Congratulations and thank you for your support of the\nPittsburgh Regional Science and Engineering Fair and the students participating\nin the fair! <\/p>\n\n\n\n
You have been identified as a member of the local\ninstitutional review board (IRB) for your school for the purposes of reviewing\nPittsburgh Regional Science and Engineering Fair projects involving human\nparticipants.<\/p>\n\n\n\n
Logging In and Accessing Forms<\/strong><\/p>\n\n\n\n In order to sign the required form for the student(s), you will need to log in to your account at https:\/\/www.STEMisphere.org\/PRSEF<\/a>. <\/p>\n\n\n\n An account was\ncreated for you when the student or their adult sponsor added your name to the\nstudent\u2019s profile. You should have\nreceived an email from CSC STEMisphereInfo at <\/a>STEMisphereInfo@CarnegieScienceCenter.Org<\/a> with\ninformation about how to log in. Please\ncheck your junk mail folder if you do not see this email. <\/p>\n\n\n\n Use the link in the\nemail to set your password and log in. If you cannot find the email, navigate\nto https:\/\/www.STEMisphere.org\/PRSEF<\/a> and use the Forgot your Password link to\ngenerate a new email.<\/p>\n\n\n\n Once you have logged\nin, you should see a list of students and their project titles. For each\nstudent, you should also see a list of required forms. Form 4 should be included in this list. Click\non the box with the number 4 in it to open and sign Form 4.<\/p>\n\n\n\n If you are filling more than one role for this student or for other science fair students, you may need to switch between profiles to access Form 4. Use the horizontal menu bar just below the black and white speckled area to move between profiles. Click on \u201cRegistration \/ Forms\u201d and then on \u201cManage Role Name\u201d<\/em> Forms.<\/p>\n\n\n\n Form Status<\/strong><\/p>\n\n\n\n The form will remain in Pending Completion status (yellow\nbackground) until all three of the signatures have been added\nsuccessfully. Once all three signatures have\nbeen added, the form will be promoted to Ready for Review status (purple). The\nform will remain in Pending Completion status on the profile of the student and\nadult sponsor until the signatures of all three members of the local IRB have\nbeen provided.<\/p>\n\n\n\n Human Participant Studies<\/strong><\/p>\n\n\n\n ISEF rules state that projects which involve any of the\nfollowing require the review and approval of a local IRB. <\/p>\n\n\n\n 1) The study\nincludes the student researcher or others participating in physical\nactivities (e.g., physical exertion, ingestion of any substance, any medical\nprocedure).<\/p>\n\n\n\n 2) The study includes psychological, educational and opinion\nstudies in the form of surveys, questionnaires, tests.<\/p>\n\n\n\n 3) The study includes the student researcher as the subject\nof the research.<\/p>\n\n\n\n 4) The study includes testing of a student designed\ninvention, prototype or computer application by human participants other\nthan<\/em> student researcher. If the student researcher is the only person\ntesting the invention and the invention does not pose a health or safety hazard,\nrespond No to this question.<\/p>\n\n\n\n 5) The study includes a data\/record review that with data\nthat is not<\/em> deidentified\/anonymous (e.g., data set that includes\nname, birth date, phone number or other identifying variables).<\/p>\n\n\n\n 6) The study includes behavioral observations that involve\nany interaction with the observed individual(s) or where the researcher has\nmodified the environment (e.g., post a sign, place an object). <\/p>\n\n\n\n 7) The study includes\nbehavioral observations that occur in non-public or restricted access settings\n(e.g., day care setting, doctor\u2019s office). <\/p>\n\n\n\n 8) The study includes behavioral observations that involve\nthe recording of personally identifiable information.<\/p>\n\n\n\n The role of the local Institutional Review Board (IRB)<\/strong><\/p>\n\n\n\n The local IRB consists of a health professional (a psychologist, medical doctor, license social worker, doctor of pharmacy, or registered nurse), a school administrator (principal, vice principal, school director etc.) and an educator (a teacher who is not the adult sponsor for the project). The health professional must have appropriate training for the topic of research; for example, a psychologist would be best suited to a project which involves emotional risk while a medical doctor would be best suited to a project which involves elevated heart rate. The local IRB can be a formal group or can consist of relevant individuals who come together solely for the purposes of approving this project. The local IRB must evaluate the risk level of the project and the need for informed consent or written parental permission in addition to providing their signatures. <\/p>\n\n\n\n During this review, the members of the local IRB should\nreview the research plan submitted by the student research to determine the\nlevel of risk to the participants and any other safety concerns. SRC\/IRB\napproval is required before recruitment of participants or data collection. See the online Risk Assessment Guide (https:\/\/sspcdn.blob.core.windows.net\/files\/Documents\/SEP\/ISEF\/Resources\/Risk-Assessment-Guide.pdf<\/a>)\nand Online Survey Consent Procedures (https:\/\/sspcdn.blob.core.windows.net\/files\/Documents\/SEP\/ISEF\/Resources\/Online-Survey-Consent-Procedures.pdf<\/a>\n) for more detailed information on risk assessment.<\/p>\n\n\n\n The Research Plan<\/strong><\/p>\n\n\n\n As stated in the instructions for Form 1A (https:\/\/www.societyforscience.org\/isef\/forms\/<\/a>),\nin addition to the rationale, question, hypothesis, expected outcomes,\nprocedure, method of data analysis and bibliography required for all projects,\nthe research plan for a human participant study should include:<\/p>\n\n\n\n a. Participants: Describe age\nrange, gender, racial\/ethnic composition of participants. Identify vulnerable\npopulations (minors, pregnant women, prisoners, mentally disabled or\neconomically disadvantaged). <\/p>\n\n\n\n b. Recruitment: Where will you find\nyour participants? How will they be invited to participate? <\/p>\n\n\n\n c. Methods: What will participants\nbe asked to do? Will you use any surveys, questionnaires or tests? If yes and\nnot your own, how did you obtain? Did it require permissions? If so, explain.\nWhat is the frequency and length of time involved for each subject? <\/p>\n\n\n\n d. Risk Assessment: What are the\nrisks or potential discomforts (physical, psychological, time involved, social,\nlegal, etc.) to participants? How will you minimize risks? List any benefits to\nsociety or participants. <\/p>\n\n\n\n e. Protection of Privacy: Will\nidentifiable information (e.g., names, telephone numbers, birth dates, email\naddresses) be collected? Will data be confidential\/anonymous? If anonymous,\ndescribe how the data will be collected. If not anonymous, what procedures are\nin place for safeguarding confidentiality? Where will data be stored? Who will\nhave access to the data? What will you do with the data after the study? <\/p>\n\n\n\n f. Informed Consent Process:\nDescribe how you will inform participants about the purpose of the study, what\nthey will be asked to do, that their participation is voluntary and they have\nthe right to stop at any time.<\/p>\n\n\n\n Human Informed Consent Form<\/strong><\/p>\n\n\n\n The purpose of the human informed consent form is to give\nthe human participants enough information about the project and their role in\nit to make an educated decision about taking part in the study.<\/p>\n\n\n\n This form is used to document written informed consent,\nminor assent, and\/or parental permission. If the form is serving to document\nparental permission, a copy of any survey or questionnaire must be attached.\nParental permission for all participants under the age of 18 is required.<\/p>\n\n\n\n This form is required if the study will involve human\nparticipants beyond the experimenter(s). This includes the administration of\nsurveys and questionnaires. <\/p>\n\n\n\n The student researcher must print and have the participants\nsign the informed consent form before they participate in the study. When\nwritten documentation is required, the researcher keeps the original, signed\nform. The student should collect and retain the hard copies of the signed forms\nuntil after the date of the fair.<\/p>\n\n\n\n The local IRB should review this form to ensure that all\napplicable and relevant information and risks are communicated to the\nparticipants. The signatures of the\nlocal IRB are not required on this form.<\/p>\n\n\n\n Form 4 Human Participants<\/strong><\/p>\n\n\n\n This form is intended to ensure the safety and well-being of\nall human participants in studies conducted by the student researcher(s). \nIt is required if the study will involve people beyond the experimenter(s).\nThis includes the administration of surveys and questionnaires. The signatures\nof all three members of the local IRB are required on this form before the\nproject can be reviewed by the PRSEF Scientific Review Committee and conducted\nby the student.<\/p>\n\n\n\n Form 4 identifies the level of risk involved in the study,\nverifies the ages of the participants and documents the review and approval of\nthe local IRB.<\/p>\n\n\n\n If you have any questions, please contact PRSEF@CarnegieScienceCenter.org<\/a>.<\/p>\n\n\n\n How to Complete Form 4<\/strong><\/p>\n\n\n\n The student researcher has provided most of the information\nneeded to complete this form. Review the attached research plan and Human\nInformed Consent Form and your familiarity with the project to respond to the\nlast three questions on this screen and then click on the Sign Form button to\nreview the information provided by the student research and to add your\nelectronic signature to the form. If the last three questions on this\nform have already been answered by another member of the local IRB, click on\nthe Sign Form button to complete your approval and add your signature.<\/p>\n\n\n\n I have reviewed the Research Plan \/ Project Summary<\/strong> which addresses ALL areas indicated in the Human Participants Section of the Research Plan \/ Project Summary Instructions attached to Form 1A \u2013 Student Checklist – When all of the requirements below have been fully addressed in the attached research plan, check \u201cYes\u201d.<\/p>\n\n\n\n The\nHuman Participants Section of the Research Plan \/ Project Summary requirements\non Form 1A indicate that the following be included in the research plan: <\/p>\n\n\n\n a.\nParticipants: Describe age range, gender, racial\/ethnic composition of\nparticipants. Identify vulnerable populations (minors, pregnant women,\nprisoners, mentally disabled or economically disadvantaged). <\/p>\n\n\n\n b.\nRecruitment: Where will you find your participants? How will they be invited to\nparticipate? <\/p>\n\n\n\n c.\nMethods: What will participants be asked to do? Will you use any surveys,\nquestionnaires or tests? If yes and not your own, how did you obtain? Did it\nrequire permissions? If so, explain. What is the frequency and length of time\ninvolved for each subject? <\/p>\n\n\n\n d.\nRisk Assessment: What are the risks or potential discomforts (physical,\npsychological, time involved, social, legal, etc.) to participants? How will\nyou minimize risks? List any benefits to society or participants. <\/p>\n\n\n\n e.\nProtection of Privacy: Will identifiable information (e.g., names, telephone\nnumbers, birth dates, email addresses) be collected? Will data be\nconfidential\/anonymous? If anonymous, describe how the data will be collected.\nIf not anonymous, what procedures are in place for safeguarding confidentiality?\nWhere will data be stored? Who will have access to the data? What will you do\nwith the data after the study? <\/p>\n\n\n\n f.\nInformed Consent Process: Describe how you will inform participants about the\npurpose of the study, what they will be asked to do, that their participation\nis voluntary and they have the right to stop at any time.<\/p>\n\n\n\n Risk\nlevel of this project<\/strong> \u2013 As stated in the ISEF rulebook which can be found\nat https:\/\/www.societyforscience.org\/isef\/international-rules\/<\/a><\/p>\n\n\n\n \u201cAll\nhuman participant projects are considered to have some level of risk. <\/p>\n\n\n\n No\nmore than minimal risk exists when the probability and magnitude of harm or\ndiscomfort anticipated in the research are not greater (in and of themselves)\nthan those ordinarily encountered in everyday life or during performance of\nroutine physical or psychological examinations or tests. <\/p>\n\n\n\n More\nthan minimal risk exists when the possibility of physical or psychological harm\nor harm related to breach of confidentiality or invasion of privacy is greater\nthan what is typically encountered in everyday life. Most of these studies\nrequire documented informed consent or minor assent with the permission of\nparent or guardian (as applicable).\u201d <\/p>\n\n\n\n If\nyou are unsure of which risk level to choose after reading the research plan,\nsee the ISEF rulebook for specific examples of each risk level and see the\nonline Risk Assessment Guide (https:\/\/sspcdn.blob.core.windows.net\/files\/Documents\/SEP\/ISEF\/Resources\/Risk-Assessment-Guide.pdf<\/a>) and Online Survey Consent Procedures (https:\/\/sspcdn.blob.core.windows.net\/files\/Documents\/SEP\/ISEF\/Resources\/Online-Survey-Consent-Procedures.pdf<\/a> ) for more detailed information on risk\nassessment.<\/p>\n\n\n\n Are\nthere any human participants who are minors? <\/strong>\u2013 If there are any human\nparticipants under the age of 18, select \u201cYes\u201d to answer this question. If the student researcher is the subject of\nthe study, they should be considered a human participant. If the student\nresearcher is studying other individuals, they should not be considered a human\nparticipant. <\/p>\n\n\n\n Are\nthere are any human participants who are over the age of 18? <\/strong>If there are\nany human participants over the age of 18, select \u201cYes\u201d to answer this\nquestion. Members of the student\u2019s family should be considered human\nparticipants if they are part of the group of individuals being studied or have\nparticipated in the project in more than an advisory capacity.<\/p>\n\n\n\n Sign\nForm<\/strong> \u2013 Click on the Sign Form button to confirm your responses and add your\nsignature to the form. Wait for the\nsystem to load the form in the gray box before continuing.<\/p>\n\n\n\n I\nconfirm all form information is correct<\/strong> – Wait for the system to load the\nform in the gray box before continuing. Review the form which has loaded in the\ngray box and confirm that your responses were recorded correctly. Click in the box next to the word \u201cYes\u201d to\nconfirm your responses. <\/p>\n\n\n\n Signature<\/strong>\n– Click in the space below the word Signature and above the signature line. Use\nyour mouse or touch pad to add your electronic signature in the box. If your signature is not legible, click on\nthe Clear button to try again. If you are happy with your signature, click on the\nAccept button. You must click on the Sign button to confirm your signature.<\/p>\n\n\n\n Date\nof Approval:<\/strong> Enter the date when the idea for the project was first reviewed\nwith the student researcher and experimentation was approved by the adult\nsigning the form. This does not need to be today\u2019s date. The adult signing\nthis form must review and approve the project before the student begins\nexperimentation. <\/p>\n\n\n\n Printed\nName<\/strong> – Type your name into the Printed Name box below the signature. You\nmust click on the Sign button to confirm your signature.<\/p>\n\n\n\n Experiments\nwhich were completed over the summer or for a school science fair will have\nexperimentation dates which are before the date this form was completed. Use\nthis field to enter the date the project was reviewed and approved by the adult\nsigning this form, not today\u2019s date. The\nDate of Approval must be before the tentative start date or actual start date\nlisted by the student on Form 1A. <\/p>\n\n\n\n How to check your signature<\/strong><\/p>\n\n\n\n Once you have completed and signed the form, click on \u201cReturn to forms manager\u201d in red font or on \u201cRegistration \/ Forms\u201d and then \u201cManage Role Name<\/em> Forms\u201d on the horizontal menu bar just below the black and white speckled area. Role names for members of the IRB include Medical Professional, Educator, and School Administrator.<\/p>\n\n\n\n Click on the form you would like to check then look for the\nred Form Status box on the right side of the screen. Click on View PDF of\nForm. Scroll to the bottom of the form\nto check your signature.<\/p>\n","protected":false},"excerpt":{"rendered":" Congratulations and thank you for your support of the Pittsburgh Regional Science and Engineering Fair and the students participating in the fair! You have been identified as a member of the local institutional review board (IRB) for your school for…<\/span><\/p>\n