Supporting Ethical

Scholarship: The Role of the

Human Subjects Review Board

(HSRB)

(It’s more fun than it sounds, we promise)

What is the HSRB?

The HSRB is a committee composed of faculty from across the university who work to ensure that the rights and welfare of human subjects participating in any research affiliated with the university are adequately protected.

The Responsibilities of the HSRB Include● Review research to ensure that potential

benefits outweigh risks to participants● Ensure that the rights and welfare of

subjects are safeguarded, including the fairness of selection procedures and proper management during the conduct of the study

● Ensure that all appropriate steps needed for true Informed Consent are planned and carried out

How This Impacts You

● It is a policy of the University to have research reviewed.

● It is also a federal policy to have research involving human subjects reviewed to assess risk to participants, especially for vulnerable populations.

● We offer CITI training for you to understand how to protect human subjects.

● If an investigator thinks she or he might want to publish or present their research outside of Metropolitan State University, HSRB review is required.

HSRB Review Criteria● When reviewing any study where there is known element of

risk, the HSRB applies these standard criteria:

○ Does the study design use methods that avoid all unnecessary risks and make use of accepted procedures for treating the illness or condition?

○ Are risks to subjects reasonable in relation to anticipated benefits, if any, and the importance of the knowledge that may be expected to result?

HSRB Review Criteria● Is the method of subject selection

equitable and appropriate given the purpose of the study?

● Will Informed Consent be obtained from each subject and documented as required by federal regulations?

● Is data collection monitored to ensure prompt recognition of trends pertinent to the safety of study subjects?

HSRB Review Criteria● Is there adequate provision to protect

the economically or educationally disadvantaged and those who may be vulnerable for other reasons to coercion or undue influence?

● Will the privacy of individual subjects and the confidentiality of data obtained be safeguarded?

Types of ApplicationsExempt Review

Expedited Review (Administration Review)

Full Board Review

Exempt Reviews● We strongly recommend that investigators informally consult with the HSRB

to confirm exempt status and to ensure human subjects protections are handled appropriately.

● Studies which are “exempt” from full HSRB review requirements must have an exempt application registered with the HSRB outlining the study.

● HSRB makes final determination of exemption.

Exempt Reviews: CategoriesResearch may be exempt from the HSRB review if the only involvement of human subjects will be in one or more of the following categories:

A. Research conducted in established or commonly accepted educational settings, involving normal educational practices such as:

1. Research on regular and special education instructional strategies; or

2. Research on the effectiveness of, or the comparison among, instructional techniques, curricula or classroom management methods.

Exempt Reviews: CategoriesB. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, 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 through identifiers linked to the subjects.

Exempt Reviews: CategoriesC. Research activities, conducted by university personnel and intended for internal use only, that are designed to assess, evaluate or otherwise examine:

1. University courses, services, and programs;

2. Procedures for obtaining benefits or services at the University;

3. Possible changes in or alternatives to services, programs or procedures; or

4. Possible changes in methods or levels of payment for benefits or services under those programs.

Exempt Reviews: CategoriesD. Research activities that are conducted within an established university course and are directed solely toward the learning of research methodology and procedures.

Exceptions that are subject to review include capstones, theses, or other research activities that are conducted beyond the boundaries of the supervisory classroom environment and involve human subjects who are not registered members of the course.

Question: Can you think of an example of an exempt study?

Expedited Reviews● An HSRB may conduct an "Expedited Review" for

certain types of studies that entail only minimal risk, and for minor changes in existing, approved protocols.

● "Minimal Risk" means 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.

● Question: Can you think of an example of an expedited study?

Full Reviews● A project that involves greater than minimal risk requires approval from the

full HSRB● Research that requires full committee review includes:

○ Research that involves greater than minimal risk○ Non-exempt research that involves children or other vulnerable populations;○ Research that involves experimental drugs or devices;○ Research that involves invasive procedures; and○ Research that involves deception.

● Survey research that involves sensitive questions or information about sexual practice or illegal behavior

● Any survey or interview that is likely to be stressful

● Question: Can you think of an example of a full review study?

Ethical Issues in ResearchAppropriate measures need to be taken to preserve subjects' anonymity and/or confidentiality

Subjects need to be informed that participation is voluntary, and coercive strategies will not be used in order to gain subjects' compliance.

Question: What is an example of a coercive strategy?

Question: Is requiring students to participate in a research study for a class assignment coercive?

Starting the Application ProcessMetro’s Human Subjects Review Board (HSRB) site:

1. What is subject to Review?

2. How to Apply?

3. Frequently Asked Questions

4. Guidelines

5. Policies

6. Procedures

How to Apply for a ReviewSubmit application and support materials via IRBNet.org

IRBNet is a web-based tool that helps researchers and HSRB administrators manage the submission and tracking process of their institution’s research projects.

IRBNet Training: D2L*Departments, Organizations & Misc -- Center for Online Learning

● Human Subject Review Board Training Site - HSRB_Site

D2L Training Materials

D2L Training Materials, continued5 Modules

1. New Project Submissions

2. Submitting a New Project “Here at Metro”

3. Post Submission Advances Topics

4. Modifying a project “Here at Metro”

5. How to Register as an IRBNet User

IRBNet.org

Download Application and Supporting Materials

IRBNet Application Create a new project

Uploading Application

Uploading Application continued

IRBNet Submission continued● Share project

● Electronically sign your application

Note: For student research the faculty advisor will be considered the Principal Investigator (PI)

● Submit application

Need help with a submission or have questions, please email HSRB@metrostate.edu.

Metropolitan State University Subject Pool

What is a subject pool?• Traditionally, the subject pool is designed to provide subjects

for psychological or behavioral science research by faculty and students in the department.• We have extended invitations more broadly at MetroState and

invite participation at a university-wide level• The studies are also designed to be part of the learning

experience of introductory psychology and social sciences.• Courses that would benefit would be any type of research

methods course or introduction to science courses

Rationale• Instructors at non–research institutions have fewer opportunities

to give students hands-on experience with research participation• Subject pools are mostly associated with psychology courses at

research institutions. Sieber and Saks (1989) found that 74% of graduate-level psychology departments have developed HSPs.

• To have our students represented in the behavioral and social research that is presented and published in our academic communities.

Sieber, J.E., & Saks, M.J. (1989). A census of subject pool characteristics and policies. American Psychologist, 44, 1053-1061.

Benefits for Students• Students have found participation to be:

• A valuable learning experience (Davis & Fernald 1975; King 1970).• Helped increase their knowledge of psychology (Coren, 1987).• A better understanding of the research process (Landrum & Chastain,

1995; Sullivan & Lashley, 2009).• Rosell et al. (2005) found that compared to lecture alone,

students’ actual knowledge about participants’ rights and informed consent increased more when they participated in experiments.

Benefits for Students, cont’d• Gil-Gomez, Leon, and Pascual-Ezama (2012) found that

students who took part in HSP studies achieved higher scores on a methods exam than students who did not.

• Research supports the idea that participation provides a rich pedagogical resource, even for nontraditional schools (i.e. community colleges; Chin & Stayte, 2014).

• Anecdotes!

SONA• SONA is the cloud-based application used to manage the

subject pool• Easy to use and easy to navigate

• Allows researchers to:• Set up studies• Manage schedules and timeslots for data collection• Pre-screen participants• Manage third-party integration (e.g. Survey Monkey)• Generate Reports• 24-hour system availability

HSRB (Human Subjects Review Board)• The subject pool has the support of the HSRB (October, 2014 meeting)• Applications, modifications, and other forms have been modified to include

options for using the Human Subject Pool to recruit participants• Works closely with Subject Pool team to ensure research projects are

appropriate for the system before they are opened for data collection.

11. Will you be using the Metropolitan State University Human Subject Pool to recruit participants via the SONA system?

NOYES 11a. If yes, please explain the rationale briefly. For question 12 you may answer N/A

Opportunities for Instructors• Instructors of courses with pedagogically appropriate goals and

learning outcomes are invited to enroll their students and course in the Human Subject Pool

• Human Subjects Pool Coordinator is available for classroom visits to introduce students to the Subject Pool and SONA systems

• Technical assistance available through the Psychology Lab Staff• Reports can be compiled and sent to the instructors at any time and

the end of the semester• Alternative options (HSRB approved) are made available for all

students in the course each semester; these will also be coordinated through the coordinator and support staff

Steps for Instructors (HSRB approved)

1. Instructors interested in incorporating a research requirement into a course via the subject pool should fill out the SONA registration form for instructors (handouts available today; email the coordinator: Kimberly.halvorson@metrostate.edu; IRBNet)

2. This form is to be submitted to the Faculty member currently serving as coordinator of the human subject pool

1. Requests for SONA registration by instructors will be reviewed by the member to ensure that requests are consistent with pedagogical and theoretical guidelines/motivation for establishing a human subject research pool

Steps for Instructors, cont’d3. For first time instructors, the faculty member serving as the

coordinator of the human subject pool will work with the instructor to ensure satisfactory implementation of a research requirement in a course in one (or more) of the following ways:

1. Email correspondence including the approved SONA syllabus attachment (handouts available) for use and/or modification and verification that it is included in the current syllabus

2. In-person meeting to discuss the SONA syllabus attachment and verify inclusion

3. Classroom visit to explain SONA syllabus attachment, facilitate registration, and answer questions.

Opportunities for Researchers• Access to a diverse and accessible human subject pool for

research opportunities• SONA software and HSRB approved protocol (including built-

in confidentiality measures and alternative options for course credit) facilitate participant recruitment in a timely and ethical manner

• Contribute to the growing culture of research at Metropolitan State; expose students to ongoing research projects on campus

Steps for Researchers• Select the Subject Pool options on question 11 in the HSRB

application• Fill out the New Study Sheet for Researchers (handout; email

Kimberly.halvorson@metrostate.edu; IRBNet)

Who to contact• Coordinator of Subject pool/Director of Psychology Lab

• Kimberly Halvorson (kimberly.halvorson@metrostate.edu)• Lab Manager

• Valerie Wilwert (Valerie.wilwert@metrostate.edu) • The HSRB

• hsrb@metrostate.edu

Supporting Student ResearchStudent Research

Classroom

Capstone

Thesis

Faculty Program/Lab

Supporting Student ResearchThe Approval Process as a Set of Instructional Tools

CITI training

Consideration of type of application

IRBNet training

Completion of application

Response to review

Example: Master’s Projects in MS CODC

Supporting Student ResearchThe HSRB Application Itself as an Instructional Tool

Supports students in thinking through:

the arc of the project

research ethics

implications for human subjects

equity and inclusion

best practices and methodologies

Supporting Student ResearchCommon Pitfalls*

Principal Investigator (cover page)

Purpose and Methods (1, 3)

Participants (9, 10, 11, 13)

Informed Consent (14)+

Benefits and Risks (15-18)

Confidentiality (19-23)

* () indicates section of HSRB application+ example: Recovery Narratives Project

Questions?Ask an HSRB member!

Chair: Katherine Johnson

Today’s presenters:

Karen Gutierrez

Kimberly Halvorson

Alex Layne

Therissa Libby

Becca Peters