Institutional Review Board (IRB) Manual

Transcription

1 Institutional Review Board (IRB) Manual Updated: April 8, 2015

2 Table of Contents Eastern Florida State College IRB Mission Statement... 2 Acceptable Research Requests... 2 EFSC - IRB Checklist for Outside Investigators... 3 Submission Instructions IRB Review... 4 Using the Online Research Proposal Submission System... 6 Human Subjects Research Application Form for Full IRB and Expedited IRB Review... 7 Sample Assent Form for Minors EFSC Consent form Template Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure Guidance on the Use of Expedited Review Procedures Federal Regulations & Institutional Responsibilities Investigator Responsibilities & Informed Consent Human Protections Administration IRB Responsibilities Criteria for IRB approval of research:... 48

3 Eastern Florida State College IRB Mission Statement The mission of the Eastern Florida State College Institutional Review Board (IRB) is to protect the safety, welfare, and confidentiality of human subject participants, researchers, and the Institution. The merit of the research is not within the scope of the duties of this board. The Eastern Florida State College IRB will act in accordance with guidelines provided by federal regulations. Acceptable Research Requests In terms of human subjects, the types of research requests and/or methods that Eastern Florida State College Institutional Review Board (EFSC IRB) is willing to accept would be approved assessments, questionnaires, interviews, and surveys. When conducting research as a requirement for a degree or for another institution, researchers must receive clearance from their home institution and from the EFSC IRB (see checklist). Currently the EFSC IRB will not review research involving animals or that would require FDA oversight. For information on conducting research with animals, click here. The EFSC IRB will permit faculty, staff, and students as human research subjects. All subjects must give informed consent. At Eastern Florida State College, the use of human subjects in research activities is governed by the Office for Human Research Protection (CFR 45 Part 46). EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 2

4 EFSC - IRB Checklist for Outside Investigators Obtain IRB approval from primary research institution Download and prepare EFSC IRB application Prepare project description which includes: 1. Brief description the proposed project and explain the purpose(s) of the research. 2. Describe how human subject information will be collected (experiment, observation, telephone survey, questionnaire, etc ). 3. Include a copy of any instrument(s) that will be used and describe the procedures that will be followed. If the information will be collected verbally, provide a list of all questions that will be used. 4. Are there any foreseeable risks or discomforts to the subjects? ("Risk" means exposure to the possibility of physical or psychological harm). If so, describe the nature and magnitude of these risks. 5. What potential benefits justify the risks or discomfort, and what steps have been taken to minimize the risks or discomfort? 6. What is the anticipated number of subjects who will be involved in the research? 7. What is the expected duration of an individual subject's participation? 8. Describe the extent to which confidentiality or anonymity of subjects will be maintained and how, both during the data collection and after the research is completed. What, if any, records may link the subject's identity to the research? 9. State specifically what information will be provided to the subject about the research. (Provide copies of any and all written materials that will be provided to subjects.) 10. Will the research involve any deception of subjects? If so, describe and justify the deception. Submit all documents via the online research proposal submission system EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 3

5 Submission Instructions IRB Review Before the Institutional Review Board (IRB) will approve an application the investigator, all coinvestigators, and all research personnel must have completed training in the use of human participants. Certificate of completion of appropriate training must be submitted along with the research application. Acceptable training certifications for research with human subjects include: Protecting Human Research Participants through the National Institutes of Health (NIH) Human Subjects Protection for Biomedical and/or Social/Behavioral Research Investigators through the Collaborative Institutional Training Initiative (CITI) Other certifications will be considered List of documents needed to submit a research application to the EFSC IRB IRB Research Application Description of including at minimum: o Rational and purpose of the study o Description of the participants o Summary of the materials/instruments required, design and procedure(s) Copies of all assessments, questionnaires, survey, and interview protocols expected to be used in the research Informed consent forms used in the research Any documents that will be used for recruitment purposes External IRB approval if research has been reviewed already Instructions: Please read and follow these directions carefully. Omission of required components of the application will delay review of your application pending receipt of all materials. 1. All information must be typed. Handwritten proposals are not accepted by the IRB. 2. If you are currently receiving or applying for funding for this study from an external sponsor (e.g., NIH, NSF, USDA, etc.), include copies of your proposal to the funding agency. The IRB cannot review your application without concurrently reviewing the funding proposal. If your research is part of your dissertation from another institution, you MUST have IRB approval from your primary institution first. 3. All documents and research instruments used in this study must be included: such as consent forms, surveys, questionnaires, deception debriefing scripts, recruitment ads/flyers/ s, etc. Omission of these items prevents review of your application. 4. You also must include any required components of Informed Consent Documents when constructing a consent form. Providing the IRB with an inadequately constructed consent EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 4

6 form delays the review process, and is the most common reason for delayed approvals. (Please see a sample consent form.) 5. Submit the IRB application and the following documents in a compressed format or zipped file via the online research proposal submission system: a) One (1) copy of the complete funding proposal (minus appendices; you may block out salary figures) and funding review comments that pertain to the use of human participants in your study (if applicable). b) One (1) copy of IRB approval from your primary institution. c) One (1) copy of the Initial Request, consent form(s), recruitment materials, and debriefing scripts. The Initial Approval Request must contain original signatures. d) One (1) copy of all other instruments: surveys, questionnaires, focus group guides, etc. e) Copy of all applicable human research ethical training certificates (NIH, CITI, etc.) If full committee review is required: Applications must be received at least three weeks prior to the next scheduled IRB meeting. There are no exceptions to the deadline. Turn-around can therefore be between three weeks and six weeks. If your study qualifies for expedited review: Please allow two to three weeks for review and notification. (If EFSC is closed for holidays, please allow additional time equivalent to the time the college is closed.) EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 5

7 Using the Online Research Proposal Submission System When you are ready to submit a research proposal download the required forms and follow instructions below complete your submission. Research requests must be submitted to the Eastern Florida State College Institutional Review Board through the online research application submission system. Prior to submitting a research application, investigators must complete the downloadable research application and provide a description of research. The research application and additional information can be found on the EFSC IRB web page: Once you are ready to submit your application proceed to the online application submission system. Directions for submitting proposals online: Research requests must be submitted to the Eastern Florida State College Institutional Review Board through the online research application submission system. Please review the IRB Meeting and Submission Dates page to be sure you submit your protocol on time for a full board review. Prior to submitting a research application, investigators must: Complete the downloadable Human Subjects Research Application Provide a description of research which includes: o The rationale and purpose of the study o Description of the participants o Summary of the materials/instruments required, design and procedure(s) o Copies of any assessments, questionnaires, survey, and/or interview protocols expected to be implemented Obtain IRB approval from primary research institution (if applicable) Submit the proposal through the EFSC IRB online research proposal submission system EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 6

8 Human Subjects Research Application Form for Full IRB and Expedited IRB Review 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 (Initial) Project Title (If project title does not match grant title, please provide grant title) Principal Investigator (PI) (Full Name and Contact Information) First: Middle: Last: Mailing Address or Campus Mail Address: Phone: College/University Department: Highest Education Level: Occupational Position: EFSC Faculty EFSC Staff EFSC Student Other Indicate the training and education, if any, completed in the protection of human subjects or human subjects records: Investigator 101 NIH HIPAA Other None EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 7

9 Co-Investigators/Research Staff (Include any individual who will have responsibility for the consent process, direct data collection from subjects, or follow-up.) Add Co-Investigators (or Research Staff). First: Middle: Last: Mailing Address or Campus Mail Address: Phone: College/University Department: Highest Education Level: Occupational Position: EFSC Faculty EFSC Staff EFSC Student Other Indicate the training and education, if any, completed in the protection of human subjects or human subjects records: Investigator 101 NIH HIPAA Other None First: Middle: Last: Mailing Address or Campus Mail Address: Phone: College/University Department: Highest Education Level: Occupational Position: EFSC Faculty EFSC Staff EFSC Student Other Indicate the training and education, if any, completed in the protection of human subjects or human subjects records: Investigator 101 NIH HIPAA Other None 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.) Faculty Advisor Department Chair Director Dean Other First: Middle: Last: Mailing Address or Campus Mail Address: Phone: College/University Department/Unit: Funding Is this research funded by an internal (EFSC) or external agency? Yes No 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 fill out the form for each of your sources. EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 8

10 Funding Source #1: This project has been/will be submitted to the following funding agency: Name of Sponsor: OMNI Number: SRS/Researcher Foundation Contact Person: The funding decision: is pending has been awarded Type of funding source: Funding Source #2: This project has been/will be submitted to the following funding agency: Name of Sponsor: OMNI Number: SRS/Researcher Foundation Contact Person: The funding decision: is pending has been awarded Type of funding source: Non-funded Projects If no, please explain how costs of research will be covered: Institutional Oversight Is this research proposal being reviewed by any other institution or peer review committee? Yes No 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 attach the documentation at the end of the application): CRC Other IRB, please specify: Other, please specify: 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. Do any of the Investigators or personnel listed on this research have a potential conflict of interest associated with this study? Yes No EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 9

11 Identify the individual(s): Has this potential conflict of interest been disclosed and managed? Yes No If you are an Eastern Florida State College researcher, please disclose your potential conflict of interest in writing for review by IRB. 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. Payment or Other Compensation for Research Subjects Will you give subjects gifts, payments, compensation, reimbursement, services without charge or extra credit/class credit? Yes No Please explain: Protocol Description and Other Detail (Use lay language, do not refer to grant or abstract. All questions are required!) Describe the objective(s) of the proposed research including purpose, research question, hypothesis, method, data analysis, research design and relevant background information etc. 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 major language is not English Involves Deception Exclusion of Women or Children Subjects (must explain why they are being excluded) Subjects studied at EFSC Subjects studied at non-efsc location(s) Students as Subjects Employees as Subjects Pregnant Subjects Fetal, placental, or surgical pathology tissues(s) Involves blood Samples (finger pricks, venipuncture, etc.) EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 10

12 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 Which methods will this study include? (check all that apply or specify other) Descriptive Formative Phenomenological Ethnographic Longitudinal Qualitative Experimental/Control Design Oral history Quantitative Field work Other, specify: Describe the tasks subjects will be asked to perform. 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.) Attach surveys, instruments, interview questions, focus group questions etc. How many months do you anticipate this research study will last from the time final approval is granted? Participant (Subject) Population Expected number of participants # of males: # of females: Total: Expected Age Range (Check all that apply) 0-7 (Attach parental permission form) 8-17 (Attach child's assent form and parental permission form) and older EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 11

13 Inclusion/Exclusion of Children in this Research: Inclusion Exclusion Other Protected Populations to be Included in this Research (Check all that apply) Protected by Federal Regulations Pregnant Woman/Fetuses/Neonates Prisoners Protected by Federal Guidelines (Refer to 45 CFR 46 subpart B and 45 CFR 46 subpart C on the populations protected by Federal Regulations) Mentally/Emotionally/Developmentally/Decisionally Impaired Persons Minority Group(s) and Non-English Speakers Elderly Subjects Gender Imbalance - all or more of one gender Inclusion and Exclusion of Subjects in this Research Study (Describe criteria for inclusion and exclusion of subjects in this study) Inclusion Criteria: Exclusion Criteria: Location of subjects during research activity or location of records to be accessed for research (check all that apply and specify): Eastern Florida State College 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: Subject's Home, specify: International Location, specify: Other Special Institutions, specify: Describe the rationale for using each location checked above Attach 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. EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 12

14 Recruitment of Participants (Subjects) Describe the recruitment process to be used for each group of subjects Attach a copy of any and all recruitment materials to be used e.g. advertisements, bulletin board notices, s, letters, phone scripts, or URLs. 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 Are subjects chosen from records? Yes No Are records "private" medical or student records? Yes No Who or what entity is the custodian of the records? Who gave approval for use of the records? EFSC 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. finder s fees, recruitment bonus, etc.) that would be paid directly to the research staff? Yes No Risks and Benefits 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: Does Research Involve Greater Than Minimal Risk to Human Subjects? Yes No "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 life or during the performance of routine physical or psychological examinations or tests. EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 13

15 Describe the nature and degree of the risk or harm checked above (The described risks/harms must be disclosed in the consent form.) 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 Describe the anticipated benefits of this research for individual subjects in each subject group. If none, state "None" Describe the anticipated benefits of this research for society, and explain how the benefits outweigh the risks. Confidentiality of Data Will you record any direct identifiers, names, social security numbers, addresses, telephone numbers, addresses, cookies etc.? Yes No 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: Will you retain a link between study code numbers and direct identifiers after the data collection is complete? Yes No Explain why this is necessary and state how long you will keep this link: Will you provide the link or identifier to anyone outside the co-investigators/research staff? Yes No Explain why and to whom: 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.) EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 14

16 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? Yes No Explain why this is necessary: 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. 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? Yes No 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 Rationale: Informed Consent Process 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. 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. EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 15

17 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: 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.) Attach all supporting documents to the online application submission system 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. 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 ) Save all files in a zipped folder prior to attaching to submission Total Number of Files Attached: Appendix A: Inclusion of Vulnerable Populations The 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. Note: 1-4 not all required but at least one must be filled out. 1. Mentally/Emotionally/Developmentally Disabled Provide justification: Explain how competency to provide consent will be determined and plan for obtaining surrogate consent: 2. Minority Group(s)/Non-English Speakers Provide justification: Provide plan for obtaining consent: 3. Elderly (65+) 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 B: Pregnant Women, Human Fetuses and Neonates involved in Research 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. 1. Does your research involve a pregnant woman or her fetus? Yes No EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 16

18 If yes, please explain: 2. Is there any risk involved in this research? Yes No 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: 3. Is there any direct benefit to the pregnant woman and/or the fetus? Yes No If yes, please explain: 4. Is the pregnant woman a minor (under age 18)? Yes No 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. Yes No If yes, please explain: 6. Is the neonate of uncertain viability? Yes No 7. Does the research involve nonviable neonates? A nonviable neonate means a neonate after delivery that, although living, is not viable. Yes No If yes, please explain: Appendix C: 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? Yes No 2. Will this study examine prisons as institutional structures or prisoners as incarcerated persons? Yes No 3. Will this study examine a condition(s) particularly affecting prisoners as a class of people? Yes No 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? Yes No EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 17

19 5. Will prisoners receive any incentives or advantages by agreeing to participate? Yes No Appendix D: Children Involved as Subjects in Research 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? Are any of the children involved in the research wards of the State? Yes No 3. Is the research not involving greater than minimal risk? Yes No 4. Explain how assent of the children will be obtained in this research: 5. Explain how permission will be obtained from the parent(s) or guardian for the participation of their child or ward in this research: Appendix D: 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? 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. (Attach 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. Attach the full debriefing "protocol" or explanation that will be provided to subjects. EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 18

20 Sample Assent Form for Minors My name is. I am a student from. I am asking if you would like to take part in a research study called, which is about. If you agree to be in this study, you will be participating by taking part in. The study may make you feel a little frustrated. This study will help me learn better the. Please talk this over with your parent(s) or guardian(s) before you decide whether or not to participate. Your parent(s) or guardian(s) must give their permission for you to take part in this study. Even if permission is granted you can still decide not to take part in the study. This study is voluntary; which means you decide whether or not to participate. No one will be upset in any way if you do not want to participate or if you change your mind later and want to drop out of the study. You can ask any questions that you have about this study. If you think of a question later you can call me at, or ask me the next time we meet. Signing your name at the bottom means that you agree to be in this study. You and your parents will be given a copy of this form after you have signed it. Name of child (please print) Signature of parent of guardian Signature of child Date Date EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 19

21 EFSC Consent form Template [Insert title of study and Consent Form ] You are invited to participate in a research study of [Insert general statement about the study]. You were selected as a possible participant because [Explain how the subject was identified]. We ask that you read this form and ask any questions you may have before agreeing to be in the study. This study is being conducted by [indicate the investigator s name and University/College Department with earned degrees(s)]. It is funded by [Indicate study sponsor, if any and state if the sponsor is also the manufacturer of the drug/device being studied if applicable]. Study Purpose The purpose of the study is [explain the research question and purpose in lay language. Indicate if the drug/device being tested is experimental]. Study Procedures If you agree to participate in this study, we would ask you to do the following: [describe in lay language the tasks and procedures to be followed and indicate if any procedures are experimental. Describe assignment to study groups, length of time for participation and frequency of proceduresinclude a table of study visits if applicable. Indicate if study participation involves withholding of standard treatment. Quantities such as blood volume to be drawn should be listed in lay language equivalents, i.e. teaspoons.] Risks of Study Participation The study has the following risks: [describe foreseeable risks or discomforts to the subject in lay language in order of severity and likelihood. Include any risks to subject confidentiality. Indicate the risks associated with being in the placebo group, if such a group exists. If standard treatment is to be withheld, indicate the risks associated with this.] Benefits of Study Participation The benefits to study participation are: [describe any direct benefit to the subject or benefit to others, which may reasonably be expected from the research. If there is no direct benefit to the subject, declare that fact. Note that payment to subjects is not considered a benefit of participation.] Alternatives to Study Participation [If the study involves treatment, disclose available alternative procedures or courses of treatment, if any, which might be advantageous to the subject.] EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 20

22 Study Costs/Compensation [Indicate whether subjects may incur any costs as a result of participation in the study and whether subjects will receive any payment. Note that subjects are not paid for participation, but are compensated for their time and inconvenience. If payments to subjects may be pro-rated, indicate how payment will be prorated.] Research Related Injury [If the research involves the potential for injury, include whether treatment will be available, including first aid, emergency treatment, and follow-up care as needed. Include whether study sponsor will pay for care. State whether care for injuries will be billed in the ordinary manner to research subject or his/her insurance company]. Confidentiality The records of this study will be kept private and confidential, to the extent allowed by law. In any publications or presentations, we will not include any information that will make it possible to identify you as a subject. Your record for the study may, however, by reviewed by [indicate if the drug/device manufacturer, study sponsor or representatives of the FDA may have access] and by departments at the University with appropriate regulatory oversight. [Indicate whether study information will be recorded in the subject s medical record. If any study data will be transmitted via the Internet, indicate what provisions for protection of privacy are in place]. Protected Health Information (PHI): Your PHI created or received for the purposes of this study is protected under the federal regulation known as HIPAA. Refer to the HIPAA authorization for details concerning the use of this information. Voluntary Nature of the Study Participation in this study is voluntary. Your decision whether or not to participate in this study will not affect your current or future relations with the University. [Indicate any other cooperating institutions]. If you decide to participate, you are free to withdraw at any time without affecting those relationships. Contacts and Questions The researchers conducting this study are [list investigator s names]. You may ask any questions you have now, or if you have questions later, you are encouraged to contact them at [provide telephone numbers. If the researcher is a student, include the faculty advisor s name and telephone number as well]. [Include the following contact language]. If you have any questions or concerns regarding the study and would like to talk to someone other than the researcher(s), you are encouraged to contact the EFSC IRB Chair at EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 21

23 You may also contact this office by at or by writing or in person to EFSC-IRB Chairperson, Dr. Mark Quathamer, 1519 Clearlake Rd, Cocoa FL, You will be given a copy of this form for your records. Statement of Consent I have read the above information, I have asked questions, and have received answers. I consent to participate in this study. Signature of Subject Signature of Investigator Date Date EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 22

24 Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure 1 Applicability (A) Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR and 21 CFR The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects. (B) The categories in this list apply regardless of the age of subjects, except as noted. (C) The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects= financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. (D) The expedited review procedure may not be used for classified research involving human subjects. (E) IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB. (F) Categories one (1) through seven (7) pertain to both initial and continuing IRB review. Research Categories (1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling. EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 23

25 (2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or (b) from other adults and children2, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week. (3) Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum base or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization. (4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual. (5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 24

26 (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR (b)(4). This listing refers only to research that is not exempt.) (6) Collection of data from voice, video, digital, or image recordings made for research purposes. (7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR (b)(2) and (b)(3). This listing refers only to research that is not exempt.) (8) Continuing review of research previously approved by the convened IRB as follows: (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long- term follow-up of subjects; or (b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis. (9) Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. 1 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 Children are defined in the HHS regulations as "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." 45 CFR (a). Source: 63 FR , November 9, EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 25

27 Guidance on the Use of Expedited Review Procedures Office for Human Research Protections (OHRP) Department of Health and Human Services (HHS) Date: August 11, 2003 Scope: The purpose of this document is to provide guidance on the use of the expedited review procedure by Institutional Review Boards (IRBs) Target Audience: IRBs, sponsors, and investigators. Regulatory Requirements: Expedited review procedures are described in HHS regulations at 45 CFR Under an expedited review procedure, the IRB Chairperson, or one or more experienced reviewers designated by the Chairperson from among the members of the IRB, reviews the research protocol. The IRB shall adopt a method for keeping all IRB members advised of research proposals that have been approved under the expedited review procedure. In conducting expedited review, the IRB reviewers may exercise all of the authorities of the IRB except that they may not disapprove the research. A research activity may be disapproved only after review by the convened IRB in accordance with the nonexpedited procedure set forth in 45 CFR (b). Under 45 CFR (d), HHS may restrict an institution's or IRB's authority to use the expedited review procedure. Guidance: The list of categories of research that may be reviewed by the IRB through an expedited review procedure was updated in 1998 and can be found at Additions to, and extrapolation from, this list by the institution or the IRB are not appropriate. For example, it is inappropriate to use an expedited review procedure for the initial review of either research that involves minimal risk but does not appear in the categories of research published in the Federal Register or research that involves greater than minimal risk. Institutions and IRBs are reminded that expedited review usually is not appropriate at the time of continuing review if the research required review by the convened IRB at the time of initial review (for information about expedited continuing review see OHRP Guidance at Like review by the convened IRB, expedited review must fulfill all the requirements of review found at 45 CFR and subparts B, C, and D, if applicable. IRBs are reminded that the requirements for informed consent (or for altering or waiving the requirement for informed consent) apply regardless of whether research is reviewed by the convened IRB or under an expedited procedure. OHRP policy provides that any institution with an OHRP-approved Assurance may use expedited review for initial or continuing review of HHS-supported or conducted research and EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 26

28 for review of minor changes in previously approved research as described in 45 CFR (b)(2). Consultants may assist the IRB in the review of issues which require expertise beyond, or in addition to, that available on the IRB. Only the IRB Chairperson, or one or more experienced reviewers designated by the Chairperson from among members of the IRB, may carry out the expedited review. The person(s) conducting the expedited review may either approve, require modifications (to secure approval) or refer the research to the convened IRB for review in accordance with the non-expedited review procedures set forth in HHS regulations at 45 CFR (b). Finally, OHRP recommends that: (1) documentation for initial and continuing reviews conducted under an expedited review procedure include: (a) the specific permissible categories justifying the expedited review; and (b) documentation of the review and action taken by the IRB Chairperson or designated reviewer and any findings required under the HHS regulations; (2) written IRB procedures include a description of policies describing the types of minor changes in previously approved research which can be approved under an expedited review procedure in accordance with HHS regulations at 45 CFR (b)(2); and (3) expedited review procedures NOT be used for research involving prisoners. However, if an IRB chooses to use expedited review for research involving prisoners, OHRP recommends that the prisoner representative of the IRB be one of the designated reviewers. EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 27