IRB FAQ

Amending Study

What kind of changes do I need to submit?

Confidentiality

Consent

What are Waivers of Informed Consent?

Exempt Categories

General

What is a Federalwide Assurance?

Need for Review

Renewing Study

Do I need to renew my protocol if I am only doing data analysis?

Review Process

Special Topics

Submission Process

Does my project involve human subjects?

Who is a human subject?
Within the context of IRB review, a human subject is defined as a living person about whom a researcher obtains data through:
  • Intervention (for example, venipuncture or cognitive tests) or 
  • Interaction (for example, interviews) with the person, or 
  • Identifiable Private Information (for example, observations or private records). A person may be a "human subject" when a researcher obtains data about the person from a third party as well as from the person directly.
What is "intervention"?
An intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.

What is "interaction"?
An 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).

What is “identifiable” information?

In this context, identifiable means that the identity of the subject may readily be ascertained by the investigator or associated with the information obtained as part of the research.

What is “private” information?

There are two kinds of private information included in the federal definition –
  • 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 which the individual can reasonably expect will not be made public, such as a medical or school record
What does "about whom" mean?
In order for a study to be considered human subjects research, the data obtained must be "about" the living individual. In some cases, a researcher may interact or intervene with a living individual, but the purpose is to obtain data about a topic other than the individual. These studies may not be considered human subjects research.

Some examples of research that is NOT considered human subjects research:
  • Asking a nongovernmental organization about its source of funding.
  • Asking an employee to describe the different functions performed by different positions at an organization and communication processes between departments, as long as no private, personally identifiable information is collected about individuals who have filled different positions.
  • Asking a teacher to describe teaching methods or techniques used in the classroom. 
Some examples of research that IS considered human subjects research:
  • Asking a teacher to describe her or his personal experience using different teaching methods or techniques. Note: This would be considered human subjects research even if the overall purpose of the study were about teaching methods.
  • Asking a political scientist who is the strongest candidate in a political race. Note: This opinion question is about the individual because it seeks a general attitude from—that is, something about—the individual; and not a concrete assessment of something within their realm of expertise.
  • The purpose of the research is to determine within-rater reliability. The researchers ask engineers who have used Systems A and B to evaluate the systems (e.g., with instructions to rate each system on a scale of 1 to 10). The researchers perform an analysis that determines the engineers have low within-rater reliability.
To know if you are conducting "human subjects research",  also see Am I conducting research? Human subjects research projects must be reviewed and approved before you begin. 

How long will it take to review my protocol?

Standard Service Level Expectations
These guidelines are based on the understanding that the ORCA office will receive a completed protocol, with all questions answered in a thorough and responsive manner, and all related requirements met. Requirements for IRB may include: CITI training, HIPAA training, EH&S clearance, and Field Study Plan approval. Some types of review may require extra time or additional reviews. If you have a project involving vulnerable populations (such as prisoners, children, or pregnant women), identifiable medical records, deception, collaboration with other institutions, or illegal activities please allow additional time for review. For protocols requiring committee approval, please keep in mind that the IRB committee is comprised largely of academic volunteers who perform these tasks in addition to their other duties. Additional time should be allotted for any committee review, if possible. Submission Instructions Protocol applications are submitted electronically as a single .pdf document to ORCA.

Review Timeline: The time it takes to receive IRB feedback on your application depends on the completeness of the application, the complexity of the research, and the volume of protocols already under review at the time your application is received. Applications are reviewed according to type and date received. The following are estimates only:

  • Exemption Requests: 3-5 weeks
  • Full Protocols (Expedited Review): 6-8 weeks
  • Full Protocols (Full Board Review): 6-8 weeks + IRB meeting scheduling
  • Continuing Review: 2-4 weeks
  • Modifications: 3-5 weeks
We recommend allowing ample time for IRB review and responding promptly to IRB feedback. Final approval/exempt determination is dependent on your timely and sufficient response to comments.

Do student activities require IRB review?

Generally, the IRB definition of "research" does not include student course work or undergraduate honors theses, unless they are to be made available to the public, used by other researchers, or there is a possibility that the research may lead to a formal presentation or publication. See Am I conducting human subjects research? However, if an instructor determines that there is a possibility that a student's proposed research project may result in a formal presentation or publication, he/she should recommend that the student submit the project for IRB review.

Internet-Based Research: Public vs. Private

If individuals intentionally post or otherwise provide information on the Internet, such information could be considered public unless the privacy policies and/or terms of service of the entity receiving or hosting the information indicate that the information should be considered private.
What is considered public on the Internet? Public sites fall into one or more of the following categories:
  • Sites containing information that, by law, is considered public (many federal, state, and local government sites are included in this category: property tax records, birth and death records, real estate transactions, certain court records, voter registration and voting history records, etc.). 
  • News, entertainment, classified, and other information-based sites where information is posted for the purpose of sharing with the public.
  • Open access data repositories, where information has been legally obtained and is made available with minimal or no restriction.
  • Discussion formats that are freely accessible to any individual with Internet access, and do not involve terms of access or terms of service that would restrict research use of the information
However, an individual’s expectation of privacy is not always “reasonable” (see What is considered private information?) and someone may assume that the information provided or available on the Internet about them is private, when it is not. The principle of beneficence may support a more conservative approach. A subject who incorrectly assumed his/her identifiable information was private, or restricted to a small group, might not have posted the information if s/he thought the information would be widely available, believing that the information could be embarrassing or damaging.

Do I need to renew my protocol if I am only doing data analysis?

You may still need to renew your protocol even if you are no longer directly interacting with human subjects. If you still have access to identifiable data, you must continue to renew your protocol until all analyses are complete or all identifiers have been destroyed. Identifiable data include audio/video recordings as well as coded data where the identifier key is retained. If all identifiable data fields have been destroyed and data analysis will be conducted using only de-identified data, no renewal application is necessary and the protocol may be closed.

What kind of changes do I need to submit for approval?

Principal Investigators (PIs) are  responsible for submitting all modifications to the study (adding personnel, funding, sites, populations, survey questions, and anything outside of correcting a typographical error). Amendments must receive UCSC IRB approval before they are implemented unless the change is necessary to eliminate apparent immediate hazards to the subjects. (see Modifications to Previously Approved Research);

Do I need approval from the UCSC IRB or a different IRB?

If you are doing human subjects research at UCSC you will need to submit either an exemption request or a full protocol to be reviewed and approved by the UCSC IRB before the research begins. Please note, there are no provisions for retroactive approval of research protocols. See Collaborative Research for information on which IRB would review for multisite non exempt research.

What is "coded" data?

In the context of Human Subjects research, "coded" means that identifying information (such as name, address, phone number or social security number) of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e. the code); and a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.

What happens after I submit my protocol?

Once ORCA has received your application, you will receive an acknowledgment email.  After that, you should hear back from ORCA within 3-6 weeks with either an approval notification or questions regarding your application.

What if my research involves oral history?

Oral history projects and other activities that consist solely of open-ended qualitative-type interviews are subject to IRB oversight when they involve research, which federal regulations define as "a systematic investigation...designed to develop or contribute to generalizable knowledge."

General principles for evaluating oral history projects

  • Oral history, journalism, biography, literary criticism, legal research, and historical scholarship, including the collection and use of information, that focus directly on the specific individuals about whom the information is collected is NOT considered human subjects research.
    • Example: An oral history video recording of interviews with holocaust survivors is created for viewing in the Holocaust Museum. The creation of the videotape does NOT intend to draw conclusions, inform policy, or generalize findings. The sole purpose is to create a historical record of specific personal events and experiences related to the Holocaust and provide a venue for Holocaust survivors to tell their stories.
  • Systematic investigations involving open-ended interviews that are designed to develop or contribute to generalizable knowledge (e.g., designed to draw conclusions, inform policy, or generalize findings) WOULD constitute "research" as defined by HHS regulations at 45 CFR 46.
    • Example: An open-ended interview of surviving Gulf War veterans to document their experiences and to draw conclusions about their experiences, inform policy, or generalize findings.
  • Oral historians and qualitative investigators may want to create archives for the purpose of providing a resource for others to do research. Since the intent of the archive is to create a repository of information for other investigators to conduct research as defined by 45 CFR 46, the creation of such an archive WOULD constitute research under 45 CFR 46.
    • Example: Open ended interviews are conducted with surviving Negro League Baseball players in order to create an archive for future research. The creation of such an archive would constitute research under 45 CFR 46 since the intent is to collect data for future research.

What do I need to know about raffles, lotteries, or offering a chance to win prizes to participants?

In the State of California, it is illegal to give out a prize by chance in exchange for payment or “valuable consideration,” and participation in research has been interpreted as a type of valuable consideration. Therefore, to avoid violating California’s lottery law, the University of California recommends you

  1. allow the drawing to be entered by anybody who asks, and
  2. allow participants to stay entered in the drawing even if they withdraw.

The protocol should make this clear and subjects should be informed that entry in the raffle or lottery is not contingent on participation in the study.

What are Waivers of Informed Consent?

A waiver of informed consent is a waiver of the requirements to obtain informed consent, or a waiver or alteration of some of the required elements of informed consent.

The UCSC IRB may waive the requirement to obtain informed consent, or it may approve a consent procedure that alters some of the elements of informed consent described above. Before the UCSC IRB does so, the researcher must include sufficient information in the research protocol for the IRB to determine that the waiver requirements have been met. The researcher must show that:

  • The research presents no risks of harm, considering probability and magnitude, greater than those ordinarily encountered in daily life or during the performance of routine examinations or tests; and
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
  • The research could not practicably be carried out without the waiver or alteration; and
  • When appropriate, the subjects will be provided with additional pertinent information after participation; or
  • The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
    • Programs under the Social Security Act, or other public benefit or service programs;
    • 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.

Waiver of Parental Permission

Alternatively, parental permission may be waived based on the above, or under 45 CFR §46.408 (c) if the IRB determines that parental or guardian permission is not a reasonable requirement to protect the subjects, such as in cases of neglected or abused children. In these cases, an appropriate mechanism for protecting the children must be substituted.

Waiver of Documented Consent

In some cases, the consent process is still required but a written consent form may not be appropriate. Examples of such cases include:

  • The research presents no risks of harm, considering probability and magnitude, greater than those ordinarily encountered in daily life or during the performance of routine examinations or tests, and the research involves no procedures for which written consent is normally required outside of a research context.
  • Research participants are not literate.
  • Participants live in a community where signing documents is looked at with suspicion.
  • In situations where the consent form is the only link to participation in study (further outlined below).

The UCSC IRB may waive the requirement for the researcher to obtain signed written consent for some or all subjects. Before the UCSC IRB does so, the researcher must satisfy the UCSC IRB requirement that either:

  • The only record in the researcher's possession linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. The UCSC IRB requires that each subject be asked whether they want documentation linking them with the research, and the subject's wishes will govern; OR
  • The research presents no risks of harm, considering probability and magnitude, greater than those ordinarily encountered in daily life or during the performance of routine examinations or tests, and the research involves no procedures for which written consent is normally required outside of a research context.

When the documentation requirement is waived, the UCSC IRB requires that the researcher provide subjects with a written or oral statement (or 'script') containing the elements of informed consent, when appropriate.

Is an institution engaged or not engaged in research on my project?

In general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research. 

More specifically, an institution is engaged in research when any of the following apply:

  • The institution is the awardee institution for a non-exempt human subjects research project, even if all activities will be carried out by employees or agents of another institution. 
  • An employee or agent of the institution intervenes with human subjects for research purposes through 
  • Invasive or noninvasive procedures (see examples below)
  • Manipulating the environment  (see examples below)
  • Interacting with any human subject of the research (see examples below)
  • Obtaining informed consent 
  • Obtaining identifiable private information or identifiable specimens, even if there is no direct interaction with human subjects (see examples below)
Examples

Examples of invasive or noninvasive procedures include:

  • drawing blood; 
  • collecting buccal mucosa cells using a cotton swab;
  • administering individual or group counseling or psychotherapy;
  • administering drugs or other treatments; 
  • surgically implanting medical devices; 
  • utilizing physical sensors; 
  • utilizing other measurement procedures. 

Examples of manipulating the environment include:

  • controlling environmental light, sound, or temperature;
  • presenting sensory stimuli; 
  • orchestrating environmental events or social interactions.

Examples of interacting include:

  • engaging in protocol dictated communication or interpersonal contact; 
  • asking someone to provide a specimen by voiding or spitting into a specimen container; 
  • conducting research interviews or administering questionnaires. 

Obtaining identifiable private information or identifiable specimens includes, but is not limited to:

  • observing or recording private behavior; 
  • using, studying, or analyzing for research purposes identifiable private information or identifiable specimens provided by another institution; and 
  • using, studying, or analyzing for research purposes identifiable private information or identifiable specimens already in the possession of the investigators 

See also Do I need approval from the UCSC IRB or a different IRB? and Collaborative Research.

For more information about identifiable information, see What is considered identifiable information?

For more information about what it means to be engaged or not engaged in research, see the Department of Health and Human Services Guidance on Engagement of Institutions in Human Subjects Research.

What is a Federalwide Assurance?

Under a Federalwide Assurance (FWA, or "Assurance"), an institution commits to the Department of Health and Human Services (DHHS) that it will comply with the requirements for human subjects research set forth in 45 CFR 46 and the Terms of Assurance. In general, if an institution receives federal funding for human subjects research, they will hold an assurance. A searchable database of assurances is available at the Office for Human Research Protections.

UCSC's Federalwide Assurance number is FWA00002797.

If you are engaged in research with another campus within the UC system, see Collaborative Research. 

What should I consider when completing a non-exempt protocol application? 

Please review the IRB’s Submission Guide for tips on what to include in your application.

What if a question on the IRB application form does not apply to my study?

If a question does not apply, please write ‘NONE’ or N/A or explain why it does not apply.

I want my project to start as soon as I get approval. What do I put for the start date?

If you want to start your research as soon as your protocol is approved, put "upon approval" for the project start date.

Who should be listed as an investigator (questions 1 and 2)?

List all personnel that will be intervening or interacting with human subjects or with their personally identifiable data. 

All human subjects investigators are required to be listed on the approved IRB application. For new investigators added after the initial approval of a project, an amendment to the IRB protocol must be submitted and approved before any new investigators may commence work on a non-exempt human subjects protocol.

Definition of investigator

A person listed as an investigator in the IRB application is "an individual who is interacting and/or intervening with human subjects or handles personally identifiable data of a human subject". The HHS regulations at 45 CFR 46 use the term “investigator” to refer to an individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB. Investigators can include professors, scientists, administrative staff, teachers, and students, among others.

Examples of human subjects research activities include:

  • obtaining information about living individuals by intervening or interacting with them for research purposes
  • obtaining identifiable private information about living individuals for research purposes
  • obtaining the voluntary informed consent of individuals to be subjects in research
  • studying, interpreting, or analyzing identifiable private information or data for research purposes
Examples of involvement that would not need to be listed include:
  • laboratory personnel receiving de-identified samples for analysis
  • collaborators at other institutions who are receiving survey responses that do not include identifiers
  • administrative personnel assisting with logistics who do not have access to study data

What if I don't know who all the investigators will be yet (e.g. I am in the process of recruiting or I will be assigned research assistants later on)?

Any research personnel not identified on the original protocol will need to be added through an amendment. This modification must be approved before any new research personnel are permitted to work on the project. See Modifications to Previously Approved Research.

What should be included in the recruitment section (question 8)?

Describe what materials and methods will be used for recruiting subjects. Describe how human subjects will be contacted in the first instance, by whom, and what they will be told. Attach the recruitment script to the application, if applicable. For the purposes of recruitment, researchers should not have access to any personally identifiable private information about a prospective participant without their consent.

What qualifies as a "risk" for the purposes of this form (question 16)?

A subject is considered at risk in research if she or he may be exposed to a possibility of harm that is greater than that ordinarily encountered in daily life or during routine examinations or tests. Please use your best judgement and consider both the magnitude of potential risk and how likely it is that participants will experience the risk. When conducting research with potentially vulnerable groups, including children and pregnant women, federal guidelines mandate the potential risks receive heightened scrutiny. Additionally, if any research protocols include a risk that participants will experience emotional distress, UCSC guidelines outline that the PI must provide all subjects with information about available mental health resources.

What is meant by the terms "confidential," "de-identified," "coded," and "anonymous" (questions 20-22)?

The terms confidential, de-identified, coded, and anonymous describe distinct practices and methods related to subjects' participation in research and the collection and storage of participant data.

Participation in research

  • An individual’s participation in a research project can be described asanonymous when no one, including the research team, can identify her or him as a participant. 
  • An individual's participation is considered confidential when the research team knows the individual's identity but is obligated not to disclose that information to others outside of the team (except as clearly described in the research protocol and consent document).

Data collection and storage

  • Data are anonymous when no one, including the research team, can connect the data to the individual participant (i.e. no personally identifying information is collected). Keep in mind that even when researchers do not collect direct personal identifiers such as name or student ID number, collection of indirect identifiers, taken in combination, might make it possible for someone to identify an individual participant from among a pool of subjects - for example, academic department and ethnicity.
  • Data are confidential when there continues to be a link between the data and the individual who provided it, but the research team is obligated to protect the data from disclosure outside of the research team (except as clearly described in the research protocol and consent document). In order to protect against accidental disclosure, the subject’s name or other identifiers should be stored separately from their research data. In the research data, the identifiers can be replaced with unique codes. Even when data are coded, they are not anonymous because it is still possible to link the codes to identifiable data.
  • Data are considered de-identified when any direct or indirect identifiers linking the data to the individual subject’s identity are destroyed.

(source: adapted from http://www.irb.umich.edu/policies/anonymous.pdf)

What should be included in the financial aspects section (question 27)?

Any costs to subjects that may result from participation in the research should be described (e.g. parking fees, transportation, child care). If remuneration or payment is offered, details should be provided regarding the amount and the proposed method of payment, as well as the researcher's reasons for believing that this payment is unlikely to unduly influence the subject's decision to participate, and that distribution is equitable. Payment should not be contingent upon completion of the study (although it may be prorated) and participants should be permitted to skip any questions or steps that they are uncomfortable with, without forfeiting remuneration. 

Why does the IRB need so much detail about the study?

Providing information with a high level of detail is necessary so that IRB reviewers can make an informed decision about potential risks to participants and promote compliance with federal guidelines for human subjects research. Completing this process can also help researchers carefully evaluate procedures prior to beginning research.

What is "identifiable" information?

Personal identifiers
For most human subjects research purposes at UCSC, personal identifiers include the following:
  • names
  • photographs 
  • audio or video recordings
  • social security numbers
  • student ID numbers
  • email addresses
  • codes that link unidentifiable data to identifiers
Information is also considered identifiable if there is enough information being collected to allow a subject's identity to be deduced. 
 
Indirect identifiers
There are instances where an investigator may not be collecting any direct identifiers, such as names, but will be collecting enough indirect information about a group of people that a person familiar with the group could potentially identify subjects, or that information could be combined in such a way as to ascertain subjects' identities.
 
For example:
  • A researcher collects both academic department and ethnicity at a university with a small number of ethnic minorities.
  • A researcher collects demographic information about a group of employees at a small company. 
  • A researcher records the age, rank, and years of service of a group of Marines who served in a small base in Afghanistan in 2012.
No identifiers
If no identifiable information (including audio and video recordings) is being collected, then the research is considered anonymous and respondents' identities are protected.

Exempt Category 1: Educational Practices

Research conducted in established or commonly accepted educational settings that involves normal educational practices, such as (a) research on regular and special education instructional strategies or (b) research on the effectiveness of or the comparison among institutional techniques, curricula, or classroom management methods. 

As noted above, research must be conducted in "established or commonly accepted educational settings" and involve "normal educational practices" to be exempt under this category.

Commonly accepted educational settings include but are not limited to K-12 schools and college classrooms. They may also include after-school programs, preschools, vocational schools, alternative education programs, and other sites where educational activities regularly occur.

Normal educational practices include established teaching methods, curriculum content and commonly accepted classroom managment techniques that are planned and implemented by the classroom teacher. Normal educational practices are activities that would occur regardless of whether the research is conducted. Thus, a study that evaluates a radically new instructional strategy or curriculum, or that randomly assigns students to different instructional strategies/curricula for comparison, would probably not be exempt, since these are not "normal educational practices." Studies that involve surveys and interviews with minors that are outside of "normal educational practices" also do not qualify for exemption.

Examples of Research Exempt under Category 1

A study evaluating the effectiveness of a commonly accepted science curriculum. For the study, researchers will observe classroom instruction and collect quizzes and class evaluations that are part of the curriculum and classroom practices

A study comparing two curricula that are currently being implemented in a school. Researchers will observe classrooms as well as interview instructors about their experiences implementing the instructional materials (but not about specific students).

A study comparing driver's education curricula offered by area driving schools. The researcher will observe classes and compare driving test scores at the end of the courses.

For more information, consult our FAQ handout.

Exempt Category 1: What is a commonly accepted educational setting?

In the context of Category 1 exemptions, commonly accepted educational settings include but are not limited to K-12 schools, college classrooms, after-school programs, preschools, vocational schools, alternative education programs, and other sites where educational activities regularly occur.

Exempt Category 1: What is a normal educational practice?

In the context of Category 1 Exemptions, normal educational practices are established teaching methods, curriculum content and commonly accepted classroom management techniques that are planned and implemented by the classroom teacher.
 
Normal educational practices are activities that would be occurring regardless of whether or not the research is conducted. Therefore, a study that evaluates a new instructional strategy or curriculum, or that randomly assigns students to different instructional strategies/curricula for the purpose of comparison, would probably not be exempt because these are not considered normal educational practices.

Exempt Category 1: What if my educational research involves videotaping?

The exemption criteria for Category 1 says nothing specific about videotaping. Videotaping may be permissible in a Category 1 exemption, so long as the research will be taking place in a commonly accepted educational setting and will be examining normal educational practices. However, researchers should review and adhere to the school's or other educational institution's policies on videotaping students and classroom instruction.  

Exempt Category 2: Educational Tests

Research involving these procedures is exempt if:

(a) Information obtained is recorded in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subject;

OR

(b) any disclosure (including accidental disclosure) of the human subjects’ responses outside the research could not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

This exempt category applies only to the activities listed above. Public behavior refers to behavior taking place in a publicly accessible location in which the subject does not have an expectation of privacy (e.g., a public plaza or park, a street, a building lobby, a government building). If subjects have a reasonable expectation of privacy at the location where the researcher is conducting the observation, the project may not be considered exempt.

EXCEPTION: This exemption does not apply to research with children, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.

The research must meet either of the following two conditions to qualify under Category 2:

(a) The data is collected anonymously (which means that no identifiers can be connected to the data, either directly or through a coding system). In addition to videotapes and photographs, audio recordings are considered to be identifiable; therefore any data collection that involves audio recordings, video recordings, or photographs of subjects would not be considered anonymous. It is also possible that 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.

(b) The information collected is not anonymous (because, for example, the researcher has a key linking respondents' names to coded identifiers), but the information is so innocuous that, in the event of disclosure outside of the research, there would be no significant detrimental consequences to the subject. The significance of "detrimental consequences" depends in part on context. For example, including a question about sexual identity in an interview study that investigates adults' plans to change careers could be non-controversial --and exempt-- in some locales, but highly sensitive --and non-exempt-- in other places.

Examples of Research Exempt under Category 2:

  • A study involving an anonymous survey regarding workplace satisfaction at area firms.
  • An observational study of pedestrians crossing a street; the researcher takes notes of what occurs, recording sex, race, and type of clothing of pedestrians, but does not interact with subjects.
  • A study involving interviews with college seniors (age 18 and older) about their plans after graduation. The answers to questions asked would present no risks to subjects if divulged outside the research.
  • A study involving focus groups with expectant mothers regarding their perceptions of parenting education.

For more information, consult our FAQ handout.

Special thanks to UC Berkeley's Committee for the Protection of Human Subjects for generously allowing us to borrow information from their website for this page.

Exempt Category 4: Existing Data 

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:

(i) The identifiable private information or identifiable biospecimens are publicly available;

(ii) 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.

To qualify for this exemption, although researchers have access to private identifiable data, the data must be recorded in such a way that the information can no longer be connected to the identity of the subjects. This means that the abstracted data set does not include direct identifiers (names, social security numbers, addresses, phone numbers, etc.) or indirect identifiers (codes or psuedonyms that are linked to the subject's identity).

Category 4 is used when researchers have access to private identifiable information (e.g., medical records, etc.) but are able to record the data with no codes or identifiable information to have an anonymized dataset.