Human Subject Institutional Review Board Proposal Form

Transcription

1 FOR IRB USE ONLY Protocol Number: IRB- Human Subject Institutional Review Board Proposal Form Activity Title: PRINCIPAL INVESTIGATOR ASSURANCE I agree to use procedures with respect to safeguarding human subjects involved in this research that conforms to the TSU policy and DHHS and FDA regulations. Except when necessary to eliminate apparent immediate hazard to the human subject, if significant changes in the investigative procedures involving human subjects are called for during the research program covered by this application, I shall seek prior approval for such changes from the Institutional Review Board (IRB), and I shall agree to follow the advice of the IRB. I further agree to report immediately to the IRB any unanticipated complications or untoward incidents with respect to human subjects. Type Principal Investigator Name Signature Date DEPARTMENTAL CHAIRMAN ASSURANCE I understand that responsibility for assessing the quality of research must be shared by both the department and the IRB. My signature as Department Chairman certifies that the proposed research has been reviewed for the proper use of human subjects. This review encompassed experimental design, scientific merit and accuracy of the proposed research. Type Dept. Chair Name Signature Date APPROVED: Signature, IRB Chairperson Date 1

2 FOR IRB USE ONLY Protocol Number: IRB- Human Subject Institutional Review Board Proposal Form Instructions: Check all appropriate boxes, answer all questions completely, include attachments, and obtain appropriate signatures. WARNING: If you wish to SAVE the text you insert on this form- SAVE this form to your computer BEFORE inserting test. REQUIRED ON ALL APPLICATIONS, CONTRACT PROPOSALS, REQUESTS FOR SUPPORT OF SPONSORED ACTIVITIES, AND ON PROTOCOLS SUBIMITTED TO THE INSTITUTIONAL REVIEWBOARD 1. Activity Title: 2. Contact Information 2.1. Principal Investigator (PI) Name UIN/UID Univ. Univ. Phone No. Department/Division Affiliation: TSU Faculty TSU Staff TSU Research Associate Highest Degree Earned: Doctoral Master s Bachelor s 2.2 Complete Section below if Proposal is for a Thesis or Dissertation: Student UIN/UID Univ. Univ. Phone No. Department/Division Affiliation: TSU Faculty TSU Staff TSU Graduate Student Highest Degree Earned: Doctoral Master s Bachelor s 3. Location of Activity Institution Building Room 4. Funding Agency Name Number For all sponsored research activities, Texas Education Code and require full and conspicuous disclosure of the research sponsor in any oral or written communication intend for public release. 2

3 5. Each Responsible Investigator (List Principal Investigator First) Institutional Review Board (IRB) 1. Last Name First Name MI Highest Degree Earned Title UIN/UID Signature, Principal Investigator Date Department Attach CITI & COI 2. Last Name First Name MI Highest Degree Earned Title UIN/UID Signature Date Department Attach CITI & COI 3. Last Name First Name MI Highest Degree Earned Title UIN/UID Signature Date Department Attach CITI & COI 4. Last Name First Name MI Highest Degree Earned Title UIN/UID Signature Date Department Attach CITI & COI 5. Last Name First Name MI Highest Degree Earned Title UIN/UID Signature Date Department Attach CITI & COI 1. Cooperating Facilities: Will data, subjects, equipment, personnel, supplies be used at or obtained from an organization outside of Tarleton State University? Facility Name Address Sponsor Phone Number **Cooperating Facilities Letter MUST be attached for review 2. Does this activity require or involve the following? (Answer All) A. Additional space, not presently available in the department, alterations and/or renovations If YES Please check all that apply: department Alternations renovations B. Subcontracting or direction outside Tarleton State University? C. Faculty Salary? If YES, check one: new positions support of current positions. D. Generation of potential direct monetary profit to the institution? E. Restrictions on publication of results? F. Activities which involve the community and social action? G. Will anyone other than the investigator(s) obtain informed consent? If YES this person MUST be listed on page 2 as an investigator. 3

4 3. Does this activity involve the use of human subjects? If YES indicate the appropriate action: This activity has not been previously approved for use of human subjects. This activity was approved for use of human subjects on. 4. A.1. Does this research proposal involve only the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens? A.2. If YES, are the sources publicly available, or will the information be recorded by the investigator(s) in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects? If so, this study may qualify as exempt research or for an expedited review procedure. B. Will this activity/research be restrictive to a survey? If you answered YES to either 4 A1, 4 A2, or 4 B skip to #7. Does your research involves the use of drugs and/or devices, recumbent DNA, hazardous materials, or any form of radiation on human subjects? If "YES", please complete #5 and #6. If "NO", please skip to #7. 5. Does this activity require or involve the following? (Answer All) A. Does this research involve the use of drugs and/or devices, recumbent DNA, or hazardous materials? If YES check all that apply: drugs devices recumbent DNA hazardous materials B. Condition or disease to be studied C. The amount, if any, charged for an investigational drug/device $. If subjects will be charged, state why sale does not constitute commercialization: D. Is there a conflict of interest between the investigator and the sponsor of the drug/device or procedures to be studies, e.g. ownership in company? N/A E. Will placebos be used? N/A F. Will the investigator(s) be directly involved in diagnostic and treatment procedures for subjects? N/A 4

5 6. Use of Radioactivity in Human Subjects: Is any form of radiation used in this study? A. If YES indicate type used: X-Ray Isotopes Pharmaceuticals B. Are studies done in vivo in vitro C. Are studies done for therapeutic experimental The purpose? D. Has the Radiation Safety Committee approval been received for this project? E. If YES give date of approval: Check off response and complete the blanks for each of the following which, in your opinion, best describes the research. 7. Risk Category Minimal Risk More than a Minimal Risk 8. Request Category of IRB Review Exempt Expedited Full Board Review 9. Benefit Category Benefit to Others: Benefit to Subjects: If YES please explain how Subject Population: Indicate whether the following groups are targeted in your subject population. Reviewers must be able to assess risk for vulnerable populations even if these populations are not targeted. 5

6 A. Normal Subject (non-patient volunteers) B. Minors (less than age 18) C. Fetuses: Nonviable Viable D. Pregnant Subjects E. LGBT F. Economically Disadvantaged G. Prisoner H. Intellectually disabled or impaired I. Age (over 65) J. Students K. Minorities-Specific: L. Inpatients-as experimental subjects M. Inpatients-as control subjects N. Outpatients-as experimental subjects O. Outpatients-as control subjects P. Non-English speaking subjects- Native language Are you targeting any specific population listed above? If YES please explain why 11. Additional Information A. Sex of subjects Male Female Both B. Age Range C. Will subjects be randomized? Yes No D. Type of study Qualitative Quantitative E. Estimated number of participants involved Experimental subjects Control subjects F. Estimated duration of study G. Duration of each subject s participation H. Will subjects be paid to participate? Yes No I. State type and amount of incentive to be offered N/A J. Will incentive be prorated for subjects who withdraw from participation? K. Estimated additional cost of subjects that may result from participation: Yes No N/A $ N/A 6

7 I. What research question(s) does this study seek to address? (Briefly explain the purpose of your study) II. Background (Give a brief description of background information) 7

8 III. Concise Summary of Project A. Please Identify your human subjects (based on question 11) B. How will you recruit your subjects (i.e., flyers, , etc.)? Attach recruiting document C. Criteria for Inclusion of Subjects D. Criteria for Exclusion of Subjects E. What type of research material will be used in your study (i.e. survey, exam/test, blood sample, etc.)? Please Attach F. Detailed description of your project, please include; how will you interact with your subjects, how will consent/assent be obtained, how will data be collected, analyzed, and reported 8

9 IV. Potential Risks & Special Precautions to Protect Subjects A. Will the result be reported in aggregate form without identifiable information included? B. Will the results be presented so as to avoid the subjects being identified directly through identifying links? C. Will you be requesting the IRB waiver documentation of informed consent (only applies if the consent form will be the only link between your subjects and the research)? D. Give details of potential risks and special precautions mitigating these risks. V. Potential Benefits of your Research VI. Risk/Benefit Assessment (explain how the potential benefits outweigh the risks) 9

10 Subject Consent to Participate in Research *Note: This is a generic consent form available for your use. If you choose to use another consent form, please make sure it contains the required elements (see Informed Consent on website under IRB Proposal Tools) Title of Study: Sponsor: Investigators: Office Phone #: Night & Weekend Phone #: You are being asked to participate in a research study. Persons who participate in research are entitled to certain rights. These rights include but are not limited to the subject s rights to: 1. Be informed of the nature and purpose of the research; 2. Be given an explanation of the procedures to be followed in the research, and any drug or device to be utilized; 3. Be given a description of any attendant discomforts and risks reasonable to be expected; 4. Be given a disclosure of any benefits to the subject reasonable to be expected, if applicable; 5. Be given a disclosure of any appropriate alternatives, drugs, or devices that might be advantageous to the subject, their relative risks and benefits; 6. Be informed of the alternatives of medical treatment, if any, available to the subject during or after the experiment if complications arise; 7. Be given an opportunity to ask any questions concerning the research and the procedures involved; 8. Be instructed that consent to participate in the research may be withdrawn at any time, and the subject may discontinue participation without prejudice; 9. Be given a copy of the signed and dated consent form; and 10. Be given the opportunity to decide to consent or not to consent to participate in research without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the subject s decision. 10

11 Title of Study: You have the right to privacy. All information that is obtained in connection with this study that can be identified with you will remain confidential within the limits of State Law. Information gained from this study that can be identified with you will be released only to the investigators, and if appropriate, to your physician and the sponsors of the study. For studies regulated by the Food and Drug Administration (FDA), there is a possibility that the FDA may inspect your records. The results of this study may be published in scientific journals without identifying you by name. In addition, members and staff of the Institutional Review Board may review the records of your participation in this study and you may be contacted by a representative of the Board for information about your experience with this study. If you wish, you may refuse to answer any questions the Board may ask of you. We also would like for you to understand that your record may be selected at random (as by drawing straws) for examination by the Board to insure that this research project in being conducted properly. We will make every effort at preventing physical injury that could result from this research. Compensation for physical injuries incurred as a result of participating in the research is not available. The investigators are prepared to advise you about medical treatment in case of adverse effects of these procedures, which you should report to them promptly. Phone numbers where the investigators may be reached are listed in the heading of this form. If you have questions about the research or about your rights as a subject, we want you to ask us. If you have questions later, or if you wish to report a research-related injury (in addition to notifying the investigator), you may call the Chairman of the Institutional Review Board during office hours at (254) Participation in this research study is entirely voluntary. Refusal to participate will involve no penalty or loss of benefits to which you are otherwise entitled. If you decide to participate, you are free to withdraw your consent and discontinue participation at any time without affecting your status (as a patient, student, employee, etc.), or the medical care that you will receive. Any significant new findings developed during the course of the research, which may relate to your willingness to continue participation in this study will be provided to you. YOU WILL BE GIVEN A COPY OF THIS CONSENT FORM TO KEEP 11

12 Title of Study: Please briefly fill out each box below. Purpose What you will be asked to do if you participate in this study. (Choose one) If you participate in the study you will be asked to: Possible Risk and Discomforts No experimental procedures are involved in this study. Possible Benefits Alternatives to Participation 12

13 Title of Study: YOU ARE MAKING A DECISION WHETHER OR NOT TO PARTICIPATE IN THIS STUDY. YOU SHOULD NOT SIGN UNTIL YOU UNDERSTAND ALL THE INFORMATION PRESENTED IN THE PREVIOUS PAGES AND UNTIL ALL YOUR QUESTIONS ABOUT THE RESEARCH HAVE BEEN ANSWERED TO YOUR SATISFACTION. YOUR SIGNATURE INDICATES THAT YOU HAVE DECIDED TO PARTICIPATE HAVING READ (OR BEEN READ) THE INFORMATION PROVIDED ABOVE. Signature of Participant/Subject Age Date Time Signature of Legally Responsible Representative Signature of Witness Typed/Printed Name of Witness Signature of Investigator Subject s Name (typed or printed): Hospital Number (if applicable): Mailing Address: Phone Number: 13