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 jkaufm@midwestern.edu 623-572-3717

Lindsay Goboly, ORSP Research Coordinator lgobol@midwestern.edu 623-572-3728