zilongwang/ReadingBank huggingface dataset:
“Services” is broadly construed to mean providing anything of value, even if no money is exchanged. Examples might be: Traveling to Iran to attend or speak at a conference Providing technical assistance to an Iranian national in Iran or an Iranian institution (cont’d from above) (cont’d from above) Providing unpublished data or research results to a person or institution in Iran Teaching or lecturing as a guest of an institution in Iran Conducting surveys and interviews inside Iran Dealing in Iranian-origin goods or services U.S. persons are prohibited from engaging in any transactions, including purchase, sale, transportation, swap, financing, or brokering transactions related to goods or services of Iranian origin or goods or services owned or controlled by the Government of Iran unless a specific export license or other form of authorization is available. Services provided in the United States by an Iranian national already resident in the United States are not considered services of Iranian origin. Financial transactions with Iran New investments by U.S. persons, including commitments of funds or other assets, loans or any other extensions of credit, in Iran or in property (including entities) owned or controlled by the Government of Iran are prohibited unless a specific export license or other authorization is available. Transactions involving blocked property or with Specially Designated Nationals (SDN) & other Restricted Parties OFAC and other government agencies involved in export controls maintain lists of individuals and entities with whom U.S. persons are prohibited from conducting transactions. Contact for a screening of the Iranian entity with which you wish to engage. Facilitation of transactions with Iran or attempted evasion of the regulations. U.S. persons are prohibited from approving, financing, facilitating or guaranteeing transactions by a foreign person that would be prohibited by the regulations if performed by a United States person or from within the United States. U.S. persons and persons within the United States are prohibited from transactions that evade or avoid, or have the purpose of evading or avoiding, or attempt to violate the regulations.
Components, Parts and/or Accessories as per product label Code catalogue number Elisa, photometry, chemiluminecence,…) Tests (for reagents) File. No: LB-FO-08 Rev: 2 3 of 6 In addition to items 1 to 7, of the Device Registration Application following information is requested, please indicate (X) which of the relevant information requirements listed below are included as attachments to this application. For details regarding content and format please refer to the GUIDANCE FOR “APPLICATION FOR AN IVD MEDICAL DEVICE REGISTRATION Cover Page X Executive summary X Table of contents - Device Description (principles of operation & materials used in construction and packaging, describing each of the functional components of the device, with labeled pictorial representation of the device in the form of diagrams, photographs or drawings.) X. Please refer to Instructions for Use Design Philosophy X. Please refer to Instructions for Use Marketing History X
Part B: Budget Summary Summary of costs Coordinating institution in Hungary Partner institution in Hungary Coordinating institution in the Islamic Republic of Iran Partner institution in the Islamic Republic of Iran TOTAL Labour costs € 0,00 € 0,00 € 0,00 € 0,00 € 0,00 Travel and subsistence € 0,00 € 0,00 € 0,00 € 0,00 € 0,00 Other costs € 0,00 € 0,00 € 0,00 € 0,00 € 0,00 Total € 0,00 € 0,00 € 0,00 € 0,00 € 0,00 Total costs/Partnership € 0,00 Please specify the calculation of specific cost items in addition to the budget sheet. Additional funding Is the project funded through other sources as well? If yes, name the funding agency/organisation and the amount of funding. Has the same proposal been submitted to funding agencies/organisations? If yes, name the funding agency/organisation. Main Applicants Signature:
PROCEDURES AND ASSESSMENT OF STUDENT LEARNING. Introduction: Student’s Actions Teacher’s Actions Resources Time Students will come in and settle down for class. Students will use notecards to participate in a discussion about what the class as a whole presented about Iran at the end of the last class period. Greet the class and introduce the topic for today. (This is summarized in the Rationale.) Students will use notecards (their homework assignment) to participate in a discussion using the following questions: What connections are you beginning to see between Iran’s government and Islam? Between foreign involvement and conflict in Iran? How might these events relate to what you already knew about Iran? 2 min. 10-15 min. Body of Lesson: Student’s Actions Teacher’s Actions Resources Time Students will participate in a class discussion about what they learned last time about Iranian history concerning: Islam’s role in Iran, the Constitutional Revolution of 1906, the Spheres of Influence, WWI, and WWII. Using the first several slides of the PowerPoint, you will engage the students in a discussion/mini-lecture about the information that was covered in the reading last class period. You will do this by: Clicking on a slide and asking the students what they remember about that particular topic (if they have their readings from last time then they can have them out). During these discussions, ask the students questions that probe at deeper issues or the main ideas of each topic. After the discussion, show the main points of that topic on the slide and move on. The topics that will be covered are Islam’s role in Iran, the Constitutional Revolution of 1906, and the Spheres of Influence. These discussions do not have to be very long, e When you get to WWI and WWII, there are clips that go with them. Discuss the topic with the students, summarize the PowerPoint. Blood and Oil. (2 min.) 10-15 min. 15 min.
Mining Managing Director Reza CHABAHAR MAMOON MINING CO. 12 IT Managing Director Vahid Safari PAYAAFZAR 13 Construction Managing Director Mohammad Bitarafan ABARGAN SAZEH FARVARDIN 14 Agriculture CEO Member of Board Amir Mohammad Mohammadi Mohammadtaghi Mohammadi PARSIRAN NOVIN 15 Medical Equipment Managing Director Rasoul Khoram ATRIN INDUSTRY PARSIAN TEB 16 Agriculture Managing Director Mohammad Baradaran SHOKHMIRAN 17 Agricultural Industry CEO Siamak Kolbadi NEGIN SABZ BORNA 18 Agriculture CEO Seyed Vahid Reza Abtahi NATIONAL UNION OF AGRICULTURAL COOPERATIVES OF IRAN ORCHARD OWNERS 19 Engineering and Technical Service Member of Board Alireza Kadkhodaei ENGINEERING AND TECHNICAL SERVICES EXPORT ASSOCIATION 20 IT Hamid Afshari IRANIAN MARKET TECHNOLOGY SERVICES 21 Medical Equipment Mohsen Shahadi Far GOSTAR 22 Pharmaceutical Nano technology Mahnaz Ghomi (Mrs) EXIR NANO SINA 23 Software-Hardware IT Mrs. Ava Heidari PAZHOHESH KHAVAR 24 Oil and Gas Equipment Mosayeb Alishir PETRO PAZHOHESH AHORA 25 Laboratory Equipment Mr. Peyman Fekri DANESH TAJHIZ FARZANEH 26 Medical Consuming materials Mehdi Shahmoradi BEHBAN SHIMI 27 Communications Ali Ghafori SABA ERTEBATE SHARIF 28
3 1. 4 2. 4 2.1. 4 2.2. 7 2.3. 8 2.4. 9 3. 11 3.1. 11 3.2. - 15 4. 17 4.1. 17 4.2. 18 4.3. 18 4.4. 23 4.5. 25 4.6. 25 5. SWOT 26 6. 28 7. 29 1: – 31 2: 34 34 (EEG) 35 36 37 38 PV 39 EEG: 40 41 3: 43 43 45 47 48 4: 49 5: 52 53 List of Figures
Annex 5: Spanish support schemes Feed-in tariffs and premiums for electricity from wind and solar energy sources, 2008 Source: IEA, 2009 p. 98 Feed-in tariffs for PV solar power plant since January 2009 Source: EPIA National PV profiles in Spain (18/03/2009) References A Draft of National Document for Strategic Technology Development, Renewable Energies, Iran, November 2009 AEE (2009): Asociacion Empresarial Eolica: Installed Wind Energy capacity in Spain reaches 16,740 MW with new 1,609 MW in 2008; last download: 18.01.2010 AHK (2009): Deutsche Handelskammer: Deutsch – spanische Wirtschaft, Tecnologías renovables de futuro, 2 0 0 9 Septiembre / Octure; http://www.ahk.es/fileadmin/user_upload/Revista/ECONOMIA_2009-3.pdf; last download: 18.01.2010 Appleyard, D., (2010) India’s Solar Spree. Renewable Energy World. 10 March, 2010. http://www.renewableenergyworld.com/rea//news/article/2010/03/solar-energy, last access 5 August 2010. Atabi, F. (2004), Renewable Energy in Iran, Challenges and Opportunities for Sustainable Development, International Journal of Environmental Science and Technology, Vol. 1, No. 1, PP 69-80, Spring. Bechberger, M. (2009): Erneuerbare Energien in Spanien, Erfolgsbedingungen und Restriktionen; Ecological Energy Policy, Band 10, ibidem- Verlag, Stuttgart BMU (2010): Pressemitteilung vom 06.05.2010: Änderung der Solarvergütung beschlossen, Nr. 063/10, Berlin, 06.05.2010; http://www.erneuerbare-energien.de/inhalt/45985/4596/; last download: 06.09.2010 BMU (2009): Renewable energy sources in figures - national and international development;
In the Post-Review state for a study being closed, the study closure letter template is presented instead of the approval template. The letter, along with the closure e-mail notification that is sent, inform the PI of the study closure. Combined and Separate Modifications and Continuing Reviews Modifications and continuing reviews can be created either separately or combined into a single submission. Combining them often makes sense. For example, suppose the study team wants to submit a consent form change about the same time that a continuing review is due. Both can be submitted and reviewed together, reducing the overhead for the study team, IRB staff, and reviewers. Caution for separate modifications and CRs: In one situation, separate modification and CR submissions that are open concurrently can both affect the attached documents. This creates potential contention over the finalization and stamping of documents. Contention can occur when a CR (or a combined modification / CR submission) is open concurrently with a separate modification that includes other parts of the study (not limited to study team membership). To handle potential conflicts in these situations, we recommend this approach: Approve the modification first before approving the CR (completing it through the Send Letter activity). This prevents contention. If you must approve the CR first, be aware that the modification will later overwrite the stamping of documents done by the CR. To correct this, make sure you finalize again in the modification all documents you finalized in the CR. Pre-Review for Modifications and Continuing Reviews Pre-review information is read-only for continuing review submissions and for modification submissions that are limited to study team membership changes. These types of submissions should not affect the pre-review information, so only the final question on the Submit Pre-Review form requires an answer. For modifications and modification / CRs that include other parts of the study, the Submit Pre-Review form is fully editable, and the answers update the study's pre-review information when the modification is approved. RNI Process Overview The basic process for reportable new information (RNI) is shown in the following diagram. The exploded view shows what occurs during the IRB review process. The legend indicates who can take major actions during each state within the process. Keep in mind that the diagram does not show all possible paths that a submission may take. The diagram shows the most likely path through the review process with common options identified. Unlike all other submission types, an RNI submission: Does not include ancillary review.
IRB Study Guide Instructions for submitting a study for review. Click the Help Center link on the left. On the Guides tab, click the name of the guide to open it. IRB Study Reviewer's Guide Instructions for reviewing an IRB submission. IRB Staff Administration Guide An overview of the IRB review and administration process. IRB Library Document templates, checklists, and IRB procedures. Click the Library link on the left.
Type of Submission (N=new, M=modification, CR=continuing review, PV=protocol violation, AE=adverse event report) Description (include items submitted, description of changes, etc.) Date of Submission Date of Approval Date of Expiration (only for New and Continuing Review) Electronic Paper
RISK IS MORE THAN MINIMAL RISK Mothers consent Mothers consent Mother and Father’s consent NOT APPROVEABLE BY THE IRB RISK IS NO MORE THAN MINIMAL RISK Mothers consent Mothers consent Mother and Father’s consent Mother’s consent Informed consent will be obtained by: Permission from mother only Permission will be obtained from both mother and father (unless father is absent, incompetent, unknown, or the pregnancy resulted from rape/incest) A waiver of informed consent/ waiver of documentation of informed consent NOTE: If a waiver is requested, please explain the reasons for this waiver.
Qualtrics Other (please specify) 1.4. Informed Consent Does the software provide a record that captures that a respondent has consented to the survey before survey initiation? Yes No If ‘YES’, please describe and attach the implied consent with the IRBNet package submission. 1.5. Secure Transmission Information sent to and from web sites can either be transmitted in clear text that could be read if the information was intercepted by a third party (http protocol) or encrypted so that a third party could not read the intercepted information (https protocol). Are there controls in place to prevent a respondent from accidentally entering survey data via the http protocol instead of the https protocol (i.e., does the server display an error message or automatically re-route the respondent to an https page)? Yes No Does the survey tool use https encryption? Yes No 1.6. Database Security Do researchers have access to their data in the database via a username and password? Yes No Has the software company maintaining the database signed confidentiality agreements preventing them from improperly accessing or disclosing information contained in databases? Yes
2. PARTICIPANTS: Describe your participants. Who are your participants and how will you recruit them? What is your estimated sample size? What demographic information will you collect from your participants and why is it relevant to your 3. METHODOLOGY: Describe in detail and in sequence the study procedures that will involve these human participants. What will your participants do as part of your study? 4. RISKS: Describe the risks for participants. What steps will you take to minimize risks? What options will be available to participants who experience adverse effects? 5. BENEFITS: Describe the benefits of this study for participants and for the broader academic community. In addition, are you offering payment or other inducements to participants in this study? 6. PRIVACY: Describe the procedures for protecting the privacy of your participants. How will you maintain privacy during the study? Where will you store the data and research records and how will you ensure their security? When will your data be destroyed?
[Consent Notice – Instructions on this template are in brackets. Remember to these instructions and brackets when preparing your consent notice. Make sure that your consent notice has been proofread for typographical, grammar, and spelling errors. This notice may only be used for minimal risk research involving adults where the signature that appears on the traditional consent form is waived.] CONSENT NOTICE TITLE OF STUDY NAME OF RESEARCHERS [In addition to your name, also include your title or affiliation in this section, for example, Ph.D. or San Jose State University graduate student. If you are a student, include your faculty supervisor’s name also.] PURPOSE [Describe what your study is about and why the study is being conducted.] PROCEDURES [Describe what participants will be asked to do and the time involved.] COMPENSATION [Provide information about the amount and nature of any compensation being offered. Otherwise, state that there is no compensation for participation.] CONFIDENTIALITY [Describe whether any identifying information will be collected and, if so, the manner and degree to which confidentiality will be maintained as well as who has access to the data.] YOUR RIGHTS [The following sample text summarizes participants’ rights.] Your participation in this study is completely voluntary. You can refuse to participate in the entire study or any part of the study without any negative effect on your relations with San Jose State University or [name any other participating institutions]. You also have the right to skip any question you do not wish to answer. CONTACT INFORMATION [Include the best way for participants to contact you if they have any questions about your study. If you are a student, please also add your faculty supervisor’s contact info.] AGREEMENT TO PARTICIPATE Your completion of the study indicates your willingness to participate. Please keep this document for your records.
Iraq Conditions Counterplans Iraq Conditions Counterplans 1 Generic – AT: Perm Do CP 3 Generic – AT: Perm Do Both 4 ** Corruption Reform CP* 5 1NC Shell 6 1NC Shell 7 Solvency Advocate 8 Solvency – Reforms 9 Solvency – Reforms 10 Solvency – Reforms 11 Solvency – Quid Pro Quo 12 Impact – Terrorism 13 Impact – Sickness 14 Impact – Ethnic Conflict 15 Impact – Democracy 16 Impact – Collapse 17 Impact – Laundry List 18 Impact – Dehum 19 Impact – Genocide 20 Impact – Instability 21 Impact – Regional Conflict 22 Impact – Regional Conflict 23 Impact – Regional Conflict 24 Impact – Global Instability 25 Iraq Says Yes 26 Iraq Says Yes 27 Politics – Link Shield 28 **Aff Answers** 29 Non-Unique 30 Rapid Withdrawal Key 31 A2: Solvency – Quid Pro Quo 32 A2: Impact – Democracy 33 A2: Impact – Terrorism 34 A2: Impact – Instability 35 A2: Solvency – Reforms 36 ** Denuclearization CP** 37 1NC Shell 38 1NC 39 1NC 40 Solvency- Bargaining Chip 41 Solvency - Says Yes 42 Solvency - Says Yes 43 Solvency - Says Yes 44 Internal Link - Concessions Needed 45 Impact – Iran Prolif 46 Impact – Iran Prolif 47 2NC AT: Appeasement DA 48 2NC AT: AIPAC 49 2NC AT: AIPAC 50
The content of the consent form must be written at a level appropriate to potential participants and use of technical jargon should be avoided. When technical or unfamiliar terms must be used, explain these terms in language understandable to a layperson. If the participants do not read English, the consent form must be translated into the appropriate language. Because TWU has many studies that use a Spanish translation of the consent form, the Spanish translation of the required verbatim statements are included in this Guide. Please note that names of individuals and agencies are used as is and do not get translated. The consent form should be typed using a legible type font (preferably no smaller than 11-point). A parent/guardian must sign the consent form if the subjects are minors. A who is capable of reading and understanding may sign an assent form that indicates the youth’s agreement to participate. An assent form can be used in addition to but not in place of the consent form signed by the parent/guardian. The following elements MUST be included in all consent forms. (A) The heading: TEXAS WOMAN'S UNIVERSITY CONSENT TO PARTICIPATE IN (B) The of your study (C) The degrees, and office phone numbers of the investigator(s) and advisor (if applicable). Do not use the title of “Dr.” in the names of persons with doctoral or medical degrees; just list the degree at the end of the name (Ph.D., Ed.D., M.D., etc.). Inclusion of home phone numbers is not recommended. E-mail addresses may also be listed. (D) A description of the research study, which must include the following: NOTE: The descriptions of these elements in the consent form must match the descriptions provided in the IRB application. An explanation of the purpose of the research. A description of the procedures to be used in the study, including details of the participant’s involvement, and identification of any procedures that are experimental. The total time commitment for the participant. If audio or video taping will be used, an explanation of the purpose of the taping and who will have access to the tapes. A description of potential to the participant and the steps that will be taken to minimize those risks. The risks identified on the consent form and the steps to minimize those risks must match the risk information in the application.
joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort. Submission Guidelines and Procedures The IRB accepts submissions on a rolling basis throughout the year. Researchers must complete and submit the required application online and upload supplementary documents as required through the IRB portal system available at . The IRB only accepts electronic submissions, and this includes all revised applications. The IRB will not accept hardcopy submissions or resubmission. Researchers submitting IRB applications are responsible for producing and filing applications in compliance with all of the guidelines posted on the IRB website at . It is the responsibility of the applicant to ensure that he or she has permitted a sufficient amount of time for a judicious review to occur. Researchers should therefore submit their applications well in advance of your intended start date to give the IRB sufficient time to review applications. There is no statutorily required time limit to completing a given review. The duration of a given review will depend on how many rounds of revision are required. The IRB will make a good-faith effort to review each application within (2 – 3 weeks) of having received a properly submitted application. Missing information or supportive documentation will delay this time-line. The IRB’s Graduate Assistant will maintain all records, of application dates and reviews in the IRB database overseen by the IRB Chair and Vice Chair. Research in Schools and Institutions Research in schools or agencies must have administrative consent/permission prior to recruitment. This will often require that a separate review by the school district, agency, or institution ethical IRB (or REB). Projects that fall under this domain may not receive final approval from the University without first receiving approval from the partnering district/agency. Researchers may receive conditional approval, which they may submit along with the application should that agency or institution require conditional university IRB approval. Please be sure to contact the school district/agency directly to determine protocol. It is the responsibility of the
Research Participant Information Provide information about the subject population (e.g., including age, gender, inclusion/exclusion criteria, and disease state). Total Sample Size Total number of subject records or samples N = Sample size rationale Provide justification for the sample size and it is adequate for answering the research question(s). Waiver or Alteration of Informed Consent To approve a waiver of informed consent, all of the following criteria must be justified by the research. Provide a protocol specific justification for each. The research involves no more than minimal risk to the subjects. Provide a protocol specific rational. The waiver or alteration will not adversely affect the rights and welfare of the subjects. Provide a protocol specific rational. The research could not practicably be carried out without the waiver or alteration (it is impracticable to perform the research if obtaining informed consent is required and not just impracticable to obtain consent). Provide a protocol specific rational.
INFORMATION For studies following a multi-center or sponsor protocol, please use this to assist in your completion of this form. For questions regarding definitions, policies, or terms referenced below see the . Study Title and Number from IRBaccess Principal Investigator Name Position UT EID E-mail Address If principal investigator is a student, describe how the PI is qualified/trained to conduct this study. Faculty Sponsor (required if the PI is a student) Name Position UT EID E-mail Address Describe how faculty sponsor will oversee the conduct of the study. Primary Point of Contact (if different from PI) Name Position UT EID E-mail Address Additional Research Staff Research staff other than the principal investigator will conduct human subject research. If additional personnel will be engaged in conducting research human subject research, complete and upload the Engaged in human subject research is defined as contact or interaction with research participants through recruitment, informed consent process, data collection, analysis of or access to identifiable research data. Purpose and Rationale for Conducting Research
Please review the to confirm if your research involves human subjects. If you determine that your study does involve Human Subjects Research, you must complete the IRB Research Protocol Involving Human Subjects, form 1004. Role of the Institutional Review Board (IRB) Mission: The mission of the RVU Institutional Review Board (IRB) is to assure adequate protections of the rights and welfare of human subjects research. To achieve this, the RVU IRB advises investigators in designing research projects in a manner to minimize potential harm to human subjects, review all planned research involving human subjects prior to initiation of the research, approve research that meets established criteria for protection of human subjects, and monitor approved research to ascertain that human subjects are indeed protected. Function: The RVU Institutional Review Board (IRB) reviews all , submitted by students, faculty and/or staff involving human subjects. The IRB has the authority to approve, require modification, or to disapprove any research project, in accordance with standards set by the U.S. Department of Health and Human Services (HHS). For additional information about the IRB’s constitution, see the . (section G.) Research and IRB Review Categories If you are conducting research that involves human subjects, you must determine which research application to submit. The IRB reviews and approves research under three distinctive categories, specified by federal regulations: Exempt, Expedited, and Full IRB Research Review. A. Exempt Review Certain research is exempt from the requirements of the HHS regulations. Nevertheless, a determination that research is exempt does not imply that investigators have no ethical responsibilities to subjects in such research. Rather, it means that the regulatory requirements related to IRB review, informed consent, and assurance of compliance do not apply to the research. At RVU the IRB is responsible for determining whether proposed research is exempt from HHS regulations for the protection of human subjects. To determine if your prospective project may qualify as Exempt, please review the and the . If the project meets the description of an Exempt project, please click here: "Request for Review - EXEMPT Research" and complete the form (1001). B. Expedited Review An Expedited review procedure consists of a review of research involving human subjects by the IRB Chairperson, or by one or more experienced reviewers designated by the Chairperson from among members of the IRB, in accordance with the requirements set forth in 45 CFR 46.110.
Quality standard for water sources according to regulations issued by Iraqi government ( Regulation 25 ) 3.14 7.25 (ds/m at 25o) EC PH 57.0 Ni2+ Total concentration for trace elements mg kg-1 3.20 Cd2+ 318.0 Pb2+ 378.0 Zn2+ 126.0 Cu2+ 355.0 Mn2+ 2525.0 Fe3+ 14.0 Total 12.5 gm kg-1 N 7.5 PO4 350.0 K Organic matter 120.0 NH2-N Mic/g 116.0 NH3-N Mic/g 42.0 SO42- 4.01 HCO3- - CO32- 16.20 CL- 0.97 K+ 17.30 Na+ 18.2 Mg2+
14. It is the responsibility of the researcher to consider any potential risk that a participant might experience. Risk to participants may be tolerable in research as long as it is necessary to gather the information and as long as the researcher has provided appropriate ways to minimize the risk. Carefully estimate risk level assumed by your participants in the table below. Level of risk A. Psychological stress greater than life (potential to perceive topic or materials as threatening, offensive, degrading, etc.) Not applicable Minimal risk Substantial risk Describe circumstances that could lead to risk if applicable. Attach additions if necessary. B. Social or economic stress greater than daily life (potential to perceive experience as potentially damaging to financial standing, to employability or ability to retain job, or to reputation) Not applicable Minimal risk Substantial risk Describe circumstances that could lead to risk if applicable. Attach additions if necessary. C. Physical or medical risk greater than life (potential for physical injury or negative impact on health) Not applicable Minimal risk Substantial risk Describe circumstances that could lead to risk if applicable. Attach additions if necessary.
18+ 65 + Other age range (Explain): All genders Females only Males Only Other (Explain): Non-English Speakers College Students General public Public officials Agency/Institutional officials Provide any other subject characteristics for inclusion in your project: List all methods of subject recruitment (Select all that apply): Flyers/letters Emails Telephone In-class announcement Subject pool Tabling in public Personal network/Snowball sampling Passive recruitment Social media post Other (Explain): Describe the step-by-step recruitment methods for each subject group (do not include any other project procedures in this section): List the setting(s) of the research activities (Select all that apply): CSULB (in class) CSULB (out of class) (online) Other College Campus K-12 School Lab Public setting Nonprofit or Other Agency Government Facility Foreign Country Subject’s work/home Prison/Jail Telephone Email Social media Amazon mTurk Online (general public) Other List the location of the research activities (Agency/school names, city, county or social media site): Do you have permission from the facility, institution or director of the organization to conduct your project? * If yes, please attach signed permission letter or data sharing agreement to this package. Yes* No In Progress Is the project primarily for training purposes? Yes No Other (Explain): List all methods of data collection (Select all that apply): Surveys/Questionnaires Groups Educational Tests/Assessments Accessing Public Records Observation Audio recording Video recording One-on-One interviews Data Mining Digital media (videos, pictures, simulation) Access to medical/academic records Biospecimen Analysis Experimental Controls Other (Explain) Is there an experimental group compared to a control group? Yes No Describe the step-by-step procedures of your project beginning with the informed consent process and continuing with all other project activities (all project activities must occur AFTER IRB approval): Will subjects be compensated for their participation? If monetary compensation is to be provided, please specify the amount and provide a justification for that amount that avoids potential coercion.
A. Psychological stress greater than daily life (potential to perceive topic or materials as threatening, offensive, degrading, etc.) Minimal risk Substantial risk Describe circumstances that could lead to risk if applicable. Explain how you will try to minimize the risk to your participant(s) and how you will handle the risk if a participant complains. B. Social or economic stress greater than daily life (potential to perceive experience as potentially damaging to financial standing, to employability or ability to retain job, or to reputation) Not applicable Minimal risk Substantial risk Describe circumstances that could lead to risk if applicable. Explain how you will try to minimize the risk to your participant(s) and how you will handle the risk if a participant complains. Attach additions if necessary. C. Physical or medical risk greater than life (potential for physical injury or negative impact on health) Not applicable Minimal risk Substantial risk Describe circumstances that could lead to risk if applicable. Attach additions if necessary. Explain how you will try to minimize the risk to your participant(s) and how you will handle the risk if a participant complains. Not applicable Minimal risk
If >MR with children, check if risk is a minor increase over minimal risk What types of benefits are described in the IRB protocol/IRB application or other materials? No direct benefit anticipated to participants; future benefits to society only Non-Therapeutic Direct Benefits to research participants Direct Therapeutic Benefits to research participants (explain): Are the benefits described in consent form are consistent with all other IRB application materials? Yes No Pending Comments: Concerns: Requirements: Recommendations: Financial Conflict of Interest (fCOI) Disclosures for PI and other “investigators for the purposes of COI” (See IRB Office Review Worksheet) No COI/No Issues Disclosures pending; Significant Financial Interest (SFI) disclosed fCOI Committee Approved Management Plan in place SFI disclosed appropriately in ICF Comments: Concerns: Requirements: Recommendations: Assent Form (s). Generally required if you are planning to enroll participants age 7-12. Present N/A Pending Comments: Concerns: Requirements: Recommendations: Information Sheet (if applicable). Required when requesting a waiver of documentation of informed consent, when IIHI or PHI is NOT involved. Present N/A Pending Comments: Concerns: Requirements: Recommendations: Information including authorization to access, use, or disclose IIHI or PHI (if applicable). Required when requesting a waiver of documentation of informed consent, when IIHI or PHI is involved. Can be used for exempt research that involves IIHI/PHI. Present N/A Pending Comments: Concerns: Requirements: Recommendations: Short Form(s). May be used for certain studies when enrolling non-English speaking participants or those with Limited English Proficiency (LEP). Indicate languages: Arabic; Simplified Chinese; Traditional Chinese; English; Haitian Creole; Spanish Present N/A Pending Comments: Concerns: Requirements: Recommendations: HIPAA Waiver(s). Present N/A Comments: Concerns: Trial
Q4: Does the activity involve obtaining, accessing, using, disclosing, or sharing any of the following? Individually identifiable private information from a living individual Education records that can be linked to any living individual Protected Health Information (PHI) about any individual (living or deceased) Substance information that can be linked to any individual (living or deceased) Genetic information that can be linked to any individual (living or deceased) HIV related information that can be linked to any individual (living or deceased) Identifiable specimens (living or deceased) Use of human specimens to validate a medical device, diagnostic instrument, or laboratory test Answer to Q4: (a) YES, FOR RESEARCH PURPOSES. If you selected “YES, FOR RESEARCH PURPOSES,” the activity meets the definition of “human research;” therefore, complete an IRB Application. (b) YES, FOR RESEARCH & OTHER PURPOSES. If you selected “YES, FOR RESEARCH & PURPOSES,” the activity meets the definition of “human research;” therefore, complete an IRB Application. (c) YES, FOR RESEARCH; HOWEVER, THE INSTITUTION IS NOT ENGAGED IN HUMAN RESEARCH. If you selected “YES, FOR RESEARCH; HOWEVER, THE INSTITUTION IS NOT ENGAGED IN RESEARCH,” go to Q6. (d) YES, FOR NON-RESEARCH PURPOSES ONLY (e.g., for quality improvement, healthcare operations) If you selected “FOR NON-RESEARCH PURPOSES ONLY,” go to Q5. (e) NO. If you selected “NO,” go to Q5. GUIDANCE FOR Q4:
SUNY Downstate Medical Center University Hospital of Brooklyn College of Medicine College of Health Related Professions College of Nursing School of Graduate Studies Graduate Program in Public Health IRB Decision Aid (Application for a Determination Letter to that IRB Approval is NOT REQUIRED) Whenever you are not sure how to answer a question, contact the IRB for help. Questions may be directed initially to: IRB Phyllis G. Supino, EdD at (718) 613-8355 Executive Director, Kevin Nellis at (718) 613-8461 IRB Staff at (718) 613-8480 For additional guidance on human subjects research, see: Privacy and HIPAA related questions may be directed to the Downstate Privacy Officer, Shoshana Milstein, at (718) 270-7470. Information Security related questions may be directed to the Downstate Information Security Officer, David Loewy at (718) 270-2431. For animal research, see: This guidance incorporates HHS regulatory definitions as well as HIPAA, FDA, and other Federal and NY state regulations. SIX TYPES OF REVIEW: REQUIRED FORM: Determination Letter (indicates IRB review is NOT required) Use this form to document and request such a determination. Exempt Review Follow the instructions on the “Application for Exempt Review” Expedited Review Follow the instructions on the “Application for Expedited or Full Review” Convened (Full) IRB Review Follow the instructions on the “Application for Expedited or Full Review” Use of a Humanitarian Use Device (HUD) for clinical purposes Follow the instructions on the “Application for HUD for Clinical Purposes” External IRB Review (some multi-site research) Follow the instructions on the “Application for External IRB Oversight” Three Key Definitions: Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Research participant means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information. Human Research (also known as Human Subjects Research) means any activity that involves a research participant in a research activity. An IRB application is required for all Human Research.
NO. If you selected “NO,” skip to Q9. Q7: Regardless of where the activity will take place, will Downstate receive any Federal funding or support for this activity (including funds passed through another institution)? YES. “yes” for Q8. NO. Regardless of the answer, go to Q8. Q8: Are any activities carried out by a faculty member, employee, student, or agent that would result in SUNY Downstate being ? YES. If you selected “YES,” the activity requires an IRB application, therefore, complete an IRB Application. Be sure to answer Q10c. NO If you selected “NO,” go to Q9. GUIDANCE FOR Q8: See or contact the IRB for assistance. Q9A: Will the activity include to posting or providing advertising or recruitment materials at SUNY DMC to inform others research taking place at another institution? NO. If you selected “NO,” go to Q10.
City, Zip City, State, Zip Telephone Number Telephone Number JSU E-mail address JSU E-mail address TITLE OF STUDY: PURPOSE OF STUDY: You are being asked to take part in a research study to determine (describe the of your study). The goal of the research project is to determine the relationship (if any) between certain (variables, conditions, ideas, etc.) and (any other procedures as they are explained to the participant). METHODS AND PROCEDURES: The entire procedure should take (time required for completion of forms/procedures). If you agree to take part, (explain what they are being asked to do to participate. Follow the example.) you will first be asked several questions about personal and background information such as your age, race, education level, and prior (describe instruments and what they measure. Follow the example.) a brief form of intelligence. The
Investigators must obtain informed consent and research authorization, prior to enrolling a research participant into a study and/or conducting any procedures required by the protocol, unless waived by the IRB. Individuals obtaining consent MUST be identified on the application form. Although the PI may delegate the responsibility for obtaining consent from research participants to members of his/her research team, the PI retains ultimate responsible for insuring that each prospective participant is adequately informed about all aspects of the research and understands the information provided. The consent process does not end with the formal signing of the consent document. Rather, it is an ongoing process that continues throughout the participation in the study. The investigators remain responsible for continued assessment of the research participant’s understanding of what is happening to him/her, his/her willingness to participate and for providing the research participant with any new information that may affect their willingness to participate. It is the PI's responsibility to train and supervise the study personnel who are obtaining consent. An adult research participant has the capacity to consent to his or her own participation in a research activity if (s)he demonstrates an appreciation: that the activity is research, not standard treatment for his/her disease or condition; of the risks and benefits of a study; of the alternatives that are available; and that, if (s)he chooses not to participate, this decision will be accepted without penalty, i.e., without jeopardizing clinical care. In reaching a decision about participation, it is essential for the potential research participant to demonstrate an ability to use this information in a rational manner as determined by the PI or in consultation with a Psychiatrist if necessary. Thus, in considering risks, benefits, and available alternatives, research participants should demonstrate they understand the aspects of these factors that are unique to them as individuals. To highlight this distinction, a person who is suffering with severe depression may be able to demonstrate an appreciation of the above, but may not care, or may want to accept the risks. Such individuals should not be considered for the research.
SUNY Downstate Medical Center University Hospital of Brooklyn College of Medicine College of Health Related Professions College of Nursing School of Graduate Studies Graduate Program in Public Health IRB Guidance: Recruitment, Referral and Screening of Research Participants, Advertising, & Incentives For more information please contact the IRB Office at 718-270-8480. Privacy and HIPAA related questions may be directed to the Downstate Privacy Officer, Shoshana Milstein, at (718) 270-7470.
Where the party responding to an EIR, FOIA or FOI(S)A request determines that it will disclose information it will notify the other party in writing, giving at least four (4) calendar days’ notice of its intended disclosure. Confidential information The receiving party agrees to take all reasonable steps to protect the confidentiality of the confidential information and to prevent it from being disclosed otherwise than in accordance with this agreement. Subject to clause 3.4 below, the participating organisation agrees to treat the results, excluding any clinical data of the study, as confidential information disclosed by the sponsor and the sponsor agrees to treat Personal Data as confidential information disclosed by the participating organisation. The receiving party agrees: To ensure that any of its employees, students, researchers, consultants or who participate in the operation of the study are made aware of, and abide by, the requirement of this clause 3 and, where relevant, clause 2. To use confidential information solely in connection with the operation of the agreement and not otherwise. Not to disclose confidential information in whole or in part to any person without the disclosing party’s prior written consent. The provision of clause 3 not apply to the whole or any part of the confidential information that is: lawfully obtained by the receiving party free of any duty of confidentiality; already in the possession of the receiving and which the receiving party can show from written records was already in its possession (other than as a result of a breach of clause 3.1 or 3.2); in the public domain than as a result of a breach of clause 3.1 or 3.2); independently discovered by employees of the receiving party without access to or use of confidential information; necessarily disclosed by the receiving party pursuant to a statutory obligation; disclosed with prior written consent of the disclosing party; necessarily disclosed by the receiving party by virtue of its status as a public authority in terms of the Freedom of Information Act 2000; published in accordance with HRA expectations on research transparency. The restrictions contained in clauses 2 and 3 shall remain in force without limit in time in respect of Personal Data or which relates to a patient, his or her treatment and/or medical records. Save as aforesaid and unless otherwise expressly set out in this Agreement, these clauses shall remain in force for a period of 10 years after the termination or expiry of this Agreement.
N/A Short Form(s) Long Form(s) (E.g., amendment needed for translated written consent document, information sheet, etc) All IRB application materials are congruent with one another: N/A Yes NO: Changes requested below. Marked-up copy of the consent document/information sheet attached: N/A Yes NO: Changes requested below. Criteria met for IRB approval: N/A Yes NO: Changes requested below. CHANGES REQUESTED: Specific Changes needed for Conditional Approval: (PLEASE BE AS SPECIFIC AS POSSIBLE) 1) 2) General Modifications Required: 1) 2) Recommendations (optional/not required): 1) 2) Comments: 1) 2) Approval Decision: For Expedited Reviews: Approval. Approval as submitted, no changes required. Conditional Approval or Modifications Required. The revised submission returned for review by an expedited reviewer. Refer for additional review by IRB member with the following area of expertise: Refer to IRB Chair. IRB Chair to resolve controverted issue(s) with PI. Refer to Full Board. PI not willing or not able to make requested changes. For Full Board Reviews: Approval. Approval as submitted, no changes required. Conditional Approval. Approval is subject to verification of specific requested revisions required to meet all approval criteria. Revisions submitted back to an expedited reviewer before final approval granted. Modifications Required. General changes submitted back to the full board). Disapproval (the submission is not approvable). Approval Period: on the assessed degree of risk and other factors outlined in (page 73-74), specify the approval period for this study: 12 months. If not 12 months, list the number of months (not to exceed 12): If less than 12 months, please explain: 1)
PROTOCOL REVIEW Date: Reviewer: IRB #: Principal Investigator: Review Type: Initial Expedited Exempt Continuing Recommendation: Full Approval No changes needed; approved as is. Pending Approval Requires minimum clarifications, protocol modifications, or consent revisions. Deferred Requires substantive clarifications, protocol modifications, or consent revisions. Disapproved PROTOCOL CHECKLIST Evaluation Area Comments Is a sound purpose statement provided? Yes No Does the rationale for the include a brief description of the relevant literature to convey significance? Yes No Are research questions or hypotheses researchable and consistent with the purpose statement? Yes No Is selection of subjects equitable, given the purpose of the research and the setting in which the research will be conducted? Yes No Are recruitment procedures adequately described and consistent with protection of human subjects? Yes No Are procedures consistent with sound research design and include a step-by-step explanation of procedures that will be performed with human subjects? Yes No Is data analysis (whether quantitative or qualitative) appropriate to answer the research questions or test the hypotheses? Yes No Are research risks to subjects reasonable in relation to anticipated benefits? Yes No Are risks to subjects and procedures for minimizing risks adequately described? Yes No If there are vulnerable populations (minors, pregnant women, economically or educationally disadvantaged, intellectually disabled, prisoners) involved, are additional safeguards included in the study to protect these subjects? Yes No N/A Are potential benefits of the research to the individual and society adequately described? Yes No Are there adequate provisions to protect the privacy of subjects and maintain confidentiality of data? Yes No