This section of the Investigator Manual provides information related to different types of research, including research in k-12 settings, analysis centers, registries, repositories, decedent research, biomedical interventions, technology and new media research, fetal tissue research, and biospecimen and data research.
Research in K-12 Settings
If you are planning on conducting research in K-12 schools, additional requirements will apply to your research. These schools are autonomous institutions that retain the right to approve/reject any human research to be conducted on their site, in their facilities, or with their teachers, staff or students. The IRB therefore requires documentation from an appropriate authority at each school or district granting permission to conduct the human research. While the IRB does not require documentation be provided to us from an appropriate authority at each school or district granting permission to conduct the human research, it is expected the study team will obtain proper permission(s).
You are responsible for contacting each school or district to obtain this permission and meet the requirements each site may have for conducting human research (e.g., review by its own research review committee). If review by a separate committee is required, you will need to plan additional time for this approval process as well as IRB review. Since some committees meet infrequently, it is especially important that you plan accordingly.
Other important items to keep in mind:
- Often K-12 school sites will require proof of IRB review prior to their approval.
- Note that human subjects research that involves students, parents and/or staff at schools that fall under the purview of Madison Metropolitan School District (MMSD) require approval by MMSD. MMSD generally requires the UW IRB to approve the study before granting its approval.
- If teachers/school staff are engaged in human research for studies that do not qualify for exemption, they must complete human subjects training, and be listed in the IRB application. If UW-Madison will be serving as their reviewing IRB, an individual investigator agreement may be required. (For assistance with such agreements, contact firstname.lastname@example.org)
- Some schools require research personnel to undergo background checks. If required, you are responsible for completing any background checks prior to starting your research.
- Many school districts will not allow research activities to take place during normal class time.
- Many schools place limitations on the use of video or audio recording in classrooms. The school will want to see your video/audio recording procedure, and the IRB requires that it is included as part of your description of the scope of research to potential sites.
- Parental consent is required for minors to be included as research subjects. You must provide an appropriate method to obtain consent from parents (i.e., send the study information and consent forms to parents for review, etc.). You will also need to plan for a method of collecting the forms from the parents, without engaging staff. You will need to describe these processes in your protocol or application.
- Minor assent is also required prior to including minors as research subjects. Once parental consent has been obtained, their child(ren) can be asked to provide assent. The assent process should be similar to the consent process. Assent documents should be appropriate for the subject population (reading level, assent procedures, etc.).
Additional steps and protections are often needed when conducting research in collaboration with American Indian or Alaska Native (AI/AN) communities and populations. The Common Rule affirms that each tribe may have its own definition of research and its own set of research protections and laws that may have more restrictions than the Common Rule. Additionally, single IRB review is not required when it would be contrary to tribal law. Researchers must receive appropriate review and approvals from the tribe for their research. If a tribe requires its own approval in place prior to IRB approval, upload documentation of the tribe’s approval in ARROW to the AI/AN Communities page in the nPBA or, if using the PBA or sIRB application, the Supplemental Information page.
NIH has issued Supplemental Information to the NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/Alaska Native Participant Data for the responsible and respectful management and sharing of AI/AN participant data under the DMS Policy.
Researchers who intend to conduct NIH funded or supported research to collect and share data from AI/AN communities should review the NIH Supplement. A summary is below:
- Tribal sovereignty means that Tribal Nations have the right to control how biomedical research can be performed within Tribal jurisdiction, including how their data can be collected, used, managed, and shared.
- Tribal sovereignty includes the right for each AI/AN Tribe to establish and enforce Tribal laws, regulations, and policies for biomedical research, and may include additional protections for research participants beyond those in the Common Rule.
- Awareness of past research abuses perpetrated against AI/AN Tribes, including instances of data misuse, should be well understood. Proactive and transparent conversations with Tribes around how data and/or biospecimens will be managed and shared are of paramount importance.
- AI/AN organizations have advocated for data disaggregation and analyses of AI/AN data, while respecting Tribal sovereignty, to better understand health disparities, protective health factors, and health outcomes of AI/AN communities. NIH’s inclusion policy may also apply, which requires reporting of cumulative subject accrual and progress in conducting analyses for differences by race and ethnicity.
The Supplement further describes best practices around planning for data management and sharing; including engaging AI/AN Tribes, establishing mutual understandings, incorporating AI/AN preferences, considering additional protections and limitations, informed consent practices, and safeguarding against future risks.
Analysis Center Projects
A significant number of research groups at UW-Madison serve as analysis centers for multi-site studies. Analysis centers are defined as providing core or central image reading or analysis, biospecimen analysis, or statistical data analysis for multi-site studies but are otherwise not involved in the conduct of the research. In some cases, UW-Madison researchers may not be considered engaged in human subjects research by serving as an analysis center and in these cases, IRB review and approval is not required. The following outline several analysis center scenarios and the criteria for determining whether IRB review and approval is required:
- Research with previously collected coded data and/or specimens – Previously collected coded data or specimens may include left-over clinical samples, medical data, research data or research samples.
- If the research is FDA regulated, IRB review and approval IS required.
- For research NOT regulated by the FDA, IRB review is not required if BOTH of the following conditions are true:
- The data or specimens to be studied were not collected specifically for the current research;
- Investigator(s) cannot readily ascertain the identity of the source(s) of the coded data or specimens because one or more of the following is true:
- The investigator(s) and the holder of the key enter into an agreement prohibiting the release of the key to the investigator(s) under any circumstances
- IRB-approved written policies and procedures for the repository or data coordinating center prohibit the release of the key to the investigator(s) under any circumstances.
- The data or specimens to be studied were not collected specifically for the current research;
Investigators that want to use research data or leftover research samples must also consult the original informed consent document signed by participants to ensure that subsequent use was specifically permitted.
- Research with coded data or specimens obtained for the current research – UW personnel receive coded data or specimens for analysis for the current research study.
- If the research is FDA regulated, IRB review and approval IS required.
- For research NOT regulated by the FDA, IRB review is not required because UW is not engaged the in human subjects research if BOTH of the following conditions are met:
- UW personnel obtain coded private information or human biological specimens from another institution involved in the research that retains a link to individually identifying information (such as name or social security number); and
- UW personnel are unable to readily ascertain the identity of the subjects to whom the coded information or specimens pertain because, for example:
- the institution’s employees or agents and the holder of the key enter into an agreement prohibiting the release of the key to those employees or agents under any circumstances;
- the releasing institution has IRB-approved written policies and operating procedures applicable to the research project that prohibit the release of the key to the institution’s employees or agents under any circumstances; or
- there are other legal requirements prohibiting the release of the key to the institution’s employees or agents.
In some circumstances, IRB review may be required by the sponsor or contract. In these cases, please consult with email@example.com.
Research Registries and Repositories
The IRB uses the terms recruitment registry, data repository, and biospecimen repository for these various research tools/resources, although terminology can vary widely across institutions. Generally, the creation and maintenance of a research registry or repository requires IRB review and approval. A protocol template for the creation and maintenance of research registries and repositories is available for researchers to use when preparing to submit to the IRB (see HRP 503a-TEMPLATE PROTOCOL-Registries and Repositories). IRB review is not required for the development of a Quality Improvement or Quality Assurance database.
Generally, a registry is a tool used to identify and track a group of individuals that have similar characteristics. The characteristics can vary widely (e.g., disease, genetic make-up, health behaviors, surgical procedures), but the intent of the registry is to track and classify these groups of individuals. The IRB prefers the use of the word “registry” to be used to describe lists of people along with limited personal and, when applicable, medical information. The primary use of these lists is to provide investigators with pools of potential study volunteers, as in recruitment registries. Recruitment registries generally require IRB approval, both for the creation and maintenance of the registry itself, as well as for future projects that wish to use a registry as a recruitment method.
A data repository is a tool used to compile a set of individual subject/patient data that will be used for analysis purposes. A data repository generally has data added to it in an on-going manner that is stored long-term. Data in the repository are intended to be distributed to multiple users and subsequently used for ongoing analysis purposes. The IRBs prefer use of the term ‘data repository’ over terms such as ‘databases’ and ‘registries.’ If the primary intent of the repository is for use in future research projects, IRB review and approval is required, and may be required for the subsequent use of the data from the repository.
A biospecimen repository (also known as a tissue bank) is a mechanism for maintaining tissue, blood, and other biological specimens for unspecified future use. These repositories typically involve the collection and long-term storage of tissue and often corresponding data to be used primarily for future research projects. Tissue to be stored in the repository can be collected retrospectively, prospectively, or both. Tissue repositories can include tissue collected from other research protocols or clinical procedures. IRB review and approval is required for banking of biospecimens and may be required for the subsequent use of the specimens from the repository.
The IRB review requirements for research involving decedents varies depending on whether the study involves ONLY decedents or decedents and living individuals.
The Common Rule (45 CFR 46.102(e)(1)) defines a human subject as “a living individual about whom an investigator (whether profession or student) conducting research (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, analyzes, or generates identifiable private information or identifiable biospecimens.”
The FDA does not explicitly state that regulations apply only to “living individuals.” The regulations, however, imply that the subject is alive. FDA regulations (21 CFR 56.102(e)) define a “human subject” as “an individual who is or becomes a participant in research, either as a recipient of a test article or as a control.” That section goes on to state that a subject may be “either a healthy individual or a patient.” And, at 21 CFR 812.3(p), “subject” means “a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease.”
Based on the above, the IRB Office has determined that Common Rule and FDA Regulations do NOT apply to studies ONLY using information or biospecimens from deceased individuals. In these cases, researchers do not need to submit an IRB application for review of decedent ONLY research.
Researchers who are conducting a study that includes both deceased AND living individuals, however, may need IRB review and oversight and should consult the IRB Office for guidance. In addition, although research on decedent only research is outside of the IRB’s purview, other regulations (e.g., HIPAA Privacy Rule) and institutional requirements (e.g., MTAs), may still apply. Researchers should ensure they are in compliance with other applicable regulations and institutional policies when conducting decedent research.
Technology & New Media Research
Online research sources such as Facebook, Twitter, blogs, chat rooms, discussion forums, and other social networking sites will be treated as publicly available data by the IRB in a very broad sense, and with a number of limitations.
The IRB does not consider sites that require the user to create an account, and then provide a log in and password, to be publicly available data. Therefore, participants must be consented before an investigator can observe or interact with participants in these online environments. Members of sites that require a log in have an expectation of privacy and do not expect that anything they post will be used for research purposes. In some circumstances, researchers can petition the IRB for a waiver of consent. In these situations, researchers will need to provide an appropriate argument/justification as to why a waiver of consent is appropriate.
Not Human Subjects Research
Some technology-based studies may not meet the definition of human subjects research per the federal regulations, and therefore not require IRB review. An example would be if a researcher is studying how many Facebook pages include images of families; the unit of measure in this case is the page, and not a human subject.
Research using public documents such as newspapers, books, or journals published online and that involve no other data source(s) is not considered human research. However, projects that combine identifiable information about individuals obtained from public documents, with identifiable information obtained from other sources, may be considered human research.
Facebook, Twitter, and others may provide data mining services where their developers will mine data from the site, for a fee, at the researcher’s request. Depending on the scope, the IRB may treat the data differently because data collection would be done by the media site and (likely) provided to the researcher without direct identifiers. The IRB deals with this type of research activity on a case-by-case basis.
Biomedical Interventions Conducted in Non-Clinical Settings
Training and Competency
You are responsible for ensuring that all personnel listed on an IRB application have the appropriate training and experience to perform their assigned duties. When considering whether certain biomedical procedures may be performed in an investigator’s research laboratory, the IRB will take into account the risk level of the procedures as well as applicable training/licensure requirements for individuals to perform certain procedures.
- In some cases, the IRB will allow non-therapeutic/non-diagnostic procedures to be carried out by non-medically licensed personnel provided they have sufficient training. Such procedures may include finger sticks, screening urine pregnancy tests, and pulmonary function testing.
- For more involved and/or more than minimal risk procedures (e.g., blood draw via venipuncture, IV drug infusion), the IRB will likely require the procedures be performed by an appropriately licensed medical professional.
Your protocol or application should include a description of emergency medical procedures that will be implemented to ensure the safety of research participants. Calling 911 may be a sufficient plan if, for example, a participant experiences an accident during an exercise study. Calling 911 alone may not be sufficient, however, if the research procedures are more than minimal risk and the participant experiences, for example, an event that may require surgery or immediate medical intervention. The IRB will consider emergency procedures on case-by-case basis. The IRB expects that emergency procedures requiring more than a 911 call will involve medically licensed/registered personnel, as determined by the level of risk.
Fetal Tissue Research
Several federal, state, and local requirements apply to use of fetal tissue in research. For details, see the Use of Human Fetal Tissue policy.
Study Personnel Training and Preparatory Activities
Research teams may need to train study team members by having them conduct or experience procedures used in a research study, such as imaging exams, exercise testing, questionnaires, or other activities. Research teams may need to run through study procedures to calibrate or optimize equipment settings or build efficiency. When such activities are performed in preparation to conduct a study and no data are retained or analyzed for research purposes, they generally do not meet the regulatory definition of human research. That is, the preparatory activities are not systematic investigations designed to develop generalizable knowledge and do not use or analyze information about the individuals undergoing the activities. However, because study activities may involve physical or informational risks, there are situations in which training or preparatory activities that are not human research may still require IRB oversight.
Note that the FDA defines research differently. This guidance does not apply to use of drugs or use of devices that could pose a significant risk.
Training and preparatory activities that require IRB oversight
- Volunteers from the community undergoing procedures for the purpose of training research team members, optimizing visit workflows or equipment, etc.
- Procedures that involve physical or informational risks greater than those of daily life.
- Procedures that need to be performed repeatedly and systematically on people to demonstrate feasibility, optimize performance, or similar goals.
- Procedures that will retain and analyze information about the people undergoing those activities.
Research teams should describe these preparatory activities in their IRB submission, including how risks will be minimized and show individuals who will undergo these activities will be consented. A consent document should be submitted, but study teams should be cognizant of how template consent language may not accurately represent the activities volunteers are being asked to undergo (e.g., data is not being collected for a research use, individuals with access to the data may be more limited in scope)
Training and preparatory activities that do NOT require IRB oversight
- Low-risk activities involving members of the research team or other employees who are knowledgeable about the procedures and their risks and freely agree to undergo them.
- Activities conducted in departments or units that have policies governing non-research participation (e.g., training of study team members, calibrating equipment, developing and optimizing workflows) in procedures used in research studies.
In these situations, the principal investigator or supervisor is responsible for ensuring that employee participation (as volunteers undergoing procedures) is optional, that employees are familiar with the potential risks and risks are minimized, and that confidentiality is maintained when activities require health screening for safety reasons or generate health-related information.