inspiration for change pepperdine university institutional review board stephanie woo, ph.d. chair,...

INSPIRATIONfor change

Pepperdine UniversityInstitutional Review Board

Stephanie Woo, Ph.D.Stephanie Woo, Ph.D.Chair, Graduate and Professional School IRBChair, Graduate and Professional School IRB

Adapted with permission from Michael Feltner, Ph.D. (Research Protections for Human Participants Presentation, 2005)


Presentation Outline

I. Statutory Basis of Human Research ProtectionII. Human Research Protections at PepperdineIII. The IRB ApplicationIV. Common IRB Questions or CircumstancesV. Concluding Remarks


Acknowledgments• GPS IRB members and support staff

• Dr. Lee Kats, Associate Provost of Research

• Dr. Michael Feltner, former chair of the Seaver and GPS IRBs

• Dr. Susan Hall, former chair of the GPS IRB


Background Information

• What is an IRB?• What is the purpose of an IRB?

– Protect Human Participants– Ensure that research is conducted in accordance with

Ethical, legal & institutional requirements• What is the mission of the Pepperdine IRBs?

– To fulfill our dual purposes and and contribute positively to educational and scholarly activities within the University.


I. Statutory Basis of Human Research Protections Regulations

• The Belmont Report – The national commission for the protection of human subjects of biomedical and behavioral research.– Respect for persons, beneficence, and justice

• Title 45 CFR 46– Known as the Common Rule because it has been

adopted by 18 federal agencies


II. Human Research Protections at Pepperdine

• Federal Wide Assurance (FWA) has been issued by OHRP – FWA00006872

• What is an FWA?– Required by Common Rule– The FWA is required of each institution engaged in

federally-supported human subject research– The FWA formalizes the institutions commitment to

protect human subjects– Agencies that require an FWA before funding are:

DHHS(NIH), NSF, DOE, VA, EPA, NASA, HUD, DOD, etc.


Human Subjects Protections at Pepperdine cont.

• It is the policy of Pepperdine University that all research involving human participants must be conducted in accordance with ethical, federal, state, and professional standards for research and that all such research must be approved by one of the University’s Institutional Review Boards (IRBs).


Human Research Protections at Pepperdine cont.

• Two Institutional Review Boards– Seaver College IRB– Graduate and Professional IRB

• Pepperdine University Protection of Human Participants in Research: Policies and Procedures Manual

(S. Hall & M. Feltner)• Website for Research Protections material created

http://www.pepperdine.edu/irb/


Applications to Pepperdine

• Pepperdine University Human Research Protections provide the protections mandated by federal and state statute

• Pepperdine University Human Research Protections do not exceed those required by law and conform to the best practices of IRBs in collages and universities nationally

• The Protection of Human Participants in Research: Policies and Procedures Manual explains and implements the policies and guidelines governing human research protections at Pepperdine.


III. The IRB Application

A. Preparation

B. Who must apply?

C. Are you conducting research with humans?

D. What type of projects require an IRB review?

E. Where do you submit an application?

F. What type of application should you submit?

G. The IRB application


A. Preparing to Submit an IRB Application

1. Go to the IRB website: http://www.pepperdine.edu/irb/2. Obtain the Pepperdine University Protection of Human

Participants in Research: Policies and Procedures Manual3. Read pages 6 – 31 of the Manual4. If necessary, consult with IRB manager or chairperson to

answer any questions5. Complete appropriate forms found in the Appendices of

the Manual or on the website, and complete any required IRB/HIPPA training• This includes faculty supervisors and research

assistants


B. Who Needs to Apply?

• Pepperdine Faculty, Students, Employees– In accordance with federal regulations (45 CFR 46.103),

Pepperdine University assures that all research involving human subjects and conducted under Pepperdine University’s auspices will be prospectively reviewed and have the continuing approval of the designated IRB.

• Collaborators– Pepperdine investigators who are working with researchers

from another institution also must ensure that IRB approval is obtained from the other institution before the research project can commence.


C. Are you conducting research with humans?

• http://www.pepperdine.edu/irb/irbforms/


Step 1: Does Your Study Involve Human Subjects?

• Does your proposed study obtain information gathered from interactions (any form of communication or personal contact) or interventions (physical procedures, manipulation of the subject, or alteration of the subject’s environment) with a living individual?

• Does the study collect private information in a form that allows the identity of the subject to be determined or associated with the data?

• Does the study use archival data gathered previously from a living individual?


Step 2: Is Your Study Research?

• Does your proposed study use a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge?

• Does your study contribute to generalizable knowledge?• Key concept for this question is the researcher’s intent.

If YES, you are conducting research.

If NO, you may still be conducting research, but it does not meet the federal definition of research.


Is an IRB Application Required?

• If YES at both Step 1 (humans) and Step 2 (Research)?– You must submit an IRB application.

• If NO at either Step 1 (humans) and Step 2 (Research)?– You are not required to submit an IRB

application.


D. What Type of Projects Require Review?

• Faculty & staff research projects• Student research projects• Some classroom/educational research and service learning

projects– See pages 14 – 16 of the Manual

• Program Evaluations and Administrative reviews that will be published and distributed to an external audience (generalizable knowledge)

• Pilot studies or focus groups if the data obtained will be used for research purposes


Classroom/Educational Research and Service Learning Projects

• Courses often require students to undertake projects in which other people are interviewed, observed, or serve as research participants

• The purpose of these course projects is to:– Educate students,– Provide students with a greater understanding of social,

educational, psychological, or biomedical research processes, and

– Allow students an opportunity to learn and practice various research methodologies

• If class projects are conducted primarily for instructional purposes within the context of a formal class, and are not designed to contribute to general knowledge, the IRB does not consider them to be research.


Classroom/Educational Research and Service Learning Projects

• Thus, IRB review and approval are not required, provided the instructor is prepared to accept professional and ethical responsibility for all research projects conducted in conjunction with the class.– IRB encourages faculty and instructors to follow human

research protections guidelines and ethical principles even when IRB review is not required

• If the results of a class project are intended for dissemination outside of the University (e.g., conference presentation, publication), IRB review is required before data collection begins.


Pilot Studies• If study is undertaken to simply refine the clarity

or an instrument/procedure, determine the completion time, etc.

AND• Data WILL NOT not be used for research

purposes (e.g., publication/presentation)

IRB review is not required for pilot study portion of project.


E. Where to Submit Applications?

• Investigators from:– Graduate School of Education and Psychology– Graziadio School of Business and Management– School of Law– School of Public Policy

• Submit applications to the Graduate and Professional Schools IRB


Where to Submit Applications? Cont.

• Investigators from:– Seaver College– Staff members or employees of Pepperdine who do not

have a faculty appointment, but who are conducting research investigations

• Submit applications to the Seaver College IRB


F. What type of IRB Application should you submit?

• If your research does not qualify for Exempted Status, you must submit an Application or Expedited or Full Review


Three Types of IRB Applications

• Exempt – 6 exempt categories

• Expedited – 8 expedited categories

• Full


Common Errors in IRB Applications

• Submission of incomplete applications– The IRB will not begin to review application until it is

complete– Students: Do not ask the IRB to contact your research

advisor to collect missing materials/signatures – this is YOUR responsibility

• Hastily or sloppily written applications (e.g., grammatical/typographical errors, no references to appendices, items in application not answered, etc).– Faculty advisors: Please carefully and thoroughly

review your students’ applications before signing off on them


Common Errors in IRB Applications• Insufficient information provided about the purpose of the

study, research questions, etc.

• Lack of detail about specific procedures to which participants will be exposed – What is the nature, timing, and sequencing of all

proposed contacts with participants?– All materials to which participants will be exposed must

be included in application

• Failure to allow sufficient time for review (e.g., submitting application a week before you wish to begin data collection)


Exempt Review Categories (6)• Research in the following 6 categories qualify for exempt status [45CFR

46.101(b)]• Exempt review is not allowed if the study involves vulnerable

populations, including children– Survey research on children is not exempt– Public observation of children is allowed if there is no participation

by the researcher in the activities being observed

1. 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


Exempt Review Categories (cont.)

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and

Any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal 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, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:

The subjects are elected or appointed public officials or candidates for public office; or

Federal statute(s) require(s) without exeption that the confidentiality of the personally identifiable information will be maintained throughout the 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 the

investigator 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 or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:

Public benefit or service programs; Procedures for obtaining benefits or services under

those programs; Possible changes in or alternatives to those

programs or procedures; or Possible changes in methods or levels of payment

for benefits or services under those programs



6. Taste and food quality evaluation and consumer acceptance studies, if:

Wholesome foods without additives are consumed, or

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


Exempt Application• Investigators must describe their study (#1), nature of

contact with human subjects (#3), and explain why protocol should be exempt (#4)

• Category from federal regulations proposed to form the basis of exemption must be specified (#2)

• How data will be recorded and records kept must be addressed (#5, #6)

• Copies of materials that human subjects will be exposed to must be included for IRB to review (#7)– This includes consent form


Exempt Application

• If study involves recruitment of participants from other organizations/entities (e.g., schools, businesses), the application must also include permissions to gain access to potential participants (#8)

• Investigator must address if study falls under HIPAA (#9)


Expedited Review

• Research activities that

1. Present no more than minimal risk to human subjects,

AND

2. Involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure

• Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests


Expedited Review• The expedited review procedure may not be used where

identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ – Financial standing– Employability– Insurability– Reputation– or be stigmatizing

unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.


Expedited Review Categories (8)1. Clinical studies of drugs and medical devices only when

specific conditions are met. 2. Collection of blood samples using specific methods in

some population groups3. Prospective collection of biological specimens for

research purposes by noninvasive means4. 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 non-research purposes (such as medical treatment or diagnosis)


Expedited Review Categories cont.

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

7. Some research projects on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or some research studies employing survey, interview, oral history, focus group, program evaluation, human factors evaluation or quality assurance methodologies

8. Continuing review of some research projects


Expedited (& Exempt) Review

• Studies that qualify for expedited (or exempt) review may be reviewed by only one member of the IRB, or an IRB subcommittee, and approved without review by the entire IRB

• IRB applications requiring expedited (or exempt) review may be submitted at any time

• Standards for approval during expedited review or during a full committee review are identical!


Full Review

• If your study does not qualify for expedited review status, it will require a full review by the appropriate IRB

• Each IRB has a posted calendar listing submission, review, and notification dates throughout the academic year– Seaver College IRB –

http://www.pepperdine.edu/irb/seaver/– Graduate and Professional School IRB –

http://gsep/pepperdine.edu/irb/


What Issues are Considered During an IRB Review? (45 CFR 46.111)

• Study design

• Investigator qualifications

• Selection of subjects

• Risks

• Benefits

• Informed consent process

• Subject privacy/confidentiality

• Data confidentiality

• HIPPA applicability & procedures followed


G. The IRB Application

• Use the application checklist to be sure all necessary items are submitted for a complete application.

• http://gsep.pepperdine.edu/irb/GSEP_application_checklist.pdf


The IRB Application – Cover Letter

• Starts with a cover letter that includes the following:1. The applicant has read and will act in accordance with the

ethical principles for human research protections. Applicants should also state that they will uphold any ethical principles from associated professional organizations (e.g., APA)

2. If applicable, applicant must state she/he has not violated any copyright laws in the use of the instruments for the proposed study (and state that she/he will either purchase instruments or provide copy of permission to use the instrument from the copyright holder);

3. The applicant has fulfilled any departmental requirements (e.g., passed the preliminary oral exam), if applicable; and

4. The applicant may add any additional information that is felt pertinent to the IRB application that is not otherwise addressed (e.g., approval received from another IRB)


The IRB Application – Investigator Info.

• All applications submitting by students must be – Signed by the Faculty Supervisor– Have a Faculty Supervisor Review Form attached

• Faculty members: Please be sure to carefully review your students’ IRB applications before they are submitted for review.

• Psychology division students: Applications for expedited/full review must first undergo review by the Psychology Pre-IRB Methods Review Committee chaired by Cary Mitchell, Ph.D.


The IRB Application – Investigator Education

• Prior to submitting an IRB application all investigators (and research assistants) must complete education and training on human subjects protections

• On-line training in human subjects protections is available at http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp

• A certificate confirming this training must be attached to the IRB application


The Expedited/Full IRB Application – Item #1. Summary of the Proposed Research

• Item 1 should be written in such a way as to be understandable to individuals who do not have a background in your area of study, and do not have training in research methods.– Provide a brief literature review that provides context for

why the study is being conducted– Indicate the purpose and importance of conducting the

study– Clearly state the research questions or project

objectives– Briefly describe the experimental design– Provide hypothesis, if relevant


Item #2. Estimated Dates of Project

• IRB approval can be granted for a maximum of one year.– IRB Consideration – Can the study objectives be

achieved in the stated timeframe?


Item #3. Cooperating Institutions • Does the project involve investigators from other

institution?• Was the application submitted to any other IRB’s.

– The other application should be attached– If PI is from Pepperdine, stipulate other IRB’s approval

before project may begin– If PI is not from Pepperdine, require other IRB’s

approval before review of Pepperdine IRB application• Insure IRB approval from other Institution(s) is

attached• Review application submitted to other IRB(s)

• Is the project funded/cosponsored by somewhere other than Pepperdine?


Item #4. Subjects• The rational for both the target number of subjects for the study

as well as the estimated number of subjects who may need to be contacted during recruitment should be addressed.

• The settings from which subjects will be recruited should be listed with the contact information.

• Copies of all materials used to recruit subjects (e.g. flyers, advertisements, scripts, email messages) should be submitted with the application.

• It is essential to obtain and document permission to recruit subjects from each site.

– In some cases, sites will only give permission after provisional approval from the Pepperdine IRB is granted.

– Permission to use dataset/data archives is also required.


Item #4. Subjects cont.

• Are subjects being compensated or reimbursed for their participation and is the amount reasonable?

• Will the subjects incur costs from participation?• If children or adolescents are involved, who receives the

compensation and is this appropriate?• How is the researcher going to assure that subjects

participation is voluntary?


Regarding Inclusion/Exclusion of subjects

• Are the appropriate inclusion and exclusion criteria specified?

• Is the choice of subjects appropriate for the questions being addressed?

• If women, minorities, or children are included or excluded, is this justified by the research design?

• Is subject selection equitable?


Item #5. Interventions/Methods

• The methods should be written in an orderly, systematic fashion so that someone could actually repeat the study by reading this description. This section may be written for an audience of those in your field.

• The instruments (e.g. questionnaire, surveys) should be explained in this section and should be included with the application as an appendix item. – Include any approvals of permission to use the

instrument if it was created by someone else.


Item #5. Interventions/Methods cont.• Is the rationale for and the details of the research procedures

adequately described and acceptable?• Are the investigators appropriately trained? Educated?• Is the location of the experimental procedures appropriate

and acceptable for the research?• Are their adequate plans to inform subjects of specific

research results, if necessary?• Is the rationale for the proposed number of subjects

reasonable?• Are the plans for data and statistical analysis defined and

appropriate?• Does the study involve the use of drugs, medical devices or

biologics?• Are the use of drugs, medical devices or biologics used in the

study approved by the FDA for the same purposes used in the study?


Item #6. Risk

• Thoughtful consideration needs to be given to all potential risks (physical, psychological, emotional, behavioral).

• Not only should the risks be identified, but also a plan of action needs to be presented in the event any of the risks become a reality.

• Things to consider:– Are the risks adequately identified, evaluated and

described?– What does the investigator consider the level of

risk/discomfort/inconvenience to be?– What is the IRB’s assessment of the level of risk ?– Does the research design minimize risks to subjects?


Item #6. Risk Cont.

• Regulatory definition of minimal risk: Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 CFR 46.102(h)(i)).


Item #7. Benefits

• There may not be any direct benefit for the subject to participate in your study and that should be stated.

• Things to consider: – Are the benefits adequately identified, evaluated and

described?– Is the likelihood of benefit maximized?– Assess the level of benefit:

• RISK/BENEFIT ASSESSMENT– Is the risk/benefit ratio acceptable for proceeding with

the research?


Item #7. Benefits Cont.

• Definition: A research benefit is considered to be something of health-related, psychosocial, or other value to an individual research subject, or something that will contribute to the acquisition of generalizable knowledge. Money or other compensation for participation in research is not considered to be a benefit, but rather compensation for research-related inconveniences.


Item #8. Informed Consent and Data Security

• Requirements for Informed Consent:– The Principal Investigator explains the research

study to the subject– The subject's informed consent is documented by

signing the protocol’s written consent document, which has been previously reviewed and approved by the IRB.

– A copy of the signed consent document is retained by the investigator.

– The subject is given a copy of the signed document.


Item #8. Informed Consent Cont.

• Informed consent templates can be downloaded from the IRB website.

• Forms on the web site are exemplar documents! It is our expectation that they will be modified and altered to fit the specific needs of each investigation.

• If you are translating consent into another language, you should address in the IRB application how the translation was conducted to provide assurance of adequacy of process– Be sure to review the Manual for procedures to follow

when subjects do not speak English


Item 8. Informed Consent Cont.

• Unless otherwise authorized by an IRB, research investigators are responsible for ensuring that informed consent shall:– be obtained in writing from the subject or the subject's

legally authorized representative;– be understandable to the subject or her/his

representative.– be obtained in circumstances that are not coercive and

that offer the subject (or her/his representative) sufficient opportunity to decide whether she/he should participate.

– The consent document should not contain language that implies or suggests that the subject (or her/his representative) gives up any legal rights or releases research investigators from liability for negligence.


Item 8. Informed Consent Cont.• Does the informed consent document include the required elements?

– 1. Statement that the study involves research• Purpose of the research is stated in lay language• Expected duration of the study• Description of the study procedures (treatments) and design in lay language

– 2. Potential risks or discomforts– 3. Direct or societal benefits– 4. Disclosure of appropriate alternative procedures or courses of treatment, if

any, that might be advantageous to the subject– 5. How confidentiality is protected and who has access to the data– 6. Statement that participation is voluntary and that refusal to participate or

discontinuing participation at any time will involve no penalty or loss of

benefits to which the subject is otherwise entitled.– 7. Information regarding who to contact for answers to pertinent questions about

the research, further information about the research, or the research subject's rights

– 8. For research involving more than minimal risk, an explanation and description of any medical treatments that are available if research subjects are

injured and whom to contact in the event of a research-related injury


Item 8. Informed Consent Cont.• If applicable,

– L. Description of any drugs/devices– M. Disclosure of any alternative treatments or procedures– N. Compensation or reimbursement– O. A statement describing the anticipated circumstances

under which a subject’s participation may be terminated without the subject’s consent

– P. Additional costs associated with participation, with expenses detailed

– Q. A statement that any new findings that affect the subjects will be disclosed

– R. Discussion of the consequences of withdrawal– S. The approximate number of subjects in the study– T. If the subject is or may become pregnant, a statement that

the particular treatment or procedure may involve risks, which are currently unforeseeable, to the subject or to the embryo or fetus;

– U. A statement concerning an investigator’s potential financial or other conflict of interest in the conduct of the study.



• Informed Consent is a PROCESS not a form!– Informed consent form can be viewed as a script that

can guide the consent process. – Informed consent process typically culminates in

signing of the consent form• Waiver or Alteration of Informed Consent

– Used for any alteration of the regular informed consent process.

– Special form must be completed and submitted with application

– Note that form has two sections: • one pertaining to a waiver/alteration of consent and• one pertaining to a waiver of documentation of

consent


Item 8. Informed Consent Cont.• Regular Informed Consent

– This section should clearly address if the potential subjects are capable of being informed and consenting on their own behalf, and on what basis this assumption is being made.

– This section should also delineate the steps that will be taken to obtain consent and insuring that the subjects understand what is being asked of them.



• Is the subject a child? If yes, describe the procedures and attach the form for assent to participate.

• Is the subject a member of another vulnerable population? (e.g. Prisoners, Pregnant Women, Cognitively Impaired Individuals). If yes, describe the procedures involved with obtaining informed consent from individuals in this population.


Anonymity and Confidentiality

• Applicants should understand the difference between anonymity and confidentiality.

– Anonymity can be defined as when a person is not named or identifiable in any manner.

– Confidentiality may be defined as when personally identifiable and private information is entrusted to an investigator to not disclose it.


Anonymity and Confidentiality Cont.

• Routine practices for assuring confidentiality include: substituting codes for identifying information; removing cover sheets (containing names and addresses); limiting access to identified data; and storing research records in locked cabinets.

– Even signed consent forms are records that contain confidential information.

– Note that none of the above examples involve anonymous data because each involve some way of linking a person to the data.


Data Security

• Describe the procedures through which the security of the data will be maintained (hard copies and electronic formats).

• Security procedures include:– Storing data securely for a minimum of 5 years (or 6

years if study falls under HIPAA) – Maintaining separation of subject identity from subject

data – Delineation of the terms of data access and use, if data

are going to be archived for use by you and/or other investigators in the future


HIPPA

• WHAT IS HIPAA?– Federal law that provides safeguards to

protect the health information of individuals obtaining healthcare in the USA, also known as the Privacy Rule.

– Since investigators may create, use or exchange individually identifiable health information when conducting research, Pepperdine University must assure compliance with HIPAA as it relates to research.


HIPPA Cont.• If HIPAA applies to your study, attach a copy of the

certification that the investigator(s) has completed the HIPAA educational component.

• Describe your procedures for obtaining Authorization from participants.

• Attach a copy of the Covered Entity’s HIPAA Authorization and Revocation of Authorization forms to be used in your study (see Section XI. of the Investigator Manual for forms to use if the CE does not provide such forms).

• If you are seeking to use or disclose PHI without Authorization, please attach the Application for Use or Disclosure of PHI Without Authorization form (see Section XI). Review the HIPAA procedures in Section X. of the Investigator Manual


IV. Common IRB Questions or Circumstances

• What happens if your research protocol changes after the study has begun?– Submit a Request for Modification form to the IRB.

• What if my project lasts for more than one year?– IRB approval is only granted for one year for expedited

and full review applications.– As the expiration of your current IRB approval

approaches, submit a Continuing Review Form.– Plan to submit the Continuing Review Form at least one

month, preferably two months, prior to your current approval’s expiration.


Common IRB Questions or Circumstances Cont.

• What If Something Bad Happens (an Adverse or Unanticipated Event)? – Investigators must report adverse events to the IRB

Chairperson ASAP and no later than 96 hours from the time of the event.

– Fatal or life-threatening events must be reported within 48 hours.

– Submit an Adverse Event Reporting Form to the IRB to document and report the event.


V. Concluding Remarks

• Key to the IRB process is education• Onus is on the investigator/faculty member to understand

and apply applicable federal and state law and institutional and professional policy.


Contact Information

• Stephanie Woo – Chairperson, GPS IRB• [email protected]• 310-258-2845

• Steve Rouse – Chairperson, Seaver IRB• [email protected]• 310-506-7975

• Jean Lee – Manager, GPS IRB • [email protected]• 310-568-5753


Questions?

inspiration for change pepperdine university institutional review board stephanie woo, ph.d. chair,...

Documents

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human subjects protections

behavioral research

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