Tulane University HRPO Uptown Workshop Social/Behavioral Research

WELCOME to the TULANE UNIVERSITY HUMAN

RESEARCH PROTECTION OFFICE WORKSHOP for SOCIAL/BEHAVIORAL

RESEARCH(March 2, 2010)

Tulane University HRPO Uptown WorkshopSocial/Behavioral Research

TULANE UNIVERSITY INSTITUTIONAL REVIEW BOARDS:

Tulane University has established 2 Institutional Review Boards (IRBs):

1 for Biomedical Research and 1 for Social/Behavioral Research

The Social/Behavioral IRB typically reviews research involving the social sciences, such as sociology,

psychology, social work, political science, and history. Typical methodologies include: direct observation,

interviews, questionnaires, focus groups, and surveys.


WHAT IS SUBJECT TO IRB REVIEW AND APPROVAL:

In accordance with Federal Regulations, all Social/Behavioral Research involving human subjects conducted at or in affiliation with Tulane University

must be reviewed and approved by the Social/Behavioral IRB prior to initiating the study.


ETHICAL PRINCIPALS GUIDING THE IRB:

In 1974, the National Research Act established the National Commission for the Protection of Human Subjects of Biomedical

and Behavioral Research. The Commission published the Belmont Report, which sets forth the basic ethical principals

that guide the conduct of research with human subjects. The IRB is guided by the 3 principles established:

Respect for Persons: Investigators are required to seek voluntary informed consent from potential subjects

Beneficence: Requires that researchers maximize the potential benefits to the subjects and minimize the risk of harm

Justice: Subjects are selected fairly and the risks and benefits of research are distributed equitably


REGULATIONS GUIDING THE IRB:The IRB reviews research in accordance with the Health and Human Subjects (HHS)

regulations published in the Code of Federal Regulations (45 CFR 46, or “The Common Rule”).

In the review of research projects, the Criteria for Approval are as follows:-Risks are minimized by the use of sound research design

-Risks to subjects are reasonable in relation to anticipated benefits-Selection of subjects is fair and equitable

-Participation is voluntary and informed consent will be sought from each subject (or the subject’s legally authorized representative)

-Informed consent will be appropriately documented-When appropriate, the research plan makes adequate provision for monitoring the

data collected to ensure the safety of subjects-There are adequate provisions to protect the privacy of subjects and to maintain

the confidentiality of data


3 TYPES OF IRB REVIEWS:

EXEMPT REVIEW

EXPEDITED REVIEW

FULL BOARD REVIEW


EXEMPT RESEARCH:

Certain categories of research can be exempt from Federal Regulations (Exempt does not mean exempt from IRB

review)In order to qualify for an Exemption, the research must fall

entirely under one or more of the 6 Categories of Exemption AND cannot place the subjects at a greater than minimal

risk.

In accordance with Tulane HRPO Policy, any international research does not qualify for exemption.

In accordance with Federal Regulations, if the research involves prisoners, it does not qualify for exemption.



EXPEDITED RESEARCH:

Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a

meeting of the IRB.

A list if 7 categories has been established in the Federal Register and in order to qualify for an Expedited review, all

research activities must only involve procedures listed in one or more of these categories and present subjects with a no more

than minimal risk.


EXPEDITED RESEARCH:

What is 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 that those ordinarily encountered in daily life or during the performance of

routine physical or psychological examinations or tests.


FULL BOARD REVIEW:-If the research study proposed does not meet the criteria for Exempt or Expedited review, then it must be submitted for full

review at a convened meeting of the Social/Behavioral IRB

-The studies reviewed by the IRB are typically studies that represent a greater than minimal risk or involve a vulnerable

population

NOTE: ALTHOUGH A PRINCIPAL INVESTIGATOR MAY APPLY FOR A SPECIFIC TYPE OF REVIEW, THE TULANE UNIVERSITY IRB

RESERVES THE RIGHT TO REQUIRE A MORE STRINGENT REVIEW OF ANY STUDY AS DEEMED APPROPRIATE.


Tulane University HRPO Uptown Workshop

Social/Behavioral Research

2010 SOCIAL/BEHAVIORAL IRB MEETING DATES AND DEADLINES

EXEMPT AND EXPEDITED SUBMISSIONS ARE TAKEN ON AN ONGOING BASIS

MEETING DATE: SUBMISSION DEADLINE:

1/26/2010 1/15/2010

2/23/2010 2/12/2010

4/6/2010 3/19/2010

4/27/2010 4/16/2010

5/25/2010 5/14/2010

6/29/2010 6/18/2010

7/27/2010 7/16/2010

8/31/2010 8/20/2010

9/28/2010 9/17/2010

10/26/2010 10/15/2010

11/30/2010 11/19/2010

12/21/2010 12/10/2010

INFORMED CONSENT:

Informed Consent is one of the basic ethical obligations for researchers.

The purpose of a Consent Form is to provide a written source of information about the research project and a place to document that

the subject’s consent was given before subject enrollment.

NOTE: IN SOME CIRCUMSTANCES, THE INFORMED CONSENT PROCESS AND/OR THE DOCUMENTATION OF INFORMED CONSENT CAN BE

WAIVED. MORE INFORMATION CAN BE FOUND ON THE TULANE HRPO WEBSITE.

NOTE: WE HAVE CREATED A SOCIAL/BEHAVIORAL INFORMED CONSENT TEMPLATE FOR YOUR USE AND URGE YOU TO USE IT, AS IT CONTAINS

ALL THE REQUIRED ELEMENTS OF A PROPER INFORMED CONSENT DOCUMENT. THE TEMPLATE CAN BE FOUND ON THE TULANE HRPO

WEBSITE.


INVESTIGATOR RESPONSIBILITES:

Responsibilities of the Primary Investigator while conducting research include:

-Following the IRB approved protocol and using only the IRB approved documents including the Informed Consent Document,

Advertisements, etc.-Submitting a Continuing Review/Progress Report before the

expiration date to the HRPONOTE: A CONTINUING REVIEW/PROGRESS REPORT MUST BE SUBMITTED IN

ENOUGH TIME PRIOR TO THE EXPIRATION DATE TO ALLOW FOR A MEANGINGFUL AND SUBSTANTIVE REVIEW. 60 AND 30 DAY NOTICES ARE SENT OUT VIA

IRBNET.-Submitting any Unanticipated Problems and Protocol Violations to the

HRPO-Submitting a Study Closure when all research activity is final



SUBMISSION TO THE TULANE HRPO:

-CITI Training

-Initial Submission Checklist

-Secondary Submission Checklist

-Electronic Submission via IRBNet(IRBNet Video: New Project Submission and IRBNet Users

Guide)


Documents

Tulane University HRPO Uptown Workshop Social/Behavioral Research