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Human Subjects Research: Institutional Review Board

 

 

 

The IRB is the body charged with reviewing all research involving human subjects conducted under the auspices of Wesleyan University.  This includes research conducted by faculty members, students, and staff, as well as that conducted by outside researchers using Wesleyan individuals as subjects.  It includes federally funded research as well as research that is not funded or is funded by other sources. Individuals proposing research using human subjects must obtain approval from the IRB prior to commencing data collection.

 

The activity of research is defined as any systematic investigation designed to contribute to a body of generalized public knowledge.  The use of human subjects in research refers to data collection through interaction with individuals as well as any collection of identifiable private information about individuals. The purpose of the IRB is to provide a single, comprehensive standard of protection for human subjects in research at Wesleyan. The intent is to ensure that investigators do not unduly put at risk or harm humans who are the subjects of research, and that subjects are aware of their rights as defined by federal regulations.

 

The safeguards provided by establishment of the IRB derive from three ethical principles: respect for the personal dignity and autonomy of all people, the obligation to protect persons from harm, and fairness in the distribution of research benefits and burdens.  These principles were first articulated in the Belmont Report issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979.  The procedures for review by the IRB adhere to the Code of Federal Regulations (Title 45, Part 46) of the U.S. Department of Health and Human Services.

 

For a better understanding of the history, purpose, goals, and procedures of the IRB as established by the federal government, researchers are strongly encouraged to consult the following sources.  The Office for Human Research Protections (OHRP) of the Department of Health and Human Services provides free online Human Subject Assurance Training.  Specifically, three training modules are offered at the site: (1) HHS Regulations and Institutional Responsibilities; (2) Investigator Responsibilities and Informed Consent; and (3) Human Research Protections Program.  The Department also publishes Protecting Human Subjects: Institutional Review Guidebook. 

 

 

BOARD MEMBERS

 

The members of the board are appointed by the provost and represent members of a wide range of disciplines at the university as well as members of the community. 

 

Coordinator   Lisa Sacks Administrative Assistant North College 310 lsacks@wesleyan.edu 860/685-3428               Chair   Andrea Patalano Associate Professor of Psychology and Program in Neuroscience and Behavior Judd Hall 404A apatalano@wesleyan.edu 860/685-2310

Wesleyan Affiliated Members   Cynthia Matthew Visiting Scholar in Psychology Judd Hall 218 cmatthew@wesleyan.edu 860/685-2942   Don Moon Dean of Social Sciences and Interdisciplinary Programs Professor of Government North College 309 dmoon@wesleyan.edu 860/685-2707   Anu Sharma Associate Professor of Anthropology and Feminist Studies Anthropology 23 asharma@wesleyan.edu 860/685-3567

Public Members        Marvin Farbman 4 Columbine Road Middletown, CT  06457 mfarbman@wesleyan.edu 860/347-8338   Marci Swede 181 Elizabeth Lane Middletown, CT  06457 mswede@wesleyan.edu 860/346-2748

 

   

 

All submitted proposals are assigned by the IRB to one of three review categories (Exempt, Expedited, or Full).  The assigned review category will guide the review process for the proposal.  Note that the below category descriptions are abbreviated summaries of federal guidelines.  Definitions of key terms are listed below the descriptions of these three categories.  Even if you believe your proposal is exempt, you must submit it so that the board has the opportunity to make this determination. 

 

Exempt (Level 1)

 

Each of the following situations is exempt from review:  Research practices that use normal educational practices in commonly accepted educational settings; use of educational tests, surveys, interviews, or observations of public behavior, unless subjects can be identified in any way and disclosure would be harmful to criminal or civil liability, financial standing, employability, or reputation (the latter is waived if subjects are figures in public office); use of existing or collected specimens, data, or records that are publically available or are not linked in any way to individual subjects; and, any research that requires prior approval of federal agencies.  Proposals determined to be exempt are waived from further review for the duration of the project.

 

Expedited (Level 2)

 

All research that poses minimal risk to participants can be expedited.  In addition to previously mentioned methods, this includes audio and video recordings, laboratory behavioral tasks that do not stress subjects, and clinically routine noninvasive procedures such as blood tests, electroencephalography, functional magnetic resonance imaging, moderate exercise, and body composition assessment.  It does not include methods involving electromagnetic exposure such as x-rays.  These conditions do not guarantee expedited review; full review is at the discretion of the board.  Expedited proposals are typically reviewed by both the chair and one member of the board. 

 

Full Review (Level 3)

 

All research that is not exempt or expedited is given full review.  This means that the proposal is reviewed by all members of the board and must receive support from the majority of board members in order to be approved.  In addition to non-minimal risk methods, such circumstances as requests for waivers of informed consent, inclusion of vulnerable populations, and use of sensitive data sometimes prompt  full review.   

 

 

Definitions

 

Minimal risk.  Minimal risk is the probability and magnitude of harm or discomfort ordinarily encountered in daily life or during a routine physical or psychological examination or test.

 

Vulnerable populations.  Vulnerable populations include children, prisoners, pregnant women, fetuses, the seriously ill, and mentally or cognitively compromised adults.

 

Sensitive data.  Sensitive data include behaviors that are typically sensitive to individuals, such as drug or alcohol use, illegal conduct, or sexual behavior, as well as information that could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation. 

 

 

 

New submissions

 

Researchers who are not affiliated with Wesleyan University but are submitting a proposal should request a research proposal form from Lisa Sacks (lsacks@wesleyan.edu) and should return the completed form and accompanying materials to her by email.  All researchers who are affiliated with Wesleyan University (i.e., most submissions) should obtain the form Description of Research Project Involving Human Participants online through WesFiles and should submit it and accompanying materials through WesFiles (see instructions at the end of this webpage).  Any difficulties or questions should be directed to Lisa Sacks.

 

Proposal expiration and renewal

 

Research approved by the IRB that is continuing must be re-reviewed on an annual basis by the IRB.  The contact principle investigator is expected to be aware of expiration dates and to initiate this re-review.  Even before re-review, throughout the year, any changes in research design must be submitted to the IRB for approval and unanticipated or adverse consequences of the research must be reported including but not limited to physical or psychological injury to subjects, improper execution of research protocol, or improper disclosure of private information.  The instructions for renewing applications are the same as those for submitting a new application except that there is an IRB Research Project Continuation Form available online for this purpose.  When submitting this form on WesFiles, please add it to the original project folder in the dropbox at: https://wesfiles.wesleyan.edu/xythoswfs/webview/_xy-5084904_2.  If this is a renewal for a project that was not submitted via WesFiles, please create a new folder following the instructions for new submissions.

 

Changes to protocol

 

If you wish to change the protocol of an approved IRB proposal, please download, complete, and submit via WesFiles the IRB Project Change of Protocol Form. You do this by adding the document to your original submission folder at: https://wesfiles.wesleyan.edu/xythoswfs/webview/_xy-5403941_2.   You should not collect data using the new protocol until it has been approved.  The procedure for reviewing changes will follow that for new proposals.  If this is a change of protocol for a project that was not submitted via WesFiles, please create a new folder following the instructions for new submissions.

 

Preparation of proposals

 

Click here for an example of a complete proposal including a sample consent form, set of research materials, and debriefing sheet.  We highly recommend that you view the sample materials if you are a new submitter.  We also strongly encourage you to complete the three modules of the online Human Subject Assurance Training, or to review relevant portions of Chapters III, IV, and VII of Protecting Human Subjects: Institutional Review Guidebook so that you understand the issues that are of central interest to the IRB and can then fully address these issues in your proposal.  If you are a student, you must document in your submission form that your faculty advisor has read and approved your proposal.  Proposals that are incomplete will be returned without review.

 

 

 

Review time frame

 

The application will be sent to one member of the IRB for review who will assign it to one of the three review levels (Exempt, Expedited, or Full Review); the chair will also read all proposals and oversee the process. (Members do not review proposals with which they have a conflict of interest.)  Unless the proposal is assigned to Full Review, the chair will return a decision (Approve, Approve Pending Revisions, Revise and Resubmit, or Deny) that will be communicated in an email to the principal investigator typically within 2 weeks of proposal submission.  If the proposal is assigned to Full Review, this will be communicated to the investigator in the first email and a decision will be provided in a second email within 2 additional weeks.  When a proposal is approved or denied, a formal letter will also be sent to the investigator; requests for revisions will be sent through email only.  Reviews will be conducted throughout the year.  However, slower turnaround times should be anticipated during school break periods.

 

Types of decisions

 

There are four types of board decisions for non-exempt proposals.  Approve means that no further action is required and the study can commence.  Approve Pending Revisions means that the proposal can be accepted by the board upon receipt of a set of specific changes.  Revise and Resubmit means that the proposal must be revised and resubmitted based on feedback from the board before it can be properly and fully evaluated.  Deny means that the board has decided that the study cannot be conducted.  Denials can be appealed one time through a written letter of argument along with any further supporting materials for a final review by the full board but, if the denial stands, the work cannot be conducted. 

 

 

1.    Download and complete Description of Research Project Involving Human Participants and save it
       to your computer. 
 

2.    Create a folder on your computer and name it according to the following convention:

       YYYYMMDD-username-project
 

       a.  YYYYMMDD is a date stamp. 20090901, for example if you are submitting on

            September 1, 2009.

 

       b.  Username is your Wesleyan email address up to but not including the @ sign

 

       c.   Project is a short code for your project, primarily for your own reference. Please use letters or
            numbers only, no spaces.

 

       d.  Example: 20090923-jprof-apptest

3.    Put all of your application documents (i.e. completed Description of Research Project Involving
       Human Participants form, consent forms, survey instrument, and other accompanying documents)
       in the folder that you created.

4.    Point a web browser (i.e. Internet Explorer or Firefox) to:
       https://WesFiles.wesleyan.edu/xythoswfs/webview/_xy-5084904_2 and login if you are required
       to do so.

5.    Click on the Upload button in the upper right portion of your screen

       a.  Make sure to choose the Advanced Uploader

       b.  Browse to your folder and click Open or drag and drop your folder into the upload area

       c.  Click Start Upload

       d.  If your upload succeeds you will be returned to the initial listing of dropbox contents where

            you will see your new folder

 

       e.  If your upload fails, please contact your Desktop Support Person or your Academic Computing

            Manager

       f.   Detailed uploading help is also available at: http://WesFiles.blogs.wesleyan.edu/how-to/upload/

6.    Uploading the folder will initiate processing 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 only

       have read access to the materials you have submitted.

7.    You will see all of your own submissions and only your own submissions in this folder.

 

 

If you are in doubt as to whether your own work falls under the heading of human subjects research, please simply submit a proposal.  A purpose of the board is to make such decisions.  Thank you for your efforts in submitting complete and thorough applications and for your respect for the review process.