Research Involving Human Subjects

Research Involving Human Subjects

Approval of proposed research being conducted by faculty or students which involves human research subjects is required prior to conducting research.

It is recommended that all faculty and students proposing research involving human subjects apply for approval by the IRB 90 days prior to starting research, particularly if research will involve protected groups such as minors or international research.

When planning a project, a Principal Investigator (PI) should allow sufficient time for the IRB to review the application, with the likelihood of significant revisions prior to approval.  It is the PI's responsibility to leave sufficient time for review; the IRB will not approve a study based on a desired start time.

ALL proposed activities that involve or potentially involve humans as subjects of the research are reviewed by both the department and the IRB.  ALL proposed research involving human subjects must be properly documented.

Please contact irb@pittstate.edu with any questions.

Does my proposed research activity need to be reviewed?

If your activity meets the definition of research and includes human subjects, it is subject to review and must be documented accordingly. 

Generalized Knowledge

Most internal program evaluations to determine student satisfaction or knowledge gained through routine program/classroom activity do not meet the federal definitions of research.  If the purpose of gathering the data is to publish the results or present the information outside of the group it was obtained (i.e. outside the classroom), the research is generalized.

Identifiable Private Information

Identifiable Private Information includes "information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record)."

If the definitions of research and human subjects apply to your activity, you need to apply for human subjects research review.

Regardless of how your human subjects research is classified, it must be documented and reviewed by (1) your department, and (2) the IRB Chair.

It is recommended that all faculty and students proposing research involving human subjects apply for approval by the IRB 90 days prior to starting research, particularly if research will involve protected groups such as minors or international research.

• Research classified as "exempt" IS STILL SUBJECT TO REVIEW and SHOULD BE DOCUMENTED.
• Review at any level may be returned for revision, so leave sufficient time before the proposed start of research.

Timeline of Application (Times shown below are guidelines only. Actual turnaround times may be longer, especially in the summer months and for first-time applicants.). 

Exempt Classification:

• Reviewed by Department Rep & IRB Chair
• Submission Deadline is TWO WEEKS before start of research
• Reviewed within FIVE WORKING DAYS of receipt

Expedited/Limited Classification:

• Reviewed by Department Rep & Two+ members of IRB
• Submission Deadline is THREE-FOUR WEEKS before start of research
• Reviewed within TEN WORKING DAYS of receipt

Full Classification:

• Reviewed by Majority of IRB
• Submission Deadline is the 20th calendar day of the month, no less than TWO MONTHS before start of research
• Reviewed 2nd Tuesday of following month*

Prior to beginning any research project application, all study personnel (PI, undergraduate or graduate student researchers, etc.) must complete the appropriate CITI Program training course through the GUS Portal.  The completion certificate must be included with all applications.  If your research activity includes ANY of the following conditions - go directly to Full Review.

• Survey or interview techniques which include minors (under 18 years of age) as subjects
• Research involving the observation of the public behavior of minors (under 18 years of age)
• Prisoners, fetuses, pregnant women or human in vitro fertilization
• The deception of subjects
• Techniques which expose the subject to discomfort or harassment beyond levels encountered in daily life (the research activity presents more than minimal risk)
• Identification of subjects/responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal
• Classified research involving human subjects

Collect all relevant study documentation, including, but not limited to:

• Surveys/quizzes/interview questions
  
• Approvals from external partners
• Advertisement materials

Review these criteria to see if your research can be approved by your department.

Research classified as "exempt" simply means that it can be approved by the department and Chairperson of IRB.  All Departmental Reviewers must have current CITI Training (see Forms & Policies), record of which must be on file with the IRB.

How do I apply for exemption review?

• Complete and print an application Application for Review.
  
• Print Review Criteria Form.  Review the listed criteria on this form to determine if one or more of the criteria apply to your research.
• Submit these application materials to your department for review and routing to the IRB.

If your department cannot approve your research, determine if your research should follow the expedited review process by using the Review Criteria Form.

Research classified as "expedited" is approved by the Department Reviewer and at least two members of the Board.  All Departmental Reviewers must have current CITI Training (see Forms & Policies), record of which must be on file with the IRB.

How do I apply for the expedited review process?

• Complete and print an application Application for Review.
• Print Review Criteria Form.  Review the listed criteria on this form to determine if one or more of the criteria apply to your research.
• Request waiver of Informed Consent Form(s):
  • Application for Informed Consent Waiver or Alteration
• Submit these application materials to your department for review and routing to the IRB.

If your research does not meet the exempt or expedited review criteria, follow the full review process.

Research classified as "full" is approved by the Department Reviewer and a majority of the full Board (IRB).  All Departmental Reviewers must have current CITI Training (see Forms & Policies), record of which must be on file with the IRB.

How do I apply for full review?

• Complete and print an application Application for Review.
• Print Review Criteria Form.  Review the listed criteria on this form to determine if one or more of the criteria apply to your research.
• Request waiver of Informed Consent Form(s):
  • Application for Informed Consent Waiver or Alteration
• Submit these application materials to your department for review and routing to the IRB.

Below are the forms and policies you may need.

Review Criteria for Research Involving Human Subjects Form

To determine the IRB review classification.

Application for Approval of Investigations Involving the Use of Human Subjects

An application is required for IRB review when research involves the use of human subjects.

Application for Informed Consent Waiver or Alteration

To obtain approval for a waiver or alteration of informed consent.

Application for Continuing Review of Investigations Involving the Use of Human Subjects

An application is required to obtain approval for continuing review of investigations involving the use of human subjects beyond your initial IRB application approval.

Protocol Amendment for Investigations Involving the Use of Human Subjects

An application is required to obtain approval for protocol amendment for investigations involving the use of humans subjects to your initial IRB application approval.

External IRB Collaboration Form

Must be completed whenever there is collaboration between PSU and any institution with or without its own IRB (or equivalent).

PSU Policy Assurance Handbook

The Policy Assurance Handbook for the Protection of Human Research Subjects contains PSU policies and procedures related to the Protection of Human Subjects Code of Federal Regulations and must be reviewed by all faculty, staff, and students applying for expedited or full review of research involving human subjects.

Belmont Report

Ethical Principles and Guidelines for the protection of human subjects of research.

Federal Regulations

Protection of Human Subjects Code of Federal Regulations.

Protecting Human Research Participants CITI Training

PSU faculty, staff, and students who are applying for review of research involving human subjects must complete the appropriate CITI Program Online Training  and submit the completion certificate with their application.  It is also recommended that research methods courses include the training program.  To access CITI Program Training, go to the GUS Portal and login using your PSU credentials. The Login button is at the top right of the portal. Once logged in, enter CITI in the search box and select CITI Program. You will then be able to register for an account or login to your existing account. Please use your PSU email address when registering.

Q:  I want to have students conduct a research project assignment as part of a class, and as part of that project, they will be surveying individuals.  Does that qualify as Human Subjects Research?

A:  If the goal of the assignment is to demonstrate the research project (as opposed to having the students answer a novel question), and the end result of the assignment is to present information (as a formal presentation or written report) within the classroom only (as opposed to publication or presentation at a local/national/international meeting), the proposed activity does not meet the requirements for research, as long as the survey does not collect personal or identifiable information.

Q:  I want to send a survey to a student group to determine their availability (days/times) for meetings and/or possible events. Does that qualify as Human Subjects Research?

A:  If the goal is intended only to inform internal processes or quality improvement, then the proposed activity does not meet the definition of research, as long as the survey does not collect personal or identifiable information.

Q:  I am submitting an IRB application for review that may include participants with physical disabilities. The study is not recruiting individuals with a physical disability, but because of the population, there is a chance of having subjects with a physical disability who can still complete the majority of the assessments based on the inclusion/exclusion criteria. Would this study be considered a Full board review?

A:  Just having participants with physical disability does not automatically qualify a study as requiring Full review unless the combination of that disability and the study activities put the subjects at increased risk. If that is the only thing that would raise the risk to an unsafe level, that could be a disqualifying condition from participation, but that would be based on the specifics of the study.

Q:  If a Principle Investigator (PI) violates a Human Subject Research policy, what are possible repercussions to the PI?

A:  Possible repercussions to the PI include suspension of the current research while the violation is under investigation, and potential loss of funding from the Federalwide Assurance (FWA) agencies (NASA, Department of Commerce, Department of Education, Department of Veterans Affairs, Department of Health and Human Services, National Science Foundation, etc.). See an example of a violation determination letter here.

Q:  What are the repercussions to the university for violations of Human Subject Research (HSR) policy?

A:  Possible repercussions to the university (for repeated violations/loss of institutional control) include losing the IRB (which means lose HSR funding and must stop all HSR), possible loss of Federalwide Assurance (FWA) status, potential loss of funding from FWA agencies, possible loss of accreditation on ethical grounds (HLC Accreditation Criterion 2.E), and possible loss of access to Federal Student Aid (FSA).

Q:  What is the best way to communicate with the IRB if there are questions about applications or projects?

A:  The best way to communicate with IRB is through email at IRB@pittstate.edu.

Q:  When will training for all employees take place for IRB policies/procedures to reduce any possible institutional vulnerability?

A:  There are many opportunities for training and information. CITI Training is offered free to anyone at PSU. The Policy Handbook and Belmont Report are available resources and recommended for review at least annually for any possible updates. Information sessions have been offered by IRB at Professional Development Day in August. 

Q:  What are the most common mistakes made when filling out the IRB application?

A:  Some of the most common mistakes include missing or incomplete forms/documentation/signatures, sections of the application being left blank, inappropriate research start date, and insufficient description of research protocol.

Q:  Is there a rubric for IRB proposals?

A:  There is not a rubric for IRB applications. Each application is viewed independently, on a case-by-case basis, and must have enough information to determine if the human subjects will be adequately protected.

Q:  Is there be a pre-screen of applications?

A:  Applications are pre-screened prior to review by IRB. When a PI completes the application, if the PI is a student, then it goes to the Faculty Sponsor for review and signature. Ideally, the Faculty Sponsor should be reviewing the application for any errors, missing information/forms, etc. Then it goes to a Department Reviewer for review and signature. The Department Reviewer is someone that is trained and authorized for that area to review IRB applications prior to being reviewed by IRB. Research + Economic and Community Development will then review the application for documentation completion, missing forms, etc. Once all pre-screens are finished, the application moves to IRB for review.

Q:  Does the administrator signature on the IRB application signify IRB approval or acknowledgement that IRB have been notified of the research?

A:  Once the research has been approved by the Full Board or the appropriate sub-set of IRB members (Full or Expedited), the IRB Chair signs the application.

Q:  Did ITS or legal counsel play any roles in the Social Media and Data Storage Policies implemented October 2023?

A:  ITS was involved in the entire process of developing these policies. PSU General Counsel reviewed and approved these policies prior to implementation.

Q:  What is the context and background behind the Social Media and Data Storage Policies that were effective October 2023?

A:  There has been a recent rise in digital security lapses, including, but not limited to City of Pittsburg (Sept. 2023) and Kansas Courts (Oct. 2023). In addition, this is in line with recent measures by State and KBOR to increase digital security (i.e., adoption of Duo 2FA). Both Social Media and Data Storage models were diffused and difficult to trace in case of an audit, with varying levels of security. Following are some examples of IRB Social Media Policies from other institutions: UPenn Medicine and Columbia Teachers College. Additionally, these are some examples of IRB Data Policies from other institutions: University of Minnesota, San Jose State, and UPenn.

Q:  How long does it take IRB to review an application?

A:  The timeline for each type of review (exempt, limited, full) is listed to the left under "Timeline For Application." Note that the timelines shown are guidelines only, and that actual turnaround times may be longer, especially if you are a first-time applicant. Be sure to plan well in advance for IRB review and potential revisions, allowing plenty of time to prevent delays in starting your research.

2024-2025 Chair

Jennifer Richardson, Ph.D. - College of Education

2024-2025 Members

Alex Binder, Ph.D. - Kelce College of Business

Paige Boydston, Ph.D. - College of Education

Jae Choi, Ph.D. - Kelce College of Business

Anu Ghosh, Ph.D. - College of Arts & Sciences

Krissy Lewis, Ed.D. - College of Technology

Carol Meza-Bakke, Ph.D. - College of Arts & Sciences

David Miller, Ph.D. - College of Technology