► IRB Application Form (for reference only)
- All applications to the WOU IRB are submitted via Submittable, the WOU IRB online submission system. To aid in the preparation of applications and as a reference, an IRB application form is provided above. Note that applications to the IRB are no longer accepted via email or campus mail, and we will not accept completed copies of the form attached above. Please use the above document when developing your application, but do not submit this document to the IRB.
► IRB Authorization Agreement (IAA) Forms
- When engaged in collaborative, multi-institutional research where another institution’s IRB will serve as the IRB-of-record, please complete and submit the WOU IIA – WOU to Cede Review form with all associated documentation (See the Preparing Submissions section for more information).
- When engaged in collaborative, multi-institutional research where the WOU IRB will serve as the IRB-of-record, please complete and submit the WOU IIA – WOU serving as IRB-of-Record form with all associated documentation (See the Preparing Submissions section for more information).
► Individual Investigator Agreement (IIA) Form
WOU IRB Policies and Procedures
► WOU IRB Policies and Procedures Manual
WOU IRB Policies and Procedures Manual (approved 01.11.2019)
- The WOU Policies and Procedures Manual addresses in detail the conduct and oversight of human subjects research at WOU. All human subjects researchers conducting investigations at WOU are encouraged to read this manual to ensure comprehensive understanding of all WOU IRB policies and procedures.
► WOU IRB Policy Documents and Summaries
WOU IRB Membership Policy (approved 12.15.2017)
- IRB Membership Policy – This policy describes the WOU IRB procedures regarding the identification, selection, and terms of IRB members. The IRB may be composed of representatives from WOU faculty, staff, and the student body, as well as the surrounding community. The committee shall have no fewer than five members and no more than fifteen, including the committee chair. Members are selected via a nomination and voting process, and the term of service is three years. See the policy document for more information.
Policy for Research Conducted by Non-WOU-Affiliated Investigators (approved 03.23.2018)
- Non-WOU-Affiliated Investigators Policy – The WOU IRB regularly and frequently entertains inquiries from outside institutions and non-WOU affiliated individuals who, whether in collaboration from WOU-affiliated investigators or not, wish to conduct research and collect some or all of their data at WOU. While we wish to encourage and facilitate such research, the requirements outlined in this policy document must be met prior to initiating any projects in order to ensure effective communication between participants, project staff, and WOU, as well as to ensure that WOU IRB policies are being followed during the conduct said research.
Collaborative Research and IRB of Record Policy (i.e., policy regarding the selection of a single IRB; approved 06.04.2018)
- Collaborative Research and IRB of Record Policy – This document describes the WOU IRB policy regarding the use of a single IRB (sIRB; i.e., IRB of Record) in situations involving collaborative research between WOU and researchers at other institutions. When engaged in collaborative research, either the WOU IRB or another institution’s IRB may serve as the sIRB, provided that the appropriate documentation is completed, submitted, and kept on file by the WOU IRB. When the WOU IRB is serving as the sIRB, the PIs at WOU will be required to submit a completed WOU IRB Authorization Agreement form, identifying the WOU IRB as the sIRB, along with all other application materials. When another institution’s IRB will serve as the sIRB, the PIs at WOU will also be required to submit a WOU Authorization Agreement, identifying the other institution’s IRB as the sIRB, along with all other required documentation (described below). Note that as per 45 CFR 46, Subpart A (i.e., the Federal Policy for the Protection of Human Research Subjects), identification of a sIRB is not required unless the project is federally funded.
Policy regarding Continuing Review of Minimal Risk Research (approved 11.03.2017)
- Continuing Review of Minimal Risk Research Policy – This policy eliminates the requirement of continuing annual review for minimal risk studies that are approved via exempt, expedited, or limited review. However, investigators engaging in ongoing research over extended periods are required to submit a formal request for continuation every five years.
IRB Expenditures Policy (approved 05.28.2018)
- IRB Expenditures Policy – This document describes the WOU IRB policy on Board expenditures. The policy states that the IRB Chair may seek and approve expenditures of less than 8% of the IRB’s total annual budget (minus overhead and recurring expenditures; e.g., unclassified salaries) without approval of the WOU IRB. Expenditures of 8% or greater than the IRB’s annual budget will only be granted with full IRB approval, and the Chair may not pursue these expenditures without said approval from the Board.
WOU Research Misconduct Policy (revised 04.01.2018)
- WOU Research Misconduct Policy – This document describes in detail the WOU administrative processes for the reviewing, investigation, and reporting of allegations of research misconduct.
► Faculty Oversight of Student Research
- Faculty Oversight of Student Research – This document describes in detail the WOU IRB approach to faculty oversight of student research.
WOU IRB Bylaws
► WOU IRB Bylaws
The following Bylaws describe the rules by which the WOU IRB regulates its members, operations, and functions. For any questions regarding these rules, please see the linked document:
- WOU IRB Bylaws (V1.1; Approved February, 2019; Amended June, 2019)
► Sample Consent Forms
The requirement to obtain the legally effective informed consent of individuals before involving them in research is one of the central protections provided for under the HHS regulations at 45 CFR part 46. WOU’s Institutional Review Board has provided Samples for your use in developing consent forms for your Study.
- Required Research Summary Information (in Word format)
- Assent Form Sample Consent Form for Youth (in Word format)
- Parent Informed Sample Consent Form (in Word format)
- Research Sample Consent Form (in Word format)
- Online Implied Sample Consent Form (in PDF format)
Research using Non-English Speakers? – If the anticipated research participants or individuals providing consent for minors do not speak English or will be unable to understand a consent form written in English, the consent form must be translated into a language understandable to the participants or parents/guardians. In some cases, the WOU IRB may request that a qualified translator confirm that the consent form has been appropriately translated.
Department of Health and Human Services regulations for the protection of human subjects require that informed consent information be presented “in language understandable to the subject” and, in most situations, that informed consent be documented in writing.
Technical answers to questions about Informed Consent can be answered at the Office for Human Research Protections (OHRP).
► Review Forms (for reference only)
A copy of the initial application review form that IRB members use to evaluate proposed projects is provided below. The WOU IRB encourages PIs to address each of the items on the form, when relevant, when developing and preparing applications for submission.
- Initial Review Form (in PDF format)
► Understanding and Assessing Risk
Federal regulations regarding research with human subjects require that the IRB review proposed research and to approve studies only when, “risks to subjects are minimized.”
What is risk and how do we judge when risks are minimized?
We can think of risk in general as the potential for harm. The IRB is specifically concerned with risks that arise from the subject’s participation in the proposed research; risks arising from activities in which the subject would normally take part in are not included in the evaluation.
According to federal regulations, “minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are 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.”
Categories of Risk
What kinds of harm might occur to subjects as a result of participation in research? The answer depends on the nature and design of the research, so each study must be assessed individually. However potential risks can be divided into several distinct categories.
- Physical Risks:Physical risks are present when the methods and procedures of a study present the possibility of pain, discomfort, injury, or illness for the subject. A physical risk may result from the subject being asked to overexert themselves performing a task required by the research, exposure to painful physical stimuli or the use of medical procedures or drugs. In social or behavioral research, physical risks might arise from exposing the subject to social situation in which violence is possible.
- Psychological Risks:Psychological risks are present when the research involves putting subjects in situations that provoke negative feelings or experiences, including anxiety, stress, fear, embarrassment, confusion, depression, guilt, shock, loss of self-esteem, and altered behavior. Studies in which participants are asked about upsetting or traumatic events pose psychological risks, as can studies whose design includes deception. Ways to reduce psychological risks include properly debriefing subjects after the research is complete or providing information about available counselling or other resources.
- Social/economic risks:Social risks include alterations in relationships with others that are to the disadvantage of the subject, and may involve embarrassment, loss of respect of others, labeling with negative consequences, or diminishing the subject’s opportunities and status in relation to others. For example, if there is a possibility that information about a subject that affects their standing in the community may be revealed by the researcher, or simply through knowledge of their participation in the study, this poses a social risk. Economic risks can include costs incurred by subjects in the course of participation (such as paying for travel, childcare and food), loss of wages or income, and/or damage to employability or insurability as a result of participation in the study.
- Legal Risks:If the research could potentially reveal that the subject has or plans to engage in behavior, including criminal activity, that might expose them or others to criminal prosecution or civil liability, legal risks are present. Researchers cannot guarantee protection for their participants in the event that data are subpoenaed, so researchers intending to collect information about illegal activities must take great care. Where the risk of accidentally collecting information about subjects’ illegal activities is present, researchers should have a plan in place for how to prevent this or delete the data after the fact.
- Invasion of Privacy/Loss of Confidentiality:Invasion of privacy occurs when information is collected without the subject’s knowledge or consent, or when their participation in the study is revealed despite assurances that it will not be. Loss of confidentiality is one of the most common risks involved in social and behavioral research, and exposes subjects to potential harm when information obtained by researchers that could adversely affect subjects is disclosed outside the research setting. It results in loss of privacy, a harm in itself, and can lead to psychological, social/economic and legal risks described above. Researchers should take great care in recording, storing and publishing their data, especially when loss of confidentiality may result in these additional kinds of risk.
For more information on identifying and assessing risk, see the CITI training module “Assessing Risk – SBE (ID 503).”
Some categories of people about whom researchers might want to conduct research are considered especially vulnerable to some or all of the harms described above. The IRB will take special care to evaluate proposals for research that will involve individuals from these categories, and may require that additional measures are taken to minimize risks for them.
Categories of people who may be considered vulnerable include:
- Cognitively Impaired Persons
- Decedents (Research Involving Health Information of Deceased Individuals (HIPAA))
- Elderly / Aged
- Non-English Speakers
- Pregnant Women, Fetuses, and Neonates
- Students & Employees
- Economically or educationally disadvantaged persons