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What is a “Human Subject” • From the Department of Health and Human Services: “Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. • Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. • Interaction includes communication or interpersonal contact between investigator and subject. • Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). • Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects”
Why Apply for IRB review? • The IRB’s position on whether or not student projects require approval is this: • If they are done solely for the purpose of training in research methods, IRB approval is not required • However, if the research will be published or publicly disseminated, IRB approval is required • So as not to foreclose the possibility that you can get a conference paper out of your research project, at least, and possibly a publication, we will seek IRB approval for all projects where appropriate • IRB now has a policy that you can collect the data and then make a request after the fact for permission; • In general you may be willing to take the risk that your project will not be approved • Unclear what recourse you will have in terms of the University’s legal protections if you conduct research without IRB approval, something bad happens, and then you try to get approval
Why apply for IRB approval, cont’d • Knowing how to complete the IRB forms and make a successful application will help you to deal with these issues when they come up in your dissertation research as well as other projects you might conduct while at USC • The IRB will point out to you areas in which you could compromise the rights of your participants or at least issues to which you could be more sensitive or which you have overlooked • Conducting your research with the IRB stamp of approval • Lends credibility to your project in the eyes of potential participants • Ex., student asked to post her questionnaire, was turned down, then provided moderator with copy of IRB approval and was accepted • Gives you institutional support in the event that complications arise
Categories of IRB applications • Research that the investigator believes does not constitute human subjects research (there is a link to a document that tries to define what is not HSR on your main folder page in iStar)-example-org comm research project in which people identified as CEOs of organizations in China reported on their company’s activities and attitudes with respect to taking on work for American companies who want to outsource to China-participants were not reporting info about a living individual (i.e. themselves) so it didn’t count as HSR • Research that the investigator believes to be exempt from IRB review • The first two categories are a little fuzzy in IRB publications • Research that the investigator believes qualifies for an expedited review (poses minimal risks to subjects) • Research that requires full board review
What Kind of Research is Exempt from IRB Review? • Various kinds of projects qualify as exempt. • (1) Research conducted in established or commonly accepted educational settings, involving normal educational practices... • (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior... • (3) Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior that is not exempt under item (2) of this section... • (4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens... • (5) Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine... • (6) Taste and food quality evaluation and consumer acceptance studies...
Exempt research category, cont’d • For example, research in which the only involvement of human subjects will be in the following category are exempt from full IRB review: • “Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Note: this category is applicable to data, specimens, etc. that are already existing at the time that the research is proposed • An example of this might be observational study of Internet chat rooms (or it might not be!)
A Matter of Interpretation • How is the investigator to decide what is human subjects research and what is exempt? Consider the following from an OPRS document: • “Observational studies of public behavior (including television and internet chat rooms) do not involve human subjects as defined when there is no intervention or interaction with the subjects and the behavior is not private. Also, studies based on data collected for non-research purposes may not constitute human subjects research if individuals are not identifiable (e.g. data such as service statistics, school attendance data, crime statistics, or election returns).”
A Matter of Interpretation, cont’d • But then consider this in the very next paragraph! • “Studies based on data that are individually identifiable but are also publicly available may not constitute human subjects research. However, the term “publicly available” is intended to refer to record sets that are truly readily available to the broad public, such as census data, or federal health, labor, or educational statistics. An investigator should not assume information qualifies as “publicly available” merely because it has been posted on an electronic website and can be accessed without authorization.” • What about postings to an HIV forum? Postings on a members-only dating web site? • As your CITI course module on Internet research notes, there is no consensus on whether study of Internet communications falls into the exempt category and it is probably incumbent on the researcher to convince the IRB that the members of an online forum do not have an expectation of privacy. To be safe, file for an expedited review and let the IRB decide if it’s exempt • Any researcher who isn’t certain if his/her proposal constitutes human subjects research should contact the IRB or submit an online “Request for Human Subjects Research Determination” through iStar
What Kind of Work Qualifies for Expedited Review? • 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 • 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.”
What Kind of Work Qualifies for Expedited Review?, cont’d • Here are the categories most likely to apply to your work (doesn’t include most medical examples; go here for full list • “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). (ex., reviews on a movie review site where anybody can post reviews)(NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.) • Collection of data from voice, video, digital, or image recordings made for research purposes. • 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” • Studies that do not qualify as exempt or for expedited review may be scheduled for full board review
How to sort all this out • My quick take • If it’s not data about people, it’s probably not HSR • If it’s about people, but it’s collected anonymously, it’s probably HSR but exempt • If it’s about people, and the information collected has been linked to the person, even if you later de-link it, it may require expedited review because you have to give assurances about data safety and confidentiality • If it’s about protected categories such as minors, prisoners, if there’s more than minimal risk, if it’s experimental, it may require full board review –example, CHLA project required full board review and CHLA and UPC did an expedited review following CHLA approval
What is Informed Consent? • Informed consent means that the participant consents in writing after having been informed about • The fact that the activity in which they are about to participate is research (and not some other type of activity) • The purposes of the research (up to a point; care must be taken not to disclose one’s hypotheses, for example) • How long it will take to complete participation • The procedures that will be followed • Any procedures that are “experimental” in nature (have unknown or unevaluated risks and benefits) • Risks or discomforts that can reasonably be foreseen • Any benefits to the individual or to society that might results from participation, such as payment, cure for disease, etc
Informed Consent, cont’d • A disclosure of advantageous alternatives (better treatment may be available elsewhere, have fewer risks; there is a whole literature devoted to balancing needs of the experiment for control with needs of persons for health and social services when randomization may result in not receiving the more advantageous treatment) • Shadish et al. book-reports the case of researchers whose funding for a study of epilepsy surgery was withdrawn because not enough participants were willing to let the decision about having part of their brains be removed decided by randomization • Not always possible for the Experimenter to know if the treatment is more advantageous than the control. If s/he did there might be no need for the study • Contact information in the event of questions • A clear statement that participation is voluntary and that the participant is free to withdraw at any time without penalty or loss of compensation. (If adverse circumstances occur during the study the experimenter must notify IRB and consider terminating the study)
Informed Consent, Cont’d • Go here to download sample IRB forms for all contingencies • Sample completed and approved consent forms are available here and here. You may also use, depending on your needs and the type of study, a verbal consent form. If you are collecting data anonymously, you may simply use an information sheet which does not require a signature. • See here for a sample consent form which combines the information sheet with the signature page, when signed consent is feasible and there is only partial anonymity. • When a signature is obtained and the participant can be connected with his or her data, additional assurances must be made about how confidentiality will be protected (except as required by law (consult Shadish for detailed treatment of legal issues) • Although you are unlikely to be using any of the following in your research this semester, be aware that more stringent criteria apply to prisoners, pregnant women, persons with certain disabilities, or children (parental consent may be required) • If you are going to be translating your information sheet or consent form into languages other than the one it was prepared in, the IRB may require you to use a certified translator although they have gotten more flexible about this. Would be more likely to require if for high risk research and for consent forms
What Documents Must I Include in my application through iStar? • 1. Your research protocol, a copy of your research proposal or at a minimum a description of your research procedure and plans for data analysis • 2. Your Consent Form or Information Sheet or any other type of consent form such as a child assent script, as applicable to the study population • 3. Surveys, Questionnaires, or Other Instruments Submit everything that is part of the material of your study including descriptions of the experimental manipulations, all independent and independent measures plus control variables, and any photos, videos, audio snippets, etc that will be used
What Information Must I Submit to the IRB, cont’d • 4.Recruitment Letters, Flyers, Advertisements, E-Mails. IRB seems unclear on whether you can mention the amount of compensation if you plan to pay them. You can always say “compensation will be provided; contact Ms. X for details” • 5.If you are working with an external agency you may have to have a letter of compliance from them: • “If any non-USC facility or agency (e.g., another research institution, local school, outside lab, etc.) is utilized as a study site or source of subjects for the proposed investigation, IRB approval may be required. If the site does not maintain an IRB, a Letter of Compliance or Permission signed by the institutional official (administrator) and written on site letterhead must be forwarded to the UPIRB. The letter must include the UPIRB number (if available), study title, name of the Principal Investigator or Co-Principal Investigator and the assurance that the site will “abide by and comply with the procedures approved by the USC UPIRB”
A Word about Recruitment of Participants • Recognize that people who respond to solicitations for participation may differ in significant ways from the population to which you wish to generalize (may have more or fewer resources, more interest in the topic, more time on their hands, greater trust of science and authority, may be less economically well-off if incentives are offered, or may hope to gain something through contact with the Experimenter or the institution s/he represents. See pp. 292-3 in Shadish et al. for a discussion of this issue. • For example, in our study of mutual touch over the Internet, virtually everyone who signed up for the study was an Engineering student from India. They could be expected to deviate from the general population in significant ways related to knowledge of and interest in advanced technology • As a rule you should avoid any kind of coercive recruitment, such as going into a fellow instructor’s classroom and making a pitch, then asking for a show of hands of “who will sign up?”. Similarly, the instructor should not “volunteer” the whole class to participate • To keep anonymity, it’s good if when you collect data from students who are doing the study for extra credit you let them participate anonymously and then give them a token to give their instructor to show they participated
Your Obligations Before and After the Class is Over • If you have finished collecting and analyzing your data you are supposed to complete a Final Report to IRB. • If you have finished collecting your data but have not yet finished data analysis you must file an application for Continuing Review • If at any time there are any adverse events, (e.g., someone has an emotional or physical reaction or is in someway disturbed by some aspect of your study) you must report it to me and an report of unanticipated events must be filed with IRB • There are links to forms on the OPRS web site
Overview of the IRB Review Process • 1. PI & Study TeamPrepare and submit application • 2. Pre-ReviewersIf applicable, the application is routed to designated faculty members who will make a determination if your application really is exempt or expedited or if full board review is required • 3. IRB Staff ReviewAn IRB Administrator will be assigned to the study. The IRB Administrator will conduct a staff review and manage the scheduling of the study • 4. IRB ReviewThe IRB committees or a chairperson (for expedited/exempt studies) will review the application and either provide feedback for the study team to address or an approval. Committee decisions, feedback and approval letter are recorded by the IRB Administrator in iStar and sent to the PI & Study Team • 5. ResponseIf feedback on the study was received, the PI & Study Team will prepare a response and submit to the IRB. Then, steps 3 and 4 will be repeated. • 6. PI & Study Team (once study is approved)Conduct research.Report adverse events.Submit requests for continuing reviews.Submit amendments.
Communication Between IRB and PIs • Email notifications will be sent to the PI and study team anytime the application is sent back for requested changes by a reviewer • Usually you will be asked to track the requested changes in your submitted document • Sometimes they may edit your application directly to save time if it’s something minor • The approval letter will be sent to the PI and study coordinator via email. A copy of the approval letter and approved consent forms will be posted with the study and available for download at anytime. The final approved version will have an official IRB “stamp” • All changes to the application and correspondence between the study team and IRB will be logged and time stamped.
iStar System • All applications for IRB review at USC are made through the online iStar system • If you do not already have an iStar username, click here to obtain one. (Actually, you needed this to get your CITI certificate!) • When creating a new study, the student should specify herself or himself as the Principal Investigator and the professor (in this case Margaret McLaughlin) as the Faculty Advisor and as a co-investigator so that I can directly edit your study application • Once the student has submitted the study application it will appear in my inbox on iSTAR and will require my approval as faculty advisor before the review process can begin
Sample Application for Expedited Review • We will show you SeungA’s Jin’s application for her dissertation research
Methods and Procedures, Prospective Studies 12.1. Describe in detail the design and methodology of the study. If applicable, include information on stratification or randomization plans. Identify and distinguish between those procedures that are standard of care and those that are experimental. Include the frequency and duration of each activity and the total length of subject participation. Copy and paste support tables 12.2. Provide a detailed description of the planned data collection, specific outcomes, and criteria for evaluation and endpoint definition. Copy and paste support table. 12.3. Describe the statistical considerations for the study, how the sample size was determined, and how the results will be analyzed, if applicable. Copy and paste support tables (here you will be skipped to the next section) 21.1. List all of the measures/instruments that will be used for this study and attach copies
Special Subject Population 22b. If you selected Employees or Students, please indicate how you will minimize the potential for them to feel coerced to participate. Discuss how the potential confusion in roles will be addressed.
Risk/Benefit Analysis 27.3.Describe the safety precautions that will be taken to minimize risks/harm 27.4.Data Safety Monitoring Plan: Describe how the studies are monitored for the safety of the participants and for the validity and integrity of the data. (If a DSMB is involved with this study, please describe the composition, plans for monitoring and distributing information to the local IRBs.) Attach the plan
Informed Consent Practices 30.1. Personnel Obtaining Consent: indicate the names and qualifications of study personnel who will be involved in the informed consent process. 30.2. Describe the consent process. Discuss when and where the consent process will take place relative to the initiation of the study procedures, as well as, how opportunities will be made for possible participants/families to discuss their participation with others before signing the consent form. Describe the steps taken to provide the prospective participant sufficient opportunity to consider whether or not to participate in the study. 30.3. Describe the steps that will be taken to assure that subjects (including children) fully understand the nature of their involvement in research. 30.4. Will you be recruiting non-English speaking subjects? 30.5. Describe how capacity for consent will be determined if some or all of the subjects have cognitive and/or language/hearing impairments. 30.5.1. If applicable, attach any instruments that will be used to determine the subject's capacity to consent 30.6Describe the procedures for identifying a legally authorized representative/guardian for those unable to consent (adults) or for minors not accompanied by their parents, as applicable.
Submitting the Study • You are given an final opportunity to supply any additional supporting documents or to communicate some message to the IRB
Exempt Status Application, cont’d • The remaining items are similar to what you would complete for an expedited review application except that there are a lot fewer of them! • You have to spend significantly less time justifying your procedures and protections • If you are collecting data anonymously and have minimal interaction with your participants (like a survey or content analysis of online posts) exempt status is the best way to go
