University Policy on Human Subjects Research: WSU IRB Approval Process, Study Guides, Projects, Research of Introduction to Sociology

Download University Policy on Human Subjects Research: WSU IRB Approval Process and more Study Guides, Projects, Research Introduction to Sociology in PDF only on Docsity! OGRD MEMORANDUM #4 January 4, 2000 MEMORANDUM TO: Deans, Chairs, Directors, Faculty, Staff and Students FROM: George A. Hedge, Vice Provost for Research SUBJECT: University Policy Regarding the use of Human Subjects in Projects Federal and university policies require that all projects conducted by faculty, staff and students using human subjects must be reviewed. The overall intent of the policy is to ensure that human subjects are treated physically, psychologically and socially in such a way as to minimize embarrassment and stress, and to avoid harm or other negative effects. A project using human subjects must have Institutional Review Board (IRB) approval of the project's protocol. Prior to initiating any portion of the project, approval from the IRB must be received. It is especially important that students who use data gathered from human subjects for theses and dissertations be fully aware of university policies. Failure to comply with university review procedures may make it impossible for the Graduate School to accept theses or dissertations. Protocols should be reviewed by department level committees prior to being submitted to the IRB for either an exempt review, expedited, or full board review. A Human Subject Workshop is offered each semester which explains the review criteria and procedures. Departmental reviewers, faculty and staff who are conducting projects that involves human subjects should attend. Approval is valid for only ONE year and must be renewed if the protocol lasts longer or is modified during that period of time. An annual review may be initiated by the investigator or by OGRD. This review requires a summary of the current status of the project including what is left to be accomplished and an anticipated completion date. A copy of the current consent form should also be submitted. Whatever the initial review category was, the same review procedure will be followed for annual reviews. If you have questions concerning these procedures, or the classification of a protocol, please contact OGRD for clarification. A summary of the current policy and the review forms are attached. WASHINGTON STATE UNIVERSITY HUMAN SUBJECTS FORM To receive approval from the WSU Institutional Review Board (IRB) for the use of human subjects, submit the following packet of materials to your department for initial review and signatures. Your department will forward the packet to the IRB for final review and approval. When your packet has been received by the IRB it will be checked for completeness. If not complete, it will be returned with a request for additional materials necessary for the review. To determine the level of review needed for your protocol turn to Section 2, Page 6. PACKET CHECKLIST EVERY PACKET MUST INCLUDE THE FOLLOWING MATERIALS. 1. Completed and Signed WSU Human Subjects Forms (Sections 1, 2 and 3, Pages 1-8). ___ 2. Documentation of Consent Procedures (one or more of the following): a. Consent Form, ___ b. Verbal Consent Script, ___ c. Cover letter. ___ 3. Any survey instruments or questionnaires to be used. ___ 4. A list of interview questions or topics, in as much detail as possible. ___ 5. Exempt protocols: (Section 2, Page 6) Signed original ___ Expedited Protocols: (Section 3, Page 7) Signed original and two copies of items 1-4. ___ Full Board Protocols: (Section 4, Page 7) Signed original and 14 copies of items 1-4. ___ 6. Original must be single-sided and not stapled. Copies may be stapled and double-sided. REVIEW TIMETABLE Exempt reviews are reviewed as the packets are received and will take no more than 10 working days for approval once they have arrived at OGRD. Expedited reviews are reviewed as the packets are received and will take about 10 working days for approval once they have arrived at OGRD. Full Board reviews will be reviewed at the next monthly meeting of the IRB, if and only if the packets are received at OGRD at least 10 working days prior to the meeting date. ELECTRONIC VERSIONS OF THIS FORM FLOPPY DISC VERSIONS AVAILABLE AT OGRD Microsoft Word Versions 5.1 and 6.0 for Macintosh Microsoft Word Version 2.0 for Windows WordPerfect and other word processing programs can use the Rich Text Format (RTF) version ELECTRONIC FORMATTING: Entire document is designed to be single spaced, left justified, typeface is Palatino 10pt. Margins are 0.5 inch on all sides, with tabs at 0.25” and 0.5” from the left margin, and every 0.5” after that. WORLD WIDE WEB SITE at www.ogrd.wsu.edu/ogrd1/ under FORMS, Human Subjects/Animals/Biosafety. HOW TO CONTACT THE IRB Phone: (509) 335-9661, Office of Grant & Research Development (OGRD) Campus Mail: campus zip 3140 Fax: (509) 335-1676 Email: ogrd@wsu.edu Mail: WSU IRB c/o OGRD, PO Box 643140, Pullman, WA, 99164-3140 WSU Human Subjects Form, Page 2 (Please attach assent form.) 5. Will any ethnic group or gender be excluded from the study pool? YES ____ NO____ If yes, please justify the exclusion. 6. Is this study likely to involve any subjects who are not fluent in English? YES ____ NO____ If yes, please submit both the English and translated versions of consent forms and surveys, if applicable. 7. Does this study involve subjects located outside of the United States? YES ____ NO____ If yes, on an attached page please explain exactly "who the subjects are,” and the identities (if possible) and responsibilities of any additional investigators. III. DECEPTION (See Definitions, Section 5, Page 9) If any deception is required for the validity of this activity, explain why this is necessary. Please include a description of when and how subjects will be debriefed regarding the deception, and attach a debriefing script. IV. RISKS AND BENEFITS (See Definitions, Section 5, Page 8) A. Describe any potential risks to the subjects, and describe how you will minimize these risks. These include stress, discomfort, social risks (e.g., embarrassment), legal risks, invasion of privacy, and side effects. B. In the event that any of these potential risks occur, how will it be handled (e.g., compensation, counseling, etc.)? C. Will this study interfere with any subjects' normal routine ? YES___ NO___ WSU Human Subjects Form, Page 5 D. Describe the expected benefits to the individual subjects and those to society. E. If blood or other biological specimens will be taken please address the following. Brief Description of Sampled Tissue(s):_________ _____________________________________________ Describe the personnel involved and procedure(s) for obtaining the specimen(s). Note that the IRB requires that only trained certified or licensed persons may draw blood. Contact the IRB for more details on this topic. V. USE OF DATA COLLECTED (Check all that apply) 1. ___ Thesis/Dissertation 2. ___ Journal Article/Publication 3. ___ Grant Activities 4. ___ Other : Briefly Describe:_________ _____________________________________________ VI. PROJECT CHECKLIST (Attach additional pages as necessary.) A. Will any investigational new drug (IND) be used? YES___ NO___ B. Will any other drugs be used? YES___ NO___ If yes to A or B, on a separate page, list for each drug: 1. the name and manufacturer of the drug, 2. the IND number, 3. the dosage, 4. any side effects or toxicity, and 5. how and by whom it will be administered. C. Will alcohol be ingested by the subjects? YES___ NO___ If yes, on a separate page, describe what type and how will it be administered. Refer to the guidelines for administration of ethyl alcohol in human experimentation (OGRD Memo No. 18 available at OGRD). WSU Human Subjects Form, Page 6 SECTION 2 Is your project EXEMPT? Exempt Reviews Federal regulations specify that certain types of research pose very low risks to subjects, and therefore requires minimal review from the IRB. To determine if your project is exempt, answer the following questions. 1. Will subjects be asked to report their own or others' sexual experiences, alcohol or drug use, and will their identities be known to you? YES__ NO__ 2. Are the subjects' data directly or indirectly identifiable, and could these data place subjects at risk (criminal or civil liability), or might they be damaging to subjects' financial standing, employability or reputation? YES__ NO__ 3. Are any subjects confined in a correctional or detention facility? YES__ NO__ 4. Are subjects used who may not be legally competent? YES__ NO__ 5. Are personal records (medical, academic, etc.) used with identifiers YES__ NO__ and without written consent? 6. Will alcohol or drugs be administered? YES__ NO__ 7. Will blood/body fluids be drawn? YES__ NO__ 8. Will specimens obtained from an autopsy be used? YES__ NO__ 9. Will you be using pregnant women by design? YES__ NO__ 10. Are live fetuses subjects in this research? YES__ NO__ If you answered YES to any of the questions above, then your project is NOT exempt, but may still qualify for expedited review (see Section 3, Page 7). If you answered NO to the questions, your research might be EXEMPT if it fits into one of the following categories. (Circle or Underline all that apply) 1. Educational Research: Research conducted in established or commonly accepted educational settings, involving normal educational practices. This is for research that is concerned with improving educational practice. 2. Surveys, Questionnaires, Interviews, or Observation of Public Behavior. To meet this exemption, the subject matter must not involve “sensitive” topics, such as criminal or sexual behavior, alcohol or drug use on the part of the subjects, unless they are conducted in a manner that guarantees anonymity for the subjects. 3. Surveys, Questionnaires, Interviews or Observation of Public Behavior. Surveys that involve sensitive information and subjects’ identities are known to the researcher may still be exempt if: (1) the subjects are elected to appointed public officials or candidates for public office; or (2) federal statute(s) specify without exception that confidentiality will be maintained throughout the research and thereafter. 4. Archival Research. Research involving the collection or study of existing data, documents, records, pathological 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. These data/samples must be preexisting, which means they were collected prior to the current project. 5. Research Examining Public Benefit or Public Service Programs. To qualify for this exemption, the research must also be conducted by or subject to review by an authorized representative of the program in question. Studies in this category are still exempt if they use pregnant women by design and their purpose is to examine benefit programs specifically for pregnant women. 6. Taste Evaluation Research. Studies of taste and food quality evaluation. Studies of taste evaluation qualify for this exemption only if (1) wholesome foods without additives are consumed; or (2) if a food is consumed that contains a food ingredient at or below the level of and for a use found to be safe. If you answered NO to the questions and your study fits into one of the six categories, then your project is EXEMPT. WSU Human Subjects Form, Page 7 SECTION 5 DEFINITIONS ANONYMOUS: Subjects’ names are unknown to the investigator, not requested and not given. If the only time the investigator asks for a name is for a signature on a consent form, the investigator should use implied consent, to preserve anonymity. ASSENT: Agreement by subjects not competent (e.g., children or cognitively impaired people) to give legally valid informed consent to participate in a study. BENEFIT: A valued or desired outcome to the study that will be an advantage to the subjects participating. CONFIDENTIAL: Subjects’ names are known to the investigator and are usually coded to a master list and/or kept separately from the data and results. This is usually used, for example, when the investigator must match test results with surveys or if there will be a follow-up survey. The investigator has a real need to know subjects’ names. DECEPTION: The protocol is designed to withhold complete information when consent is obtained. DIRECTLY or INDIRECTLY IDENTIFIABLE: Identities of individual subjects are kept by the investigator. If subjects’ identities are inseparable from data, then data are directly identifiable. If subjects’ identities are kept separate from data, with information connecting them maintained by codes and a master list, then data are indirectly identifiable. In either case, investigator must assure that confidentiality will be maintained, and must explain how subjects’ identities will be protected. INFORMED CONSENT: Subjects’ voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in a study or to undergo a diagnostic, therapeutic or preventive procedure. INTENTIONALLY IDENTIFIED: Subjects’ names are to be used in connection with their data when project results are presented to the public. This procedure is common for journalistic-type interview studies, where subjects are public figures or in oral histories. In these cases, the investigator should seek explicit consent from the subjects for the use of their names in connection with their data. MINIMAL RISK: A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed study is not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. The definition of minimal risk for research involving prisoners differ somewhat from that given for noninstitutionalized adults. POPULATION: A group of people in society meeting certain criteria to be eligible as subjects in a project’s protocol. PRINCIPAL INVESTIGATOR: The individual (s) with primary responsibility for the design and conduct of a project’s protocol. PROTOCOL: The formal design or plan of a study’s activity; specifically, the plan submitted to an IRB for review and to an agency for support. The protocol includes a description of the design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen (s), and the proposed methods of analysis that will be performed on the collected data. RISK: The probability of harm or injury (physical, psychological, social or economic) occurring as a result of participation in a study. Both the probability and magnitude of possible harm may vary from minimal to significant. SIGNIFICANT RISK: A study’s design that presents a potential for serious risk to the health, safety or welfare of the subjects. SUBJECTS (HUMAN): Individuals whose physiologic or behavioral characteristics and responses are the object of study in a project. Under the federal regulations, subjects are defined as living individual (s) about whom an investigator conducting a study obtains: data through intervention or interaction with the individual; or identifiable private information. WSU Human Subjects Form, Page 10 SECTION 6 FREQUENTLY ASKED QUESTIONS CONCERNING CONSENT PROCEDURES FOR SAMPLES OF THE DIFFERENT TYPES OF CONSENT, GO TO PAGE 11. 1. Do I need to get consent? Can I get a waiver from the consent requirements? If you are using archived data, consent may not be necessary or even possible. Some data do not meet the definition of “archived data,” but researchers may still seek a waiver of consent requirements. Only studies with a restricted set of conditions may use this option, and each waiver request is separately reviewed and considered by the IRB. 2. What if I want to give my subjects anonymity? You should not use a written consent form. Instead you can use a consent script (e.g., phone surveys) or a cover letter (e.g., mail surveys). These documents do the same basic job as a written consent form does informing subjects about the study and their rights. The only difference is that subjects do not sign their name. 3. Do I need to get consent if my project is exempt? The requirement for some form of consent applies to ALL research, although most exempt projects (particularly mail or phone surveys) can use a consent script or cover letter (for implied consent). 4. What if I audio or video tape my subjects? You will need to get written consent. The consent procedure needs to specify WHEN the tapes will be destroyed, WHERE they will be stored, and WHO will have access to the tapes. Use a version of the WRITTEN CONSENT FORM. . What if I want to intentionally identify individuals in my research report(s) (i.e., quote individuals who you interviewed and gave their identities)? Then you will be required to get their written consent. 6. What if my project is BIOMEDICAL in nature? Use the sample for written consent forms and the BIOMEDICAL CONSENT FORM CHECKLIST. 7. What are the special consent considerations for children? If a child is between the ages of 7 and 18, then you should seek both written parental consent and child assent. The assent form language should be at about the same grade level as the child. If the child is between the ages of 3 and 7, then you should use a VERBAL ASSENT, which is a consent script with language appropriate for the child’s age. A child younger than age 3 is considered incapable of participating in the consent process. At all age levels, the final power of consent is usually left to the parents or guardians. 8. Are there laws that affect the consent process? In the course of your research, if you become aware that any specific individual is in imminent danger of harming himself or others (i.e., due to acute depression) or is currently suffering mental or physical abuse, or abusing another individual, you are required by Washington state law to inform the appropriate authorities. If there is a reasonable chance that you may discover such information about your subjects, you must tell them of this requirement when you ask for their consent, because the law requires you to break confidentiality in these circumstances. Contact the IRB for more information on this topic, including specific language to be used. WSU Human Subjects Form, Page 11 GUIDELINES FOR FORM OF CONSENT If the data collected is anonymous the consent is verbal, or implied. If the data collected is confidential the consent is written. If the data collected is intentionally identified the consent is written. If research involves minors: Parental/Guardian Consent is necessary, and Child Assent is necessary for participants between age 7-18. Assent must be written in language appropriate to the age of participant. If Data Collection Method Is: Survey: Administered by: Investigator or In person = Written Subject or Mail = Written if confidential, Implied if anonymous Phone = Verbal (if anonymous) Interview: One-on-one, Oral history, or Focus group = Written Observation of Public Behavior: In classroom = Seek waiver of consent At public meetings = Seek waiver of consent Examination of Archived Data or Records: (records must be preexisting) Academic, Medical or Legal: Seek waiver of consent Taste/Sensory Evaluation: Food tasting, or Olfactory = Written Examination of Pathological or Diagnostic Tissue Specimens: Therapeutic, Biomedical, Psychological, or Physical Therapy = Written Experimental: Biomedical or Psychological = Written SECTION 7 SAMPLES OF FORMS OF CONSENT The following samples are provided to help you compose your own consent procedure. Decide which form of consent you will need, and then use the appropriate sample to make your own. Place the specific information for your project in the appropriate places, as indicated. Once you have written your own version, read it to make sure all the necessary information is there, that there are no mistakes, spelling or grammatical errors, and that it is not ambiguous or otherwise confusing. Below is the Bill of Rights that reflects the philosophy of informed consent and may be included in your consent form. WSU Human Subjects Form, Page 12