Additional Guidance

The Common Rule allows the involvement of prisoners if they are not a specific study population – that is, the research is aimed at a broader subject population that only incidentally includes prisoners. In addition, the Preamble to the Revised Common Rule states that subjects may continue their participation in exempt research if they become prisoners after beginning their participation.

For studies that qualify for the UW Flexibility Policy (GUIDANCE Authority and Responsibilities of HSD and UW IRB), research that focuses on prisoner records is allowable if it meets the criteria for an appropriate exempt category. No research involving interactions or interventions with prisoners qualifies for exempt status.

Additional Guidance

Deception includes deceiving the subjects about the nature or purpose of the research.

Conditions of deception or concealment means: the nature of the deception or concealment; how likely it is that the subjects will learn of the deception or concealment; the nature of any de-briefing; how likely it is that anyone outside the research team would learn results about a subject that could cause them distress.

The HSD policy named above is based on the recommendations of the Secretary’s Advisory Council on Human Research Protections (SACHRP) as described in the minutes for SACHRP’s meeting held on March 8-9, 2011, Attachment E, “The Use of Deception in Research”.

HSD policy does not require subject de-briefing unless the HSD reviewer determines that a de-briefing is necessary in order to reduce the risk level to no more than minimal risk.

Examples of research that may or may not be exempt

• A study that involves interviews and the secondary analysis of research data recorded without identifiers may qualify for exempt status because the research activities are described in exempt categories 2 and 4.
• A study that involves interviews and blood draws will not qualify for exempt status because while interviews are described in exempt category 2, a blood draw is not an activity described in the categories of exempt research.
• The first phase of a two-phase study involves only surveys and interviews. The second phase involves surveys, interviews, chart reviews, blood draws, and MRIs. The first phase may qualify for exempt status because interviews are included in the categories of exempt research, but the second phase will not. HSD staff may review the first phase as a stand-alone project and issue a determination of exempt status. The second phase could later be submitted as a modification, or as a separate IRB application, requiring IRB review.

Additional Guidance

Established or commonly accepted educational settings are settings where one would go to have an educational experience that is regularly offered in the location where the research will be conducted or that is commonly accepted in a specific culture or population. This could include a wide variety of traditional and nontraditional settings if they are established or commonly accepted, such as:

• Public or private schools and classrooms offering K-12 education, college degrees or technical vocational instructions and certifications
• After school clubs or programs, vocational schools, alternative education programs
• Boy or Girl Scout meetings
• Professional development seminars or programs (e.g., Toastmasters)
• Driver education programs or schools
• Education in applied settings (e.g., grocery stores that offer cooking or nutrition classes; bicycle shop that offers bicycle repair and maintenance classes; woodworking techniques instruction offered in a community “maker space”; skills development programs in children’s summer camps)
• Distance and online educational programs
• Internships and study abroad programs

Normal educational practices are activities that could occur in the specific educational setting regardless of whether the research is conducted. This includes a variety of activities that normally occur in the classroom or that are considered “best practice”. Examples include established teaching methods (not considered to be experimental) or curriculum, and commonly accepted classroom management techniques that are planned and implemented by the classroom teacher.

• Examples that would likely be considered normal educational practice:
  • 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 practice.
  • Comparisons of curricula, different instructional methods, or classroom management techniques that are currently being implemented in a school. Researchers will observe a classroom as well as interview instructors about their experiences implementing the instructional materials or methods (but not interview specific students).
  • A study comparing driver’s education curricula offered by area driving schools. The researcher will observe and compare group driving test scores at the end of the course.
  • Evaluation of student attitudes toward learning.
• Examples that are generally not considered to be normal educational practice:
  • Research that involves deception because deception is not a normal education practice.
  • Collecting privileged or sensitive personal information for research purposes.

Tribal consultation. The Preamble to the Revised Common Rule states that, “where appropriate or mandated by tribal law, tribal consultation should take place”. HSD interprets this to apply to research that will occur in a tribal setting (e.g., at a school on tribal land) or in an educational setting where the majority of the students are Native American or Alaskan Native. There is nothing that prohibits tribal consultation in other circumstances as well, if appropriate.

Additional Guidance

Risk and risk mitigation. Although it is conceivable that there may be psychological risks to participating in surveys or interviews, or situational risks where awareness that someone was surveyed or interviewed poses a risk, the assumption for this category is that the potential risks are largely informational. It is reasonable to expect that individuals will understand that actively providing responses to educational tests, surveys, or interview procedures constitutes agreement to participate and that the risks associated with their participation are related to disclosure of the information they provide. Thus, the most important role the IRB (or other determination body) might play in reducing potential harm is to ensure appropriate privacy and confidentiality safeguards.

Limited IRB review. For details review the section on limited IRB review below.

Protected and vulnerable populations. There are no restrictions on the involvement of pregnant women. Research in this category must comply with the general restriction on the involvement of prisoners (General Exclusions from Exemptions). Children may not be involved in this category as described above.

Survey means the collection of information about individuals through questionnaires or similar procedures. It does not include the collection of biospecimens.

Public behavior means behavior taking place in a publicly accessible location in which the subject does not have an expectation of privacy. Examples of location include: a public plaza or park, street, building lobby or sections of a government building that are open to the public, some websites and social media sites. The Preamble to the Revised Common Rule states that the public behavior must not be influenced by the investigator and cannot involve an intervention. For examples, research involving observation of public behavior does not qualify for this exemption if the investigator intervenes with the subject by offering them a supposedly lost wallet to see if they will accept it.

Intervention. The use of an intervention is not allowed. The Preamble to the Revised Common Rule states that interventions that are distinct from the information collection methods allowable under this exemption do not satisfy the conditions of this exemption. It notes, however, that educational tests may include exposing test takers to certain materials as part of the test, and that such materials do not constitute interventions distinct from the test.

• Examples of activities that are not interventions, because the activities are not distinct from data collection:
  • A reading comprehension test that directs subjects to read a passage and then answer questions about it
  • A geography test that presents a map to the subjects and asks them to draw information from the map
  • Survey that contain some information about which the subjects are asked questions
• Examples of activities that are interventions:
  • Randomly assigning students to take an education test in a quiet room or a room with moderate noise
  • Randomly assigning students to consume a snack (or not) before taking a test
  • Surveys or interview in which the purpose is to see whether respondents answer questions differently depending on the interviewer’s gender

Task compared with intervention. The purpose of an intervention is to determine how an activity changes the subjects or their performance. Many tasks do not meet this definition of an intervention. In general, asking subjects to physically manipulate an object, play a game, complete a specific physical action, read, write, look at visual stimuli, listen to auditory stimuli, or imagine something would be considered interventions only if the intent of the activities were to change subjects or to compare results across different activities, physical stimuli, visual stimuli, auditory stimuli, etc.

• Not an intervention – Ask subjects to physically manipulate an object as part of an educational test and ask subjects about the object or their manipulation of it
• Not an intervention – Activities intended to elicit subjects’ strategy, method, or ability for performing a specific goal-directed activity
• Intervention – Ask subjects to manipulate two objects with the purpose of comparing the results for object 1 versus object 2
• Intervention – Ask subjects to read a paragraph about a current event in order to assess subjects’ attitudes about a societal problem before and after reading the paragraph
• Intervention – Research that uses activities or stimuli in order to see whether the subjects’ thoughts, emotions, behaviors, or cognitive performance can be manipulated or changed by the activities or stimuli

Interpretation of the word “only”. HSD interprets the word “only” (i.e., the third word in the regulatory description) as defining what is acceptable for category 2. It does not exclude research from being considered exempt if some parts of the research fit into category 2 and the rest of the research fits into one or more of the other exempt categories.

Additional Guidance

Category 3 versus category 2. Unlike category 2, this category allows: (1) interventions distinct from other data collection methods; and (2) audiovisual recording is allowed without any educational tests, survey or interview procedures occurring.

Benign behavioral interventions are defined as brief in duration¹, harmless, painless, not physically invasive, not likely to have significant adverse lasting impact on the subjects, and the researcher has no reason to think that the subjects will find the interactions/interventions/observations to be offensive or embarrassing.

¹Brief in duration is intended to refer to the intervention as opposed to the intervention and the data collection activities together. Thus, the data collection activities could proceed over a longer period of time without precluding the applicability of this exemption. If the intervention and the data collection are intertwined and difficult to separate, the entirely of the activity should be brief in duration. To meet the requirement of brief in duration, the benign behavioral intervention should occur within one month and not exceed a few hours in its entirety.

Prospective agreement. Subjects must be asked to agree to participate in research. This is not the same as the requirement for consent or for documentation of consent. The request may be tailored to the nature of the specific study.

Deception. If the research involves deceiving subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subjects authorize deception through a prospective agreement to participate in research in circumstances in which the subject is informed that they will be unaware of or misled regarding the nature or purposes of the research.

Limited IRB review. For details review the section on limited IRB review below.

Examples that qualify for this category

• Having subjects play an online game
• Having subjects solve puzzles under various noise conditions
• Having subjects decide how to allocate a small amount of received cash between themselves and someone else
• Comparing the test performance of test takers in quiet versus noisy surroundings

Examples that do not qualify for this category due to having some reason to think subjects would find the interventions offensive or embarrassing.

• Milgram’s obedience experiments
• Stanford Prison Experiment

Additional Guidance

The category allows the use of both retrospectively and prospectively gathered information or biospecimens.

Data from prisoners. This category allows for the use of identifiable information or biospecimens obtained from prisoners so long as the research does not intentionally recruit prisoners (i.e., only incidental inclusion of prisoners is allowed).

The category is limited to the secondary use of information or biospecimens. Secondary means re-using identifiable information and identifiable biospecimens that are collected from some other “primary” or “initial” activity; in other words, not for the purpose of the specific proposed study.

“For which consent is not required” is not defined in the Common Rule or its Preamble. In the absence of federal guidance, HSD’s interpretation is the same as the SACHRP federal advisory body. It means: (1) there are no federal or state laws that require subject consent for the proposed secondary use; and (2) during the original collection of the information or biospecimens, the individuals (if asked) agreed to secondary uses that were described in a manner consistent with the proposed research.

Publicly available is described as applying to secondary research use of (for example) archives in a public library, government or other institutional records where public access is provided on request, or from a commercial entity if the information is provided to members of the public on request or if the only requirement for obtaining the information is paying a user fee or registering or signing in as a visitor to an archive. It also applies if a commercial entity makes identifiable biospecimens available to anyone on request for a fee.

• HSD generally interprets the use of publicly available identifiable information or specimens as being not human subjects because the public availability seems inconsistent with considering the information or specimen to be private. Private is defined by the Common Rule as being (1) information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and (2) information/biospecimens that have been provided for specific purposes by an individual where the individual can reasonably expect they will not be made public.

Use of identifiable health information means use of personal or protected health information (PHI) that is covered by the HIPAA regulations. This means that (1) the subjects must have provided HIPAA authorization for future, secondary research uses of PHI, or that (2) an IRB or HIPAA Privacy Board granted a waiver of the HIPAA authorization requirement. This part of the exempt category cannot be used for PHI from anywhere where there are state laws requiring consent (as distinct from authorization) or an IRB-granted waiver of consent.

• The PHI provision of exempt category 4 does not apply to research involving data or specimen sharing, even if the shared data are specimens are de-identified. The Common Rule states that this application of exempt category 4 is valid only for PHI collection and analysis “involving the investigator’s use of identifiable health information” (45 CFR 46.104(4)(iii).
  • HSD interprets “the investigator” as meaning the investigator’s research team, not a broader national group of investigators. For example, sending identifiable PHI to a PCORI repository would not be considered exempt.
  • This also means that this exempt category is not appropriate for research that will establish a database of PHI for use by multiple investigators. For example, this category does not apply to the establishment of a departmental database. Such research would be reviewed by the expedited process.
  • If the researcher’s application is not clear about data/specimen sharing but it mentions a database or repository, ask the PI to clarify.
• Researcher’s obtaining consent may still qualify for the PHI provision of exempt category 4, as long as the consent is not being obtained because of a state or federal law.
• The proposed data security protections should be appropriate for the sensitivity or risk associated with the specific PHI being accessed and used, so that the research may appropriately be considered minimal risk.
• Combination with other exempt categories. This category can be combined with other categories, but the PHI must be secondary use. In generally, this means that the PHI is already being collected as part of routine clinical care – it does not refer to PHI that is generated specifically because of the study.

An example of research that qualifies for this category would be if a graduate student has access to identifiable data from a study previously conducted by a faculty advisor, and they record the information they need in a way so that the data being analyzed for the research cannot be traced back to the individual subjects.

Additional Guidance

Requirement for the federal department or agency conducting or supporting the project. The federal department or agency conducting or supporting the project must establish, on a publicly accessible federal Web site or in such other manner as the department of agency head may determine, a list of the research and demonstration projects the federal department or agency conducts or supports under this exempt category. The department or agency head can determine what sort of information will be included on this list and maintains its oversight. The project must be published on the list before the researcher can begin the project; however, exempt status can be granted before the publication occurs. Review the OHRP guidance for more information.

Examples of public service or benefit programs per federal guidance: (1) programs that provide financial or medical benefits under the Social Security Act; (2) social supportive or nutrition services as provided un the Older Americans Act.

Specific federal statutory authority means there is a federal law requiring the research or demonstration project to be conducted.

Concurrence of federal agency. A member of HSD Leadership will contact the funding agency on behalf of HSD for this purpose.

Example of research in this category. 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 UW researcher to collect data for this project.

Additional Guidance

FDA-regulated research. While FDA regulations (21 CFR 56) allow the use of exempt category 6, FDA-exempt research must still comply with FDA regulations (21 CFR 50) about obtaining consent. Due to this challenging combination of regulations, it is HSD policy to not grant exempt status to FDA-regulated research. Review the worksheet, Human Subjects Research Determination to determine whether the activity is human subjects research as defined by the FDA.

Definition of food. Research involving the consumption of alcohol, vitamins, and nutritional supplements does not qualify for exempt status because these items are not considered “foods”.

Acceptable sources of food. Foods may be obtained from: (1) a public retail facility that has a valid permit/inspection from the applicable health department (such as a restaurant or grocery store), or (2) a licensed commercial kitchen if they are used without manipulation. Foods not meeting this description are evaluated for this exempt category on a case-by-case basis.

Unacceptable risk. The research may not involve the consumption of any type of food, or volume of food, that involves the risk physical harm (significant indigestion; serious allergic reaction; vitamin or other nutrient deficiency). The research must involve what would be considered reasonable eating behaviors.

Examples that qualify for this category:

• A taste test on different varieties of a fruit to determine consumer preference, when the fruits do not have 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 investigator can document that the amount of the additive was at or below the levels approved by the USDA.

IRB Determinations for Broad Consent

Note that broad consent requires recording and tracking of: (1) who has agreed to or refused the broad consent; and (2) the terms of the broad consent to determine whether proposed future secondary research use falls within the scope of the identified types of research and circumstances of the use.

1. Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained in accordance with the following requirements:
   • Broad consent is obtained from the subject or the subject’s legally authorized representative (LAR)
   • Circumstances provide the prospective subject/LAR sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.
   • The information given to the subject/LAR is in language understandable to the subject/LAR
   • The prospective subject/LAR is provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information
   • The consent does not include any exculpatory language through which the subject/LAR is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence
   • The following information will be provided to the subject/LAR:
     • A description of any reasonably foreseeable risks or discomforts to the subject.
     • A description of any benefits to the subject or to others that may reasonably be expected from the research
     • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
     • A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
     • (If appropriate) A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
     • (If appropriate) For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
     • A general description of the types of research that may be conducted with the identifiable private information or biospecimens. This must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted.
     • A description of the identifiable private information or biospecimens that might be used in research whether sharing of identifiable private information or biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or biospecimens.
     • A description of the period of time that the identifiable private information or biospecimens may be stored and maintained (which period of time could be indefinite), and a description of the period of time that the identifiable private information or biospecimens may be used for research (which period of time could be indefinite).
     • Unless the subject/LAR will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the subject’s private identifiable information or biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies.
     • Unless it is known that clinically relevant research results, including individual research results will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject.
     • An explanation of whom to contact for answers to questions about the subjects’ rights and about storage and use of the subject’s private identifiable information or biospecimens, and whom to contact in the event of a research-related harm.
2. Broad consent is appropriately documented, or waiver of documentation is appropriate.
3. If there is a change made for research purposes in the way the identifiable private information or biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

List of Category 8 Criteria

1. Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or biospecimens was obtained in accordance with all of the requirements described for exempt category 7.
2. Documentation of informed consent or waiver of documentation of consent was obtained
3. An IRB conducts a limited IRB review and makes the following determinations:
   • When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data
   • The research to be conducted is within the scope of the broad consent provided by the subjects
4. The investigator does not include returning individual research results to subjects as part of the study plan. Note, this provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

Additional Guidance

Anthropometrics means dimensional descriptors of body size, shape, and dimensions collected by methods that do not involve the application of energy to the subject or placing the subject into a machine. Examples of acceptable anthropometrics include (but are not limited to): height, weight, shoe size, body composition using calipers, but not bioimpedance or water tank), limb length.

Benign means painless; not physically invasive; not likely to have significant adverse lasting impact on the subjects; involves no sedation, local anesthesia, or the use of noxious chemicals; and the researcher has no reason to think that the subjects will find the assessments to be offensive or highly embarrassing.

Cognitively competent means there is nothing inherent in the setting, study circumstances, or subject population that would suggest that subjects are unable to comprehend their circumstances and setting.

Vital signs means standard non-invasive measurements of the body’s essential functions that are commonly monitored by medical professionals and health care providers. For the purposes of determining exempt status, they include: (1) body temperature (except when measured rectally or by a glass thermometer containing mercury); (2) pulse rate; (3) respiration rate; (4) blood pressure; (5) oxygen saturation (e.g., finger clip oximetry). HSD Leadership will consider requests for inclusion of other measurements.

Federal support or regulation. If the research is determined to qualify for this exempt category and it later becomes federally supported or regulated by an agency that signed the Common Rule, the research must immediately cease research activities until IRB approval is obtained.

Changes that always require an HSD re-determination of exempt status

• New types of subjects, data, or specimens. For example, adding: children, patients with a different disease, records (e.g., student records, medical records) when previously those records were not used, changes in the scope of questionnaires, surveys, interviews, focus groups.
• New types of procedures, when it means that the research methods no longer fit into the same exempt category.
• Obtaining federal funding or other support from the Department of Justice or for research that previously had no federal support and that qualified for exempt status in Category 101.
• Obtaining or recording identifiable data or specimens for studies that previously obtained only de-identified or anonymous data or specimens. Identifiable data may require adding a limited IRB review.
• Increased risk due to any change. For example, adding questions to a survey when the answers to the new questions increases the risk of damage to a subject’s employability or reputation.
• Decreased data security measures. For example, changing from level 3 to level 2 as described in the guidance, Data Security Protections.
• New intent to submit the research data to the Food and Drug Administration (FDA).

Changes that do not require an HSD re-determination of exempt status

• Adding similar survey or interview questions that do not increase risk. Questions must be similar in scope, content, and sensitivity level to what is already described in the IRB Protocol.
• Revising an intervention (defined in category 3) to something similar that does not increase risk. The new intervention must be comparable in nature, duration, and potential for harm, embarrassment, or discomfort as was already described in the IRB Protocol.
• Switching the method of data collection to another method within the same category for example, from a focus group to an individual interview or an interview to a survey on the same topics.
• Increasing data security protections for a study with limited IRB review. No additional limited IRB review is required when a more protective safeguard is put in place.
• Adding a subject population that is similar to what is already approved. For example, it would not require a modification to add interviews with surgeons, generally when the application describes interviewing neurosurgeons or to add UW graduate students when the application describes UW undergraduates.
• Making changes to: number of subjects, payment, consent and recruitment materials or methods, survey platform being used, or study instruments so long as the changes don’t fall into one of the categories that require a re-determination, as listed above.
• Updating the study team in Zipline unless the changes are needed to grant access to the Zipline application.