Ask the IRB:Student International Research Edition

Christopher Ryan, PhD, CIPDirector, Pitt IRB

Professor of Psychiatry, Psychology, and Health & Community Systems

ryancm@upmc.eduTeri Merolli Reiche, CIP

reichetm@upmc.eduJanuary 31, 2008

IRB Mission Statement - 1

• Protect rights and welfare of human subjects participating in research activities– IRB determines that benefit / risk ratio

associated with study participation is ‘favorable’

– IRB ensures that investigators inform subjects fully about the study, and study-related risks & benefits, so subjects can make autonomous decision to participate

Mission Statement - 2• Ensure that investigators are compliant with ethical

standards, and federal, state and local regulations and policies governing human research– Research activities are consistent with established

ethical principles (Belmont Report) and Federal Regulations (DHHS [45 CFR 46; ‘Common Rule’])

– Research is ‘scientifically sound’– Research activities are conducted and documented

appropriately

Ethical Principles: The Belmont Report1. Respect for Persons

• Individuals should be treated as autonomous agents– Person has self-determination and is capable

of deliberating about personal goals (and participation in research)• Application: Need for detailed disclosure in consent

1. Respect for Persons (continued)

• Individuals in potentially coercive situations (e.g., children, prisoners, pregnant women) or individuals with diminished capacity that may affect their understanding, are entitled to additional protections– Decision about level of autonomy should be

periodically reevaluated• Application: questioning participants about continued participation; re-consenting

2. Beneficence

• Investigators have an obligation to do good• Maximize possible benefits and minimize

possible harms– Application: accurate and complete

presentation of risks and benefits in protocol, and in consent form

3. Justice• Who receives the benefits of research, and who bears

its burdens?• Equitable selection of subjects

– Particular concern about use of members of minority populations or welfare patients as research subjects• Application: Ensure that subject recruitment

strategies and inducements are fair– In international drug research, ensure that subjects

may ultimately obtain effective drug when study ends

Pitt IRB Jurisdiction

• All research involving human subjects conducted at the University – including all Schools, Centers and Regional Campuses

• All research conducted by students, faculty or staff associated with any of those institutions– If a Pitt/UPMC person is a PI or Co-I on

research conducted at another institution [anywhere in the world!], that protocol and consent must be reviewed and approved by Pitt IRB

Please Note:

• If you are gathering research data at a site that is not affiliated with Pitt (e.g., CMU; a school district in Saudi Arabia; the University of Gottingen in Germany; a clinic in Tanzania), you need written permission (at the very least!) from that site to collect data, and that must be included in the Pitt IRB submission

• Many institutions have their own IRBs or “ethics committees”, and their approval is needed before research can begin

When is IRB Oversight Required?

When an activity is human subjects ‘research’:• Research: “A systematic investigation…designed

to develop or contribute to generalizable knowledge”Examples:• Testing of a hypothesis or question for which an

answer requires more information• Prospective or retrospective collection of data from

human subjects with the prior intent to publish or otherwise disseminate such results

What are Human Subjects?• A human subject is a living individual about

whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, OR (2) identifiable private information

• Therefore: If the researcher is not interacting or intervening with an individual AND is not obtaining identifiable private information, no IRB oversight is usually required

No Human Subjects, continued

• The federal regulations do not require that the IRB make a formal determination that a particular activity does not meet the criteria for ‘no human subjects’ involvement, or for ‘not a research activity’ BUT

• Many funding agencies may wish a formal letter from the IRB, as may journals

• Determination can be made easily: Go to our website, to exempt webpage, to ‘no human subjects’, and complete form

3 Types of Review

• Exempt (determination made by IRB)–Limited, very restricted categories of research that

are exempt from Federal research regulations • Expedited Review (administrative review)

–Minimal risk research that falls into certain categories

• Full Board Review–Usually more than minimal risk research, or

research that cannot be expedited

Exempt Review http://www.irb.pitt.edu/Exempt/default.htm

• Tests, surveys, interviews, focus groups• Research in educational settings (e.g., classrooms!)• Existing data, documents or records• Existing data: Retrospective Medical Record

Reviews• Analysis of tissue, blood or other specimensNOTE: ordinarily identifiers should not be recorded

unless information is benign

Typical Psychosocial International Study # 1: Interview / Questionnaire / Survey Exemption

• Are children included? – If yes, STOP; study does not qualify for exemption

• Will adults be asked questions about ‘sensitive’ topics?– If no, study meets criteria for exemption– If yes (questions on sex, politics, drugs, disease, etc.),

• Will personal identifiers be linked to responses?–If no, study is exempt; if yes, study must be

expedited and consent form must be used

• The Pitt IRB requires investigators who are conducting exempt studies in a foreign site to provide some evidence that local officials or academics are aware that the study will be conducted and that they feel that the nature of the study (e.g., questions) are consistent with local mores and values

• If sensitive issues are being studied, all data must be collected without personal identifiers – data must be entirely anonymous! Alternately, written informed consent and full board review will be required

Typical Psychosocial International Study # 2: Classroom Research

• Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as – research on regular and special education instructional

strategies, or – research on the effectiveness of or the comparison

among instructional techniques, curricula, or classroom management methods.

• Written permission from local school authorities is required

2. Expedited Reviews• Review by 1 or more IRB members (team)• Standard protocol format must be followed• Prior scientific review is required• Written consent must be obtained, unless waived by IRB• Research is no more than “minimal risk”• Can NOT be used where identification of subjects or their

responses would place them at risk for criminal or civil liability or be damaging to their reputation (i.e., when information is “sensitive”)

• Must meet additional criteria (next slide)

Research Categories for Expedited Review

• Research on individual or group characteristics or behavior

• Collection of data through non-invasive means (excluding X rays, but including MRI and EEG)

• Materials collected initially for non-research purposes (e.g., medical diagnosis; school performance)

• Collection of blood samples• Prospective collection of biological specimens by non-

invasive means

Expedited or Full Board International Research IRB Protocols Must Address:

• The scope of research activities• Types of subject populations and languages spoken• Size and complexity of the foreign site(s)• Standards of professional conduct and practice• Methods for ensuring equitable selection of subjects • How subjects’ privacy & data confidentiality are protected• Whether local staff have appropriate research expertise• If federally funded, site needs a Federal Wide Assurance

Expedited or Full Board International Research IRB Protocols Must Include:

• Letter from authorized official permitting the Pitt investigator to conduct research at the local site

• Some countries may require that the research activity also be reviewed by their ‘IRB Equivalent’ (usually, an ‘ethics committee’)

Pitt IRB Must Have Knowledge of Local Research Context For Expedited

& Full Board Reviews

• Regulations require that the IRB has knowledge of local research context. Requirement best met by having a local IRB provide review

• In the absence of local IRB, appropriate local consultants must be identified

• For more than minimal risk research, additional information will be needed (see Manual)

Requirements for IRB Submission

Completion of “Responsible Conduct of Research” Training Modules (https://cme.hs.pitt.edu)

• Certification in Research Integrity (Module 1)• Certification in Human Subjects Research (Module 2)

– 2A: Biomedical Research– 2B: Social/Behavioral Research

• Must be completed by ALL investigators listed on an IRB protocol

• Must be completed by Faculty Mentor, if applicable

Student Research Web Page (www.irb.pitt.edu)

• Student Research Liaison: Erin Holmes Grabowski

• FAQs about the submission process• Model consent forms (for expedited

studies)

OSIRIS Submissions

• All IRB applications must be submitted via our Online Submission for Institutional RevIewS (www.osiris.pitt.edu)

• Electronic, internet-based system uses ‘smart forms’ that provide extensive branching questions to produce an IRB protocol; special forms can be uploaded for exempt submissions

• Automated e-mail notifications permit direct communication between review entities and research staff, and will allow investigators to track review progress

Be Informed

• Join the IRB email at http://www.irb.pitt.edu/ • Attend Ask the IRB sessions

– 3rd Thursday of the month at David Lawrence Hall• Office hours Wednesday mornings by

appointment– contact Nick Landolina at landna@upmc.edu