Presentation on theme: "Portland State University Institutional Review Board (IRB)"— Presentation transcript:
1Portland State University Institutional Review Board (IRB) https://sites.google.com/a/pdx.edu/research/integrity/human-subjects
2IRB Application Formatting Guidelines The IRB application has three parts:Investigator’s Assurance cover sheet (Section I)Narrative application (Sections II-X)Appendices (Section XI)Applications must be written in at least 12 pt font. Applications must be page numbered.Please submit complete applications with Investigator Assurance form toI. Investigator’s AssuranceThis form, located here on page 5, is separate from the narrative guidelines below. This form serves as the researcher’s contact information page and signature of assurance. This form must be filled out completely and accompanied by the proper signatures. Electronic signatures will be accepted accounts.
4Narrative Guidelines II. Project Title & Prospectus In 300 words or less, clearly identify the research question and provide a summary of the project and its significance, including a brief description of the methods and procedures to be used. Use neutral, unbiased language and do not use jargon. Define any acronyms used.
5Narrative Guidelines III. Type of Review If your research falls into one of the categories that qualify for an exemption or expedited review, cite the appropriate exemption or expedited category and the associated rationale. These studies must be of no more than minimal risk and may not include a vulnerable population. Such studies may involve use of existing data or research on educational practices. When thinking about categories of review for studies without identifying information of human subjects, please note that anonymity means that the subject’s/respondent’s identity is unknown (in other words, that responses cannot be linked to individuals); confidentiality implies that, while the researcher can identify each subject and his/her responses, the identity of the subject will be kept private, and not revealed to others. Studies that do not meet criteria for exempt or expedited review require full committee review (see link to categories here).
6Narrative Guidelines IV. Subject Recruitment This section should provide a description of the subject population, including the number of participants which the researcher expects to recruit, the characteristics of that population, which can include age, gender, ethnic background and health status, and the methods to be used for their recruitment. A description of how subjects are selected, approached and invited to participate in the research must be included (i.e., , flyer, phone calls, etc.). Criteria for inclusion and exclusion should be detailed; justification is required if the subject population is restricted to one gender, age or ethnic group, as the federal government strongly encourages investigators to include women, children and ethnic minorities in their research. If different subject groups are to be included in the research, recruitment information must be included for each group.
7Narrative Guidelines V. Informed Consent Both federal and university regulations require researchers to obtain informed consent from their subjects before they may be part of research, unless otherwise permitted by the IRB. Describe both by whom and in what manner consent will be obtained from each appropriate sample category (see below) and include a copy of the informed consent form(s) or cover letter (s). If requesting a waiver of signed consent or alteration of the process, a justification must be included (see consent samples and information about altering or waiving the consent process here).Sample Consent Categories:Adult subjects (includes persons 18 years of age and over)Child subjects (includes all persons under 18 years of age) will require written parent/guardian permission, as well as verbal or written assent/consent from the subjects themselves.In some cases, vulnerable subjects, such as prisoners and mental health patients, may require the consent of an appropriate witness in addition to that of the participant him- or herself.When the researcher seeks to use a passive consent process, the Committee must determine that research is one in which a waiver of signed consent is appropriate. If the research and passive consent process is being done in an in an educational setting, the Committee must be assured that the passive consent process has been approved by an appropriate school official. When writing the passive consent form, the researcher should give the subjects (and parent/guardian if subject is a minor) ample time to decline participation and must offer a variety of ways in which the researcher can be contacted to decline participation. The method of declining participation or opting out must be clearly stated in the passive consent document.
8Narrative Guidelines VI. First-Person Scenario Provide a short paragraph that presents the experience from the subject's point of view (e.g., “I received a letter last week in the mail which described a new research study…Once I decided to participate, I set up an appointment to meet the researcher…I was seated at a table with the investigator and…I participated in the following activities…at the end of the study I was happy to have been invited to participate”). This scenario should begin when the subject is first contacted, whether by letter or in person, should describe each activity in which he or she is required to take part, and should conclude only with the end of the subject’s participation. If different subject groups are to be included in the research, a scenario must be included for each group.
9Narrative Guidelines VII. Potential Risks and Safeguards The risk/benefit ratio for subjects is particularly crucial to a human subjects review. Some research cannot be approved unless the possible benefits to participants or to humanity outweigh the possible risks. Please describe any potential physical, social, psychological, employment, legal, economic, risk of coercion, or other risks to subjects, including discomfort or embarrassment (e.g., nature and seriousness of risk, incidence of probability, etc.). Also describe the safeguards which will be adopted to eliminate or manage these risks, and/or the steps to be taken to detect and treat any injury or distress incurred by subjects. Even if there are no anticipated risks, this must be justified and explained in the application. There must be a statement about risks and safeguards, including all those mentioned in the application, in the consent document—even if risks are expected to be minimal.
10Narrative Guidelines VII. Potential Benefits Describe briefly the anticipated benefits of participation in the study. Subjects might benefit directly, such as having an opportunity to share their story, or indirectly, as the results of a study of blood donors leads to a better-marketed blood drive and, therefore, increased blood bank stores. If a form of compensation is offered for participation in research, it should be described as a token of appreciation for participating, not as a benefit of the research. Benefits should not be overstated.
11Narrative Guidelines IX. Confidentiality, Records & Distribution Discuss procedures which will be used to maintain subject confidentiality, including the implementation of any codes or pseudonyms to conceal identities, both during the course of research and in the period thereafter. Regarding confidentiality in a group setting, the researcher must address, both in person and in the consent process, the risk that confidentiality cannot be guaranteed in a group setting. Also, explain records storage and access methods, the description of which must include information regarding where and for what length of time data provided by subjects will be stored. Describe whether data will be transported, and if so, how data will be kept secure during transit. If possible, records should be securely stored at PSU and/or on a secure PSU network. If subjects will be audio- or videotaped during their participation, the purposes of such recordings must be explained, as well, both in this section and on the consent document. Federal guidelines suggest that data and records shall be kept on file for a minimum of three years after the completion of research. The manner in which records will be destroyed and the timeframe should be specified.
12Narrative Guidelines X. Training and Experience State any of the researchers’ specialized training, education, or experience that would help to minimize the risks of research, particularly if working with vulnerable populations and/or sensitive topics. Alternately, if the researcher will be advised by an expert, note this information in the application. A helpful human subjects research training can be found through NIH at
13Narrative Guidelines XI. Appendices All recruitment materials and flyers, survey instruments, telephone and introductory scripts, focus group guides, interview questions and informed consent documents must be included and clearly labeled in your application.