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1. What qualifies as human subjects' research (and thus requires IRB approval)?

A. Definition of a Human Subject under the Common Rule, 45 CFR 46

Human Subject means a living individual 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.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. 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 (for example, a medical record).

Citation from the Code of Federal Regulations—Section 102(f) of 45 CFR 46

Note: Private information must be individually identifiable in order for obtaining the information to constitute research involving human subjects (i.e. the identity of the subject is or may readily be ascertained by the investigator, whether an investigator at Tulane or at another institution, or associated with the information).

B. Determination of Human Subject Involvement

The key questions to answer in determining whether a research activity involves a "human subject" are:

Will data ABOUT a living individual be obtained through an intervention or interaction with that individual?

Will identifiable private information be obtained about a living individual?

If the answer to either question is yes, the research involves "human subjects" and the proposed research proposal must be submitted to the HRPO for the appropriate review and approval prior to initiating the research.

C. Additional Aids to Determination of Whether "Human Subjects" are Involved in Research

Examples of Research Activities that do not involve "human subjects"         

• The study of individually identifiable private information about dead persons, and no intervention or interaction with living individuals will occur; ·        
• the study of public information about living persons, and no intervention or interaction with living individuals will occur; and
• the study of publicly available information files, such as publicly available census files, in which persons are not identifiable (including, but not limited to, the presence in the file of names; social security numbers; codes which the owners of the file or a researcher could reasonably use to identify a living individual; combinations of information from which a persons identity could easily be determined, such as zip code and birth date) and no intervention or interaction with living individuals will occur

Note: The preceding bulleted activities would meet the Federal regulatory definition of "human subject" if anyone, at any point in time, beginning with the commencement of the proposed research, holds information necessary to link a file record to the identity of any living person and the information in that record would be considered private information.

D. Definition of Human Subject Decision Chart

A decision chart entitled, "Chart 1: Is an Activity Research Involving Human Subjects Covered by 45 CFR 46?" from the Office of Research Protections (OHRP) of the U.S. Department of Health and Human Services (DHHS) may be helpful in determining whether a research proposal involves "human subjects" as defined in HHS Regulations (45 CFR 46_Common Ruse). You can find this and other decision charts here and in our Investigator Guidance Section.

2. When is my submission going to be processed?

The length of time that it takes to review an IRB submission depends significantly on the quality of the application, when it is received by the IRB, and the type of review that it requires. Submissions that are incomplete will not be processed until all documents have been submitted to the IRB. Exempt reviews normally take 1-2 weeks from the date the application is determined to be complete. Expedited reviews usually take 3-4 weeks and full board reviews normally take 4-8 weeks from the date the application is determined to be complete, depending upon the extent of the revisions required by the reviewer(s).  

The IRB Review Timeline gives an estimated timeline for each type of submission. 

Keep in mind that incomplete submissions will delay the amount of time it takes to process and review your application. Please submit your submission in a timely manner. We cannot allow exceptions once the submission deadline has passed.  

3. The submission instructions posted on the web site suggest that I qualify for Expedited Review. Does this mean that my proposal will be reviewed and approved more quickly?

Not necessarily. If in fact your proposal is determined to be expedited, this does not mean that your submission will be processed more quickly. It merely means that you proposal is required to be reviewed by only one or two reviewers instead of the entire committee; research is generally of minimal risk to study participants.  

4. How will I know that I have approval to conduct my research?

If the study being proposed complies with federal regulations and Tulane policies regarding the rights and welfare of human subjects, a decision letter is posted in IRBNet and you will receive an  e-mail notification.      

5. Can an investigator begin research on human subjects without prior IRB approval?

No, all research involving human subjects must obtain final IRB approval prior to beginning research activities. Submissions that are provisionally approved do not qualify; final approval is required.  

6. What if I were to forget to submit my application for continuing review?

As a courtesy to investigators, the IRB sends investigators study renewal reminder(s) 90 days, 60 days, and 30 days prior to the expiration of the study. It is the responsibility of the Principal Investigator to ensure that the continuing review submission is submitted through IRBNet in sufficient time to be reviewed at a convened IRB meeting prior to the study's expiration. You may submit continuing review applications 60 days prior to the expiration date, and you should definitely submit them at least 30 days before the expiration date to allow enough time for the IRB review.  If an investigator has failed to provide continuing review information to the IRB, or the IRB has not reviewed and approved a research study by the expiration date, IRB approval expires automatically and the research must stop, unless the IRB finds that it is in the best interests of individual subjects to continue participating in the research interventions or interactions.  The continuation of research after expiration of IRB approval is a violation of the regulations 45 CFR 46.109(e), and 21 CFR 56.103(a).  However, if the investigator is actively pursuing renewal with the IRB and the IRB believes that an over-riding safety concern or ethical issue is involved, the IRB may permit the study to continue for a period of 30 days following the expiration date.  If a renewal request is received within 30 days of expiration, the request will be processed as continuing review.  After 30 days following expiration, the study is officially closed and cannot be reopened.  The IRB will administratively close expired studies and send the principal investigator a closure notification.

7. Do HIPAA regulations apply to data sets containing protected health information (PHI)?

Yes. Protected health information is any information that relates to the past, present or future physical or mental health or condition of an individual. HIPAA regulations require researchers to have valid authorization for all uses and disclosures of research-related PHI. A valid authorization must include specific elements:

• A description of the PHl being used.
• A statement of the purpose of the use of PHI.
• A list of those who can use the PHI.
• A list of those who can receive the PHI, including the possibility of re-disclosure.
• A statement that once PHI is disclosed by the recipient it may no longer be protected by the  Privacy Rule.
• Information about the expiration of the authorization.
• Information about the right to revoke the authorization.
• Individual identifiable health information consists of:  Names
• Social security numbers
• Geographic information including street address, city, county, precinct, zip code, and their  equivalent geocodes.
• Voice and fax telephone numbers
• Web universal resources locators ( URL ) and Internet Protocol (IP) address numbers  Email addresses
• Health plan beneficiary numbers, medical record numbers, or other health pla11 account  numbers
• Vehicle identifiers and serial numbers, including license plate numbers
• Device identifiers and serial numbers
• Biometrics identifiers, including finger and voice prints
• Full face photographic images and any comparable images
• All elements of dates (excluding year) including birth date; admission date, discharge date,  date of death

Information is considered de-identified if all of the above identifiers have been removed, and there is no reasonable basis for belief that the remaining information could be used to identify a particular person.  

8. Can the HIPAA form be changed so the study subjects can better understand it?

No. The IRB will not review your authorization form unless it appears in the Tulane authorization template, with Tulane boiler-plate language (this is not applicable to studies conducted at the Veterans Affairs Hospital). Our HIPAA template is located in the  designer in IRBNet.  

9. I will be conducting interviews which I will audio tape and later transcribe. Does my study qualify for Exemption from IRB Review?

No. Audio and video recordings are not allowed in exempt studies because they are considered identifiers. Your study may qualify for expedited review if it meets the criteria outlined in the expedited review guidelines.  

10. I have transferred to Tulane from another institution at which I had an open study involving human subjects research. What would I need to do to transfer the study to Tulane?

You must submit for review a new initial submission.  

11. I am new to human subjects research; your web site talks about CITI training. What does that involve, and what are your requirements for continuing education?

CITI stands for the Collaborative IRB Training Initiative, a web-based training package maintained by the University of Miami and is used as Tulane's ethical research training certification. Tulane University pays an annual fee to give our research community access to the various modules. Anyone engaged in human subjects research must complete the module specific to their discipline. The CITI training module expires three years after the date of completion, At that time, researchers will be required to take the CITI refresher course.  CITI Training can be found at www.citiprogram.org.

12. Does a retrospective chart review qualify for exempt status? 

No, these types of studies will be reviewed according to the expedited submission process.  

13. What should I know regarding the collection of blood samples by finger stick, heel stick, ear stick, or venipuncture?

What should be considered is:

A) from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or

B) from other adults and children (children are defined in the HHS regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted."), considering the age, weight, and health of subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50ml or 3ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.