human subjects research: successful completion of an irb application
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Human Subjects Research: Successful Completion of an IRB Application. Jason A. Kaufman, Ph.D. Assistant Professor, Dept. of Anatomy Chair, MWU Glendale Institutional Review Board. - PowerPoint PPT PresentationTRANSCRIPT
Human Subjects Research: Successful Completion of an
IRB Application
Jason A. Kaufman, Ph.D.Assistant Professor, Dept. of Anatomy
Chair, MWU Glendale Institutional Review Board
When submitting an application to an IRB
outside of Midwestern, be sure to contact their
IRB Chair for information on policies and
procedures specific to that institution.
Objectives Training for Investigators:
What is the function of the Institutional Review Board (IRB)? Does your project constitute human subjects research? Categories of human subjects research: where does your
project fit? What are the elements of a complete IRB application? What elements are necessary in an Informed Consent
Document? What are some common mistakes and how can they be
avoided?
What is the function of the Institutional Review Board?
Responsibilities of the IRB An Institutional Review Board (IRB) is a committee
established to help protect the rights and welfare of human research subjects. Regulations require IRB review and approval for human subjects research.
IRB review is guided by three basic ethical principles*
Respect for persons Beneficence Justice
*(Belmont Report, 1979; §45 CFR 46)
Elements of your application that the IRB is mandated to review Respect for persons (autonomy)
Ensure that subjects receive full disclosure and participate voluntarily: Informed Consent
Evaluate safeguards for privacy of subjects and confidentiality of data
Assure protections for individuals with diminished autonomy
Vulnerable populations: pregnant women, prisoners, children, mentally disabled, students
Elements of your application that the IRB is mandated to review Beneficence
Determine that research risks are minimized Verify that risks are justified by benefits Confirm that research design and methods are
appropriate, scientifically valid, and therefore justify exposing subjects to research risks
Ensure that investigators are qualified to perform procedures and handle adverse events
Elements of your application that the IRB is mandated to review Justice
Ensure that subjects are recruited equitably and free from coercion or undue influence
Recruitment methods for student subjects must minimize the potential for coercion or undue influence
Does your project constitute human subjects research?
Projects that meet federal definitions of both “research” and “human subjects” must be reviewed by the IRB “Research” – a systematic investigation . . . designed to
develop or contribute to generalizable knowledge “Human Subject” – A living individual* about whom an
investigator obtains data through intervention, interaction, or the collection of identifiable private information
* HIPAA’s “Privacy Rule” extends research protections concerning private health information to the deceased
Examples of activities that are not considered to be human subjects research Case reports are not considered human
subjects research if certain conditions are met Case report / case study form available on ORSP website
Examples of activities that are not considered to be human subjects research Data gathered solely for internal campus use
(e.g., course evaluation or institutional program development), or are part of classroom projects that will not be presented outside the classroom are not considered human subjects research
Subjects deserve protection regardless of whether the research is published or presented externally
Examples of activities that are not considered to be human subjects research Research involving only coded (de-identified)
biological specimens or private information is not considered human subjects research if: the coded specimens or private information were
not collected specifically for the purpose of the proposed research, and
the investigator(s) cannot readily ascertain the identity of the individuals to whom the coded private information pertains
Determination of whether a project does, or does not, constitute human subjects research should
be made in consultation with the IRB Chair
Categories of Human Subjects Research
Categories of Human Subjects Research Exempt Expedited review Full IRB review
Categories of Human Subjects Research Exempt
“Exempt” means that a project is exempt from review by the full IRB committee
If investigations qualify as exempt they may be administratively reviewed and approved by the chair of the IRB
Once approved, exempt studies do not require continuing review (no annual reporting) as long as the protocol and sample size do not change
Research on vulnerable populations is never exempt (pregnant women & fetuses, children, prisoners)
Anonymous pedagogical studies
Common types of exempt research
Anonymous surveys or test instruments
Research on existing data, documents, records, or specimens if the information is recorded by
the investigator in such a way that subjects cannot be identified
Categories of Human Subjects Research Expedited Review
Certain types of research involving no more than minimal risk
“Minimal risk” defined as those risks that are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests
Expedited applications are reviewed by the IRB chair and two committee members
Collection of blood samples; collection of biological specimens by noninvasive means; noninvasive procedures routinely employed in
clinical practice (excluding x-rays or microwaves)
Common types of expedited research
Surveys, test instruments, or research on data, documents, records, or specimens if the information is recorded by the investigator in such a way that subjects can be individually
identified either directly or indirectly.
Common types of expedited research
Categories of Human Subjects Research Full Review
Research involving more than minimal risk to human subjects must be reviewed by the full Institutional Review Board
What are the elements of a complete IRB application?
Elements of a complete IRB application Necessary documents
Form A – summary of the proposal (background, literature review, hypotheses, and methodology), personnel involved and their qualifications, subject recruitment, inclusion and exclusion criteria, confidentiality, risks and benefits
Informed Consent Document (or application for waiver) Any recruitment materials including introductory letters Questionnaires, surveys and/or interview questions Certificate of completion of the NIH training on human
subjects research (for all persons listed on Form A) (http://phrp.nihtraining.com/users/login.php)
Current signed & dated CV for the PI Letters of permission from non-MWU performance sites
Letters of Permission If data collection will be performed outside of MWU,
the application must include a letter of permission from the administrator of the site
Administrator provides letter on performance site’s letterhead. Must include: What administrator is allowing you to do (e.g., observation,
intervention, access to patients, access to medical records) Statement that the administrator will accept MWU’s IRB
approval
Dual IRB Review An MWU IRB will not require dual review if all of the
following conditions are met: The research is conducted at an institution with a registered
IRB that has approved the research (MWU retains the right to accept or reject the other institution’s approval)
The primary appointment of the PI is with the other institution
MWU is not the primary recipient of funding for the research Data collection is conducted entirely at the other institution
Form A
Principal Investigator must be MWU faculty member
If data collection to be performed at locations other than MWU, submit letter of support from each location
Anticipated number of subjects = maximum number approved for protocol (can be amended later)
Form ASelect Research Category if Exempt or Expedited
Form A
Summary of the proposal Clearly explain what you plan to
do, who you plan to do it on, and why you plan to do it
Describe in detail your procedures Describe comparisons (justify
sample size) Describe hypotheses or expected
outcomes
Personnel Identify all individuals involved in
the study and describe their qualifications
Subject recruitment Describe and justify your subject
population Describe recruitment methods Include recruitment materials
E-mail, flyers, survey introductions, etc.
Informed Consent Describe how you will obtain
informed consent, or include application for waiver
Confidentiality Describe how you will protect
individual privacy and confidentiality of data
Describe how information will be stored, and how and when study records will be destroyed
Investigators must retain consent documents and research records for at least 3 years after the completion of research activity
Describe how anonymity will be maintained in published format
Risks to subjects Describe risks associated with
your research Physical risks Psychological risks Social/Economic risks Legal risks Breach of confidentiality Loss of privacy
Estimate the magnitude and probability of the risks
Describe procedures used to minimize risk
Benefits Describe benefits (to subjects or to
others)*
Explain how benefits outweigh risks
*Basic science (pursuit of knowledge) is a perfectly valid benefit
Informed Consent
Purpose of Study Procedures Risks/Discomforts Benefits Alternatives Financial Costs to Subjects Statement on Compensation
for Research Injury Payments to Participants Confidentiality Voluntary consent and the
right to discontinue without penalty
Contact information
Informed Consent 3 key principles of Informed Consent
Full disclosure Explain exactly what the subject will experience
Avoid the terms “I agree to . . .” or “I understand . . .” Use the second-person
Adequate comprehension Written at a 7th grade reading level
Voluntary participation Individuals may refuse to participate at any time without penalty or
loss of benefits Exculpatory language is not permitted
Informed Consent Adequate comprehension
Use fewer words Use smaller words Use shorter, less complex sentence structure Avoid technical jargon or scientific terms Use second person
Think about the education level of your subject population and their familiarity with research!
Correction of inappropriate comprehension level in the Informed Consent is one of the most-commonly requested revisions by the IRB
Informed Consent Research involving children or protected health
information requires HIPAA-compliant consent form
HIPAA Identifiers (Protected Health Information) Names (excluding initials) All geographic subdivisions smaller than a State, including ZIP code All elements of dates (except year), including birth, death, admission and discharge dates; all ages over 89
years (may include age ≤ 89 years) Telephone numbers Fax numbers Email addresses Social security numbers Medical record numbers Health plan beneficiary numbers Account numbers Certificate/license numbers Vehicle identification numbers and serial numbers, including license plate numbers Device identifiers and serial numbers URLs IP addresses Biometric identifiers, including finger and voice prints Full face photographic images and any comparable images Any other unique identifying number, characteristic, or code
Informed Consent Children
Adolescents (> 12 years but < 18 years). HIPAA-compliant consent/assent form signed by parent and adolescent
Children 4-12 years. Two forms: Description of experience for child to sign. HIPAA-compliant consent form – parental permission
Children < 4 years. Consent form signed by parent
Informed Consent Signed consent is not always required
Example: survey research Survey may be preceded by an introductory letter
containing the relevant elements of informed consent State that completion and submission of the survey
indicates consent to participate in the research study Contact person must be MWU faculty with MWU
phone number / email
What are some common mistakes and how can they be avoided?
Common mistakes Incomplete application (e.g., NIH training
certifications not provided for all investigators) Check that application contains all necessary elements
Application lacks required signatures PI and Department Chair must sign Form A
The PI on the IRB application is not an MWU faculty Research is described as having no risks
Loss of privacy and/or breach of confidentiality is always a risk and needs to be recognized as such
Common mistakes No justification for payment of subjects
Must provide justification for compensating subjects A procedure is included without any justification
Provide justification for all procedures listed in protocol Exclusion criteria are provided, but there is no
questionnaire to screen potential subjects Provide screening questionnaire
No justification of sample size Justify sample size with power analysis or reference to
published studies
Common mistakes Application contains spelling mistakes, grammatical
mistakes, or is otherwise below the threshold of acceptable academic writing Informed Consent must be linguistically correct Have a colleague proofread your application PIs mentoring students should proofread application
Data collection initiated before IRB approval All research must be approved prior to initiating study
Project exceeds approved number of subjects Additional subjects requires an amendment request
You’ve been approved!! Investigators must retain consent documents and
research records for at least 3 years after the completion of research activity
Expedited and Full Review protocols must receive continuing review: PI submits annual report, and final report when complete Exempt studies do not require continuing review as long as
the protocol and sample size do not change Changes in protocol or sample size require an
amendment request
Further Information http://www.midwestern.edu/ORSP.html
Forms, templates, policies http://www.hhs.gov/ohrp/
Federal regulations and guidelines Contact information
Jason Kaufman, MWU Glendale IRB Chair [email protected] 623-572-3717
Lindsay Goboly, ORSP Research Coordinator [email protected] 623-572-3728