Submission Decision Tree

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This tool was created to help study teams identify the type of review their study may undergo, as well as provide guidance on who to contact and how to begin the review process.

Please note that the review decision provided by the tool may not be completely accurate in some cases. Additional information may be needed to make these determinations and can result in a different review level.

Please review the IRB guidance for more information and contact the Office of Research Integrity Assurance if you have any questions.

Decision Tree Form

Current IRB Questions
Results
Complete

During your study, will you:

Interact with, intervene with, or obtain/access private, identifiable information or data about, a living individual (includes online surveys)?

Conduct research on a drug, biologic, or medical device?

Do none of the above

The study you are conducting is likely considered to be Human Subjects Research. Will your study involve any of the following procedures?

Normal educational practices in established or commonly accepted educational settings.

Use of educational tests, surveys, interviews, observation of public behavior, or research involving benign behavioral interventions.

Use of educational tests, surveys, interviews, or observation of public behavior if: the human subjects are elected or appointed officials or candidates for public office or; if federal statute requires without exception that the confidentiality of the pe

Collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens if these sources are publicly available of if the information anonymous.

A federally-funded evaluation of a public benefit or service program.

Taste and food quality evaluation and consumer acceptance studies.

None of the above.

During your study, will you interact with, intervene with, or obtain/access private, identifiable information or data about, a person who is considered a minor (under the age of 18)?

Yes

Please answer the following questions about the data being collected:

The subjects can possibly be re-identified, and linking the data to the subjects can be considered harmful (e.g., criminal history, medical history, sexual history, opinion about current employer, etc.)?

The data presents no harm if the subjects were to be re-identified.

Will the data include any of the 18 HIPAA Identifiers?

Name

Address

(all geographic subdivisions smaller than state, including street address, city county, and zip code)

All elements

(except years) of dates related to an individual (including birthdate, admission date, discharge date, date of death, and exact age if over 89)

Telephone numbers

Fax number

Email address

Social Security Number

Medical record number

Health plan beneficiary number

Account number

Certificate or license number

Any vehicle identifiers and serial numbers, including license plate numbers

Device identifiers and serial numbers

Web URL

Internet Protocol (IP) Address

Biometric identifiers, including finger or voice print

Photographic image - Photographic images are not limited to images of the face.

Any other characteristic that could uniquely identify the individual

None of the above

All of the materials and/or data was or will be collected in the:

Past (existed before IRB approval)

Future (will be obtained after IRB approval)

Both

Will any the data that is collected be highly sensitive in nature and identifiable (e.g., criminal history, medical history, etc.)? If you are doing an intervention, will the intervention be invasive in any way?

Yes

Will your study involve any of the following procedures?

Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture.

Prospective collection of biological specimens for research purposes by noninvasive means (e.g., hair and nail clippings, sweat, saliva, etc.).

Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice (e.g., physical sensors, MRI, fMRI, EEG, infrared imaging, etc.).

Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).

Collection of data from voice, video, digital, or image recordings made for research purposes.

Research on individual or group characteristics or behavior, or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

None of the above.

Will the subjects from which you will collect blood from be healthy, non-pregnant adults who weigh at least 110 pounds?

Yes

Will you collect more than 550 ml in an 8 week period and/or collect more frequently than 2 times per week?

Yes

Will the blood collection exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and/or occur more frequently than 2 times per week?

Yes

Are x-rays or microwaves being used to collect the data?

Yes

Will you be using an MRI or fMRI that is located at the Center for Brain Imaging?

Yes

Will you be using an MRI or fMRI that is located at the Center for Brain Imaging?

Yes

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Submission Decision Tree

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Georgia Institute of Technology