Research Involving Human Subjects

All research involving the participation of human subjects must be submitted for review by the IRB (Institutional Review Board for the Protection of Human Subjects)

DHHS Definition

45 CFR 46.102(d) Research means a systematic

investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

DHHS Definition

45 CFR 46.102(f) Human subject means a living individual

about whom an investigator (whether professional or student) conducting research obtains

(1) Data through intervention or interaction with the individual, or(2) Identifiable private information.

Review Categories

Exempt Expedited Review Full board Review Depends on the Risk Level

What is “minimal risk”? Minimal risk means that 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.

Review Categories May be “Exempt”

Projects that present no more than “minimal risk” to the participants and do not compromise the privacy of the participants or confidentiality of the data

Fits 1 of 6 categories Reviewed and approved by IRB Chair Common in Educational Research- No

identifiers

Review Categories May be “Expedited”

Projects that present no more than “minimal risk” to the participants, and for minor changes in approved research

Has to fit 1 of 7 categories Reviewed and approved by 2 IRB

Committee Members Common in Educational Research for

data collection methods that use audio/visual data collection- Retain identifiers

Review Categories Full Board Review

Projects involving more than minimal risk Full Committee meets once per month

(Applications must be received at least 10 days before the next meeting date)

Researcher presents the research proposal Committee members ask the researcher

questions regarding the research and participation of human subjects

Vote is taken (in the absence of the researcher) and recommendations are made

Review Categories Continuing Review

Annually for Expedited or Full Board approved applications.

Email notifications sent two month prior to approval expiration date.

Must complete the Continuing Review Form and attach a copy of the consent form.

Same type of review as the original application with some exceptions.

Criteria for IRB Approval of Research

Risks to subjects are minimized sound research design which do not

unnecessarily expose subjects to risk, using procedures already being

performed on the subjects for diagnostic or treatment purposes.

Risks to subjects are reasonable in relation to anticipated benefits, and the importance of the knowledge that may result.

Selection of subjects is equitable.

Criteria for IRB Approval of Research

Informed consent is sought and documented.

Plans for monitoring the data collected to ensure the safety of subjects.

adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

additional safeguards to protect vulnerable population (children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons).

Analyzing Risks and Benefits

To judge the application the IRB needs full information about: the selection and recruitment of

subjects, research design, scientific rationale, conflicts of interest.

Informed Consent Participants must understand the nature

of the research. Participants must be able to

knowledgeably and voluntarily decide whether or not to participate.

Participants must understand the risks and benefits of participation.

The IRB must determine that informed consent will be properly obtained.

Elements of Informed Consent

Eight Basic Elements Research, Purpose, Procedures

(experimental), Expected duration Risks and discomfort Benefit Alternatives procedures (Treatments) Confidentiality of records Medical treatment in case of research

related injury Contact Info: Research Qs, Rights Qs, Injury

Qs Participation is Voluntary

Elements of Informed Consent Additional elements, as appropriate

Unforeseeable Risk (embryo or fetus) Participation may be terminated by

researcher Additional cost to subjects Consequences of early withdrawal by

subjects Significant new findings that may affect

wiliness to continue participation Approximate number of participants

Elements of Informed Consent

Voluntary Consent if voluntary, free of coercive

elements Right to refuse or withdraw with no penalty Unjustifiable pressures occur when persons in

authority urge a course of action for a subject Coercion is likely whenever possible sanctions

are involved (implied or actual) Undue influence occurs through an offer of an

excessive, unwarranted, inappropriate or improper reward

Consent process may not involve the use of “exculpatory language”

Elements of Informed Consent

Comprehension Organized Ample time for consideration Opportunities for questions Lay language appropriate for subject

Important Components of Protection

Minimizing Risk Maintaining Confidentiality Maintaining and Destroying Records

Maintained for at least 3 years after the completion of the study and then destroyed in a manner that will protect the identity of human subjects.

Reporting Adverse Events Related to Research

Approved Research Research must be conducted as

approved by the IRB. Any changes to original application

must also be approved before implementation.

Report changes to IRB through e-mail message to Judette Haddad.

IRB approval is valid for a maximum of one year – a “Continuing Review Form” must be submitted to extend the research beyond one year.

How to Apply Submit and application at

http://www.oakland.edu/research All sections of the form must be completed An endorsed hard copy of the signature

page must be forwarded to the Research Office, 530 Wilson Hall.

All research must be conducted or sponsored by an Oakland faculty member.

What Happens? For research falling within the categories of

exempt or expedited review, maybe reviewed and approved within 2-3 weeks.

For research review by the full committee, you will be sent a written invitation to attend the committee meeting at which it will be discussed.

Investigator will provide explanations and rationale for all procedures, discuss the risks and benefits, and information about informed consent procedures.

If approved by the majority of IRB members attending the meeting, you will be notified in writing within a few days.

Faculty Responsibilities All investigators conducting research involving human

subjects need to be familiar with Oakland University IRB Guidelines http://www.oakland.edu/?id=9074&sid=177

Faculty training is available periodically throughout the year Take the tutorial at

http://www.oakland.edu/?id=9087&sid=177 Faculty must inform students with whom they are working to

read OU Guidelines Faculty must approve student application before it is

submitted to the IRB All research must be exempted or approved before it can be

conducted Research must be conducted as described in the approved or

exempted application Research applications must be submitted through the

Research Application Manager (RAM 2.0)

Where Do I Find Information?

Most information on guidelines, procedures, and submitting research applications can be found at http://www2.oakland.edu/research

Contact Dr. Judette Haddad (Compliance Coordinator) at haddad@oakland.edu or 370-4898

Contact Jim Cipielewski (Chair, IRB) at cipielew@oakland.edu or 370-3098

Tips: Before you Apply Get a login and password for the RAM 2.0 Be familiar with the questions that are asked on

the application Write the major components of the application

(Abstract, Protocol, Consent Form(s), Instruments)

Use the “suggested language” on the checklist within the consent form

Attach other items given to subjects such as survey questionnaire or advertisements

Allow ample time for the review process to take place

CITI Training Collaborative Institutional Training

Initiative https://www.citiprogram.org Register- Choose OU as Participating

Institution Student Module Mandatory Starting January 2011

CITI Course in Basic Human Subject Research

Undergraduate Students1. Oakland University2. Research Misconduct 1-12153. Students in Research – SBR

CITI Course in Basic Human Subject Research- OU Maters Final Projects or Theses, and Doctoral Dissertations

1. Oakland University2. Belmont Report and CITI Course Introduction3. Defining Research with Human Subjects – SBR4. Assessing Risk in Social and Behavioral Sciences – SBR5. Informed Consent – SBR6. Privacy and Confidentiality – SBR7. Records-Based Research8. Internet Research – SBR9. Research and HIPAA Privacy Protections10. Research Misconduct 1-121511. Data Acquisition, Management, Sharing and Ownership 1-130812. Conflicts of Interest and Commitment 1-1622If Applicable:1. Research with Children– SBR2. Research with Prisoners – SBR3. Vulnerable Subjects - Research Involving Pregnant Women and

Fetuses in Utero

CITI Course in Basic Human Subject Research-

OU Faculty Modules 1. Oakland University2. Belmont Report and CITI Course Introduction3. Defining Research with Human Subjects – SBR4. Assessing Risk in Social and Behavioral Sciences – SBR5. Privacy and Confidentiality – SBR6. HIPAA and Human Subjects Research7. Data Acquisition, Management, Sharing, and Ownership8. Informed Consent – SBR9. Conflicts of Interest in Research Involving Human Subjects10. Records-Based Research11. Internet Research – SBRIf Applicable:1. Research with Children – SBR2. Research with Prisoners3. Vulnerable Subjects – Research Involving Pregnant Women

and Fetuses in Utero