Overview

• Definitions

• Historical Framework

• Federal Guidelines

• Human Subjects Research at ASU

Institutional Review Board (IRB)• Reviews all proposed research involving human subjects to

ensure that subjects are treated ethically and that their rights and welfare are adequately protected

• Diverse membership– At least 5 members – Males and Females– Scientists– Non-scientists– At least one unaffiliated member

Research “a systematic investigation, including research

development, testing and evaluation, designed to develop or

contribute to generalizable knowledge”

Human Subject “a living individual about whom an investigator

conducting research obtains data through intervention or interaction

with the individual or identifiable private information”

Human Subjects Research

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

“ “ Those who cannot remember the Those who cannot remember the past are condemned to repeat it ."past are condemned to repeat it ."

- George Santayana- George Santayana

History

Tuskegee Syphilis Study• Initiated by the US Public Health Service

• Participants were told that they were being treated for “bad blood”

• Individuals were deceived by the officials that conducted the study

• In 1997, President Clinton apologized on behalf of the United States Government to living survivors of the study

Nazi War Crimes World War II• "Medical experiments" were performed on

thousands of concentration camp prisoners• Examples of tortures: – Forced killings– Injecting people with gasoline – Immersing people in ice water– Forcing people to ingest poisons

• 23 physicians and administrators were indicted before the War Crimes Tribunal at Nuremberg

Nuremberg Code (1947)• Voluntary consentVoluntary consent• Anticipate scientific benefitsAnticipate scientific benefits• Benefits must outweigh risksBenefits must outweigh risks• Perform animal experiments firstPerform animal experiments first• Avoid sufferingAvoid suffering• No intentional death or disabilityNo intentional death or disability• Do no harmDo no harm• Subjects can withdraw at any timeSubjects can withdraw at any time• Investigators must be qualifiedInvestigators must be qualified• Research will stop if harm occursResearch will stop if harm occurs

http://www.hhs.gov/ohrp/references/nurcode.htm

Belmont Report (1979)• The National Commission for the Protection of Human

Subjects of Biomedical and Behavioral Research issues a report: “Ethical Principles and Guidelines for the Protection of Human Subjects”

• Expanded upon Nuremberg Code

• Established 3 ethical principles for human subjects protection

http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

Federal Regulations45CFR46 – Federal Policy for the Protection of Human Subjects

21CFR50 (Protection of Human Subjects)– Regulations about FDA-regulated clinical investigations

21CFR56 (Institutional Review Boards)– Regulations about responsibility of IRBs that review FDA-

regulated clinical investigations

What are the differences?

• Common Rule is based on funding

• FDA regulations are based primarily on use of FDA regulated

products: drugs, devices, or biologics

Office for Human Research Protections (OHRP)

Regulates

• Federally-supported research

• Institutional Review Boards (IRB)

• All research if a university chooses to apply 45CFR46 to research

http://www.hhs.gov/ohrp/

OHRP

ASU Human Subjects ReviewAll human subjects research must be reviewed & approved

prior to data collection• Exempt Studies

• Expedited Review

• Full BoardREVIEW TIME DEPENDS UPON THE TYPE OF STUDY!

Review takes approximately 1-6 weeks from receipt by the Office of Research Integrity and Assurance!

Categories of Exempt Research1)Research conducted in educational settings, involving normaleducational practices(i) research on regular and special education instructional strategies, or (ii) researchon effectiveness of or comparison among instructional techniques, curricula, or classroom management methods.

2) Research involving use of educational tests, survey procedures,interview procedures or observation of public behaviorunless: (i) information obtained is recorded in such a manner that human subjects can beidentified, directly or through identifiers linked to subjects; and (ii) any disclosure of the humansubjects' responses outside the research could reasonably place the subjects at risk ofcriminal or civil liability or be damaging to the subjects' financial standing, employability,or reputation.

3) Research involving the use of educational tests (cognitive,diagnostic, aptitude, achievement), survey procedures, interviewprocedures, or observation of public behavior that is not exempt if: (i)human subjects are elected or appointed public officials or candidates for publicoffice; or (ii) federal statute(s) require(s) without exception that confidentiality of personallyidentifiable information will be maintained throughout research and thereafter.

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 theinvestigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

5) Research and demonstration projects which are conducted by orsubject to the approval of department or agency heads, and which aredesigned to study, evaluate, or otherwise examine:(i) Public benefit or service programs; (ii) procedures for obtaining benefits or servicesunder those programs; (iii) possible changes in or alternatives to those programs orprocedures; or (iv) possible changes in methods or levels of payment for benefits orservices under those programs.

6) Taste and food quality evaluation and consumer acceptance studiesif wholesome foods without additives are consumed or (ii) if a food is consumed thatcontains a food ingredient at or below the level and for a use found to be safe, oragricultural chemical or environmental contaminant at or below level found to be safe, bythe FDA or approved by the EPA or the Food Safety and Inspection Service of the USDA.

Exempt Research at ASU Application for Exempt Research

Identify exemption and provide rationale

Include methodology, survey forms, etc.

Submit 1 copy of the application to ORIA

Studies that fall under an exempt category must be submitted for review!

Application Process for expedited and full board studies• Human Subjects application and supplemental materials

– Social Behavioral Application

– Bioscience Application

• Researchers submit 1 copy of application and supplemental materials to the Office of Research Integrity and Assurance when the application is complete

Expedited Review Categories1) Clinical studies of drugs and medical devices only when certain conditions

are met

2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture when certain conditions are met

3) Prospective collection of biological specimens for research purposes by noninvasive means.

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.

5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).

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

7) 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 methodologies.

8) Continuing review of research previously approved by the convened IRB as follows:

(a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active on for long-term follow-up of subjects;

(b) where no subjects have been enrolled and no additional risks have been identified; or(c) where the remaining research activities are limited to data analysis.

9) Continuing review of research, not conducted under an IND application or IDE where categories 2 through 8 do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

Principal Investigator

Faculty or full-time staff member who assumes the following responsibilities:

• Submission of all required forms to the appropriate review committee

• Conduct of the research

• Compliance with IRB decisions

• Submitting proposed changes to previously approved research

Making changes to a protocolSubmit ANY proposed changes for review andapproval before implementing the changes using a ModificationForm

Examples of such changes include:• Alteration of study design, methodology, or recruitment• Changes to any instruments • Changes to informed consent documents• Addition/deletion of investigators• Alteration of project title• Addition of research sites

Changes to exempt studies do not need review unless the change makes the study non-exempt.

Study Approval

• Non-exempt studies may be approved for up to 1 year

• Study is complete when data analysis and data collection are complete

What happens if research lasts longer than 1 year?

• Submit a Continuing Review Form if the project is to last longer than the approval period, which is typically one year

• If data analysis is continuing, submit the continuing review form

What happens when the research is done?

• Submit a Close Out Report to the Office of Research Integrity and Assurance when data analysis and data collection are complete

• Submit report 1 month after approval expiration

Conclusions

• Treat human subjects ethically

• Be aware of Federal, State, and Institutional regulations and guidelines

• Ask questions