Revision(s) to an Approved Study Form

Transcription

1 Revision(s) to an Approved Study Form Revisions may range from a request to change a typographical error in the consent form to a significant change in the study design. Federal regulations and University policy require that each change must be reviewed and approved by the IRB prior to initiation. Revisions include amendments, modifications, addenda, updates, and administrative changes, additions, and other labels identified with study changes. Minor revisions involve procedures that are no more than minimal risk, or risks to subjects are not increased, and/or the revision is not a significant alteration of the study design. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. At FSU, the Chair is designated to review and approve minor revisions to approved studies. Examples may include changes in telephone numbers, addition or deletion of associates or staff, reduction in the number or research participants, or the deletion of questions in a survey. Substantive (major) revisions: Any revision to a study that involves increased risk to subjects or significantly affects the nature of the study must be reviewed by the full IRB. Examples may include revisions to the recruitment plan, adding, revising, eligibility criteria, adding or changing a research site, changing the Principal Investigator, or changing the consent form to include a newly identified side effect. Project Title Protocol Number Principal Investigator Approval Date Expiration Date Changes are requested to the (check all that apply) Protocol Consent form Questionnaires Other *Describe the proposed revision(s) to the study and justification (rationale) for the revision. If changes are requested in the protocol state each section in which changes are requested and fill out those sections in the application provided:

2 *State whether the proposed revision(s) increases or decreases the risk to participants (thereby changing the risk/benefit ratio) and if so, describe. If the level of risk remains the same, please descirbe this as well. Increase Decrease Same *Please describe: Upload two (2) copies of the revised questionnaires and/or consent form inclusive of all revision(s) proposed. In one copy, the revisions should be identified in bold or highlightedto facilitated IRB review. The second copy should be a "clean" copy. Translations: The consent forms and other applicable subject materials must be in a language easily understood by the subject and all translations must be approved by the IRB prior to use. Translated consent form or other subject material must be uploaded for review. Human Subjects Application For Full IRB and Expedited Exempt Review Logout te: If you logout or close the browser during the submission process, the information you have already input is saved. When you re-login next time, you are directed to the breaking point to continue your application. You can click the navigation bar on the top to review and edit previous steps. In each step, click Save and Go to Next button to save your changes. Only after you pressed Save and Go to Next button is the information on that screen saved. DO NOT open/or have open more than one HSC application (HSC applications in other tabs/windows). This may cause errors in the system and a delay in the review process. If you need to reference other applications you may view and print any application from the Investigator Homepage.

3 1. Project Title and Identification As Principal Investigator of this study, I assure the IRB that the following statements are true: The information provided in this form is correct. I will seek and obtain prior written approval from the IRB for any substantive modifications in the proposal, including changes in procedures, co-investigators, funding agencies, etc. I will promptly report any unexpected or otherwise significant adverse events or unanticipated problems or incidents that may occur in the course of this study. I will report in writing any significant new findings which develop during the course of this study which may affect the risks and benefits to participation. I will not begin my research until I have received written notification of final IRB approval. I will comply with all IRB requests to report on the status of the study. I will maintain records of this research according to IRB guidelines. The grant that I have submitted to my funding agency which is submitted with this IRB submission accurately and completely reflects what is contained in this application. If these conditions are not met, I understand that approval of this research could be suspended or terminated. *I Agree 1.1 *Project Title (Project title must match grant title. If different, also provide grant title) *Project is: Dissertation Thesis Teaching Other: * Required Field 1. Project Title and Identification 1.2 Principal Investigator (PI) Name: *First: Middle: *Last: *Mailing Address or Four Digit Campus Mail Code: *Phone: Fax: * *University Department:

4 *Highest Education Level: *Occupational Position: Faculty Staff Student Other *Indicate the training and education, if any, completed in the protection of human subjects or human subjects records: FSU Training Module NIH HIPAA Other ne CITI Project Title and Identification 1.3 Co-Investigators/Research Staff Include any individual who will have responsibility for the consent process, direct data collection from subjects, or follow-up. Check following checkbox button to add Co-Investigators (or Research Staff). te: If you are a student do not place major professor(s) as Co-PI. Add Co-Investigator/Research Staff #1: Co-Investigator Research Staff Name: *First: Middle: *Last: *Mailing Address or Four Digit Campus Mail Code: *Phone: * *University Department: Fax: *Highest Education Level: *Occupational Position: Faculty Staff Student Other Indicate the training and education, if any, completed in the protection of human subjects or human subjects records: FSU Training Module NIH HIPAA Other ne CITI

5 1. Project Title and Identification 1.4 Faculty Advisor/Chair/Dean Information If the PI is a student, the advisor's information is required. If PI is faculty or staff, the Department Head's information is required. If PI is also the Department Head, the Dean or Division Head's information is required. Name: Faculty Advisor Department Chair/Director Dean Other *First: Middle: *Last: *Mailing Address or Four Digit Campus Mail Code: *Phone: * *University Department/Unit: 2.1 Is this research funded by an internal (FSU) or external agency? Sponsored or Funded Projects If you are applying for funding, please answer all of the following questions. If you are receiving funding from multiple sources, please check Add More Funding Source checkbox button and fill out the form for each of your sources. Funding Source #1: This project has been / will be submitted to the following funding agency: *Name of Sponsor: OMNI Number: *SRS/Research Foundation Contact Person: The funding decision: is pending has been awarded *Type of funding source:

6 2.1 Is this research funded by an internal (FSU) or external agency? n-funded Projects *If no, please explain how costs of research will be covered: 3. Institutional Oversight 3.1 *Is this research proposal being reviewed by any other institution or peer review committee? *Please select which other committee approvals are required for this research and provide documentation of their approval if it has been granted, or the application submitted if approval has not been granted (please upload the documentation at the end of the application): CRC Other IRB, please specify: Other, please specify: 4. Conflict of Interest Federal guidelines encourage Institutions to assure there are no conflicts of interest in research projects that could adversely affect the rights and welfare of human subjects. If this proposed research study involves a potential conflict of interest, additional information will need to be provided to the IRB. Examples of potential conflicts of interest may include: any sort of compensation, in cash or other form, for services to an individual and his or her immediate family, the value of which exceeds $10,000 in a one-year period or an equity interest which exceeds $10,000 or which exceeds a five percent ownership interest. 4.1 *Do any of the Investigators or personnel listed on this research have a potential conflict of interest associated with this study?

7 *Identify the individual(s): *Has this potential conflict of interest been disclosed and managed? If you are a Florida State University researcher, please disclose your potential conflict of interest in writing for review by your Department Head and Dean. Final IRB approval cannot be granted until all potential conflict matters are settled. The full IRB committee determines what disclosure language should be in the consent form. 5. Payment or Other Compensation for Research Subjects 5.1 *Will you give subjects gifts, payments, compensation, reimbursement, services without charge or extra credit/class credit? *Please explain: 6. Protocol Description and Other Detail Use lay language, do not refer to grant or abstract. All questions are required! 6.1 *Describe the objective(s) of the proposed research including purpose, research question, hypothesis, method, data analysis, research design and relevant background information etc.

8 6.2 *For Evaluation of your project, please check the following which apply: Mentally or Physically Challenged Subjects Children or Minor Subjects (under 18 years old) Prisoners, Parolees, or Incarcerated Subjects Filming, Video or Audio recording of Subjects Questionnaires or Surveys to be administered Review of Existing Data, Archives, or Medical Records Subjects primary language is not English Involves Deception Exclusion of Women or Children Subjects (must explain why they are being excluded) Subjects studied at FSU Subjects studied at non_fsu location(s) Students as Subjects Employees as Subjects Pregnant Subjects Fetal, placental, or surgical pathology tissues Involves blood Samples (fingerpricks, venipuncture, etc.) 6.3 Survey Techniques: check applicable category if the only involvement of human subjects will be in one or more of the following categories: Research on normal educational practices in commonly accepted educational settings Research involving educational tests (cognitive, diagnostic, aptitude, achievement) Research involving survey or interview procedures Research involving the collection or study of existing data, documents, records, archives, specimens 6.4 *Which methods will this study include? (check all that apply or specify other)

9 Descriptive Formative Phenomenological Ethnographic Longitudinal Qualitative Experimental/Control Design Oral history Quantitative Field work Other, specify: 6.5 *Describe the tasks subjects will be asked to perform. Upload (at the end of the application) surveys, instruments, interview questions, focus group questions etc. Describe the frequency and duration of procedures, psychological tests, educational tests, and experiments; including screening, intervention, follow-up etc. (If you intend to pilot a process before recruiting for the main study please explain.) 6.6 *How many months do you anticipate this research study will last from the time final approval is granted? 7. Participant (Subject) Population 7.1 *Expected number of participants. of male:. of female: 7.2 Expected Age Range (Check all that apply) 0-7 (Upload parental permission form) 8-17 (Upload child's assent form and parental permission form) and older 7.3 *Inclusion/Exclusion of Children in this Research 7.3 *Inclusion/Exclusion of Children in this Research

10 Inclusion Exclusion If this study proposes to include children, this inclusion must meet one of the following criterion for risk/benefit assessment according to the federal regulations (45CFR56, subpart D). Please check: (404) Minimal Risk (405) Greater than minimal risk, but holds prospect of direct benefit to subjects (406) Greater than minimal risk, no prospect of direct benefit to subjects, but likely to yield generalizable knowledge about the subject's disorder or condition Inclusion Exclusion If this study would exclude children, NIH guidelines advise that the exclusion be justified, so that potential for benefit is not unduly denied. Indicate whether there is potential for direct benefit to subjects in this study and if so, provide justification for excluding children. te that if inclusion of children is justified, but children are not seen in the PI's practice, the sponsor must address plans to include children in the future or at other institutions. Please check: direct benefit established (exclusion of children permissible) Potential for direct benefit exists Provide justification for exclusion of children: 7.4 Other Protected Populations to be Included in this Research (Check all that apply) Protected by Federal Regulations Pregnant Woman/Fetuses/Neonates Prisoners (Refer to 45 CFR 46 subpart B and 45 CFR 46 subpart C on the populations protected by Federal Regulations)

11 Protected by Federal Guidelines Mentally/Emotionally/Developmentally/Decisionally Impaired Persons Minority Group(s) and n-english Speakers Elderly Subjects Gender Imbalance - all or more of one gender 7.5 *Inclusion and Exclusion of Subjects in this Research Study Describe criteria for inclusion and exclusion of subjects in this study Inclusion Criteria: Exclusion Criteria: 7.6 *Location of subjects during research activity or location of records to be accessed for research Check all that apply and specify: Florida State University TBA1 TBA2 Other, specify: Hospitals, specify: Community Clinic, specify: Elementary/Secondary Schools, specify: Community Center, specify: University Campus (non-clinical), specify: Prisons/Halfway Houses, detention centers, specify: Nursing Home(s), specify:

12 Subject's Home, specify: International Location, specify: Other Special Institutions, specify: 7.7 *Describe the rationale for using each location checked above Upload copies of IRB approvals or letters of cooperation from other agencies or sites, if it has been granted or the application submitted if approval has not been granted ( at the end of the application): 8. Recruitment of Participants (Subjects) 8.1 *Describe the recruitment process to be used for each group of subjects Upload a copy of any and all recruitment materials to be used e.g. advertisements, bulletin board notices, s, letters, phone scripts, or URLs. 8.2 *Explain who will approach potential subjects to take part in the research study and what will be done to protect individuals' privacy if required in this process 8.3 *Are subjects chosen from records? Are records "private" medical or student records? *Who or what entity is the custodian of the records?

13 *Who gave approval for use of the records: 8.4 *FSU policy prohibits researchers from accepting gifts for research activities. Is the study sponsor offering any incentive connected with subject enrollment or completion of the research study (i.e. finders fees, recruitment bonus, etc.) that would be paid directly to the research staff? 8.5 *Is the study going to be posted on the Research Studies at Florida State University recruiting website? 9. Risks and Benefits 9.1 Does the research involve any of these possible risks or harms to subjects? Check all that apply Use of a deceptive technique. Use of private records (educational or medical records) Manipulation of psychological or social variables such as sensory deprivation, social isolation, psychological stresses Any probing for personal or sensitive information in surveys, interviews or questionnaires Presentation of materials which subjects might consider sensitive, offensive, threatening, degrading or dangerous Possible invasion of privacy of subject or family Financial standing, employability, or reputation Criminal, civil, or legal liability Other risks, specify: 9.2 *Does the Research Involve Greater Than Minimal Risk to Human Subjects? "Minimal Risk" means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily

14 life or during the performance of routine physical or psychological examinations or tests. *Describe the nature and degree of the risk or harm checked above (The described risks/harms must be disclosed in the consent form.) 9.3 *Explain what steps will be taken to minimize risks or harms and to protect subjects' welfare. If the research will include protected populations (see question 7.4) please identify each group and answer this question for each group 9.4 *Describe the anticipated benefits of this research for individual subjects in each subject group. If none, state "ne" 9.5 *Describe the anticipated benefits of this research for society, and explain how the benefits outweigh the risks. 10. Confidentiality of Data 10.1 *Will you record any direct identifiers, names, social security numbers, addresses, telephone numbers, addresses, cookies etc.?

15 *Explain why it is necessary to record findings using these identifiers and describe the coding system you will use to protect against disclosure of these identifiers: 10.2 *Will you retain a link between study code numbers and direct identifiers after the data collection is complete? *Explain why this is necessary and state how long you will keep this link: 10.3 *Will you provide the link or identifier to anyone outside the co-investigators/research staff? *Explain why and to whom: 10.4 *Where, how long, and in what format (such as paper, digital or electronic media, video, audio, or photographic) will data be kept? In addition, describe what security provisions will be taken to protect this data (password protection, encryption, etc.) 10.5 *Will you place a copy of the consent form or other research study information in the subjects' record such as medical, personal or educational record? *Explain why this is necessary: 10.6 If the data collected contains information about illegal behavior, please refer to the NIH Certificates of Confidentiality Kiosk for information about obtaining a Federal Certificate of Confidentiality *Will you be given or have access to personal information regarding employee, customer, student, parent and/or patient accounts with Florida State University?

16 *Please upload a signed copy of the Employee Confidentiality Statement. For more information, read the OP-F-7 Policy on Safeguarding of Confidential Financial and Personal Information. PDF: 11. Use of Protected Health Information (PHI): HIPAA Requirements In the course of conducting research, researchers may desire to obtain, create, use, and/or disclose individually identifiable health information. Under the HIPAA Privacy Rule, covered entities (healthcare providers, health plans, employer or healthcare clearinghouses) are permitted to use and disclose protected health information for research with individual authorization, or without individual authorization under limited circumstances set forth in the Privacy Rule *As part of this study, will you be accessing PHI from a covered entity for research purposes? *Please explain which of the following you will be utilizing to comply with the HIPAA regulations for use of PHI: Research Use/Disclosure Without Authorization Documented Institutional Review Board or Privacy Board Approval (alteration or waiver of research participants' authorization) Preparatory to Research Research on Protected health Information of Decedents Limited Data Sets with a Data Use Agreement Research Use/Disclosure With Individual Authorization 12. Informed Consent Process 12.1 *Recognizing that consent itself is a process of communication, please expand on your responses to questions 8.1 and 8.2 and describe what will be said to the subjects to introduce the research. Do not say see consent form. Write the explanation in lay language. If you are using telephone surveys, telephone scripts are required.

17 12.2 *In relation to the actual data gathering, when will consent be discussed and documentation obtained? (e.g., mailing out materials, delivery of consent form, meetings) Be specific *Please name the specific individuals who will obtain informed consent and include their job title/credentials and a brief description of your plans to train these individuals to obtain informed consent and answer subject's questions: 12.4 *What questions will you ask to assess the subjects' understanding of the risks and benefits of participation? (Questions should be open-ended and go beyond requiring only a yes/no response.) 12.5 Informed Consent Waivers Request waiver of documentation of consent In some instances, the written consent of subjects increases risk of exposure or embarrassment. The IRB may in some specific instances waive documentation. See 45 CFR An IRB may waive the requirement for written documentation of consent but still require that consent be obtained if either of the following conditions exist: (select the conditions that apply)

18 The only record linking the subject and the research would be the consent form and the principle risk of the research would be the potential harm from a breach of confidentiality: (the IRB may allow an option to sign or decline) The research involves minimal risk and includes no procedures for which written consent is normally required outside the research context. te: The IRB may, in either case, require the researcher to provide the participant with a written statement about the research. Upload copy of written statement about research. Request waiver of consent The IRB may, in some specific instances, waive the requirement for informed consent in accordance with 45 CFR (d). Select the following that apply to this research: (All answers must be checked to qualify for a waiver) The research involves no more than minimal risk to the subjects. A waiver will not adversely affect the rights and welfare of the subjects. The research could not practicably be carried out without waiver or alteration. Where appropriate, the subjects will be provided with additional pertinent information after participation. Appendices Click on each link below to finish all the required appendices. Prisoners as Subjects in Research Inclusion of Vulnerable Populations Use of Deception Pregnant Women, Human Fetuses and neonates involved in Research Children Involved as Subjects in Research Research Studies at Florida State University Seeking Volunteers Documents Upload all supporting documents to the application such as consent forms, assent forms, cover letters, parental permission forms, guardianship permission form, reminder postcards, recruiting flyers, questionnaires, support letters for research sites, and other IRB approval letters.

19 The following file extensions are acceptable formats:.doc,.pdf,.xls,.ppt, and.vsd. Name each file with the PI's last name and type of document it is. ( e.g. Smithconsentform.doc ) The size of uploaded file can not be larger than 4MB. Total Number of Files Uploaded: 0 Document: After you have submitted all the required appendices and uploaded all the related documents, please click the Submit Application button below to confirm the submission. OR you can simply close the browser and re-login in the future time to edit and submit your application later on. In either case, YOU MUST CLICK THE FOLLOWING BUTTON TO COMPLETE YOUR APPLICATION. Please click here to check your application before submitting. If you have any technical problem, please contact webmaster. Appendix: Prisoners as Subjects in Research Federal Regulations require that investigators comply with the additional protections as summarized below. Please respond to each factor below for consideration: 1. *Will this study examine the possible causes, effects, or processes of incarceration and/or criminal behavior? 2. *Will this study examine prisons as institutional structures or prisoners as incarcerated persons? 3. *Will this study examine a condition(s) particularly affecting prisoners as a class of people? 4. *Will this study examine a procedure, innovative or accepted, that will have the intent or reasonable probability of improving the health or well being of the subjects?

20 *If, how will prisoners be assigned to groups? 5. *Will prisoners receive any incentives or advantages by agreeing to participate? he targeting or inclusion of potentially vulnerable populations (other than children, pregnant women/fetuses and prisoners) in research requires special considerations. Provide information on the following populations, if applicable, in this research. *te: 1-4 not all required but at least one must be filled out. 1. Mentally/Emotionally/Developmentally Disabled Targeted Included Provide justification: Explain how competency to provide consent will be determined and plan for obtaining surrogate consent: 2. Minority Group(s)/n-English Speakers Targeted Included Provide justification:

21 Provide plan for obtaining consent: 3. Elderly (65+) Targeted Included Provide justification: If competency to provide consent may be an issue, describe how competency will be determined and plan for obtaining consent: 4. Gender Imbalance If all or more of one gender are targeted, provide justification for this: Appendix: Use of Deception Subjects must be told the purpose of the study, the reason for the deception and given an opportunity to withdraw their data from the project. (For guidance, see APA Ethical Standard 8.07) 1. *Explain the scientific rationale for deceiving the study subjects. Which aspects of study procedures will be withheld from subjects? Why?

22 2. *Describe when the subjects will be told the true purpose of the study, the reason for the deception and explain how they will be informed and by whom. (Upload a copy of the material or script to be used) 3. *Describe how and when subjects will be given an opportunity to withhold use of the data gathered under deceptive conditions. 4. Upload the full debriefing "protocol" or explanation that will be provided to subjects. Appendix: Pregnant Women, Human Fetuses and Neonates involved in Research 1. *Does your research involve a pregnant woman or her fetus? Federal regulations define pregnancy as encompassing the period of time from implantation until delivery. A woman shall be assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery. Fetus means the product of conception from implantation until delivery. *If yes, please explain: 2. *Is there any risk involved in this research? *If yes, the risk must be the least possible for achieving the objectives of the research. Please explain how any risk has been minimized for subjects:

23 3. *Is there any direct benefit to the pregnant woman and/or the fetus? *If yes, please explain: 4. *Is the pregnant woman a minor (under age 18)? *If yes, how will you obtain assent and permission of the parent? 5. *Does this research involve a neonate? Neonate is defined in the federal regulations to mean a newborn. *If yes, please explain: *Is the neonate of uncertain viability? *If yes, please explain: 6. *Does the research involve nonviable neonates? A nonviable neonate means a neonate after delivery that, although living, is not viable. *If yes, please explain: Appendix: Children Involved as Subjects in Research

24 Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted (in Florida, the age of 18). Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. Permission means the agreement or parent(s) or guardian to the participation of their child or ward in research. Parent means a child's biological or adoptive parent. Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care. 1. *What is the age range of the children involved in the research? 2. *What is the psychological and maturity state of the children involved in the research? 3. *Are any of the children involved in the research wards of the State? 4. *Does the research involve less than minimal risk? a. *Does the research involve greater than minimal risk but presents the prospect of direct benefit to the individual subjects? b. *Does the research involve greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject s disorder or condition? 5. *Explain how assent of the children will be obtained in this research: 6. *Explain how permission will be obtained from the parent(s) or guardian for the participation of their child or ward in this research:

25 Appendix: Research Studies at Florida State University Seeking Volunteers HSC Number: 1. *What is the research study title? Such as title from consent form. a 2. *Give a brief study description: Such as Purpose and Procedures section of consent form. 3. *Where is the study located? Street address, bldg. name, room number, etc. 4. *What is the estimated participant study length? 5. *Will there be any compensation for the participant? 6. *Participant Criteria: *Gender: Female Male *Age Range(s): Ages: -

26 7. *Contact Information: *First Name: *Last Name: *FSU Address Only: Phone Number: