Protection Regulations Human Subjects Research

1. NTR 629 - Week 7B Protection RegulationsHuman Subjects Research

2. Institutional Review Board • IRB’S must be guided by principles outlined in Belmont Report: • Respect for persons: respect for patient autonomy • Beneficence: maximize benefits and minimize harm • Justice: Equitable distribution of research burdens and benefits Information on IRB membership: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.107

3. Regulation of Research • Research involving the use of human subjects is difficult to conduct. • Before any research commences, the research must be approved by the (IRB) Institutional Review Board at the institution (e.g., Benedictine University). • The review takes place regardless of the number of researchers or who is financing the project. • The IRB is in charge of weighing the risks of subjects, checking informed consents, and the treatment of subjects. • The revised guidelines exempt many projects from regulations by the HHS (Health and Human Services) • Once the research has been approved by IRB, the researcher must obtain a group of subjects who are willing to participate in the study.

4. Three Categories of Review Exempt Expedited Full Review Research activities reviewed by Chair or designee. Two cautions however: Only for activities involving minimal risk-i.e., no more risks than those in everyday life. Cannot be used if subject responses might pose civil or criminal risk to subject, unless reasonable protections can be implemented so that risks related to invasion of privacy and breach of confidentiality are minimal • Higher risk research. These research activities are reviewed by the full IRB.NOTE-research not approved by IRB cannot be approved by higher authorities, however approved research may be disapproved by higher authorities Research that exposes participants to minimal risk, or no risk at all, Research activities reviewed by IRB Chair.

5. Exempt IRB Review • Federal law details six categories of exempt research (refer to IRB proposal for details on all). The following types of studies MAY qualify for a determination of exemption by the IRB: • Studying educational methods • Interviewing public figures • Utilizing publicly available data sets • Utilizing specimens of human tissue stripped of identifiers • EXEMPTION #1 (45 CFR 46.101(b)(1)): • Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

6. Exempt IRB Review (con’t) • EXEMPTION #6 (45 CFR 46.101(b)(6)): • Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) 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 chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

7. Expedited IRB Review • Only for activities involving minimal risk, i.e., no more risks than in everyday life. Cannot be used if subject responses might pose civil or criminal risk to subject, unless reasonable protections are implemented so that risks are minimal • Collection of specimens by noninvasive means • excreta, sweat, amniotic fluid, hair, teeth, plaque, hair, nails • Some studies of approved drugs or devices • Collection of voice, video, digital, or images for research • Collection of blood from adults • Not to exceed 550mL in 8 weeks • Not more often than 2x/week

8. Expedited IRB Review (cont.) • Research involving surveys, interview, focus group, program evaluation or quality assurance methods • Collection of data through noninvasive means, excluding x-ray and microwave • EKG, MRI, weighing, ultrasound, exercise, flexibility testing, etc. • Research involving records, specimens collected, data or that will be collected solely for non-research purposes. • Research on individual or group characteristics or behavior including: • Perception, cognition, motivation, identity, language, beliefs or practices, etc.

9. Full IRB Review • All other studies, including those involving supplements and diet modification trials. • Investigational drugs or devices, invasive techniques (PET scan), implants, etc. • Research with children and other vulnerable populations • Survey research that involves sensitive questions or information about sexual practice or illegal behavior. Any survey or interview that is likely to be stressful for the subject requires full committee review. IRB staff will make this determination. • Any research involving deception.

10. Subject Deception • Deception refers to intentionally misinforming the subjects to some or all aspects of the research topic. • Many studies cannot be carried out unless some deception takes place. • It is often difficult to find situations where observations or obtainment of certain data can occur at certain specified times. • The possibility of harm could be created from these actions, so the following guidelines have been developed: • Whenever possible, conduct the study using methods that do not require deception • If alternative methods cannot be devised, the researcher must determine if deception is justified by the value obtained • If participants are deceived, the researcher must ensure that the participants are provided with sufficient explanation as soon as possible

11. IRB Approval To be approved: When appropriate, research plan must ensure continued safety of subjects Where appropriate, provisions made to protect privacy of subjects and data When working with subjects vulnerable to coercion, must consider added safeguards • Risks must be minimized by sound research design • Risks must be reasonable in relation to benefits • Selection of subjects must be equitable • Informed consent will be sought from each subject • Informed consent will be appropriately documented

12. Ensuring Confidentiality • All subjects should be assured that any data collected will be held in confidence, as well as that all participants have the right to withdraw from the study, if necessary. • Once data is collected, researchers should make sure that no one else has access to the data. • Names of subjects should be removed from all data forms, if possible. • The researcher should have no knowledge of the particular data linked to a subject.

13. Informed Consent • Not needed for exempt studies • Required for Expedited Review-but may be simplified for low risk studies • Rigorous consent for Full Review projects • May be waived by IRB for emergency Medicine research-controversial issue • Consent signed by subject or legal representative and investigator • Subject must be given copy of consent • No exculpatory language may be used in the written consent Consent must address critical elements or points outlined by Federal Law. Refer to: http://www.hhs.gov/ohrp/policy/consentckls.html and http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116 for a checklist and links to related descriptions.

14. Special Population - Children • The young are more vulnerable, have fewer legal rights, and may not understand language of informed consent. • Children may never be coerced into participation in any study • Informed consent of the parents or guardians is required. • Assent of the child: Usually verbal, confirmed by parents. “Assent” can usually be provided by children over six years of age, but varies based on maturity and psychological state. Failure to object should not, absent affirmative agreement, be construed as assent. • Researchers should not present themselves as diagnosticians or counselors in reporting results to parents, nor do they report info. given by children in confidence. The IRB approved three categories of research involving children: http://www.hhs.gov/ohrp/policy/populations/guidance_407process.html

15. Special Populations -Prisoners • There are four categories of permitted research: • Causes, effects, or processes involving incarceration • Study of prisons as institutional structures or of prisoners as incarcerated persons • Study of conditions affecting prisoners as a class • Vaccine trials for diseases prevalent in prisons • Study of social behavior of prison population • Study on practices having the intent and reasonable probability of improving the health or well-being of the subject. • There are special guidelines regarding: • IRB membership • Additional considerations that IRB must review http://www.hhs.gov/ohrp/policy/prisoner.html

16. Continuing IRB Review • For research continuing more than one year, an annual review is required • New standards under review: • Will probably require IRB monitoring of some clinical trials • Constant assessment of conflict of interest of the investigators

17. Federal Oversight • FDA spot checks IRBs to monitor compliance with drug and device studies • Recent problems at Rush, Duke, UIC, U of Colorado, U of Oklahoma, and Hopkins have prompted calls for greater scrutiny of IRBs • New 2000/2001 DHHS guidelines require: • Training of investigators and “key” personnel in human research protection • Certification by investigators that they have received training (NIH offers on web) • Certification that investigator has no conflict of interest • Monitoring of clinical trials by IRB

18. Federal Oversight (con’t) Education on “Responsible Conduct of Research”: Collaborative science Human subjects Research involving animals Research misconduct Conflict of interest and commitment • Nine Areas: • Data acquisition, management, sharing, ownership • Mentor, trainee practices and responsibilities • Publication practices and responsible ownership • Peer review

19. New HIPAA regulations • Health Insurance Portability and Accountability Act of 1996 • Privacy Rules effective April 14th, 2001 • Health insurers must safeguard personal health information • May not disclose to employers for employment-related decisions • However, information can be used for research approved by a properly convened IRB • http://www.hipadvisory.com/regs/finaladvisory/gresearch.htm

20. HIPAA Research Guidelines • HIPPA allows research with conditions: • If material has been or can be de-identified, no conflict with HIPAA regulations • Appropriate if records custodian uses data • Often not practical to disclose since records custodian may simply state this is too difficult • To use or disclose data without patient authorization: • Discloser (records custodian) must document that waiver (of consent) has been obtained from an IRB • OR Researcher must represent in writing or orally, that disclosure is preparatory to research, and no records will be removed • OR Researcher must represent in writing or orally that the disclosure is for research on decedents • Document of death may be required by disclosure

21. BU IRB Information • Information about the IRB proposal and review process, including the needed forms, is online: • http://www.ben.edu/programs/education_health/IRB/