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Protection RegulationsHuman Subjects Research

NTR 629 - Week 7B

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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

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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.

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Three Categories of 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

Research that exposes participants to minimal risk, or no risk at all, Research activities reviewed by IRB Chair.

Exempt Expedited Full Review

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

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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.

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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.

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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

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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.

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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.

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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

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To be approved: 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

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

IRB Approval

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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.

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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.

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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

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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

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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

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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

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Education on “Responsible Conduct of Research”: Nine Areas:

1. Data acquisition, management, sharing, ownership

2. Mentor, trainee practices and responsibilities

3. Publication practices and responsible ownership

4. Peer review

5. Collaborative science6. Human subjects7. Research involving

animals8. Research misconduct9. Conflict of interest and

commitment

Federal Oversight (con’t)

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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

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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

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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/

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