Perfect Protocols

1. Perfect Protocols

2. P2 The Sequel

3. Perfect Protocols Linda Kephart Fallon Coordinator, Research Programs and Services Senior Editor / HIPAA Coordinator

4. Perfect Protocols When should the Protocol be prepared? It depends upon the funding source. Federal grant sources no longer require IRB approval prior to the submission of the grant.

5. Perfect Protocols Three types of submissions: Exempt Submissions Expedited Submissions Full Board Submissions

6. Perfect Protocols UF FWA Part 2, III, D: The IRBs are responsible for reviewing the preliminary determinations of exemption by investigators and supervisors and for making the final determination based on Section 101 of the regulations. Notice of concurrence for all exempt research will be promptly conveyed in writing to the investigator. All nonexempt research will be reviewed in accordance with 45 CFR 46.

7. Exempt Protocols When is a study considered “Exempt?” • Virtually “no” risk to humans • No Informed Consent Form • Reviewed by a member of the Executive Committee

8. Exempt Protocols 1. Research conducted in established or commonly accepted educational settings involving normal educational practices such as: research on regular and special education instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

9. Exempt Protocols 2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey or interview procedures, or the observation of public behavior, so long as confidentiality is maintained. Exempt status cannot be granted if (a) information is recorded in such a manner that the subject can be identified, directly or through identifiers linked to the subject, and (b) the subject’s responses, if known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation.

10. Exempt Protocols 3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or the observation of public behavior that is not exempt under # 2 if: The human subjects are elected or appointed public officials or candidates for public office; or federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

11. Exempt Protocols 4. Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. What is existing?

12. Exempt Protocols 5. Research and demonstration projects, which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under these programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.

13. Exempt Protocols 6. Taste and food quality evaluation and consumer acceptance studies: (a) if wholesome foods without additives are consumed, or (b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemicals or environmental contaminant at or below the level found to be safe, by the Food & Drug Administration, or approved by the Environmental Protection Agency, or the Food Safety and Inspection Service of the United States Department of Agriculture.

14. Exempt Protocols What is submitted? Introductory Questionnaire – Short Form

15. Expedited Protocols

16. Expedited Protocols • Considered no more than minimal risk Risks are those encountered through every-day life events • Reviewed by a member of the Executive Committee

17. Expedited Protocols 1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met: (a) Research on drugs for which an investigational new drug application (21 CFR part 312) is not required. Note: Research on a marketed drug is not eligible if the research significantly increases the risks or decreases the acceptability of the risks associated with the use of the drug. (b) Research on medical devices for which (1) an investigational device exemption application (21 CFR part 812) is not required, or (2) The medical device is both cleared/approved for marketing and being used in accordance with its cleared/approved labeling.

18. Expedited Protocols 2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) Subjects are healthy, non-pregnant adults who weigh at least 110 pounds; amount drawn may not exceed 550 ml over 8 weeks; and collection may not occur more frequently than 2 times per week, or (b) Subjects are other adults and children (defined in 45 CFR 46.402(a) as persons who have not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction in which the research will be conducted), considering the age, weight, and health of the subjects; the collection procedure; the amount of blood to be collected; and the frequency with which it will be collected. For these subjects, the amount collected may not exceed the lesser of 50 ml or 3 ml/kg over 8 weeks, and collection may not occur more frequently than 2 times per week.

19. Expedited Protocols 3. Prospective collection of biological specimens for research purposes by noninvasive means. Examples: hair and nail clippings, if collected in a non-disfiguring manner; deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; permanent teeth, if routine patient care indicates a need for extraction; excreta and external secretions (including sweat); uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; placenta removed at delivery; amniotic fluid obtained at the time of rupture of the membrane before or during labor; supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; sputum collected after saline mist nebulization.

20. Expedited Protocols 4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are generally not eligible for expedited review, including studies of cleared medical devises for new indications.) Examples: physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; weighing or testing sensory acuity; magnetic resonance imaging; electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography; moderate exercise, muscular strength testing, body composition assessment, and flexibility testing, where appropriate to the age, weight and health of the individual.

21. Expedited Protocols 5. Research involving materials (data, documents, records or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis). Note: Some research in this category may be exempt from the regulations for the protection of human subjects as noted in 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.

22. Expedited Protocols 6. Collection of data from voice, video, digital or image recordings made for research purposes.

23. Expedited Protocols 7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices and social behaviors) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation or quality assurance methodologies.Note: Some research in this category may be exempt from the regulations for the protection of human subjects as noted in 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.

24. Expedited Protocols What is submitted? Introductory Questionnaire Protocol Informed Consent Form

25. Full Board Submissions Greater than minimal risk Perceived as greater than minimal risk Deadlines apply

26. Full Board Submissions What is submitted? Introductory Questionnaire Protocol Informed Consent Form

27. Perfect Protocols Do you have a sponsor’s protocol? You do not need to write a new protocol; you can submit the sponsor’s protocol instead.

28. Perfect Protocols Do you intend to participate in all portions of the sponsor’s protocol? Yes. Provide the sponsor’s protocol.

29. Perfect Protocols Do you intend to participate in all portions of the sponsor’s protocol? No. Provide the sponsor’s protocol AND delineate everything you will NOT be doing in Item 6 – Research Plan.

30. Perfect Protocols 6.Research Plan: ·Provide a description of what you will NOT do. ·Be specific about what you will not be doing by citing the relevant sections of the sponsor’s protocol. A simple addendum will be sufficient.

31. Perfect Protocols What does the IRB want to see in a Protocol?

32. Title Be sure the title of your project is the same on ALL of your submission materials. • Introductory Questionnaire • Informed Consent Form • Protocol

33. Title Be sure the title of your project is the same on ALL of your submission materials. • GRANT APPLICATION!

34. Investigators List the name of the Principal Investigator and all sub-Investigators. Students must list the names of their supervisory chair and committee members.

35. Abstract The abstract must be clear, concise, and include the following information:

36. Abstract Objectives: Identify the primary and secondary objectives of the research project.

37. Abstract Design: Describe the basic design of your research project, including study interventions.

38. Identify locations where your research project will be conducted. Abstract Setting:

39. Abstract Study Participants: Identify the subjects you intend to study.

40. Abstract Outcome Measures: Describe the data you will collect and the statistical measures you will use.

41. Abstract Follow-up: If you intend to collect longitudinal data, identify your follow-up measures.

42. Specific Aims Identify the hypothesis or the objectives of the research project.

43. Have animal studies been conducted? Have human studies been conducted? Background & Significance: Provide a literature review, including background information:

44. Background & Significance: Discuss why your project is a logical step toward solving the problem and why this next step is important.

45. Research Plan Include a discussion of the expected results and how these results may be important.

46. Research Plan Provide a thorough description of what you intend to do. Include a study visit schedule.

47. Research Plan Discuss dosing regimens, blood draws, and other study parameters. How were these parameters determined? Provide a justification.

48. Research Plan Describe the inclusion and exclusion criteria. You may wish to design inclusion and exclusion criteria with flexible parameters to avoid protocol deviations at some future date.

49. Research Plan Discuss how research interventions differ from standard therapies.

50. Research Plan A word or eighteen about HIPAA: The Protocol is the most important document when assessing HIPAA information provided to subjects on the consent document.