Principal Investigator's Manual

Preparing an IRB Protocol Application Form for Submission and Review

The IRB converted to a paperless electromic system on May 7, 2007. Investigators may use a previously assigned ARGIS username and password to log into the system at the iRIST home screen at https://iris.research.ucf.edu. Researchers who do not know their ARGIS username and password can click on "obtain your username and password" which appears on the IRB Web site at http://www.research.ucf.edu/Compliance/irb.html and then select "iRIS User Access Request Form". This will generate a form to gain access to the system. This form can be faxed to (407) 823-3299 or e-mailed as an attachment to IRB@mail.ucf.edu. For quickest service, phone the IRB office at 407-823-2901 or 407-882-2012 (M-F, 8 am - 5 pm). The IRB reviews all University of Central Florida research projects involving human participants, or biological/tissue samples collected from live human participants, and safety and effectiveness studies for medical devices or radiation emitting devices, biological products, investigational drugs (IND phase III and IV only, off-label use, emergency use), or In-Vitro diagnostic test product studies to determine if the research participants are placed at risk and if their rights and welfare are adequately protected. The majority of the studies reviewed by the IRB involve social, behavioral or educational research often involving the use of surveys, questionnaires or interviews. The IRB also reviews studies in which the UCF researcher plays a collaborative role particularly those which are subcontracts for a human subject participation portion. There are times when more than one IRB will review a study and there are other times when UCF might rely upon another IRB or another IRB might rely upon UCF IRB.

The iRIST Protocol Application Form has been designed to provide the IRB with the information it needs to evaluate your project. The electronic form uses branching logic to present additional questions when certain boxes are checked or in response to some of the "yes" or "no" answers. If an investigator does not completely understand the question as presented, he/she may select the wrong answer and be routed away from information needed for the review. In this case, the IRB office member doing a pre-review will explain the situation and ask that an answer be changed on the protocol application. The application can easily be retracted by the investigator and then he/she can make the changes, answer the additional questions, use the "save and continue" button to the end of the application, and then resubmit the protocol application. It is not necessary to complete the whole form a second time. Refer to the Fast IRB Approval Helpful Hints document on the IRB web site to check what is required for your study.

Two examples of problem areas that are often answered incorrectly are the initial questions in the "Recruitment" and "HIPAA-Use of Protected Health Information" sections. Recruitment: If there will be any interaction or intervention with human participants, even for just survey research, you are recruiting participants and the study will require the use of a consent form with the signature of participants or a waiver of documentation of consent which provides the consent form elements, but does not require a signature. HIPAA: If your study involves the use or disclosure of protected health information (PHI), the Health Insurance Portability and Accountability Act (HIPAA) regulations probably apply. The help balloons within iRIST explain the Privacy Rule. Please contact the IRB office if you need HIPAA guidance.

Use the hyperlinks and balloons within iRIST to obtain UCF information or federal guidance. The help balloons will link you directly to the federal regulations documents which provide guidance by topic and in searchable form. The Protocol Application Form and related uploaded documents must be approved prior to beginning any sponsored or non-sponsored research involving human participants. The provision of grant applications or awards is required. Any documents or test instruments which cannot be photocopied, scanned and uploaded as attachments should be delivered or mailed to the IRB office, UCF Office of Research & Commercialization, 12201 Research Parkway, Suite 501, Orlando, Florida 32826-3246, or through campus mail at zip +0150. All delivered or mailed documents must be labeled with the IRB protocol number, title of the protocol and the name of the principal investigator.

Completing the IRB Electronic Protocol Application Form

Information regarding the following topics will be requested in the IRB Protocol Application Form which is the form used within the iRIST System for the initial submission of a new study.

General Information

Title of Project (never give two studies the same title, add "II" if necessary)
Research ID Number (Research ID# is assigned by ORC when applying for a grant)
Department Selection(s)
Key Study Personnel (KSP) - PI(s), Research Staff, Contacts, Faculty Advisor
Note: For studies that receive funding-grant or contract-be sure to list the researcher who is the funding recipient as the study PI; the other researchers listed on the grant/ contract should be listed as co-PIs or in other KSP roles. Animal or Human Subjects Selection (select Human, IACUC is not using iRIST)
iRIS System Guidance and IRB Information-Help links (UCF) and Help balloons (federal)
Project Information - Proposed Dates, Activities Planned for which Approval is Needed Quickly
Type of Research, Lay Summary
Collaborating Institution(s) and Researcher(s)
Federalwide Assurances (FWAs), Roles, Subcontracts, Contacts Project
Funding Information-Type and Sponsor Selection
Title of Grant
Research Study Elements
Stem Cell Use Question (If "yes," other questions appear as below) Stem Cell Research Section
HIPAA Protected Health Information (If "yes," other questions appear as below)

Biosafety or Radiation Committee Review
Using Tissue/Specimen Samples/DNA (If this is checked in elements list, other questions will appear, as below)

Recruitment (If "yes," other questions appear as below)

Compensation for Participation
Alternative Treatment Options
Alternative Assignments
Project Scientific Purpose/Methodology
Image/Tape Storage (If "yes" to imaging question, other questions appear)
Data Use, Collection, and Protection
Use of Previously Collected Data
Risks/Benefits
Consent Process Decision
Waiver of Documentation of Consent
Waiver of Documentation of Consent-Non-FDA Regulated
Waiver of Consent Process/Form
Informed Consent
Investigational Drug Information (If "yes," other questions appear)
Investigational Medical Device Information (If "yes," other questions appear)
Financial Disclosure/Conflict of Interest for PIs and Research Team Members

Informed Consent Process

One of the main ethical responsibilities of a principal investigator is to ensure that potential participants have been provided with all the information they might reasonably need to know regarding a research project in order to make an informed decision whether or not to participate. Utilizing human participants requires the informed consent of those participants. Potential participants have the right to know what they are being asked to do prior to voluntary participation, and the potential and actual risks they will be exposed to no matter what the nature of the project and no matter how innocuous it may seem. The procedure of advising potential participants and obtaining voluntary agreement is known as the informed consent process. Informed consent is a process that involves providing participants with a description of the planned procedure in language appropriate to the level of understanding of the participants and that requests voluntary participation in accordance with applicable regulations. Note: OHRP requires that written informed consent documents have an expiration date affixed by the IRB at the time of approval. The IRB may make a determination to waive the requirement for the investigator to obtain a signed consent form for some or all participants as outlined in applicable regulations. In cases where the IRB determines that written documentation of consent may be waived and that consent may be obtained orally, a written version of the process and the script to be delivered orally to the participant must still be included in the protocol. In accordance with the American Psychological Association guidelines, individuals taking part in research should be referred to as "research participants," not "subjects."

No informed consent, whether oral or written, may include any exculpatory or other self-serving language through which the participant or the representative of the participant (e.g. a parent or guardian who represents a child participant) is made to waive or appear to waive any of the participant's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence that causes personal or property injury to the participant. In research that is considered to be greater than minimal risk, the following statement should be included in the consent document: "If you believe you have been injured during participation in this research project, you may file a claim with UCF Environmental Health & Safety, Risk and Insurance Office, P.O. Box 163500, Orlando, FL 32816-3500 (407) 823-6300. The University of Central Florida is an agency of the State of Florida for purposes of sovereign immunity and the university's and the state's liability for personal injury or property damage is extremely limited under Florida law. Accordingly, the university's and the state's ability to compensate you for any personal injury or property damage suffered during this research project is very limited."

Make every effort to keep informed consent brief and to the point. In most cases, informed consent should be written in the second person (i.e., you, your), with the exception of the signature portion. When duplicate copies are to be used, divide the information portion of the written consent from the signature section with a solid line. When a "tear-off portion" is to be used for the signature section in a social behavioral type study, a dotted line is suggested. Written consent forms should be kept to a few pages whenever possible, but the complexity and type of study may warrant a longer consent form (i.e., a clinical trial or medical device study). If more than one typed page is necessary, consider two-sided photocopying.

Before uploading the Word consent document into the iRIST electronic system for the IRB's review, check for spelling, grammatical, and typographical errors. Consent forms should be written in sixth to eighth grade language unless the targeted population is college-educated (i.e., teachers). The reading level can be lowered by replacing three syllable words, using phrases like "take part in" rather than "participate", and by shortening sentences. This is especially important when consent form letters are being sent home to the parents of school children as their capacity to read and understand may be limited particularly if the parents were special education or English as a second language students themselves. Remember to convert technical language into laymen's terms.

The following information is provided to assist you in preparation of the informed consent documentation for your research project. The consent form and the protocol or description of the specifics of the research study, as well as the grant application if applicable, should match in content. Consent forms which are copied for distribution to participants should always bear the IRB stamp of approval with the expiration date which will be placed on the most current version by the IRB office within the iRIST electronic system. When uploading a consent form for review, give the document a descriptive title like "Parental Consent", "Informed Consent for Adult", "Child Assent", etc. Next give it the number "1" in the version box provided. If or when you revise the consent form, iRIST will update the number to 1.1, 1.2, etc. One research study may have several consent forms as each one will be applicable to a different participant group or target population (i.e., one for parents to give permission for themselves to participate, one for parents to give permission for their child to participate, or one for teachers to agree to their own participation). Make sure the title of the consent form reflects the appropriate participant group so that the correct form can be easily distinguished. If there are also consent forms written in a foreign language, they should likewise be labeled appropriately in the description box within iRIST. Any time there will likely be several participants who primarily speak a language other than English, consent forms written in both English and the other language should be submitted to the IRB for review and labeled with the language in the title within iRIST. Note who did the translation, whether that person is a native speaker or is a certified translator, etc. Surveys and other test instruments should also be provided in the other language and English. Provide the IRB with an explanation of the steps taken to verify that the translated document is accurate. A third party, not involved in the research in any way, should verify that the English and other language consent forms say the same thing. If a company is used to do the translation or to do a back translation, the company can supply the PI with a letter or certificate that can be submitted to the IRB. If the study is sponsored by a pharmaceutical company and involves a clinical investigation, the sponsor will provide a translated consent form usually when a participant has been identified through pre-screening as being eligible for the study. It is the PI's responsibility to make these arrangements with the sponsor, but the IRB must approve the translated consent form.

Note: The principal investigator is responsible for maintaining signed consent documents in a locked file cabinet or other appropriate area for a period of three (3) years [six (6) if HIPAA- regulated protected health information is involved] after completion of the research and the closeout of the funding account. If the research is FDA-regulated (i.e., investigational drug, medical device or other biological test article study), records and signed consent forms should be kept indefinitely, if possible, because it takes many years for a drug or device to be approved and go to market. In the protocol application, clearly state who will be doing the research procedures and who will do the consenting of participants. If graduate students will consent participants, their names should also be listed on the consent form as Co-investigators and they must complete the CITI human subjects protection training.

a. Identify yourself by name, specify your connection to the University of Central Florida, and, when applicable, identify your faculty supervisor.

b. Provide a statement that the study involves research, and a fair explanation of your research procedures (what you expect the participants to do) and the purpose of the research, including identification of any procedures that are experimental. Note the amount of time (number of sessions, if more than one) the participant can expect to devote to the project.

c. Explain how participants' privacy will be protected. It is not adequate to only state "Data collected will be kept confidential to the extent provided by law." You must also indicate the steps you will take to protect the participant's privacy. If identifiers will be replaced with codes, note at what point in the research this will take place and how the linking list, if any, will be kept confidential, who will have access to the linking list, when it will be destroyed, etc.. If there is a key being kept to link the identity of the participant to the survey or other research information, the investigator may not state that the research is anonymous. It is confidential. Anonymity can be promised when there are no personal identifiers at all or, if there are such identifiers, they are not attached to the data or available to the public. Anonymity can be promised when there are no personal identifiers being collected by or given to the researchers. Avoid seeking participant's social security numbers unless it is necessary (e.g. because financial compensation of $600 or more to participants must be reported to the IRS and, in some cases, have withholdings taken out) and the participant has consented for the specific use of the social security numbers. Avoid even the use of the last four digits of the social security number or UCF PID number. With student permission, use student ID numbers to assign class credit when applicable.

d. Should tape recording, or imaging, of participants be a part of the study, inform the potential participants of this as part of the informed consent procedure. Specify whether "audio" or "video" tape will be used, whether personal information, (e.g. name, address, etc.) will be requested during the taping, who will have access to the tapes, how the tapes will be securely stored, what steps will be taken to black out participants' faces and to delete personal information from the tape, and what the disposition of the tapes will be (i.e., audio tapes will be transcribed and erased at the earliest possible time). Describe any process of identifying people on the tape by a number which either links, or does not link, to the person's identify. Images of live persons are also considered to be data. If taping is optional, provide a check off line where participants may say they "do" or "do not" want to be audio or video taped. Also state how those who do not want to be taped will be separated from those who give permission (sitting in a different section of the room, etc.). The reason for needing to keep audio tapes for anthropological or folklore type studies should be explained.

e. Include a description of anticipated risk or discomfort. If none is anticipated, make a statement to that effect. Almost all research in which identifiers are collected bears the risk of breach of confidentiality. This is usually a minor risk, but may be greater than a minimal risk when sensitive information is collected which could affect the reputation, employability, insurability of the participants or the possibility of criminal or civil litigation. Social harm refers to decreases in quality of life that result from information being created or used in a way that is damaging to the individual in question. Social harm may also disrupt interpersonal relationships by causing embarrassment, humiliation, discrimination, or stigmatization. Social harm is a result of the creation or transfer of information in a way that may negatively affect the research participant. Provide contact information for the UCF Counseling Center for student research if there is the possibility that study questions may disturb or affect participants (i.e., asking participants to remember or retell past abuse experiences). If you state that there are minimal risks, you should state what those risks are and how they will be minimized. Remember that risks of harm may include those that could affect the participant physically, psychologically, emotionally, socially, financially, etc.

f. Include a description of direct benefits to participants. If none is anticipated, make a statement to that effect. Think about what the participant may learn or gain even if it is just knowledge of how a research study is conducted which is often the case in student research conducted by the Psychology Department. A direct benefit derived by a participant might be, for example, improved well being, empowerment of the individual by giving him or her a voice, or even developing eye/hand coordination or increased dexterity while performing the activities like those done in simulated virtual reality environments. Remember it is not necessary to have a direct benefit to the participant if there really is no risk. If there are risks to participants, there should be a personal benefit to them not just that the research study will benefit the researcher or society in general. Describe the benefits to society or any indirect benefits to participants as well. Indirect benefits can be defined as gain to society or science through contribution to the knowledge base.

g. State whether or not compensation will be awarded. Specify what compensation is offered. When monetary compensation is offered, indicate the amount. If experimental credit to meet a course requirement is to be awarded, indicate the amount of credit offered and the course number. Where extra points or class credit are to be given, indicate the amount of extra credit, total possible points for the course, and the course number. If individual instructors will determine whether or not class or extra credit will be given for participation, it should be made clear in the consent form that this is the case. Also, describe alternative means for class or course credit for students who do not wish to participate so that such students will not be penalized for non-participation. Failure to have alternative means for class or course credit might be viewed by OHRP as a form of coercion to participate in the research. If students under the age of 18 are not eligible to be participants in a study, an alternative assignment of equal value and effort should be made available to them to receive the credit. The IRB does not approve the use of prize drawings or lotteries as only a few participants benefit.

h. Indicate that taking part in this procedure is voluntary. Include a statement that the participant is free to withdraw at any time without penalty. This would be a voluntary withdrawal. May it clear if data already collected will be used. If tissue samples are involved, make it clear whether or not the samples and attached data can be removed from storage if the samples were stored for future use. Include a statement to advise participants to consult with the investigator before discontinuing any investigational drug administration. There may be health issues that will need to be addressed in this situation. Explain any circumstances under which you, as principal investigator, might terminate an individual's participation (e.g. those not scoring above 50 percent will be dropped from this project or in a clinical study those not taking the medications as prescribed will be dropped from the study). These are examples of involuntary withdrawal. Both voluntary and involuntary withdrawals should be reported to the IRB in the annual progress report (continuing review or termination).

i. When questionnaires, surveys, or interviews are involved, note that the participant does not have to answer any question he/she does not wish to answer. Do not attach any conditions to the statement. Remember, participation is voluntary, and a participant does not have to be able to provide a reason for not answering a question. When conducting research involving sensitive information, use of the following statement is recommended: "You do not have to answer any questions that make you uncomfortable."

j. Offer to answer any inquiries concerning the procedures and provide contact information including your campus or other telephone number, e-mail address and/or campus address that a participant can use to reach you (and faculty supervisor, if applicable) later.

k. If your study is funded, add a funding source statement and an address. Also add a conflict of interest statement, if applicable.

l. If your study involves more than an everyday risk of living liability (greater than minimal risk), then it is recommended to include the "State Limited Liability Statement" as a paragraph within the consent form: "If you believe you have been injured during participation in this research project, you may file a claim with UCF Environmental Health & Safety, Risk and Insurance Office, P.O. Box 163500, Orlando, FL 32816-3500 (407)823-6300. The University of Central Florida is an agency of the State of Florida for purposes of sovereign immunity and the university's and the state's liability for personal injury or property damage is extremely limited under Florida law. Accordingly, the university's and the state's ability to compensate you for any personal injury or property damage suffered during this research project is very limited."

m. Conclude all written consent forms which require a signature with the following statement or its equivalent: "I have read the procedure (or research project) described above. I voluntarily agree to participate in the procedure, and I have received a copy of this description."

n. Identify yourself by name and provide the title of the project on the signature portion of the informed consent form particularly if the signature page will be separated and/or mailed back to the investigator. If mailing the consent form or a survey to the investigator is a requirement or a possibility, be sure to include the correct address for such mailing. When no address is given, the IRB office may receive the survey and not be able to forward it to the investigator if it cannot be linked to a particular study.

o. Provide places for dated signatures of the participant, the principal investigator and, where appropriate particularly in FDA-regulated research, a witness for written informed consent. Do not provide signature lines or reference to signing if a waiver of documentation of consent is being requested. This waiver is not allowable in FDA-regulated research.

p. Provide the participant with a duplicate copy of the informed consent document and retain signed copies for a period of three (3) years beyond completion of data collection and analysis or the closeout of the grant funding account. Documentation of a HIPAA Authorization or Waiver of Authorization for use or disclosure of protected health information (PHI) should be kept for (6) six years, but identifiers should be destroyed at the earliest time possible

q. When appropriate, particularly in clinical trials research, one or more of the following additional elements of information should also be provided in the informed consent document which is given to each participant:

(1) A statement that the particular procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant) that are currently unforeseeable;

(2) Anticipated circumstances under which the participant's participation may be terminated by the investigator without regard to the participant's consent (e.g., missed appointments, failure to take medications as prescribed, new developments in health condition);

(3) Any costs to the participant that may result from taking part in the research (additional visits or tests not being paid for by the sponsor) and a statement that the participant's insurance company may or may not pay for the charges; and the participant is ultimately responsible;

(4) The consequences of a participant's decision to withdraw from the research and procedures for orderly termination of participation by the participant (some medications require a tapering off period, the participant's condition may worsen);

(5) A statement that significant new findings developed during the course of the research, that may relate to the participant's willingness to continue, will be provided to the participant; and

(6) The approximate number of participants involved in the study (local, national or international expected enrollment numbers).

r. In studies that recruit college students do not assume that all are legal adults. The Informed Consent document must include the stipulation: "You must be 18 yeas of age or older to participate." If you wish to enroll students who are younger than 18 years of age, you must submit to the IRB a parental consent form and a child assent form that will be used for students younger than 18. If students turn 18 during the study, they should be reconsented with the adult consent form.

Federal regulations require written documentation of the parent(s') or guardian(s') consent before the researcher may approach the potential child (i.e., minor) participant (in Florida this is less than 18 years of age). This documentation is typically in the form of a consent letter to the parents or guardians or a consent form with built-in headings, both of which should contain a signature area. All of the previously listed consent form documentation for adult participants information regarding what should be included in a consent form is also applicable to a parental consent form, but the language should always be in the form of "your child" in the main part of the consent form and "I give my permission for my child" in the permission/signature area. Remember this is the parent giving permission for the child to participate. It should be clearly stated in the consent form what the child will do in the research project. If a consent form or consent letter is sent home to the parents, it should be written in sixth grade language with few three syllable words using short sentences and no technical language. Additionally, depending on the student population if this is school research, it may be appropriate to provide a parental consent form translated into the expected native language of the population.

Some additional information to consider and/or include in the parental consent form is as follows:

a. Include foreign language consent forms where appropriate. Federal regulations require that the consent form be written in a language that the participant understands. This applies to the parents who will consent for the child's participation as well. This requirement is applicable to all types of research. If a consent form or consent letter is sent home to parents, it should be written in sixth grade language with few three syllable words, using short sentences, and no technical language. Additionally, depending on the student population if this is school research, it may be appropriate to provide a parental consent form translated into the expected native language of the population. For example, research being done in the Dade County School District should never include only English parental consent forms or surveys since a high proportion of the student population comes from Spanish-speaking homes.

b. Indicate who will administer the procedures (e.g., you, the teacher, your supervisor, a colleague). Make certain that the language you use in any research document is understandable and "reader friendly" for the person to whom your document is directed. Avoid technical terms and jargon. Do not assume the parents understand anything about what your instrument measures or that they know the difference between a survey, an inventory, or some other instrument. If the parents are also participants and, for example, will be completing surveys themselves, a combination consent form using the language "Your or your child" is acceptable but not preferred. It often gets confusing in this type of consent form who is doing what, the parent or the child. It is the IRB's preference that you submit two separate consent forms, one for the parents giving permission for themselves to do an activity, if applicable, and the other for the permission for their child to do an activity.

c. When the procedure is to take place during school hours, make note of the activity the child will miss in order to take part in the study. Inform the parents or guardians if the child will be removed from academic classes and, if so, whether or not the child will be allowed to make up any missed work. Indicate if this procedure is part of the ordinarily scheduled instruction by the teacher.

d. Where applicable, include a statement that participation or non-participation in this study will not affect the child's grade in any class or status in his/her program. An additional statement that may be used is: "If you decide that you do not want your child to be in this study, it will not affect how the school treats your child."

e. If you will be approaching an intact class or group for participation, indicate what those without permission to participate in the study, or those without permission to be video taped, will be doing while the research procedure is taking place.

f. Note benefits that may result for a child taking part in the study, including knowledge gained. Describe any appropriate alternative procedures that might be advantageous for the participant. If no direct benefits are anticipated, make a statement to that effect. (e.g. There is no direct benefit or anticipated risk to/for participants). Remember, if there is no direct benefit to the child, the risk must be minimal.

g. Explain how the child's identity will be protected (anonymous response, coding, etc.) and, if applicable, make a positive statement regarding confidentiality (e.g. include a statement that individual student scores will be kept confidential to the extent provided by law through a numerical coding system and that only group scores will be published). Make it clear in the submission whether you will receive school test scores with individual student names or without individual student names. If you are receiving the identifiers, explain either your process to de-identify the database or the reason you need the identifiers and how you will protect them. State whether or not data will be shared. If so, indicate specifically what data will be shared, whether group or individual, and with whom (e.g., parent, teacher, school board). FERPA regulations apply to school research regarding the collection of data. The IRB does not allow passive consent.

h. Indicate whether compensation will be awarded. When monetary compensation is offered, state the amount. If another form of compensation will be offered, be specific (e.g., sticker, pencil). Avoid vague statements like "Children will receive a small prize for participation." When children will be rewarded for returning the informed consent form, include provisions for non-participation in the signature portion similar to the following: I voluntarily agree to allow my child, , to participate in ___ . or I do not wish for my child, , to participate in .

i. If your study involves more than an everyday risk of living liability (more than minimal risk) then it is recommended to include the "State Limited Liability Statement" as noted in the previous adult participant consent form documentation section.

j. Specify that the parents or guardians (as well as the child) have the right to withdraw permission for the child's participation or for the use of the child's data at any time, without any penalty or prejudice. Do not place conditions on the right to withdraw (e.g., "Your child may stop at any time." instead of "Your child may stop if he or she becomes frustrated."). Explain any circumstance under which you, as principal investigator, might terminate the individual's participation (e.g., Children who do not score above 70 percent on the pretest will not be included in the experimental session).

k. When questionnaires, surveys, or interviews are involved, state that the child does not have to answer any question that he/she does not wish to answer. Do not attach conditions to this statement.

l. Parental/guardian informed consent should conclude with the following statement or its equivalent: "I have read the procedure described above and I voluntarily agree to allow my child, , to participate in Dr. 's (brief description here) study, and I have received a copy of this description."

m. Provide a signature line labeled Parent/Guardian and a place for the date and a second signature line labeled 2nd Parent/Witness with a place for the date. This is to accommodate parents with court-appointed joint custody. Because it is not your responsibility to become knowledgeable as to which children require joint permission, if a consent form is returned with only one parental signature, you may assume this child's parents do not fall into that category. Federal regulations require the signature of both parents under the following circumstances: when research involves greater than minimal risk with no prospect of direct benefit to individual participants, but is likely to yield generalizable knowledge about the participant's disorder or condition; or when research, otherwise not approvable, presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. Foster parents may not give permission for children in their care to participate in research. Biological parents may give permission even when Department of Children and Families has removed the children from the home as long as the parental rights have not been taken away. Contact the IRB office if your research study will involve children or adolescents who have been placed in alternative living arrangements by the court system (e.g., adolescents placed in a group home by the court). In cases like these, the IRB may need to address issues regarding additional regulations as the adolescents may be considered prisoners according to federal definition. Passive consent has been used in some school-based research in response to the difficulties of securing prior written permission from parents. The IRB does not approve the use of passive consent in which teachers or schools attempt to notify parents that research will be conducted, but do not require written permission from parents to allow their child to participate. Passive consent means children automatically enter the research study unless a parent objects and removes them. Often the forms never make it out of the childrens' backpacks and parents are then not aware. The passive consent process is not equivalent to informed consent. Federal regulations require that parental or guardian permission be obtained or waived according to the four criteria provided in the regulations.

n. When sensitive information is being gathered which might have the potential to reveal child abuse or neglect, provide the participant's parents or guardians with a statement in the consent form which alerts them that Florida law requires mandatory reporting. Use the following language in the consent form: "It is the responsibility of the investigators to disclose to the proper authority any information or behaviors we become aware of concerning your child that may endanger your child or could constitute abuse. All other study related information will be kept confidential as stated earlier."

o. Provide the participant's parents or guardians with a copy of the informed consent document and retain signed copies of consent forms for a period of three years beyond completion of data collection (six years if HIPAA and protected health information are involved).

Assent is an individual's voluntary, affirmative agreement to participate in research. A minor participant's failure to object cannot be construed as assent. Assent of minor participants is required in addition to written consent from their parent or parents (in the case of greater than minimal risk research). An assent form or a verbal assent script is required as part of the IRB submission whenever minor participants are involved (ages 7-17). Assent scripts should be brief, to the point, and at a language level appropriate to the participant. The following information, along with examples available on the IRB web site at http://www.research.ucf.edu/Compliance/irb.html or within the iRIST electronic submission system, may be helpful to you in preparing this document. The assent form for children is usually labeled "Child Assent". An assent form should also be used for decisionally impaired adults whose legal guardian or healthcare surrogate has signed an informed consent document, but the participant is cogniscent enough to understand a simple description and give agreement to taking part. Teachers may read a group assent script to the children to gain their agreement particularly when the children are young. Older children are capable of signing an assent form to establish that agreement to take part. Remember, keep it simple. If a group of children or adults do not likely have the ability to understand what they are being asked to do, the IRB has the authority to "waive" the assent if it believes the research will not harm the individuals, but this must be documented by the IRB in the review and approval paperwork. The principal investigator should note if there are different levels of functioning within the population and explain how it will be determined which participants are capable of assenting (particular testing that applies or attributes).

a. Identify yourself and your connection to the University of Central Florida.

b. Explain what you are asking the child to do. Include a statement that the child can stop at any time and, where when applicable, that he/she does not have to answer all questions and that it will not affect his/her grades if he/she does not want to take part.

c. Conclude with a question, about the child's willingness to participate, to which the child can respond either positively or negatively.

Submitting Protocol Application Attachments within iRIST for Review by the IRB

  • Attachments to be Uploaded in the Submission Portion of the Protocol Application in the Consent Documents Area:

a. Consent Forms: Written in both English and other languages as deemed appropriate for the population being recruited.

b. Assent Forms/Scripts: If children (ages 7 - 17) or decisionally impaired persons will be enrolled, an assent form (or script, particularly for younger children) should be uploaded into iRIST .

c. Debriefing Forms: Whenever deception is involved as part of the research or information is withheld from a participant before or during the research, this information must be disclosed to the participant at the close of the research either verbally or in writing. A copy of this statement must be attached to the protocol. Additionally, some departments such as the Psychology Department require debriefing after the session as an educational tool. If this applies to your research, upload a copy of the debriefing statement to your IRB submission portion of the application.

  • Attachments to be Uploaded in the Submission Portion of the Protocol Application in Other Documents Areas:

a. Grant Proposal or Subcontract: Whenever funding for a project is being sought from any source, whether on or off campus, the grant proposal must be uploaded for review. Upload subcontracts when possible. Explain if any human subjects portion is to be done by someone who is not a UCF employee or agent.

b. Research Instruments: Upload a copy of any survey, questionnaire, and/or interview questions as well as test instruments. Upload instruments written in other languages if appropriate for the study. Include an English version as well. A protocol should be provided for medical research, particularly clinical trials or medical device studies. Additional materials which should be included for medical studies include case report forms, medical history intake forms, the 1572 form, an investigator agreement for device studies, curriculum vitae for medical staff, and an investigational drug brochure when available.

c. Advertisements or flyers: If participants will be obtained through advertisements or flyers, upload a copy of the ad or flyer as part of your IRB submission. These items must be approved by the IRB before they can be used. Remember to describe in the recruitment section how the advertisement or flyer will be used (posted at "location" or distributed by "names of distributors or groups"), etc. This also applies to e-mail and letters used to recruit study participants.

d. Certificates of Confidentiality: When data are being collected about sensitive issues (including illegal behavior, alcohol or drug use, or sexual practices or preferences), principal investigators may consider applying for a Certificate of Confidentiality. Under federal law, researchers can obtain a Certificate of Confidentiality that will provide protections against a subpoena for research data [Public Health Service Act 301(d)] that, if released, could reasonably be damaging to an individual's financial standing, employability, or reputation in the community; information that would normally be recorded in a patient's medical record, and the disclosure of which could reasonably lead to social stigmatization or discrimination; information pertaining to an individual's psychological well being or mental health; or genetic information. Protection will be granted sparingly and only when the research is of such a sensitive nature, that protection is judged necessary to achieve the research objectives. This protection is not limited to federally funded research. Certificate information appears at http://www.hhs.gov/ohrp/humansubjects/guidance/certconf.htm. You may also contact one of the Central Resources (NIAAA, NIMH, NCI, etc.) at http://www.grants.nih.gov/grants/policy/coc/contacts.htm. The IRB has the authority to request that a PI obtain a Certificate of Confidentiality when deemed appropriate for the study. For studies being funded by the National Institute of Justice, investigators are responsible for completing and signing the Privacy Certificate which is reviewed and approved by either the IRB chair or the IRB coordinator.

e. HIPAA Authorization or Waiver of Authorization Forms: The UCF HIPAA Authorization Form is available on the IRB web site at http://www.research.ucf.edu/Compliance/irb.html. Once completed, detailing who will use or disclose information and to whom it will be disclosed, the form should be uploaded into iRIST. The Waiver of Authorization has been built into the HIPAA section of the protocol application within iRIST. If a hospital or other medical entity HIPAA Authorization form is being used, upload a copy of that form. If the HIPAA Authorization language is part of the hospital or other medical entity consent form being used for this study, upload that document and make a note in the text box.

f. Reference Search or Bibliography: Include these when the complexity of the study warrants it or it is part of a grant application. This information should be included particularly in federally funded studies and clinical trials.

g. Letters of Support: This would include letters from sponsors, collaborators, management, principals or school districts. This is particularly important when surveying workers in a company or students or teachers in a school. Orange County School District requires completion of the Orange County Research Request Form and approval of the form by the district, but most other school districts will provide a letter which can be uploaded.

h. Human subjects protection training certificates and a description of the classes if the investigator is requesting that this training be substituted for the mandatory CITI training. Substitute training should be equivalent in complexity and scope to the CITI training. If CITI training was completed at another university or hospital within the last three (3) years, upload a copy of the documentation to meet the requirements. The link to the CITI training is available on the IRB web site.

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