Institutional Review Board: Human Subjects Research

HISTORY AND PURPOSE - BOARD MEMBERS - OVERVIEW OF REVIEW PROCESS - FAQ - SUBMISSION MATERIALS - RESOURCES - NEW PROPOSAL - UPDATE/CHANGE/RENEWAL FORMS - CONCLUSION - PRESENTATION SLIDES

HISTORY AND PURPOSE

The Human Subjects Institutional Review Board (IRB) is charged with reviewing all research involving human subjects conducted under the auspices of Wesleyan University. The purpose of an IRB is to provide a single, comprehensive standard of protection for human subjects in research. This includes federally funded research as well as research that is not funded or is funded by other sources. Faculty, staff, and students proposing research using human subjects must submit a written description of their proposal and obtain IRB approval of the proposal prior to commencing research.

For the purposes of the IRB, research is defined as "any systematic investigation designed to contribute to a body of generalized public knowledge." The use of human subjects refers to "data collection through interaction with individuals or the collection of identifiable private information about individuals." Activities that meet this definition of human subjects research should be submitted to the IRB for review following the procedures described on this website. 

Please refer to this chart to determine whether your work meets the definition of research and should be submitted to the IRB for review.  

On January 21, 2019, HHS implemented a Revised Common Rule that includes important changes to the federal guidelines for human subjects research. The Revised Common Rule involves changes related to continuing review, exemptions, informed consent, and determination of a single IRB of record. 

Continuing Review 

No longer required for some minimal risk research, including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data. However, for studies that do not require continuing review, the study investigator should submit an annual update using the Project Update Form to report on the status of the study, and any events or incidents related to participant risks.  

Exemptions  

New categories and clarification of existing categories. For details on exemption changes, see Exemption Category Changes. 

Informed Consent - A new "Key Elements" section and a rearrangement of content is designed to facilitate a potential subject's decision to participate or not.   

Single IRB of Record (sIRB) - Starting January 20, 2020, IRB oversight for most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB (sIRB).  

RESPONSIBLE CONDUCT OF RESEARCH

The Wesleyan University policy on Responsible Conduct of Research (RCR) states that Wesleyan faculty, staff, students, graduate students, and postdoctoral fellows conducting human subjects research are required to complete RCR training. More information regarding this policy and the link to the online RCR training can be found on the the Wesleyan University RCR web site (http://www.wesleyan.edu/acaf/support/RCR.html).

Many ethical issues surround non-research-related teaching and scholarship activities of the University (e.g., journalistic endeavors). These activities do not fall under the purview of the IRB. In these cases, researchers are encouraged to review the informational websites and documents provided here towards enriching their understanding of ethical issues, and to consult with their home departments regarding internal guidelines and expectations.   

BOARD MEMBERS

Chair

Jennifer Rose
Research Professor of Psychology
Allbritton 118
jrose01@wesleyan.edu 
860/685-2406

Coordinator

Lisa Sacks
Assistant Director for Curricular Initiatives, Office of Academic Affairs
North College 322
lsacks@wesleyan.edu

860/685-3428

Wesleyan Affiliated Members

Rachael Barlow
Associate Director for Assessment
Institutional Research
rbarlow@wesleyan.edu 
860/685-2423

Logan Dancey (Alternate)
Assistant Professor of Goverment
ldancey@wesleyan.edu
860/685-3416

Matthew Kurtz
Professor of Psychology
Judd Hall 314
mkurtz@wesleyan.edu 
860/685-2072

Cynthia Matthew
Visiting Scholar in Psychology
cmatthew@wesleyan.edu 

Louise Neary
Adjunct Associate Professor of Spanish
Downey House 120
lneary@wesleyan.edu 
860/685-3098 

Public Members     

Lucy McMillan
Gilead Community Services
222 Main Street Extension, Middletown, CT 06457
lmcmillan@gileadcs.org

Elizabeth K. Nocera, MPA
Office of Development and Planning
181 State Street, New London, CT  06320
ENocera@ci.new-london.ct.us 

OVERVIEW OF REVIEW PROCESS

Individuals whose research meets the definition of human subjects research are expected to submit a Description of Research Form to the IRB for review before beginning research on a project. Questions on the form prompt the researcher to provide information needed by the IRB to make a determination about whether the research meets required ethical standards. The questions of the form also prompt the researcher to include accompanying documents, as applicable, such as written informed consent forms, recruiting advertisements, and surveys. The IRB, upon receiving a submitted proposal, will respond to the investigator by email with a decision within two weeks, though delays may be longer during holidays and summer recess. If the proposal is not initially approved, the investigator will be given feedback, usually in the form of requests for clarification or revision, so that the proposal might be approved on resubmission. Research may not commence until the proposal has been approved by the IRB. Faculty researchers will be sent hard copies of final decision letters for their records. 

Once a project has been approved, the research may begin but remains under oversight by the IRB in the following ways. First, any proposed changes to research protocol must also be submitted and approved, prior to implementation, with a Change of Protocol Form. For minimal risk studies having undergone expedited review, and for which the IRB has determined that they do not require continuing review, researchers should submit a Project Update Form each year. For studies requiring continuing review, IRB approval of a study is valid for only one year from the date of issuance. Researchers who plan to continue beyond the year are responsible for submitting a Project Continuation Form at the start of each year the research project continues.  Third, any adverse or unanticipated consequences must be reported to the IRB at the time that they occur including but not limited to physical or psychological injury to subjects, improper execution of a research protocol, or improper disclosure of private information.

Exemptions

Per Federal Guidelines, some types of research are exempt from IRB oversight. For research that investigators believe may qualify as exempt, researchers are required to complete only a few sections of the Description of Research Form (as indicated on the form), so that the Board has enough information to make such a determination.  If the Board agrees that the research is exempt, the researcher will receive an email (and hard copy for faculty) with this decision. Otherwise, the researcher will be asked to fully complete and resubmit the form, making sure that the protocol complies with the Federal Guidelines. When a project is deemed exempt, this means that further communication with the IRB about changes in protocol or continuation are not required. However, should the researcher make major revisions to the research that results in it no longer being exempt, it is the researcher’s responsibility to submit a full proposal at that time. 

Research activities are likely to be exempt if the only involvement of human subjects is in one or more of the following categories (see Federal Guidelines for less-common exemptions). If you believe your work falls into one of these categories, please indicate this accordingly on the submission form. 

EXEMPTIONS 

(1) Research conducted in established or commonly accepted educational settings involving normal educational practices such as: (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or comparison among instructional techniques, curricula, or classroom management methodsThe research must also not be likely to adversely impact the student’s opportunity to learn required educational content or the assessment of educators who provide the instruction. Research involving prisoners as participants is excluded from this exemption. (45 CFR 46.104(d)(1)) 

(2) Research that only involves use of educational tests, surveys, interviews or observations of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified directly or indirectly through identifiers linked to the subjects; (ii) any disclosure of subjects responses outside the research could reasonably place the subjects at risk of criminal or civil liability or damage their financial standing, employability, reputation, or educational advancement. This exemption may include recording identifiable information (even if sensitive), provided that an IRB determines through limited review that, when appropriate, there are adequate privacy and confidentiality protections in the study. Research involving children may only be included in this category for education tests or observation of public behavior, and only when the investigator does not participate in the activities being observed. Research involving prisoners as participants is excluded from this exemption. (45 CFR 46.104(d)(2)) 

(3) Research involving benign behavioral interventions with adults who prospectively agree to the research, when the information collected is limited to verbal or written responses, including data entry or audiovisual recordings. Research may qualify for this exemption only if it meets the following criteria: (i) the information recorded cannot be readily linked back to the subjects in such a manner that subjects’ identity can be readily ascertained, directly or through identifiers linked to the subjects; or (ii) any disclosure of this information would not place the subjects at risk of certain harms, or (iii) the information is recorded in an identifiable manner, even if sensitive, provided that an IRB determines through limited review that, when appropriate, there are adequate privacy and confidentiality protections in the study.  This exemption applies to behavioral interventions only. It is not applicable to biomedical research. Research involving prisoners, children, or individuals with impaired decision-making capacity as participants is excluded from this exemption. (45 CFR 46.104(d)(3)).  

(4) Research involving the collection or study of data, documents, records, pathological specimens, or biospecimens, 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. This exemption also applies to research using identifiable private information or identifiable biospecimens, if at least one of the following criteria is met: 

(i) The identifiable private information or identifiable biospecimens are publicly available; 

(ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that 1) the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, 2) the investigator does not contact the subjects, and 3) the investigator will not re-identify subjects. 

(iii) Research that is conducted by, or on behalf of, a Federal department/agency or using government-generated or government-collected information obtained for non-research activities 

Many ethical issues surround non-research-related teaching and scholarship activities of the University (e.g., journalistic endeavors). These activities do not fall under the purview of the IRB. In these cases, researchers are encouraged to review the informational websites and documents provided here towards enriching their understanding of ethical issues, and to consult with their home departments regarding internal guidelines and expectations.    

STUDENT RESEARCH

University policy requires that students conducting thesis research involving human subjects must obtain IRB approval prior to collecting data. The IRB application needs to be signed by the faculty mentor prior to IRB submission. Please reveiw this PowerPoint presentation, Student IRB Workshop, before completing your proposal.

Anthropology, Psychology, or Sociology students may be eligible to submit their proposal to a departmental IRB. Please review the information provided by each department to determine your eligibility. All other student projects need to be submitted to the University IRB. Note also the requirements concerning collecting data at other colleges/universities or outside of the United States.

RESEARCH INVOLVING OTHER INSTITUTIONS/ORGANIZATION

With the exception of NIH-funded multi-site studies, studies involving collection at other universities will require IRB approval of that other institution. The Wesleyan University IRB does not have purview of research practices or policies of other colleges or universities. If you plan to collect data at another such institution, you will need to obtain ethics approval through the IRB of the institution that you plan to collect data from. Be aware that most IRBs require that protocols be submitted by full-time faculty member of the respective institutions, so a collaborator at other campus sites is almost always needed. Also note that because you are a member of the Wesleyan community, approval by Wesleyan University IRB is also required. When applying for Wesleyan IRB approval, along with your usual submission materials, provide the approval letter from the institution where you plan to collect data. Note that the departmental IRB committees cannot review or approve protocols that involve another institution. 

National Institutes of Health (NIH) multi-site grant applications (new, renewal, revision, resubmission) received on or after January 21, 2018 are required to utilize a single IRB-of-Record (sIRB) for the review of human subject protections. This sIRB requirement currently applies only to domestic, NIH-sponsored multi-site studies for which the same protocol is used at multiple sites 

Starting January 20, 2020 IRB oversight for most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB.  

GUIDANCE ON INTERNATIONAL RESEARCH

All research involving living human beings needs to adequately protect the rights and welfare of the research participants, whether the research is conducted in the United States or at foreign sites. Investigators conducting studies in international settings should take appropriate steps to ensure respect for differences in language, education, cultural and social history, and social mores, as well as compliance with local law. Investigators contemplating conducting international research should review the information and policies provided by the Department of Health and Human Services: http://www.hhs.gov/ohrp/international/  

FREQUENTLY ASKED QUESTIONS

Does my activity constitute human subjects research? 

The definition of research is “systematic investigation designed to contribute to a body of generalized public knowledge.” To be classified as research, a project must intend at the outset to generate conclusions that can be applied to or used to make predictions about similar or future circumstances. The definition of human subjects data is “data collection through interaction with individuals” or “collection of identifiable private information about individuals.” Definitions of both research and human subjects data need to be met in order for a project to fall under the IRB. The following are more specific responses to the question, as interpreted by the Wesleyan IRB, for various activities.

InterviewsJournalistic Activitiesand Oral Histories. Many of these activities do not meet one or both elements of the definition for human subjects research and thus would not require IRB submission. The objective of the activities is to provide an accurate and evidence-based portrayal of the individuals involved, and not to develop generalizable knowledge. Examples of such activities include: observing public behavior and conducting interviews for the purpose of creating a video (e.g., of skate boarding culture); interviewing domain experts in their areas of expertise and referencing their reflections in a scholarly publication (e.g., quoting stock brokers discussing market activity); or audiotaping individuals discussing their memories of a historical event with the goal of creating an archive (e.g., viewing the first moon landing). In these cases, either individual private information is not being collected, or the goal is not generalization and prediction. In contrast, if the purpose of collecting recollections about the first moon landing were to test predictions about memory accuracy, IRB approval for the interviews would be required.  Or, if stockbrokers were systematically asked to predict changes in the prices of stocks and the data were used to test a hypothesis about prediction bias, this activity would constitute human subjects research as well.      

Program Improvement Activities. Activities that are intended solely for improvement of a local program for its constituents are also not under the purview of the IRB.  Examples of such activities include mailing a satisfaction survey about library services, requesting feedback about a new photocopying service, or helping a local bank assess the how much customers like its new website.  However, activities that combine a program improvement goal with a research goal do require IRB submission.  An example of such an activity would be one in which two websites are designed for the bank, each based on different design principles, so that the web designers can assess which type of display is generally more user friendly. 

Classroom Activities. Data collection activities that are solely for the purpose of educational demonstration do not need to be submitted to the IRB because they do not contribute to generalizable public knowledge. However, activities that might in fact contribute to such knowledge, such as projects that contribute to the instructor’s research program or that might be presented at a professional conference, would require IRB review. Because classroom research activities can be, from the perspective of the participant, indistinguishable from other human subjects research, it is assumed that the instructor will take responsibility for reviewing any student proposals and for ensuring they meet the standards of the IRB as well as any guidelines of home department for such activities.   

Secondary Data Analysis. Secondary analysis of deidentified or publically available data must be submitted to the IRB, usually with a request for exemption status. The IRB will make a determination as to whether the data meet the definition of human subjects research. This procedure is in place, so that the IRB can independently confirm that the data are no longer private or identifiable and can establish that the use of these data does not violate the conditions under which the data were initially collected. Even though the research might no longer involve human subjects, the goal is to continue to protect the welfare of the human subjects who participated in the original study. 

Who determines whether a study is exempt from review?

The IRB makes this determination. On the application form, you may selected a check-box indicating that you believe your study is "exempt" and explain the reasons why you believe your project is exempt.

Do I need to submit to the IRB if I am a student conducting research abroad?

Research conducted while a student is abroad or at another institution in the U.S. does not need to be submitted to the Wesleyan IRB as long as: (1) the student is being fully supervised by a faculty or staff advisor at the visiting institution, and (2) the work has been submitted to an IRB of the visiting institution.  If these conditions are not met, or if the student plans to continue the research upon returning to Wesleyan, the research must be submitted to the Wesleyan IRB.      

How long does it take to obtain IRB approval?

The IRB strives to complete evaluation of an application within 2 weeks of receipt. The following factors may slow down the review process:

1. Incomplete applications, i.e., application text lacks sufficient detail for the IRB to make judgment or the application lacks required supplemental materials (e.g., consent form).

2. Study involves more than minimal risk: such projects need to be reviewed by the full IRB committee and this may take more time than an expedited review.

3. Study involves vulnerable populations

4. Study involved prisoners; special review requirements apply to research of incarcerated individuals.

5. Application is submitted during the summer/winter break. The IRB does not convene the middle of July to the middle of August or between December 20 - January 15. No applications will be reviewed during these times.

What is de-identified information or biospecimens?

Information is de-identified or non-identifiable if it is recorded in a way that there is no possible way to link the data to the subjects’ identities, the researcher does not have any contact with the subjects, and will not re-identify the data.

What is an identifiable biospecimen?

An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

What is expedited review?

Research that involves no more than minimal risk to participants may qualify for an expedited review. Expedited review can be conducted by a single experienced IRB member. The expediting reviewer has the authority to make a determination or to refer a submission for full board review for multiple purposes (e.g., clarification, expertise).

Expedited review can be conducted for most minimal risk 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. Minor changes to research previously approved by full IRB review may also qualify for expedited review if the changes do not increase risk to participants. See the OHRP Expedited Review Categories for other types of research that may qualify for expedited review. Only the IRB can determine whether research meets the criteria for expedited review. 

What is a benign intervention?

A benign behavioral intervention is brief in duration (although data collection may take longer) and must be harmless, painless, and not physically invasive. The intervention must not be likely to have a significant adverse lasting impact on the participant, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Some examples include: playing an online game, solving puzzles under various noise conditions, deciding how to allocate a nominal amount of cash between individuals, and listening to various prompts to identify sounds.

What is “private information”?

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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).

Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

Please Note: No reviews will be conducted between May 20 - June 14, 2019. 

SUBMISSION MATERIALS

New submissions

Researchers should download the form Description of Research Form from the web, complete it electronically, and submit it and accompanying materials by email.  Researchers who have any difficulty downloading the form (e.g., non-Wesleyan-affiliated researchers) should contact the IRB Administrative Coordinator and request emailed copies.  Upon receiving a new submission, the IRB Administrative Coordinator will create a WesFiles folder for the project.  Students must have a Wesleyan faculty or staff research advisor in order to have their proposal reviewed by the IRB; this faculty member must review and approve the student's application prior to sending it on the IRB website.

Renewal of proposals

A Project Update Form must be completed annually for ongoing non-exempt research projects that do not require continuing review. Ongoing non-exempt research projects that require continuing review must be renewed on an annual basis.  The principal investigator is expected to be aware of the expiration date and to initiate this process.  To renew an approved protocol, download the form Project Continuation Form, complete it electronically, and submit it via WesFiles.  When submitting this form on WesFiles, add it to the original project folder. 

Changes to proposals

To change the protocol of an approved IRB proposal, download the form Change of Protocol Form, complete it electronically, and submit it via WesFiles.  When submitting this form on WesFiles, add it to the original project folder. Do not collect data using the new protocol until the protocol has been approved.    

USEFUL RESOURCES

Informed Consent Template

Release Form Template

Elements of Informed Consent

INSTRUCTIONS FOR SUBMITTING A NEW PROPOSAL

1. Complete a Description of Research Form making sure to include your project number. Your project number is named using the following convention: YYYYMMDD-username-project

          a.   YYYYMMDD is a date stamp for the date of first submission.
                E.g., 20130101 if you are submitting on January 1, 2013.
          b.   Username is your Wesleyan email up to but not including the @ sign.
                Project is a short name for your project, of your choosing.
          c.    Project is a short name for your project, of your choosing. 
                Please use letters or numbers only, no spaces.
          d.   Example: 20130101-jprof-apptest
 
This will be the label for the project for all future correspondence with the IRB so choose accordingly (e.g., when a student is involved in a faculty research project, use the username name of the faculty member).  
 
2. Attach your completed application documents (e.g., Description of Research Form, consent forms, survey instrument, and other accompanying documents) to an email and send it to IRB@wesleyan.edu


3. Upon receiving your email, the IRB Administrative Coordinator will upload your folder to WesFiles.  This process will automatically initiate review of your application.
 

4. At any time, you can get read-only access to all of your project folders (but not those of other researchers) by pointing your web browser to: https://wesfiles.wesleyan.edu/xythoswfs/webview/_xy-5084904_2 and logging in if you are prompted to do so.

INSTRUCTIONS FOR SUBMITTING CHANGE, ANNUAL PROJECT UPDATES, AND CONTINUING REVIEW FORMS

1. Point a web browser to: https://WesFiles.wesleyan.edu/xythoswfs/webview/_xy-5084904_2 and login if you are prompted to do so. 


2.  Go to the project folder of interest where you wish to add your completed Project Update Form, Project Continuation Form, or Change of Protocol Form.


3. Click on the Upload button in the upper right portion of your screen 
         a.   Choose the Advanced Uploader.
         b.   Browse to your to-be-uploaded file and click Open.
               Alternatively, drag and drop your file into the upload area.   
         c.   Click Start Upload.
         d.   If your upload succeeds, you will be returned to the listing of dropbox
               contents where you should now see your file.
         e.   If your upload fails, please contact your Desktop Support or your Academic Computing Manager.
         f.   Detailed uploading help is also available at: http://WesFiles.blogs.wesleyan.edu/how-to/upload/
 
4. Uploading the folder will initiate IRB review automatically. For a short time, you will still be able to delete files that you uploaded, but within a day that permission will be changed so that you will have read-only access. 

CONCLUSIONS

Thank you for your efforts in submitting complete, thoughtful, and carefully proofread applications, and for your respect for the review process. Administrative questions should be directed to the IRB Administrative Coordinator; questions about evaluations of research should be directed to the IRB Chair. 

For more information on Responsible Conduct of Research please visit http://wesleyan.edu/acaf/support/RCR.html.

PRESENTATION SLIDES

Common Rule Changes Presentation