Research Involving Human Subjects

1. Research Involving Human Subjects Institutional Review Board (IRB) Judette Haddad, PhD, CIP

2. History and Ethical principles • Nuremberg Code 1947 • Declaration of Helsinki 1964 • National Research Act 1974 • Belmont Report 1979 • Respect for person- Informed consent • Beneficence- Favorable benefit-risk ratio • Justice- Selection of subjects • Public Heath Services Act 1985

3. Human Subject Protection Regulations • DHHS Regulations • 45 CFR part 46- Subparts A, B, C, D, & E • FDA Regulations • 21 CFR part 50, Protection of Human Subjects • 21 CFR part 56, Institutional Review Boards • 21 CFR part 312, Investigational New Drug Application • 21 CFR part 812, Investigational Device Exemptions

4. OU Federal Wide Assurance • 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).

5. 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.

6. DHHS Definition (cntd) 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.

7. DHHS Definition (cntd) • Private Information: • Information about behavior that occurs in a setting in which the individual can reasonably expect that no observation or recording is taking place • information that has been provided for specific purposes, other than research, where the individual can reasonably expect that it will not be made public (e.g., a medical record.) [45 CFR 46.102(f)]. • Protected Health Identifiers (PHI)

8. DHHS Definition (cntd) • Coded Private Information or Biological Specimens • DHHS Office of Human Research Protection (OHRP) policy considers private information or specimens to be individually identifiable when they can be linked to specific individuals either directly or indirectly through coding systems. • DHHS OHRP guidance states that only a knowledgeable person or entity is authorized to determine if coded specimen or data constitute research. An investigator cannot make that determination.

9. Institutional Review Board • IRB is a review committee established to help protect the rights and welfare of human research subjects. • Authority of the IRB: • Approve, disapprove, or modify research • Conduct continuing reviews • Observe and verify changes • Suspend or terminate approval • Observe the consent process and research procedures

10. Review Categories • Exempt • Expedited Review • Full board Review • Depends on the Risk Level (physical, psychological, social and economic risk)

11. 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.

12. Review Categories (cntd) • 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 by IRB Chair or a designated member • Common in Educational Research- No identifiers

13. Review Categories (cntd) • 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 1 or 2 IRB Committee Members • Common in Educational Research for data collection methods that use audio/visual data collection- Retain identifiers

14. Review Categories (cntd) • 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 are invited to present the research • 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

15. Review Categories (cntd) • 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.

16. Review by Institution • Research that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. • However, institutional officials may not approve the research if it has not been approved by an IRB.

17. Criteria for IRB Approval of Research 1. 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. 2. Risks to subjects are reasonable in relation to anticipated benefits, and the importance of the knowledge that may result. 3. Selection of subjects is equitable.

18. Criteria for IRB Approval of Research (cntd) 4. Informed consent is sought. 5. Informed consent is appropriately documented. 6. Plans for monitoring the data collected to ensure the safety of subjects. 7. adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. 8. additional safeguards to protect vulnerable population (children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons).

19. IRB Requirements • IRB must review: • Qualification of the PI and collaborators • Full description about conflicts of interest • A complete description of the proposed research • Provisions for the adequate protection of rights and welfare of subjects • Compliance with pertinent federal and state laws/regulations and institutional policies

20. HIPAA Requirements • Health Insurance Portability and Accountability Act • Mandated standards for storage and transmission of healthcare information • HHS- The Privacy Rule & Security Rule • The research must be HIPAA compliant • HIPAA language requirement in consent form • PHI- Protected Health Information- 18 identifiers • Authorization, Limited Data Set (16 ids) and Data Use Agreement • De-identified Health Information- No restrictions

21. Informed Consent Process • It is a process and not just a form. • It includes: • Recruitment materials • Verbal instructions (in person or via video, DVD) • Written materials • Q & A session(s) • Documentation of consent by signature

22. Informed Consent Process (cntd) • 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.

23. 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

24. Elements of Informed Consent (cntd) • 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

25. Elements of Informed Consent (cntd) • 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”

26. Elements of Informed Consent (cntd) • Comprehension • Organized • Ample time for consideration • Opportunities for questions • Lay language appropriate for subject

27. Waiver or Alteration of Consent • The IRB may approve a waiver or alteration of the consent process provided: • The research involves no more than minimal risk to the subjects; • The waiver or alteration will not adversely affect the rights and welfare of the subjects; • The research could not practicably be carried out without the waiver or alteration; and • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

28. 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

29. 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 Dr. Haddad haddad@oakland.edu • IRB approval is valid for a maximum of one year – a “Continuing Review Form” must be submitted to extend the research beyond one year.

30. How to Apply • Submit an 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. • Non-tenured track professors and staff members may obtain a “Special Permission” to sponsor research.

31. 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.

32. 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 • Complete CITI Training. • Faculty training is available periodically throughout the year. • Faculty must inform students with whom they are working to read OU Guidelines and complete CITI training.

33. Faculty Responsibilities (cntd) • 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).

34. 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 Officer) at haddad@oakland.edu or 370-4898. • Contact Dr. Chris Stiller (IRB Chair) at cstiller@oakland.edu or 370-4047.

35. 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.

36. CITI Training • Collaborative Institutional Training Initiative • https://www.citiprogram.org • Register- Choose OU as Participating Institution • Four Routes: • Undergraduate Student • Graduate Students • Faculty and Staff • IRB Members • Mandatory Starting January 2011

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

38. 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

39. 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

40. Questions? haddad@oakland.edu