Northwestern University Institutional Review Board (IRB)
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1 Northwestern University Institutional Review Board () Marcella Oliver Education Specialist
2 Role in Research The sole mission of the is the protection of humans who participate in research.. It is not to annoy researchers.
3 The structure of the NU
4 NU Facts >10,000 Submissions a Year 6 Review Boards (2 Campuses) Avg. 655 Studies Reviewed at Panel each Year 60% Biomedical and 40% Social Behavioral
5 Three administrative areas: Training and Education Human Research Compliance
6 Northwestern Affiliated Partners Northwestern Medicine (NMFF, NMPG, NMH) Rehabilitation Institute of Chicago LCH Lurie Children s Hospital Research Privacy Board
7 Why do we need?
8 Tuskegee Syphilis Study Willowbrook Hepatitis Study Stanford Prison Study University of Minnesota Psychosis Study Source: NIH Office of Extramural Research-Training Modules
9 But really--why do we need in this day and age? No one can be objective about their own work history bears this out but it is true. People underestimate the risks involved with areas they are very familiar (procedures, CT scans, adding supplements, surveys on sensitive issues, etc.) People overestimate the benefit of things that are important to them.
10 The evaluation of the conduct of research involves: Codes of Ethics Standards of practice NU HSPP 5.0 Academic / Professional Values Belmont Ethical decision making Moral philosophy Framework for ethical decision making Moral Virtue Legal / Regulatory Standards CFR, FDA, FERPA, HIPAA, MHDDCA, etc.
11 Ethical Responsibilities Belmont Report (1979): 3 Ethical Principles 1. Respect for Persons 2. Beneficence 3. Justice
12 Trust is the highest honor and obligation in research
13 Day-to-day
14 When Does the Get Involved? When it is Human Research. It s Research when there is a systematic investigation. It s Human Research when there are: Living individual(s) about whom information is collected through intervention or interaction; or Identifiable Private Information When it is a systematic investigation that involves living people or their identifiable information about whom the information collected is intended to develop or contribute to generalizable knowledge the needs to see it. Other resources: Human Research Determination Form (HRP-503) HRP-310 WORKSHEET Human Research Determination
15 Review Categories Review Type Description Minimal risk Exempt Belmont Principles still apply Does not apply to FDA regulated research unless it falls under Emergency Use Minimal risk, identifiable, more personal information Expedited Reviewed in the office except for vulnerable populations. If expedited reviewer does not approve, the study must go to the full board. Minimal risk research not in exempt or expedited review categories Full Board Research that is more than minimal risk Certain research with vulnerable populations (children, pregnant women, prisoners)
16 .111 Regulatory Criteria Participant Selection Vulnerable Populations Voluntary Consent Benefits Risks Research Design
17 Speaking
18 What the is looking for: 1. Risks to participants are minimized. 2. Risks are reasonable in relation to anticipated benefits. 3. Selection of participants is equitable. 4. Informed consent is sought from each participant and is appropriately documented. 5. The researcher has adequate training and experience and there is not a conflict of interest. 6. Privacy and confidentiality of participants is protected. 7. Additional safeguards are included for vulnerable populations. 8. Data collection is monitored to ensure participant safety. 9. The research methodology is reasonable and will accomplish the purpose of the study. 10. Participants are fully debriefed if deception used.
19 Special considerations: International Research: Observation, privacy, and boundaries in the field Cultural sensitivity in recruitment, consent and data collection. Data management plan to protect confidentiality. Researching illegal activity When there are two s involved Special considerations with Internet Research: Private v public forum Is it just text or is it a person? Who owns the information on the Internet?
20 NU Submission Process PI Submits New Application Coordinator Pre-Review Assigned to Reviewer or Panel Approval Criteria Met? Modification Required for Formal Review Changes Requested Post Approval Modifications Continuing Review Reportable new information
21 Pop Quiz! Which study meets the definition of research with human subjects? a) A physician plans to conduct a study of comments posted on a blog for patients with diabetes. b) A psychologist proposes videotaping interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression. c) A grad student proposes asking the director of a local free clinic about the number of patients in the last two years with newly diagnosed HIV/AIDS. d) A university designs an in-house study to improve the mentoring of students with the proposed outcome consisting of a report of recommendations for the department.
22 Correct Answer: b a) A physician plans to conduct a study of comments posted on a blog for patients with diabetes. (Publicly available info) b) A psychologist proposes videotaping interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression. c) A grad student proposes asking the director of a local free clinic about the number of patients in the last two years with newly diagnosed HIV/AIDS. (No human subjects no identifiers collected) d) A university designs an in-house study to improve the mentoring of students with the proposed outcome consisting of a report of recommendations for the department. (Not generalizable knowledge)
23 Which are the ethical pros and cons of: Recruitment of participants using: 1. Paper flyers or posters posted on bulletin boards 2. solicitation 3. Craigslist 4. Facebook
24 General Contact Information For additional information on submission templates, regulatory guidance, upcoming education/training opportunities, and staff contacts, please visit our website: Main number (BioMedical): General queries: e assistance/queries: Compliance queries/issues: Training queries/issues: Social and Behavioral :
25 Contact Information Marcella Oliver Education Specialist Northwestern University, Office
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