► 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.
► Faculty Verification of Student Submission Form
All student submissions will need to be approved by the associated faculty sponsor. When completing the IRB application, the student will enter the faculty sponsor’s contact information, and a request for verification will be automatically sent to the listed faculty member. For convenience, the verification form is provided above.
► 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 (V1.3.; Approved February, 2019; Amended June, 2019; Amended February 2020)
► 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. Please note that if using translated forms, applicants will be required to provide a description of the translation procedures used to develop those forms on the IRB application.
Technical answers to questions about Informed Consent can be answered at the Office for Human Research Protections (OHRP).
► Readability of Consent Forms
To provide informed consent, potential participants need to be able to understand the information contained on the informed consent form, and all forms should be written at the appropriate readability level. Readability is the ease with which text can be read. The WOU IRB recommends that the reading level of informed consent documents should be no higher than an 8th grade level. The IRB recognizes that some consent forms are of such a technical nature that it may not be possible to keep to an 8th grade reading level. However, we encourage researchers to consider primary factors involved in readability including: vocabulary, sentence length and structure, amount of information, page design and formatting, and logical order.
Informed Consent Readability is about making sure research participants understand what they are agreeing to when consenting to a study. Undoubtedly, informed consent readability strategies and practices should be responsive to the populations of participants they target. In general we suggest researchers consider these four principles of plain language:
- Use terms your audience can easily understand
- Write in a conversational style as if you were speaking
- Organize & filter content with your readers’ needs in mind
- Format your document so that it looks easy to read, approachable
The WOU IRB now requires that your IRB application include a Flesch-Kincaid Grade level score for your consent form(s) within Submittable. It is important to acknowledge the difficulty of the reading level of your consent forms so as to ensure participants understand the meaning of participation in the study. We anticipate that many authors will make the suggested small but powerful adjustments to aid readability. However, the IRB reserves the option to request that researchers make additional attempts to lower the Flesch-Kincaid Grade level if it is warranted for the target population. To determine the Flesch-Kincaid Grade level of your informed consent text, please see below.
If using Microsoft Word, you can find the Flesch-Kincaid Grade level by:
- Go to File > Options.
- In the Proofing tab, check the following options:
- Under “When correcting spelling and Grammar in Word,” make sure “Mark grammar errors as you type” is selected.
- Select “Show readability statistics”
- Click OK.
- Click to Review > Spelling & Grammar to check your document for spelling or grammatical errors and also see the readability level of your document.
If using Google Docs, you can copy and paste your google doc text into a word doc and repeat prior steps.
You can also get the Flesch-Kincaid Grade level in Google Docs by installing the ProWritingAid Add-on:
- Within Google Docs > Add-ons
- Click Get add-ons
- Search ProWritingAid (beta)
- Click the ProWritingAid (beta) icon
- Click the “install” button
- Click “continue” in the ready to install pop up window
- Select the google account you’d like to add the readability score feature in the “Choose an account to continue to ProWritingAid” pop up window
- Click “allow” in the “ProWritingAid wants to access your Google Account” pop up window
- Click “done” and close the “ProWritingAid (beta) has been installed!” pop up window
- Back in your google docs > Add-ons
- Click ProWritingAid (beta) > summary report
- Scroll down to the fourth row of data and collect the Flesch-Kincaid Grade level from the Readability Measures section, under Grade Level Measures
For more information and resources regarding readability, please see the Readability of Informed Consent Forms document.
► 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
► Research Compensation and Avoiding Coercion
Research subjects are commonly compensated for their time and inconvenience, as well as to incentivize participation in studies. Subjects may be compensated with money, food, drawings, coupons, or by numerous other means, including extra credit if the subjects are students. Additionally, compensation may be in the form of reimbursement for costs associated with participation, such as travel and lodging expenses. However, because research subjects must consent to participate without coercion, compensation cannot be large enough that it is an undue influence on potential subjects. While compensation can be prorated, it cannot be contingent upon completion of the study.
The form and amount of compensation that will create an undue influence is dependent on many factors, therefore the form and amount of compensation should be a thoughtful decision on the part of the researchers. Some important factors to consider are:
- Socioeconomic status
- Cultural context
- When compensation occurs, including how compensation is prorated
- How much discomfort the subject will experience
Many freely available online resources provide guidelines for considerations in determining appropriate compensation, several of which are provided below:
► Research with Archival/Secondary Data
Research using secondary or archival data may require WOU IRB review and approval. Secondary/archival data (hereafter referred to as secondary data) is any data that someone else collected (e.g., data contained in a publicly available database) or that the researcher previously collected for a different purpose. Research involving secondary data analysis (e.g., medical records, purchased data, data from the Internet, etc.) is considered human subjects research when data about individuals is both private and identifiable. Please see the following for examples of projects that are unlikely to be, might be, and are considered human subjects research.
- Projects that are unlikely to be human Subjects Research because they involve only:
- Public use data sets such as the US Census—data is available to the public at large and not restricted to researchers.
- Data sets from an outside source that have been stripped of all identifying information and that links back to identifiers before being provided to researcher.
- Facebook public profiles found from Google searches.
- Twitter tweets not in private setting.
- Publicly accessible forums or comments sections where users have no expectation of privacy (e.g., New York Times, YouTube, etc.).
- Data that is completely de-identified—any and all personal information and/or context that would allow a reasonable person to ascertain the identity of a participant has been removed and no key exists (anywhere) that links the data to individuals.
- Projects that might be human subjects research because they involve:
- Purchasing/obtaining enhanced data sets—data on individuals which may include enough information to potentially identify individuals.
- Receipt of coded data where data holder has code key—depending on whether the data holder only provides data or is a collaborator in the research, and whether an agreement between institutions prohibits receiver from ever receiving identifiers, etc.
- Forums or chats where users must register as belonging to a certain group (e.g., cancer survivors) or housed in areas that are not public, e.g., where special passwords are needed to join.
- Data I collected from a previous study, but now I want to use it to answer new research questions that are different from what the participants initially consented to.
- Projects that are human subjects research because they involve:
- Data that includes participants who are/were prisoners, HIPAA-covered entities, or is FDA -regulated research.
- Private data sets obtained with identifiers (e.g., traffic violation data with driver’s license numbers, survey data with email addresses, medical records with protected health information [PHI], restricted use datasets, etc.).
- Stolen, hacked, accidentally released data about individuals—although data may now be publicly available (such as on the surface web or the dark web), the individuals whom the data is about had expectation of privacy, i.e., that the data would not be hacked, stolen, etc.
Researchers who are unsure whether their project is human subjects research should contact the WOU IRB (email@example.com) for consultation.