Human Subjects Research: Successful Completion of an IRB Application

1. Human Subjects Research: Successful Completion of an IRB Application Jason A. Kaufman, Ph.D. Assistant Professor, Dept. of Anatomy Chair, MWU Glendale Institutional Review Board

2. When submitting an application to an IRB outside of Midwestern, be sure to contact their IRB Chair for information on policies and procedures specific to that institution.

3. Objectives • Training for Investigators: • What is the function of the Institutional Review Board (IRB)? • Does your project constitute human subjects research? • Categories of human subjects research: where does your project fit? • What are the elements of a complete IRB application? • What elements are necessary in an Informed Consent Document? • What are some common mistakes and how can they be avoided?

4. What is the function of the Institutional Review Board?

5. Responsibilities of the IRB • An Institutional Review Board (IRB) is a committee established to help protect the rights and welfare of human research subjects. Regulations require IRB review and approval for human subjects research. • IRB review is guided by three basic ethical principles* • Respect for persons • Beneficence • Justice *(Belmont Report, 1979;§45 CFR 46)

6. Elements of your application that the IRB is mandated to review • Respect for persons (autonomy) • Ensure that subjects receive full disclosure and participate voluntarily: Informed Consent • Evaluate safeguards for privacy of subjects and confidentiality of data • Assure protections for individuals with diminished autonomy • Vulnerable populations: pregnant women, prisoners, children, mentally disabled, students

7. Elements of your application that the IRB is mandated to review • Beneficence • Determine that research risks are minimized • Verify that risks are justified by benefits • Confirm that research design and methods are appropriate, scientifically valid, and therefore justify exposing subjects to research risks • Ensure that investigators are qualified to perform procedures and handle adverse events

8. Elements of your application that the IRB is mandated to review • Justice • Ensure that subjects are recruited equitably and free from coercion or undue influence • Recruitment methods for student subjects must minimize the potential for coercion or undue influence

9. Does your project constitute human subjects research?

10. Projects that meet federal definitions of both “research” and “human subjects” must be reviewed by the IRB • “Research” – a systematic investigation. . . designed to develop or contribute to generalizable knowledge • “Human Subject” – A living individual* about whom an investigator obtains data through intervention, interaction, or the collection of identifiable private information *HIPAA’s “Privacy Rule” extends research protections concerning private health information to the deceased

11. Examples of activities that are not considered to be human subjects research • Case reports are not considered human subjects research if certain conditions are met • Case report / case study form available on ORSP website

12. Examples of activities that are not considered to be human subjects research • Data gathered solely for internal campus use (e.g., course evaluation or institutional program development), or are part of classroom projects that will not be presented outside the classroom are not considered human subjects research • Subjects deserve protection regardless of whether the research is published or presented externally

13. Examples of activities that are not considered to be human subjects research • Research involving onlycoded (de-identified) biological specimens or private information isnot considered human subjects research if: • the coded specimens or private information were not collected specifically for the purpose of the proposed research, and • the investigator(s) cannot readily ascertain the identity of the individuals to whom the coded private information pertains

14. Determination of whether a project does, or does not, constitute human subjects research should be made in consultation with the IRB Chair

15. Categories of Human Subjects Research

16. Categories of Human Subjects Research • Exempt • Expedited review • Full IRB review

17. Categories of Human Subjects Research • Exempt • “Exempt” means that a project is exempt from review by the full IRB committee • If investigations qualify as exempt they may be administratively reviewed and approved by the chair of the IRB • Once approved, exempt studies do not require continuing review (no annual reporting) as long as the protocol and sample size do not change • Research on vulnerable populations is never exempt (pregnant women & fetuses, children, prisoners)

18. Common types of exempt research Anonymous pedagogical studies Anonymous surveys or test instruments Research on existing data, documents, records, or specimens if the information is recorded by the investigator in such a way that subjects cannot be identified

19. Categories of Human Subjects Research • Expedited Review • Certain types of research involving no more than minimal risk • “Minimal risk” defined as those risks that are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests • Expedited applications are reviewed by the IRB chair and two committee members

20. Common types of expedited research Collection of blood samples; collection of biological specimens by noninvasive means; noninvasive procedures routinely employed in clinical practice (excluding x-rays or microwaves)

21. Common types of expedited research Surveys, test instruments, or research on data, documents, records, or specimens if the information is recorded by the investigator in such a way that subjects can be individually identified either directly or indirectly.

22. Categories of Human Subjects Research • Full Review • Research involving more than minimal risk to human subjects must be reviewed by the full Institutional Review Board

23. What are the elements of a complete IRB application?

24. Elements of a complete IRB application • Necessary documents • Form A – summary of the proposal (background, literature review, hypotheses, and methodology), personnel involved and their qualifications, subject recruitment, inclusion and exclusion criteria, confidentiality, risks and benefits • Informed Consent Document (or application for waiver) • Any recruitment materials including introductory letters • Questionnaires, surveys and/or interview questions • Certificate of completion of the NIH training on human subjects research (for all persons listed on Form A) (http://phrp.nihtraining.com/users/login.php) • Current signed & dated CV for the PI • Letters of permission from non-MWU performance sites

25. Letters of Permission • If data collection will be performed outside of MWU, the application must include a letter of permission from the administrator of the site • Administrator provides letter on performance site’s letterhead. Must include: • What administrator is allowing you to do (e.g., observation, intervention, access to patients, access to medical records) • Statement that the administrator will accept MWU’s IRB approval

26. Dual IRB Review • An MWU IRB will not require dual review if all of the following conditions are met: • The research is conducted at an institution with a registered IRB that has approved the research (MWU retains the right to accept or reject the other institution’s approval) • The primary appointment of the PI is with the other institution • MWU is not the primary recipient of funding for the research • Data collection is conducted entirely at the other institution

27. Form A • Principal Investigator must be MWU faculty member • If data collection to be performed at locations other than MWU, submit letter of support from each location • Anticipated number of subjects = maximum number approved for protocol (can be amended later)

28. Form A Select Research Category if Exempt or Expedited

29. Form A

30. Summary of the proposal • Clearly explain what you plan to do, who you plan to do it on, and why you plan to do it • Describe in detail yourprocedures • Describe comparisons (justify sample size) • Describe hypotheses or expected outcomes

31. Personnel • Identify all individuals involved in the study and describe their qualifications

32. Subject recruitment • Describe and justify your subject population • Describe recruitment methods • Include recruitment materials • E-mail, flyers, survey introductions, etc.

33. Informed Consent • Describe how you will obtain informed consent, or include application for waiver

34. Confidentiality • Describe how you will protect individual privacy and confidentiality of data • Describe how information will be stored, and how and when study records will be destroyed • Investigators must retain consent documents and research records for at least 3 years after the completion of research activity • Describe how anonymity will be maintained in published format

35. Risks to subjects • Describe risks associated with your research • Physical risks • Psychological risks • Social/Economic risks • Legal risks • Breach of confidentiality • Loss of privacy • Estimate the magnitude and probability of the risks • Describe procedures used to minimize risk

36. Benefits • Describe benefits (to subjects or to others)* • Explain how benefits outweigh risks *Basic science (pursuit of knowledge) is a perfectly valid benefit

37. Informed Consent

38. Purpose of Study • Procedures • Risks/Discomforts • Benefits • Alternatives • Financial Costs to Subjects • Statement on Compensation for Research Injury • Payments to Participants • Confidentiality • Voluntary consent and the right to discontinue without penalty • Contact information

39. Informed Consent • 3 key principles of Informed Consent • Full disclosure • Explain exactly what the subject will experience • Avoid the terms “I agree to . . .” or “I understand . . .” • Use the second-person • Adequate comprehension • Written at a 7th grade reading level • Voluntary participation • Individuals may refuse to participate at any time without penalty or loss of benefits • Exculpatory language is not permitted

40. Informed Consent • Adequate comprehension • Use fewer words • Use smaller words • Use shorter, less complex sentence structure • Avoid technical jargon or scientific terms • Use second person • Think about the education level of your subject population and their familiarity with research! • Correction of inappropriate comprehension level in the Informed Consent is one of the most-commonly requested revisions by the IRB

41. Informed Consent • Research involving children or protected health information requires HIPAA-compliant consent form

42. HIPAA Identifiers (Protected Health Information) • Names (excluding initials)  • All geographic subdivisions smaller than a State, including ZIP code •  All elements of dates (except year), including birth, death, admission and discharge dates; all ages over 89 years (may include age ≤ 89 years) •  Telephone numbers •  Fax numbers •  Email addresses •  Social security numbers •  Medical record numbers •  Health plan beneficiary numbers •  Account numbers •  Certificate/license numbers •  Vehicle identification numbers and serial numbers, including license plate numbers •  Device identifiers and serial numbers •  URLs •  IP addresses •  Biometric identifiers, including finger and voice prints •  Full face photographic images and any comparable images •  Any other unique identifying number, characteristic, or code

43. Informed Consent • Children • Adolescents (> 12 years but < 18 years). HIPAA-compliant consent/assent form signed by parent and adolescent • Children 4-12 years. Two forms: Description of experience for child to sign. HIPAA-compliant consent form – parental permission • Children < 4 years. Consent form signed by parent

44. Informed Consent • Signed consent is not always required • Example: survey research • Survey may be preceded by an introductory letter containing the relevant elements of informed consent • State that completion and submission of the survey indicates consent to participate in the research study • Contact person must be MWU faculty with MWU phone number / email

45. What are some common mistakes and how can they be avoided?

46. Common mistakes • Incomplete application (e.g., NIH training certifications not provided for all investigators) • Check that application contains all necessary elements • Application lacks required signatures • PI and Department Chair must sign Form A • The PI on the IRB application is not an MWU faculty • Research is described as having no risks • Loss of privacy and/or breach of confidentiality is always a risk and needs to be recognized as such

47. Common mistakes • No justification for payment of subjects • Must provide justification for compensating subjects • A procedure is included without any justification • Provide justification for all procedures listed in protocol • Exclusion criteria are provided, but there is no questionnaire to screen potential subjects • Provide screening questionnaire • No justification of sample size • Justify sample size with power analysis or reference to published studies

48. Common mistakes • Application contains spelling mistakes, grammatical mistakes, or is otherwise below the threshold of acceptable academic writing • Informed Consent must be linguistically correct • Have a colleague proofread your application • PIs mentoring students should proofread application • Data collection initiated before IRB approval • All research must be approved prior to initiating study • Project exceeds approved number of subjects • Additional subjects requires an amendment request

49. You’ve been approved!! • Investigators must retain consent documents and research records for at least 3 years after the completion of research activity • Expedited and Full Review protocols must receive continuing review: PI submits annual report, and final report when complete • Exempt studies do not require continuing review as long as the protocol and sample size do not change • Changes in protocol or sample size require an amendment request

50. Further Information • http://www.midwestern.edu/ORSP.html • Forms, templates, policies • http://www.hhs.gov/ohrp/ • Federal regulations and guidelines • Contact information • Jason Kaufman, MWU Glendale IRB Chair • jkaufm@midwestern.edu • 623-572-3717 • Lindsay Goboly, ORSP Research Coordinator • lgobol@midwestern.edu • 623-572-3728