Human Subjects Research and

Scholarly ActivityMs. Denise BallAssociate Director, Office of the Institutional Review Board for Human Use

Human Subjects Research & the IRB Institutional Review Board for Human

Use (IRB) The committee that reviews all UAB research involving human subjects. The aim of the IRB review is to protect the rights and welfare of study participants.

The IRB review is based on the three ethical principles described in the Belmont Report http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm - April 1979

Belmont Report – Ethical Principles Respect for Persons – autonomous agents,

respect people with diminished autonomy or capacity for decision making.

Beneficence – Risk vs. Benefit - not all risks physical – risk to reputation, employability, financial standing, etc.

Justice – Risks and possible benefits of research to be equally shared by all that may benefit from the research.

Research Research - a systematic

investigation including research development, testing, and evaluation; designed to develop or contribute to generalizable knowledge. (45 CFR 46)

Human Subject

A living individual(s) about whom an investigator (whether professional or student) conducting research obtains:(1) data through intervention or interaction with the individual, or (2) identifiable private information.

(45 CFR 46)

Definitions -

Intervention: Includes both physical procedures and manipulation of the subject or his environment for research purposes.

Interaction: Includes communication or interpersonal contact between investigator and subjects.

Definitions (continued)

Private Information - Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g. med record).

Human Subjects - examples

Not only living persons, but also human tissue, blood samples, diagnostic/pathologic specimens, study of medical records, observation of public behavior, and all questionnaires.

Not Human Subjects Designation Cadaveric Materials, Cell Lines

Former UCLA exec pleads guilty to body trafficking – October 17, 2008 LOS ANGELES (AP) — The former chief of UCLA's

cadaver program pleaded guilty Friday for his role in selling donated body parts to medical, drug and research companies in a scheme that netted up to $1 million, prosecutors said.

Henry Reid, 58, pleaded guilty in Los Angeles County Superior Court to one count of conspiracy to commit grand theft, with a special allegation that he damaged or destroyed more than $1 million worth of school property, which refers to the donated bodies.

IRB Application Types No Humans – cadaveric/cell lines

Exemption – little or no risk, no identifiers

Expedited Review – Minimal Risk (the risk in daily living)

Full Review – more than minimal risk - vulnerable subject groups, investigational drugs, investigational devices

Not Human Subjects Designation Cell lines, Cadavers, Use of data in which the

participants cannot be linked to data – written agreement must be in place.

What is de-identified data? What is anonymized data? Is there a code/link? If so, who keeps the

code, who has access, will the code be broken????

Not Human Subjects Designation http://www.uab.edu/irb/forms/nhsr.doc No Human Subjects Training Required No Protocol Oversight Review by Department

(protocol oversight review is for scientific integrity/validity)

Need signature of faculty advisor/mentor No continuing review required Student may be listed as Principal

Investigator

Exemption Review

http://www.uab.edu/irb/forms/irb-exemption-review.doc

Training is required, initial and biennial continuing

Protocol Oversight Review by Department Signature of Advisor Address Informed Consent Continuing Review/Final Report Required Student Listed as Principal Investigator

Expedited & Full (convened) Review http://www.uab.edu/irb/forms/hsp.doc - the

Human Subjects Protocol Training is required, initial and biennial

continuing Protocol Oversight Review by Department Signature of Advisor Address Informed Consent Continuing Review/Final Report Required Student Listed as Principal Investigator

Expedited & Full (convened) Review Full reviews have deadline dates -

http://main.uab.edu/show.asp?durki=60362 Special Approvals – as applicable

Hospital, TKC, Children’s, Highlands, etc. Off-campus locations International locations – Ethics review locally for

issues of local context Radiation Safety, Pharmacy, Biosafety

Changes (Amendments) to Approved Protocols If your advisor will add you to an existing,

approved protocol – he/she must submit an amendment to that protocol. http://www.uab.edu/irb/forms/project-revision-amendment.doc

Amendment must clearly state the student’s name and role/duties associated with the protocol (data collection, data analysis, informed consent, etc.).

Changes (Amendments) to Approved Protocols (continued) If the students’ work is for a dissertation ir

thesis the name of the thesis should be included on the amendment form.

Student are required to have human subjects training.

The IRB may require that the student have a separate application based on the extent of the student’s work and independence.

Amendment Form - Example1. Contact Information

Principal Investigator's Name: Dr. Faculty Member BlazerID: facultymember E-mail:  facultymember@uab.eduContact Person's Name: Ann Assistant BlazerID: aass E-mail: aass@uab.eduTelephone: 4-3789 Fax: 4-1301 Campus Address: Old Hillman Building

2. Protocol IdentificationProtocol Title: Faculty Member’s Protocol IRB Protocol Number: F100100100

Current Status of Project (check only one): Currently in Progress (Number of participants entered:100) Study has not yet begun (No participants entered) Closed to participant enrollment (remains active)—

Number of participants on therapy/intervention:     Number of participants in long-term follow-up only:     

Closed to participant enrollment (data analysis only)—Total number of participants enrolled:     

Amendment Form - ExampleThis submission changes the status of this study in the following manner

(check all that apply): Protocol Revision Revised Consent Form Protocol Amendment Addendum (new) consent form Study Closed to participant entry Enrollment temporarily suspended by

sponsor Study Closure Change in protocol personnel

Other, (specify)      

3. Reason for changeBriefly describe, and explain the reason for, the change. If normal, healthy controls

are included, describe in detail how this change will affect those participants. Include a copy of the protocol and any other documents affected by this change (e.g., consent form, questionnaire) with all the changes highlighted.I am requesting that Medical Student, John Doe be added to this protocol. Mr. Doe will be involved in data collection, data analysis (please be specific) as part of his MS-2 scholarly activity project. He has completed human subjects training. Note if you will be using data, obtaining samples, etc or if you plan to use the information/specimens for a dissertation, you will need to include the title of the dissertation here as well.

Amendment Form (continued) Must be specific to each student’s work Address applicable items for student’s work

and put n/a if not applicable

Informed Consent

Informed consent is the cornerstone of research with people

Informed Consent Document with signatures Verbal Consent with documentation waived – no

signature Waiver of Informed Consent

• Minimal risk research• Waiver or alteration will not adversely affect the rights and welfare of

participants• Research could not be practicably be carried out without

waiver/alteration• Additional Information provided when appropriate• For more info – see 45 CFR 46.116

Informed Consent – Essex IRB Study 578 individuals randomly selected to assess level of

understanding of some commonly used terms in consent forms

Results: A placebo is a small animal like an amoeba. Double-blind means being blind in both eyes. Serum is a drug. An Institutional Review Board is a committee in a

hospital that reviews your medical records to see whether or not you should be institutionalized.

Other examples of consent form out-takes...

“The autopsy will have no benefit to you.”

“This page left intestinally blank”

A note about expository writing.... How to make a peanut butter and jelly

sandwich

How to contact the IRB

irb@uab.edu 470 Administration Building, 701 20th Street

South 205.934.3789 – phone 205.934.1301 – Fax http://main.uab.edu/show.asp?durki=30246

or www.uab.edu/irb

Questions?