Research Involving Human Subjects

1. 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)

2. 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.

3. 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.

4. Review Categories • Exempt • Expedited Review • Full board Review • Depends on the Risk Level

5. 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.

6. 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

7. 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

8. 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

9. 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.

10. 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.

11. 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).

12. 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.

13. 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.

14. 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

15. 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

16. 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”

17. Elements of Informed Consent • Comprehension • Organized • Ample time for consideration • Opportunities for questions • Lay language appropriate for subject

18. 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

19. 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.

20. 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.

21. 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.

22. 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)

23. 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

24. 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

25. CITI Training • Collaborative Institutional Training Initiative • https://www.citiprogram.org • Register- Choose OU as Participating Institution • Student Module • Mandatory Starting January 2011

26. CITI Course in Basic Human Subject Research Undergraduate Students 1. Oakland University 2. Research Misconduct 1-1215 3. Students in Research – SBR

27. CITI Course in Basic Human Subject Research- OU Maters Final Projects or Theses, and Doctoral Dissertations • Oakland University • Belmont Report and CITI Course Introduction • Defining Research with Human Subjects – SBR • Assessing Risk in Social and Behavioral Sciences – SBR • Informed Consent – SBR • Privacy and Confidentiality – SBR • Records-Based Research • Internet Research – SBR • Research and HIPAA Privacy Protections • Research Misconduct 1-1215 • Data Acquisition, Management, Sharing and Ownership 1-1308 • Conflicts of Interest and Commitment 1-1622 If Applicable: • Research with Children– SBR • Research with Prisoners – SBR • Vulnerable Subjects - Research Involving Pregnant Women and Fetuses in Utero

28. CITI Course in Basic Human Subject Research-OU Faculty Modules • Oakland University • Belmont Report and CITI Course Introduction • Defining Research with Human Subjects – SBR • Assessing Risk in Social and Behavioral Sciences – SBR • Privacy and Confidentiality – SBR • HIPAA and Human Subjects Research • Data Acquisition, Management, Sharing, and Ownership • Informed Consent – SBR • Conflicts of Interest in Research Involving Human Subjects • Records-Based Research • Internet Research – SBR If Applicable: • Research with Children – SBR • Research with Prisoners • Vulnerable Subjects – Research Involving Pregnant Women and Fetuses in Utero