Office of Research Integrity and Outreach

Transcription

1 Office of Research Integrity and Outreach Request for Determination of Research Involving Human Subjects INSTRUCTIONS: Complete this form if you would like to request a formal, written determination, from the Office of Research Integrity and Outreach (ORIO) regarding whether a planned activity constitutes research with humans subjects. Submit PRIOR to collecting data. Use the spaces provided after each question to provide explanations if required or additional information that you would like to provide. Explanations should be succinct and no more than 3-5 sentences. If additional information or clarification is needed you will be contacted via the address provided below. IMPORTANT: (1) If your funder requires an IRB review, go to eprotocol. Click here for : Instructions and Guides Direct to eprotocol (2) If a project includes multiple components and at least one of those components is designed to develop or contribute to generalizable knowledge, then the entire project is classified as research unless the components are separable. (3) If this is a student-conducted activity, this project must have a Faculty or Staff Advisor. The roles and responsiblity of an Advisor can be found: The Role and Responsibilities of the Faculty Advisor (4) If this a student-conducted activity, this project may be eligible for review under the Student Classroom Project's Standard Operating Procedure. If this project is eligible for review under the Student Classroom Project Policy the INSTRUCTOR should complete the Student Classroom Project Form. (5) Only complete submissions will be reviewed. Please contact ORIO at or via at usmorio@maine.edu with questions. ORIO welcomes any feedback on how this form works, any problems, and suggestions for improvement usmorio@maine.edu or * Required Q1 Principal Investigator (PI)*

2 Q2 You are:* Faculty Staff Graduate Student Undergraduate Student Other Please specify other: * Address* Department* Phone Number* Faculty Advisor Advisor Advisor Phone Number Study Title* Estimated Project Duration* Start Date End Date Funding Source Project Information IS THE ACTIVITY RESEARCH AS DEFINED IN 45 CFR (d) Q3 What is the purpose of the activity? What are the activities being conducted? Who are the intended subjects? Provide a 3-5 sentence explanation in easy-to-understand language: *

3 Q4 Is the intent of the activity to generate new information that has relevance beyond the population or program from which it was collected? * Q5 Are the project activities experimental? * Q6 Are you comparing a standard and non-standard intervention in an experimental-type design? * Q7 Do you expect that the project will generate new knowledge that has relevance beyond the population or program from which it is collected? *

4 Q8 Is the purpose of the activity to test a new, modified, or previously untested intervention, procedure, service or program? * Q9 Do you intend to use any data collected for the purposes of this project for future studies? * Q10 Is the purpose of the activity limited to measuring or evaluating the quality or performance of a specific program or service? * Q11 Are the intended benefits primarily or exclusively for the participants or the participants community? * If no, please explain: Q12 Is the purpose of the activity limited to improving course curriculum and/or other educational programming specifically at USM? * Q13 Is the purpose of the activity limited to gathering and preserving historical information through recorded interviews with participants in past events or ways of life? *

5 Q14 Who do you expect may benefit from the activity? Please explain: * Q15 Who is the audience for your study? How do you expect the audience to use the results of your study? Please explain: * Q16 Do you intend to present or publish the findings? * Q17 Will the generated findings be added to the scientific literature? * Q18 Does the funder or sponsor intend to use the findings as part of its own research or preliminary to conducting its own research? * IS THE ACTIVITY HUMAN SUBJECT RESEARCH AS DEFINED IN 45 CFR (f)? Q19 Will you be obtaining data or specimens containing identifiable private information (i.e., the identity of the subject is or may be readily ascertained or can be associated with the information) *

6 Q20 Does your project include obtaining data or specimens about a living individual(s) through intervention or interaction with them? * Q21 Does your project involve the use of existing ( on the shelf ) data or specimens? If no, skip to question 25. * Q22 Are the data or specimens coded such that a link exists that could allow the data or specimens to be re-identified? Q23 If obtaining data from a third party, does an agreement exist prohibiting the PI and their staff access to the key to the code? Click icon below to attach a copy of the agreement: Q24 Were the data or specimens originally collected for research purposes under a USM IRB approved protocol? If yes, please list IRB Protocol#: Other Considerations

7 Q25 Do the funder and/or sponsor require IRB review? If yes, please submit a protocol for IRB review here: e-protocol Submission Process? * Q26 Are you obtaining or recording Protected Health Information (PHI)? *

8 Q27 Are you requesting a determination to fulfill the W-9 form requirements? If yes, please answer the following questions: * Who will be responsible for obtaining, securing, and dispersing compensation? If participants were required to complete a W-9 form, would it negatively impact your study? If so, how? How will you be compensating your study participants (e.g., cash, gift card, gift, other), please specify: What is the total (dollar amount) compensation amount per participant? On how many separate occasions throughout the study will a participant receive compensation? Please describe the process that will ensure a participant does not obtain more than $600 in income resulting from participation: How will compensation to participants be distributed? Please describe the process that will ensure a participant does not obtain more than $600 in income resulting from participation: Where will compensation be stored until it is dispersed? What security provisions will be in place to prevent theft?

9 Q28 Will your project receive IRB review at any other institution? * Q29 Does your activity involve recombinant DNA, human or animal blood, body fluids, or tissues, infectious agents, or select agents and toxins? If yes, please contact the Institutional Biosafety Committee(IBC) * Q30 Additional information you would like to provide: Only complete submissions to the ORIO will be reviewed. A completed copy of this form will be sent to the provided above, and advisor if applicable. Signature Q31 By checking the box below, I, Primary Investigator named above accept responsibility for the information provided. I understand that if it is determined that my project constitutes research involving human subjects I will be notified in writing and I am REQUIRED to submit a formal application for review with the IRB. The USM Assurance for the Protection of Human Subjects prohibits the start of any research involving human subjects (including recruitment of subjects) that has not been reviewed and approved or exempted by the IRB or its designee. I agree Q32 If applicable, by checking the box below, the Advisor named above attests that he/she has read the information contained in this submission, and agrees to provide appropriate education and supervision of the student investigator. I agree and will provide confirmation upon request