introduction to the institutional review board (irb): minnesota state university, mankato patricia...

Introduction to the Institutional Review Board (IRB):

Minnesota State University, Mankato

Patricia M. Hargrove, Ph.D.IRB Coordinator

Anne Blackhurst, Ph.D. Dean/IRB Administrator

IRB Framework

• 1974--National Research Act– 1978--National Commission for

Protection of Human Subjects•Belmont Report *

• 1991--Common Rules and FDA

1978: The Belmont Report

• Principle 1: Respect for Persons

• Principle 2: Beneficence• Principle 3: Justice

Respect for PersonsMAJOR COMPONENTS:

• Right to autonomy and self-determination

• Protecting vulnerable subjects

Respect for PersonsIRB REQUIREMENTS:• Avoid coercion or undue influence

versus voluntary actions• Provide informed consent.• Maintain privacy and

confidentiality.• Insure the right to withdraw from

participation without penalty.

Beneficence

MAJOR COMPONENTS:

• It is important to insure the well-being of research participants.

• There are trade-offs between individual and societal benefits to research.

BeneficenceIRB REQUIREMENTS:• The risks of research are

justified by the potential benefits to subjects and/or society.

• The study is designed so that risks are minimized.

• Conflicts of interest are managed adequately.

JusticeMAJOR COMPONENTS:

• Distribute the risks and potential benefits of research equally among those who may benefit from the research.

JusticeIRB REQUIREMENTS:

• Vulnerable subjects are not targeted for convenience.

• People who are likely to benefit from research participation are not systematically excluded.

Purpose of the Minnesota State

Mankato IRB• Safeguarding the rights and

welfare of subjects in research and related activities.

• Assisting faculty and staff engaged in relevant research from unknowingly committing unethical acts.

Steps in Applying to the IRB: Paper Application

1. The PI must be MSU faculty or staff.

2. Go to the IRB webpage (http://grad.mnsu.edu/irb/) and review the IRB Proposal Guidelines and IRB Information.

Steps in Applying to the IRB: Paper Application

3. Complete the application (IRB Proposal Guideline).4. Submit the application.

- Graduate Office- AH 103 (Speech & Hearing

Clinic)5. Wait until you receive approval to begin

data collection.

Steps in Applying to the IRB: Online Submission

1. The PI must be MSU faculty or staff.

2. Go to the IRB webpage (http://grad.mnsu.edu/irb/).

3. Click on “Online Proposal Submission.”

Steps in Applying to the IRB: Online Proposal

4. Student be sure to click on “Special Note for Students Submitting Online Proposal.”

• be sure to get advisor’s (PI’s) support.

5. Complete the application (IRB Proposal Guideline).

6. Submit the application.7. Wait until you receive approval to

begin data collection.

Steps in Applying to IRB: Online Submission

• HINTS:– Make start date about a week out– If student submits, he/she must

notify advisor that he/she needs to• Go online• Access the proposal• Submit and notify • Provide permission

IRB Levels

• IRB is concerned with 3 levels of research

BUT

• Classroom activity, laboratory courses, or field assignments are normally not classified as research and typically are not reviewed by the IRB. – These are considered to be exempt

at MSU.

Level I• See Level I Review Checklist

– Children– Standardized educational tests, surveys,

interviews, observations of public behavior• Cannot identify participants• Disclosure does not put participant at risk• Public officials

– Pre-existing data– Wholesome food

Level I

• Research involves less than minimal research.

Level II

• Proposals which involve minimal or less risk and are not eligible for Level I review.

• Recordings of identifiable information with minor risks.

• See IRB Manual

Level II

• Moderate exercise by healthy volunteers.

• Research on individual or group behavior or characteristics of individuals (e.g., as studies of perception, cognition, game theory, or test development.)

Level II (some examples)

• Recording of data from subjects 18 years of age or older using non-invasive procedures routinely employed in clinical practice.

• Collection of blood samples in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week.

Level III

• Involves the most serious risks.

Characteristics of a Consent Form

• Purpose provided.• Procedures clearly described.• Risks and discomforts disclosed.• Potential benefits provided.• In intervention research, describe

alternative treatments.• Confidentiality provisions

detailed.

Characteristics of a Consent Form (continued)

• Note that the research is voluntary.

• Assent form for minors or vulnerable adults

• Provide contact information for– Student investigator (optional)– Principal investigator– IRB Administratorand explain why they are resources

Hints

• Remember to include signature(s) in all paper versions.

• Number pages on paper versions.• The PI has to be a faculty

member or a staff member.• Consent forms must be held by

PI.

CASE

• A researcher wants to investigate the social experiences of elementary school children from migrant families. To obtain consent to interview the children, she sends a consent form home to their parents.

Case

• A researcher wants to investigate the career aspirations of inner city youth. She advertises her study by posting fliers in several community centers. The fliers state that participants will be given an iPod in exchange for their participation.

Case

• A researcher wants to study the effects of a stress reduction technique. She contacts a local halfway house and requests permission to recruit residents to participate in her study.

Case

• A graduate student in English wants to compare the composition skills of high school students who are English language learners with students for whom English is their first language. She contacts a local high school teacher and requests access to students’ writing assignments. The assignments will not include students’ names.

Case

• A researcher wants to study the social networks that often form in assisted living facilities and long-term care facilities for older adults. She plans to obtain informed consent from the residents before conducting individual interviews and focus groups to explore the role of social networks in their lives.

Case• A researcher wants to investigate the

effectiveness of an employee assistance program for chemically dependent employees. She contacts a local corporation and obtains permission to implement the program at their corporate headquarters. She plans to obtain informed consent to collect data on substance use and absenteeism from employees who voluntarily participate in the program.

Case

• A researcher is interested in how teen girls make decisions about contraception and STD protection. She plans to recruit girls who seek contraception or pregnancy counseling at a local Planned Parenthood clinic and interview them about their sexual histories and sexual decision making.

References

• Amdur, R. J., & Bankert, E. A. (2007). Institutional Review Board: Member handbook (2nd ed.) Sudbury, MA: Jones and Bartlett.

MSU Contact Information

• http://grad.mnsu.edu/irb/

• patricia.hargrove@mnsu.edu