Although exempt research is exempt from some of the federal regulations, in most cases of interaction with participants, a consent process is indicated. It’s important to understand that even though consent may not be documented with a signature, as is the case with much of exempt research, consent is still being obtained. For example, when a consent script that contains basic elements of consent is used for a phone survey, the participant may choose whether or not to proceed with the survey based on the information provided. That is consent; it is not implied.
- Title of Study or the UAB IRB Project Number (IPN) assigned to the study
- Purpose of the research and procedures of the research
- Participation is voluntary
- That the activities involve research
- Confidentiality of the responses and/or anonymity of the process
- Costs and payment, only if applicable
- Alternatives, if needed (e.g., students not participating may be doing something else while others complete the study)
- Employee or student language from UAB IRB’s Sample Consent, if applicable.
- Approximate time of participation
- Contact information for the Principal Investigator, including phone number
- Contact information for the UAB IRB, as follows: If you have questions about your rights as a research participant, or concerns or complaints about the research, you may contact the UAB Office of the IRB (OIRB) at (205) 934-3789 or toll free at 1-855-860-3789. Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday through Friday.
NOTE: Except for the last item, this list is not intended as the text you should use in your document. Rather, these are the consent items that should be addressed, using language appropriate to your specific research, setting, and participants.
- An email containing a link to a survey
- An Information Sheet handed out at the beginning of an interview session
- A phone script for a phone survey
- An Information Sheet sent home to parents regarding an educational intervention
- The landing page to an online survey that provides the required research information
- A letter sent to participants asking if they’d like to attend a focus group
The Regulatory Citation and How It Applies:
“Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for the use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.” [§46.104(d)(6)]
SPECIAL INFORMATION
Taste and food quality evaluation studies conducted under this exemption may not involve the consumption of any type or volume of food that would present any risk to the subjects and should fall into what would be considered reasonable eating behaviors by the subject.
Research involving the consumption of alcohol, vitamins, and nutritional supplements does not qualify for exempt status because these items are not considered “foods.”
This category may be applied to research involving children; however, written parental consent to include children in taste testing studies is required. Inclusion of children in Food Quality and Consumer Acceptance Studies may pose greater than minimal risk to participants and may require Expedited or Full IRB review.
EXAMPLES
- A taste-test on different varieties of a fruit to determine customer preference, when the fruits do not have any additives and subjects are asked to indicate which fruit they prefer.
- A study that involves taste-testing of various beef products from cattle that have been given feed with a chemical additive. If the researcher can document that the amount of the additive was at or below the levels approved by the USDA, the research may qualify for an exemption.
- Consumer acceptance study of various brands of frozen meals that could be readily purchased.
The Regulatory Citation and How It Applies:
“Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
(i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects. [§46.104(d)(5)]
Exemption Category 5 only applies to research on public benefit programs (e.g., Social Security) conducted by or subject to the approval of the federal government and is rarely applied to research at UAB. Research and demonstration projects in general (e.g., state or city funded public service programs) do not fit under this exempt category.
As described in federal guidance, all of the following criteria must be satisfied.
- The program under study delivers a public benefit or service.
- The project must be conducted pursuant to specific federal statutory authority.
- There must be no statutory requirement that the project be reviewed by an IRB.
- The project does not involve significant physical invasions or intrusions upon the privacy of participants.
- The funding agency concurs with the exemption.
DEFINITIONS
SPECIAL INFORMATION
EXAMPLES
- The federal Department of Housing and Urban Development (HUD) is charged by Congress with providing periodic reports about the effectiveness of a federal housing subsidy program, as indicated by perceptions of individuals about the procedures and time required to qualify for the program. HUD contracts with a UAB researcher to collect the data for the report.
The Regulatory Citation and How It Applies:
Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
- The identifiable private information or identifiable biospecimens are publicly available;
- Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
- The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of ‘‘health care operations’’ or ‘‘research’’ as those terms are defined at 45 CFR 164.501 or for ‘‘public health activities and purposes’’ as described under 45 CFR 164.512(b); or
- The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.” [§46.104(d)(4)]
Secondary research uses of identifiable, private information or identifiable biospecimens for which consent is not required is exempt under this category if at least one of the following is true:
- Part i: The identifiable private information or identifiable biospecimens are publicly available.
In most cases, publicly available datasets or biospecimens are de-identified and qualify for review under Not Human Subjects Research (NHSR). This exemption allows that some public datasets do in fact, contain private, identifiable data (e.g., Wikileaks). Use of this exemption will be fairly rare.
- Part ii: Use of Information or biospecimens, which may include some identifiers, but is not readily identifiable.
The data or biospecimens obtained may contain dates (date of birth, date of graduation, date of event, etc.) and geographic locations except street address. However, if these data in combination with other factors in the dataset or when combined with other available datasets allow the identity of the participant to be ascertained, the research will not meet this Category 4 exemption criteria.
Names, email address, phone/fax number, street address, SSN, medical record number, health plan beneficiary number, account numbers, certificate or license numbers, vehicle identifiers and serial numbers, device identifiers and serial numbers, biometric identifiers (e.g., fingerprint), URLs, IP addresses, or full photographic images are not allowed under part ii of this exemption.
If your data or biospecimens contain another variable from the paragraph above that you feel does not render the data any more readily identifiable than the two variables noted above, describe the variable and provide justification for why the variable fits this criteria. The reviewer will consider this justification in their evaluation of the project.
- Part iii: Use of Information or biospecimens regulated by HIPAA
The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under HIPAA regulations, for the purposes of health care operations, research, or public health activities and purposes (as those purposes are described in the HIPAA regulations).
- Part iv: Research conducted by or on behalf of the federal government using information generated or collected by the government for non-research purposes, when the information is subject to other regulatory protections for data confidentiality.
- FISMA
- Information covered under the Privacy Act of 1974
- Information subject to the Paperwork Reduction Act of 1995
DEFINITIONS
Secondary means the re-use of identifiable information and identifiable biospecimens that are collected from some other “primary” or “initial” activity. In other words, data that were not collected for the purpose of the specific proposed study.
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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
Publicly available (Part i) describes identifiable information or biospecimens that are available from public entities such as the following:
- Libraries
- Online data repositories if the only requirement for obtaining the information is paying a user fee, registering, or signing in as a visitor. If access to the data is “limited” or “restricted,” then the data set is likely not “publicly available.”
- Government or other institutional records where public access is provided on request.
- Information/biospecimens from a commercial entity available to anyone on request for a fee.
SPECIAL INFORMATION
- Online datasets are typically categorized as either Public or Restricted.
- Publicly available datasets often have no identifying information stored in the dataset and do not require any special effort on behalf of the investigator to obtain the data. The general public can get the data/biological specimens with minimal effort and the data are available to anyone regardless of occupation, purpose, or affiliation. These data often fit the criteria for Not Human Subjects Research.
- Restricted datasets generally require a Data Use Agreement (DUA) to be completed by the investigator.
- Your application must differentiate clearly as to whether the data are publicly available or restricted/limited use from a commercial or online source.
- The onus for documentation of the contents of the dataset and/or documentation of the applicability of it to the Category 4 exemption is the responsibility of the investigator.
- Many national biorepositories only offer coded and deidentified specimens, and these biospecimens likely fit the criteria for Not Human Subjects Research.
- If the biospecimens are identifiable in some way, a Material Transfer Agreement (MTA) and/or DUA may be required to obtain them.
- As with the above, MTAs, DUAs, or other agreements may need to be in place.
- The onus for documentation of the contents of the dataset and the source is the responsibility of the investigator.
- If from an existing UAB study, obtain the following documentation:
- Permission to use the data from the Principal Investigator and a description of the information/biospecimens (including any identifiable information provided).
- Documentation from the study (e.g., a copy of the consent form) that the participant allowed for the sharing of identifiable data/specimens.
- If the source study is covered via HIPAA regulations, a Waiver of HIPAA Authorization must be submitted to the OIRB.
- Most simple medical record reviews will be allowable under this exemption.
- Submit a Waiver of HIPAA Authorization to the OIRB with your submission if the number of records is large enough that is not practicable to obtain authorization from each patient whose data will be used.
Category 4 - Secondary Use of Data
The Regulatory Citation and How It Applies:
Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
- The identifiable private information or identifiable biospecimens are publicly available;
- Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
- The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of ‘‘health care operations’’ or ‘‘research’’ as those terms are defined at 45 CFR 164.501 or for ‘‘public health activities and purposes’’ as described under 45 CFR 164.512(b); or
- The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.” [§46.104(d)(4)]
Secondary research uses of identifiable, private information or identifiable biospecimens for which consent is not required is exempt under this category if at least one of the following is true:
- Part i: The identifiable private information or identifiable biospecimens are publicly available.
In most cases, publicly available datasets or biospecimens are de-identified and qualify for review under Not Human Subjects Research (NHSR). This exemption allows that some public datasets do in fact, contain private, identifiable data (e.g., Wikileaks). Use of this exemption will be fairly rare.
- Part ii: Use of Information or biospecimens, which may include some identifiers, but is not readily identifiable.
The data or biospecimens obtained may contain dates (date of birth, date of graduation, date of event, etc.) and geographic locations except street address. However, if these data in combination with other factors in the dataset or when combined with other available datasets allow the identity of the participant to be ascertained, the research will not meet this Category 4 exemption criteria.
Names, email address, phone/fax number, street address, SSN, medical record number, health plan beneficiary number, account numbers, certificate or license numbers, vehicle identifiers and serial numbers, device identifiers and serial numbers, biometric identifiers (e.g., fingerprint), URLs, IP addresses, or full photographic images are not allowed under part ii of this exemption.
If your data or biospecimens contain another variable from the paragraph above that you feel does not render the data any more readily identifiable than the two variables noted above, describe the variable and provide justification for why the variable fits this criteria. The reviewer will consider this justification in their evaluation of the project.
- Part iii: Use of Information or biospecimens regulated by HIPAA
The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under HIPAA regulations, for the purposes of health care operations, research, or public health activities and purposes (as those purposes are described in the HIPAA regulations).
- Part iv: Research conducted by or on behalf of the federal government using information generated or collected by the government for non-research purposes, when the information is subject to other regulatory protections for data confidentiality.
- FISMA
- Information covered under the Privacy Act of 1974
- Information subject to the Paperwork Reduction Act of 1995
DEFINITIONS
Secondary means the re-use of identifiable information and identifiable biospecimens that are collected from some other “primary” or “initial” activity. In other words, data that were not collected for the purpose of the specific proposed study.
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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
Publicly available (Part i) describes identifiable information or biospecimens that are available from public entities such as the following:
- Libraries
- Online data repositories if the only requirement for obtaining the information is paying a user fee, registering, or signing in as a visitor. If access to the data is “limited” or “restricted,” then the data set is likely not “publicly available.”
- Government or other institutional records where public access is provided on request.
- Information/biospecimens from a commercial entity available to anyone on request for a fee.
SPECIAL INFORMATION
- Online datasets are typically categorized as either Public or Restricted.
- Publicly available datasets often have no identifying information stored in the dataset and do not require any special effort on behalf of the investigator to obtain the data. The general public can get the data/biological specimens with minimal effort and the data are available to anyone regardless of occupation, purpose, or affiliation. These data often fit the criteria for Not Human Subjects Research.
- Restricted datasets generally require a Data Use Agreement (DUA) to be completed by the investigator.
- Your application must differentiate clearly as to whether the data are publicly available or restricted/limited use from a commercial or online source.
- The onus for documentation of the contents of the dataset and/or documentation of the applicability of it to the Category 4 exemption is the responsibility of the investigator.
- Many national biorepositories only offer coded and deidentified specimens, and these biospecimens likely fit the criteria for Not Human Subjects Research.
- If the biospecimens are identifiable in some way, a Material Transfer Agreement (MTA) and/or DUA may be required to obtain them.
- As with the above, MTAs, DUAs, or other agreements may need to be in place.
- The onus for documentation of the contents of the dataset and the source is the responsibility of the investigator.
- If from an existing UAB study, obtain the following documentation:
- Permission to use the data from the Principal Investigator and a description of the information/biospecimens (including any identifiable information provided).
- Documentation from the study (e.g., a copy of the consent form) that the participant allowed for the sharing of identifiable data/specimens.
- If the source study is covered via HIPAA regulations, a Waiver of HIPAA Authorization must be submitted to the OIRB.
- Most simple medical record reviews will be allowable under this exemption.
- Submit a Waiver of HIPAA Authorization to the OIRB with your submission if the number of records is large enough that is not practicable to obtain authorization from each patient whose data will be used.
IMPORTANT NOTE ABOUT STORAGE AND TRANSMISSION OF PROTECTED HEALTH INFORMATION (PHI) AND SPECIMENS CONTAINING PHI:
EXAMPLES
- A study involving the analysis of public officials’ leaked emails currently available via Wikileaks.
- A UAB researcher would like to analyze an existing study’s dataset for barriers to healthcare. The research involves geocoding participants’ to the nearest dialysis center. The PI of the source study provides zip codes and kidney disease status to the investigator.
- An analysis of biospecimens from a UAB IRB-approved biorepository that contain the date of specimen collection and are accompanied by the date of birth, smoking status, and clinical data regarding cancer diagnosis. Participants in the biorepository agreed to allow for sharing of some identifiers with other researchers.
- A review of national Census data that contains zip codes.
- A medical record review of clinical data for 20010-2018 with continued data collection yearly.
- An analysis of biospecimens from an IRB-approved biorepository.
- A medical record review of UAB clinical data, with a follow up phone call to the participant to obtain missing information needed to conduct the analysis. This research is not eligible for Category 4 exemption as it involves direct data collection from the participant.
- Research involving the collection of an extra biopsy sample for evaluation for research purposes. This research involves direct data collection and will also require consent from the participant. Therefore this research is not allowed under Exempt Category 4.
- Evaluation of secondary, recorded data from a series of interviews with truckers and commercial drivers regarding their adherence to rest/sleep requirements while on the road. Drivers used their own names in the interviews. Although secondary in nature, this research contains identifiable data and is not regulated under HIPAA or those regulations in Part iv.
FAQs Regarding Exempt Category 4
The Regulatory Citation and How It Applies:
“Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
A. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;B. Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; orC. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review.” [§46.104(d)(3)]
Limited Review
- The information is recorded anonymously (Part A).
-
The information is recorded with identifiers but the research would not place the participant at risk (Part B).
Definitions
- No identifiers can be connected to the data, either directly or through a coding system.
- Video/audio recordings and photographs are not considered anonymous.
- Multiple pieces of information, none of which are identifiable on their own, may uniquely identify a person when brought together; in this case, the data would be identifiable and would not be considered anonymous.
- brief in duration
- harmless
- painless
- not physically invasive
- not likely to have a significant adverse lasting impact on the participant
- the investigator has no reason to think the participants will find the interventions offensive or embarrassing.
Brief in duration means no more than a few hours in a single day.
SPECIAL INFORMATION
EXAMPLES
- A study asking nurses to watch a one-minute video on handwashing and then mail in an anonymous survey about their handwashing practices over the following week.
- Research involving the placement of a diabetes education pamphlet in a clinic and asking patients in the waiting room to complete a pre-/post test after reviewing the pamphlet to determine increase in diabetes knowledge. Participants placed completed pre/post surveys in an envelope in a locked, slotted box in the waiting room when done. No identifiable data was collected.
- A study asking graduate students to browse a popular social networking site and then time their efforts to solve a complex word puzzle.
- Randomly assigning diners to be provided either a suggested tip or no suggested tip after their meal, and are then provided a survey regarding their experiences. Participants are told about the study and informed that certain aspects of the study will be revealed to them only at the conclusion of the survey.
- Healthy adult participants are asked to take part in two 1-hour-long assessments of memory, attention and information processing speed before and after 1 hour of cognitive enhancement exercise using specially designed computer software. The procedures are conducted during a single visit, and subjects are encouraged to take breaks when desired.
- A study involving interviews with college seniors (age 18 and older) about their career plans after reviewing a documentary on job growth in various sectors. The researcher will record their date of birth and give the participant an algorithm to create a unique code (e.g., the last 4 digits of your cell phone number plus the first four letters of your mother’s maiden name).
- A group of expectant mothers are asked to screen educational material regarding post-partum depression and are interviewed regarding their understanding of post-partum depression.
- Participants are given a diabetes education pamphlet and asked to perform video-recorded testing based on their recollection of the information provided.
- A study involving the videotaping of pedestrians’ behavior when the timing of a public Walk/Don’t Walk is manipulated. This involves a benign behavioral intervention; however, participants could not prospectively agree.
- A study involving a month-long music intervention at a retirement home with a pre-test and then a follow up survey a month after the intervention ended. The study is a benign behavioral intervention but is not brief in duration.
- Recordings of blood pressure and pulse are obtained along with the collection of a saliva specimen for the measure of cortisol level from adult subjects in a study linking physiological arousal to cognitive performance on a standard series of computer games. The procedures last 75 minutes. The data collection methods described in this research are not allowable under Exemption Category 3.
- College students take part in a study involving computer simulation of an online dating app in which each student is ultimately rejected by a prospective date who is in fact a member of the study team. The students are asked to agree to the research and are told that aspects of the research goals and methods are being withheld from them until after their participation. This study could involve embarrassment for the participant and is, therefore, disallowed under Exemption 3.
FAQs Regarding Category 3 Exemption