IRB for Humanists. Naomi E. Coll, MPH, CPH, CIP Manager of Research Integrity

Transcription

1 IRB for Humanists Naomi E. Coll, MPH, CPH, CIP Manager of Research Integrity Grace Caskie, Ph.D. Associate Professor Counseling Psychology IRB co-chair Patti Manz, Ph.D. Associate Professor School Psychology IRB co-chair

2 Today s Agenda 1. What is the IRB? 2. Defining Human Subjects Research 3. Informed Consent 4. Submitting IRB applications 5. IRB review 6. Upcoming changes to the regulations 7. FAQs and your questions

3 What is the IRB? Institutional Review Board independent committee. Review, approve, monitor research with human subjects. Scientific validity Ethical review protect human subjects Composition requirements: Diverse, at least 5 members, scientists, non-scientists, at least 1 member not affiliated with the University

4 Belmont Report Foundation for today s IRB system. Outlines ethical research principles: 1. Respect for persons = informed consent 2. Beneficence = favorable risk/benefit assessment 3. Justice = selection of subjects

5 What is human subjects research? Research = a systematic investigation designed to develop or contribute to generalizable knowledge. Systematic = system, method, plan. Generalizable = universally or widely accepted.* *Note does not apply to student research at LU

6 What is human subjects research? Human subjects = living individuals about whom an investigator conducting research obtains either: 1. Identifiable private information OR 2. Data through intervention or interaction

7 Identifiable Information Individual identities can be readily ascertained or associated with the information.

8 Private Information 1. Information about a behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. OR 2. Information provided for a specific purpose in which the individual can reasonably expect that it will not be made public.

9 Physical procedures. Intervention Manipulation of the individual or their environment for research purposes. *Interaction* Communication or interpersonal contact with individuals.

10 Interaction most common for research in the humanities Surveys/questionnaires Interviews Focus groups

11 Minimal risk 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 exams or tests

12 Informed Consent Central to the protection of participants. Both a process and a procedure: Process = exchange of information before, during, after Procedure = developing an informed consent document and having the participant sign

13 8 Required Elements of Informed 1. Activities involve research, the purpose, duration, procedures, and which procedures are experimental 2. Foreseeable risks/benefits 3. Appropriate alternatives 4. Extent to which confidentiality will be maintained

14 8 Required Elements of Informed Consent (continued) 5. [research which may result in injury does not apply] 6. IRB contact information 7. Participation is voluntary, refusal to participate will involve no penalty or loss of benefits, and subject is free to withdraw any time 8. Additional elements as appropriate

15 Informed Consent Templates that include all elements of informed consent are posted on the IRB website.

16 Waiving or Altering Informed Consent Some or all of the 8 elements may be waived or altered. Must meet regulatory criteria listed in IRB policy. Must be approved in advance by IRB.

17 Waiving Written Documentation of Informed Consent Some studies may be approved to waive documentation of informed consent (i.e. no signed consent document). Must meet regulatory criteria listed in IRB policy. Must be approved in advance by IRB. IRB may require the investigator to provide subjects with a written statement regarding the research.

18 Vulnerable Populations Regulatory and consent implications: Adults who are unable to consent Infants, teenagers, children Pregnant women Prisoners Must be indicated in your inclusion criteria. Must be approved in advance by the IRB.

19 Submitting an application to the IRB Must have advanced approval of the IRB. Submit at least six weeks in advance. Guidance, worksheets, FAQs, policy on IRB website. IRBNet - tutorials on IRB website.

20 Submitting an application to the IRB All investigators must complete NIH Protecting Human Research Participants online tutorial. All investigators must sign IRBNet package prior to submission to IRB. Faculty must serve as PI and lead the process.

21 Submitting an application to the IRB A new protocol application includes: Protocol application form NIH certificates (for faculty first time, for students each time) Consent documents Recruitment materials (flyers, , etc.) Letters of permission for research in schools or similar institutions

22 Three levels: 1. Exempt 2. Expedited 3. Full committee IRB Review

23 IRB Review Exempt Review Six categories of research are eligible for exempt review. Three categories are the most common for humanists

24 IRB Review Exempt Review Educational tests, survey procedures, interview procedures, observation of public behavior, unless: Information is recorded in such a manner that subjects can be identified, and Identification could place subjects at reasonable risk of criminal or civil liability or be damaging to their reputation, financial standing, or employability. * If children only applies for observation of public behavior if investigator not participating in activities being observed or use of educational tests

25 IRB Review Exempt Review Research using educational tests, surveys, interviews, or observation of public behavior not exempt under cat. 2, if subjects are elected or appointed public officials or candidates for office, or federal statutes require without exception that confidentiality will be maintained.

26 IRB Review Exempt Review Collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if sources are publically available and information is recorded so that subjects cannot be directly or indirectly identified.

27 Additional requirements for exempt research: No more than minimal risk. Equitable subject selection. If recording identifiable information must be adequate provisions to maintain confidentiality. If interacting with subjects - must be a consent process that includes: Disclosure that the activities involve research Procedures Participation is voluntary Name and contact info for investigator Adequate protection of privacy

28 IRB Review Expedited Review Minimal risk only. Apply to all ages, except where noted. May not be used when identification of subjects can be damaging to their financial standing, employability, insurability, reputation or be stigmatizing, unless protections are implemented so risk of confidentiality breach is no greater than minimal.

29 IRB Review Expedited Review Nine categories of research are eligible for expedited review. Three categories are the most common for humanists

30 IRB Review Expedited Review Research involving materials (data, documents, records, specimens) that have been collected or will be collected for research purposes.

31 IRB Review Expedited Review Collection of data from voice, video, digital, or image recordings made for research purposes.

32 IRB Review Expedited Review Research on individual or group characteristics or behavior, or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methods.

33 IRB Review Full Committee Review Protocols that are not qualified for exempt or expedited review are referred for full committee review. Must be submitted at least four weeks in advance of the IRB meeting date. IRB meetings - second Tuesday of each month.

34 IRB Review Determinations Approved Modifications Required to Secure Approval A response submission must be submitted in IRBNet If conditions are met, approval is issued Disapproved (rare) Do not proceed with any aspect of your research without approval in hand!

35 Investigator s Post-Approval Obligations Continuing Review for expedited and full review protocols. Modifications for all protocols (exempt, expedited, full review). Submit reportable events as required to the IRB. Conduct research according to IRBapproved protocol.

36 Upcoming changes to the regulations Changes to the Common Rule (federal regulations) were finalized at end of Obama s term. Take effect 2018/2019. Fairly likely that they will not be signed into law under the current administration.

37 FAQs 1. My protocol meets the exempt review criteria, do I have to submit an application to the IRB?

38 FAQs Yes IRB must make the exempt determination.

39 FAQs 2. I m not collecting any identifiable information, do I need to submit an application to the IRB?

40 FAQs Yes if you are actively collecting any data, even de-identified, through intervention or interaction. If you are using existing data (e.g. secondary datasets, biological specimens), you may not require review. You must contact the IRB first.

41 FAQs 3. When can I begin recruiting?

42 FAQs You must have official IRB approval (i.e. approval notice on IRB letterhead) prior to any interaction with subjects, including recruiting, data collection, etc.

43 FAQs 4. Can the IRB approve a project retroactively?

44 FAQs No federal regulations do not allow retroactive approval.

45 FAQs 5. How does informed consent for online research (e.g. surveys) work?

46 FAQs Implied consent by knowingly participating, i.e. completing the survey, the subject is providing consent. This is a form of waiving documentation of informed consent. Must meet criteria for approval.

47 FAQs 6. When do I have to submit a Modification for my IRB-approved project?

48 FAQs You must submit an amendment when the study design, informed consent procedures, or research personnel changes. Submit it in advance of making the change. Wait for approval *exception remove immediate hazard (must submit report to IRB afterwards).

49 Questions? Naomi E. Coll, MPH, CPH, CIP