and description of all study instruments and/or data that will be collected (e.g., surveys, questionnaires, demographic questions, interview questions, data collection forms, observations, recordings, etc.). Study instruments should be referenced here and uploaded into IRBNet as separate documents. If data will be collected via video-taping, or photography, this should be specified. Expected time commitment for participants (per specific procedure or task and in total). A description of any source records that will be used to collect data about subjects (e.g., student educational records, medical records, online resources, etc.). For record reviews, specify the date range for the collection of data. A description of the setting, sites, and/or locations where your research team will conduct the research. Any provisions to protect the privacy interests of subjects. “Privacy interest” refers to a person’s desire to place limits on whom they interact or whom they provide personal information. (Example of a privacy protection: Conducting interviews in a quiet setting where others cannot overhear the conversation.)
Include the full protocol title. Name Primary Department Telephone Number Email Address If the principal investigator’s primary role at UH is resident, fellow or student, identify a faculty advisor. Name Primary Department Telephone Number Email Address Include the version number of this protocol if assigned by an outside entity. Include the date of submission or revision. Please leave the rest of this page blank and remove this text.
Indicate whether you will follow “INVESTIGATOR GUIDANCE: Documentation of Informed Consent (HRP-803).” If not, provide a description of how you will document consent in writing. Vulnerable Populations If the Human Research involves individuals who are vulnerable to coercion or undue influence, describe additional safeguards to protect their rights and welfare. Indicate whether you will include any of the following populations: Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners If the Human Research involves cognitively impaired adults, review the “WORKSHEET: Adults Lacking Capacity (HRP-414)” to ensure you have provided sufficient information for the IRB. If the Human Research involves persons who have not attained the legal age for consent to treatments or procedures involved in the research (“children”), review the “CHECKLIST: Children (HRP-310)” to ensure you have provided sufficient information for the IRB. If the Human Research involves pregnant women, review the “CHECKLIST: Pregnant Women (HRP-305)” to ensure you have provided sufficient information for the IRB. If the Human Research involves prisoners, review the “CHECKLIST: Prisoners (HRP-308)” to ensure you have provided sufficient information for the IRB. Drugs or Devices If the Human Research involves drugs or devices, describe your plans to store, handle, and administer those drugs or devices so that they will be used only on subjects and be used only by authorized investigators. Multi-Site Human Research If this is a multi-site study where you are the lead investigator, describe the management of information (e.g., results, new information, unanticipated problems involving risk to subjects or others, or protocol modifications) among sites to protect subjects. Sharing of Results or Incidental Findings with Subjects Describe whether results (study results or individual subject results, such as results of investigational diagnostic tests, genetic tests, or incidental findings) will be shared with subjects or others (e.g., the
What are my rights as a research subject? As a research subject, you have the following rights: Be told of the nature and purpose of the research study. Be told of the procedures to be followed, and any drug or device to be used. Be told any common or important discomforts and risks. Be told of any benefits you might expect. Be told of other procedures, drugs or devices that might be better, and their risks and benefits. Be told what medical treatment, if any, is available for complications. Be given a chance to ask questions about the research study. Be told you can stop taking part in the research study at any time without affecting how you are treated. Be given a copy of the signed and dated written consent form. Be given enough time to decide whether to take part without force, fraud, deceit, duress, coercion, or undue influence.
Justify the feasibility of recruiting the required number of suitable subjects within the agreed recruitment period. For example, how many potential subjects do you have access to? What percentage of potential subjects do you need to recruit? Describe the time that you will devote to conducting and completing the research. Describe your facilities. Describe the availability of medical or psychological resources that subjects need as a result of an anticipated consequences of the human research. Describe your process to ensure that all persons assisting with the research are adequately informed the protocol, the research procedures, and their duties and functions. Approvals Describe any approvals that will be obtained prior to commencing the research. (E.g., school, external site. funding agency, laboratory, radiation safety, or biosafety approval.) Local Recruitment Methods This section is for recruitment methods the control of the local site and not central recruitment managed by the sponsor. Describe when, where, and how potential subjects will be recruited. Describe the source of subjects. Describe the methods that will be used to identify potential subjects. Describe materials that will be used to recruit subjects. (Attach copies of these documents with the application. For advertisements, attach the final copy of printed advertisements. When advertisements are taped for broadcast, attach the final audio/video tape. You may submit the wording of the advertisement prior to taping to preclude re-taping because of inappropriate wording, provided the IRB reviews the final audio/video tape.) Describe the amount and timing of any payments to subjects. Local Number of Subjects Indicate the total number of subjects to be accrued locally. If applicable, distinguish between the number of subjects who are expected to be enrolled and screened, and the number of subjects needed to complete the research procedures (i.e., numbers of subjects excluding screen failures.) Confidentiality
CONTINUING REVIEW REMINDER June 10, 2012 <Name of Principal Investigator> <Address of Principal Investigator> <Phone Number of Principal Investigator> <Fax Number of Principal Investigator> <Email Address of Principal Investigator> Dear <Hailing of Principal Investigator>: On <Date of IRB Meeting> the IRB approved the following protocol from <Approval Start Date> to <Approval End Date> inclusive: Title: Investigator: IRB ID: Funding: Grant Title: <Indicate “None” if there is none.> Grant ID: <Indicate “None” if there is none.> or IDE: <Indicate “None” if there is none.> Before <Continuing Review Deadline Date> you are to submit a completed “FORM: Continuing Review (HRP-212)” and required attachments to request continuing approval or study closure. No further reminders will be sent. If you do not submit a completed “FORM: Continuing Review (HRP-212)” and required attachments to request continuing approval or closure by <Continuing Review Deadline Date> you will not be able to submit new research to the IRB until this information has been submitted. If continuing review approval is not granted before the expiration date of <Expiration Date> approval of this research expires on that date. If IRB approval expires, all research activities must stop. This includes recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information. Advertisements currently running in the media must be pulled. Sincerely,
CONTINUATION OF SUBJECTS IN EXPIRED RESEARCH December 31, 2011 <Name of Principal Investigator> <Address of Principal Investigator> <Phone Number of Principal Investigator> <Fax Number of Principal Investigator> <Email Address of Principal Investigator> Dear <Hailing of Principal Investigator>: On <Expiration Date> IRB approval of the following protocol expired: Title: Investigator: IRB ID: Funding: Grant Title: <Indicate “None” if there is none.> ID: <Indicate “None” if there is none.> or IDE: <Indicate “None” if there is none.> Under federal regulations all research activities must stop. This includes recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information. Advertisements currently running in the media must be pulled. Based on discussions with the IRB Office, <the following/no> subjects or class of subjects may continue: <describe here or delete if none> The procedures that may continue must be limited to: <describe here or delete if none> A copy of this letter will be forwarded to the sponsor and your supervisor. Sincerely, IRB Manager
Legally recognized privileged or analogous relationships, such as those of lawyers, physicians, and ministers Religious practices, affiliations, or beliefs of the student or the student’s parent Income than that required by law to determine eligibility for participation in a program or for receiving financial assistance under such program) The right of a parent of a student to inspect, upon the request of the parent, any instructional material used as part of the educational curriculum for the student Any applicable procedures for granting a request by a parent for reasonable access to instructional material received The administration of physical examinations or screenings that the school or agency may administer to a student The collection, disclosure, or use of personal information collected from students for the purpose of marketing or for selling that information (or otherwise providing that information to others for that purpose), including arrangements to protect student privacy that are provided by the agency in the event of such collection, disclosure, or use. The right of a parent of a student to inspect, upon the request of the parent, any instrument used in the collection of personal information before the instrument is administered or distributed to a student Any applicable procedures for granting a request by a parent for reasonable access to such instrument within a reasonable period of time after the request is received Access to instructional material used in a research or experimentation program: All instructional material, including teachers' manuals, films, tapes, or other supplementary instructional material, which will be used in connection with any research or experimentation program or project must be available for inspection by the parents or guardians of the children engaged in such research. Definitions: “Prior consent” means: Prior consent of the student, if the student is an adult or emancipated minor Prior written consent of the parent or guardian, if the student is not an emancipated minor “Research or experimentation program or project” any program or project in any research that is designed to explore or develop new or unproven teaching methods or techniques. “Children” are persons enrolled in research not above the elementary or secondary education level, who have not reached the age of majority as determined under state law. "Psychiatric or psychological examination or test" means a method of obtaining information, including a group activity, that is not directly related to academic
However, GINA will not protect you if you already have a genetic disease or disorder and does not prohibit discrimination on the of an existing genetic disease or disorder. In addition, this new Federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. Please Note: The GINA language section above MUST be included in your consent form if the research proposal involves ANY genetic evaluation of human tissue samples. If the proposal does not involve genetic analysis, this section may be omitted from the consent form.
What will happen to any specimens that I give? Who has reviewed and approved this study? Could I get worse during the study? What will happen if I do? What other options or choices do I have if I decide not to take part? Will I be charged anything or paid anything to be in this study? If I decide to take part in this study, how will it affect my daily life? What will happen to me at the end of the study? Will I be told the results of the study? Who will find out that I am taking part in this study? How do I end my taking part in this study if I change my mind? Whom do I contact for questions and information about the study? What is informed consent? Informed consent is the process of learning the key facts about a research study before you decide whether or not to volunteer. Your agreement to volunteer should be based upon a clear understanding of what will take place in the study and how it might affect you. Informed consent begins when the research staff explains the facts to you about the research study. The research staff will assist you with the “informed consent document” that goes over these facts so you can decide whether or not you want to take part in the study. These facts include details about the study, procedures you may receive, the benefits and risks that could result, and your rights as a research volunteer. Who will answer my questions about the informed consent form? You should take your time when you read the consent form. If you have any questions, ask the research staff. If you don’t understand something, ask them to explain it to you so you do understand. If English isn't your native tongue, ask for an interpreter to be present when you are discussing the study with the research staff. The written and verbal informed consent information will be given to you in a language that you know. You can take the information home with you and discuss it with your family, friends, a health care provider, or others before you decide whether or not to take part in the study. If you decide to take part in the study, you will be asked to sign the informed consent form. However, the informed consent process is more than just signing a piece of paper. It is a
Date Friday, 22 September 2017 Time 1.00pm – 3.00pm Location Ministry of Health, 48 Hereford Street, Christchurch Chair Evan Davies Members in Margaret Wilsher, Tony Lanigan, Dr John Wood attendance Ex Officios Michael Hundleby - Director Critical Projects, David Meates – Chief Executive Canterbury DHB & West Coast DHB Attendees Ministry of Health:, John Hazeldine - Chief Advisor DHB Funding and Planning, Marbeth Isaac – Hospital Redevelopment Finance Manager (via teleconference), Lynn Archibald - minutes CDHB: Bragg, CDHB member/Observer, Dr Rob Ojala – Joint Clinical Lead Facilities Development Project, Dr Richard French – Joint Clinical Lead Facilities Development Project, Brad Cabell, Programme Director Construction and Property RCP: Waren Warfield - Programme Director RLB: Neil O’Donnell – Quantity Surveyor Turner & Townsend Thinc: Leonie Kelly – Project Director, Adrian McLay – Director - item 3. Johnstaff: Alistair Burke (Project Director) items 4 and 5. Item Subject The Chair extended a welcome to Dr Richard French who is sharing the role of Clinical Lead Facilities Development project with Dr Ojala. 1 a Apologies Angela Tony Lloyd Register of Interests Noted Dr Wood’s interests have been added. Minutes and Action Points of 31 August 2017 It was recommended that the minutes of the meeting held on 31 August 2017 were accepted as a true and correct record. Moved from the Chair Carried
Date Thursday, 8 June 2017 Time 10.00am – 12.00pm Location Ministry of Health, 133 Molesworth St, Wellington – room GC.2 Chair Evan Davies (Chair) Members in attendance Margaret Wilsher and Tony Lanigan Attendees Ministry of Health: Michael Hundleby - Director Critical Projects from 11.33am, John Hazeldine - Chief Advisor DHB Funding and Planning, Tony Lloyd Director, Marbeth Isaac - Finance Manager CDHB: Mary Gordon - Executive Director of Nursing, Sir Mark Solomon - Chair CDHB/Observer, Dr Rob Ojala - Clinical Lead Facilities Development Project, Angela Mills - Programme Manager Facilities Development Project, Brad Cabell - Programme Director Construction & Property RCP: Waren Warfield - Programme Director. RLB: Neil O’Donnell Turner & Townsend Thinc: Adrian McLay - Associate, Ross Dunkerley – Regional Director NZ item 3(a). Johnstaff: Alistair Burke (Project Director) items 2(b) and (c) Item Subject Evan Davies opened the meeting at 10.00am and extended a welcome to Sir Mark Solomon who was attending the meeting. 1a Apologies David Meates, Barry Bragg. Apologies for lateness Michael Hundleby. 1b Conflicts of Interest Noted. Margaret advised that she is no longer a Director for the New Zealand Health Innovation Hub. 1c Minutes of 5 May 2017 That the minutes of the meeting held on 5 May 2017 are accepted as a true and correct record. Moved from the Chair Carried With regard to item 9 (carparking). Rob updated the meeting on a short term parking solution the CDHB were investigating.