91´ÎÔª

Chapter 6: Reviews Requiring Special Consideration

1. Projects Involving Indigenous Peoples

As a research institution, the 91´ÎÔª has far-reaching potential to collaborate with and conduct research, outreach, and instructional activities with a variety of indigenous peoples, including the recognized American Indian Tribes located within the State of Montana.

The 91´ÎÔª recognizes that property for indigenous people may have intangible, spiritual manifestations and that it, along with knowledge and traditional resources (such as plants, animals, and other material objects with sacred, ceremonial, heritage, or aesthetic qualities), are central to the maintenance of identity for indigenous people.

Any research conducted with indigenous people or on sovereign tribal land comes under the indigenous people’s individual governing authority. This includes, but is not limited to, the Tribal Council, Tribal Cultural Committee, and Tribal IRB. UM involvement must comply with all applicable tribal, federal, state, and University regulations, policies, and procedures.

Montana is home to twelve federally recognized tribal nations and seven reservations. Each tribal government has differing requirements to conduct research on its lands. It is extremely important for researchers to build a positive relationship with the tribal entities with which they plan to work and to learn what the tribal requirements are to conduct research. Equally critical is that researchers and tribal entities work together to build a clear understanding of what is to be researched and how this information will be used. It is the Tribes’ legal right to stop any and all research and to control how any information will be used. Information collected may become the Tribes sole property. Ultimately, Tribes have the right to say no to any type of research on items that fall under their legal sovereign right.

IRB proposals for research that may impact the resources or interests of a federally or state recognized American Indian or Alaska Native Tribal Nation (Tribal Nation) will not be approved without prior written approval from the official(s) designated by the relevant Tribal Nation(s). For purposes of this provision, references to "resources or interests of a Tribal Nation" are limited to resources and interests connected to Tribal Nation lands or those aspects of Tribal life that are within the domain of a Tribal Nation, (including, but not limited to, Tribal languages and subsistence rights on Tribal Nation lands) as opposed to individual Tribal Nation members.

If the activity is externally sponsored, the UM PI will follow OSP guidelines to ensure compliance with sponsor, state, and University requirements. If appropriate, UM may informally involve tribal members as UM employees or independent contractors, or may issue a subaward to the tribal entity. Subrecipients function as co-investigators on a sponsored activity and are involved in a creative way in designing or conducting the sponsored activity.

IRB proposals that seek to involve Indigenous peoples as human subjects in research must:

1. Seek guidance from the potentially impacted Tribal Nation(s) regarding which activity/activities require(s) review and prior approval from an authorized designee(s) of the Tribal Nation(s); and
2. Based on the guidance received, submit a written request to the relevant Tribal Nation(s), for approval to carry out the proposed activity(ies) that require(s) Tribal Nation review and approval. Examples of such activities may include, but are not limited to, the following:
   1. research or projects that involve Tribal Nation members and would invoke the Tribal Nation in any way (including but not limited to referencing a Tribal Nation in materials, public forums, or publications). Note that this type of proposal may also require a separate Tribal IRB or other mechanism that a Tribal Nation may have in place to review proposed research (this would exclude cases where Tribal Nation members voluntarily participate in the proposed research as individuals, not as members representing a Tribal Nation);
   2. carrying out studies or research on Tribal Nation reservations, territories, and other locations where Tribal Nations have legally protected rights to resources or to engage in activities; and
   3. using Tribal Nation-controlled information or data in research.

As a research university, the 91´ÎÔª most often collaborates with Indigenous people in the role of research subjects. All UM employees and students doing research on human subjects must follow requirements per UM's Institutional Review Board (IRB) for the Protection of Human Subjects and meet any course requirements for human subjects protection. Tribes are sovereign nations and establish their own rules, policies, and procedures for conducting research on their respective reservations. When UM undertakes activities affecting American Indian tribal rights or interests, such activities should be implemented in a knowledgeable, sensitive manner that is respectful of tribal sovereignty and reflects tribal cultural protection and preservation concerns.

Timing

When planning projects, UM researchers should allow adequate time to obtain the proper approvals. Each tribal nation reviews projects differently and according to their own internal policies, procedures, and cultural customs. The UM IRB urges UM researchers to plan months in advance if you plan on seeking tribal approval for a project. Tribal approval for research may come from a tribal IRB or its equivalent, such as the tribal council, tribal cultural committee, or another alternative culturally-appropriate body that is authorized to make decisions on behalf of the tribal nation.

Research and Indian Health Services (IHS) Facilities

Any proposed research at an Indian Health Service (IHS) facility, whether on or off a reservation, will require additional review by the IHS IRB or its designee.

UM IRB Expectations of PIs When Working with Indigenous Peoples

The UM PI will, at a minimum:

• Ensure compliance with University, tribal, and federal guidelines, policies and/or regulations. 
• Work effectively with indigenous people and respect tribal cultural and intellectual property, and recognize the rights the involved Tribe(s) retains over all shared information (e.g., cultural knowledge, practices, and traditions).
• Comply with tribal requirements regarding cultural and data ownership, and adhere to the feedback of the involved Tribe(s) regarding collection or handling of materials, information, data, and samples.
• Collaborate with the involved Tribe(s) to identify what information should be protected, and establish and agree upon safeguards.
• Secure appropriate written permission from the involved Tribe(s) that details any expectations of the Tribe regarding reports or involvement.
• Work closely with the involved Tribe(s) and provide - in layman's terms - reports, presentations, or other updates as requested and entertain feedback and suggestions.
• Update the tribal governing body on research progress as requested (quarterly is recommended). 
• Provide the tribal governing body a yearly written report, unless the involved Tribe(s) requests more frequent reports, that contains a full summary of all research activities.
• Request and secure permission to disseminate research findings in academic or popular literature, conferences, and/or any other endeavors that will involve the presentation of the research findings (e.g., submission of abstracts, poster presentations, oral presentations, and publication).

Approvals and Agreements

Any employee, adjunct faculty member, or student who, on behalf of the 91´ÎÔª, conducts research using human subjects must receive IRB approval prior to recruiting or screening human subjects. The UM IRB will conduct its own review of protocols involving Indigenous peoples as human subjects but will not issue final approval until all of the appropriate tribal permissions have been obtained and submitted in writing to the IRB. Tribes are not required to follow single IRB (sIRB) requirements as outlined in 45 CFR 46.114.

The UM IRB may conduct a review at the tribe's request, or it may enter into a reliance agreement with the tribal IRB, such that the tribal IRB assumes oversight. When the UM IRB conducts the review, separate written permission must be obtained from the collective tribal governing body to conduct research on the reservation. UM IRB approval or an approved reliance agreement and tribal IRB approval must be finalized before any research is conducted. If the research does not involve human subjects, collective written permission by the tribal governing body may be adequate. Consult with the UM IRB to determine appropriate documentation.

Memorandums of Understanding (MOU)

In some cases, a Memorandum of Understanding (MOU) may be executed between a tribe and UM. Typically initiated by the tribe, an MOU may be written in addition to IRB review and an IRB reliance agreement. The MOU will be signed by the UM IRB manager or other authorized institutional official. Components may include:

• a collaborative scope of work, timeframe, target population, and materials, information, data, and/or samples collected;
• a description of how the research process will benefit the tribal community or tribal members (e.g., financial benefits, social benefits, economic development, increased knowledge and innovation, capacity building);
• a description of any required progress reports to be supplied by UM, whether verbal or written, and the level of detail required;
• an expectation that the UM PI will conduct presentations to interested tribal entities to inform the community of project findings and to garner feedback and suggestions;
• procedures for UM dissemination of research findings;
• ownership of materials, information, data, and/or samples is typically retained by the involved Tribe(s);
• procedures for returning, storing, and/or destroying materials, information, data, and/or samples to the involved Tribe(s), specifying any agreed-upon confidentiality requirements;
• an expectation that all sensitive materials, information, data, and/or samples have been destroyed, or disposed of in accordance with involved Tribe(s) instructions upon the completion of the research project.

2. Vulnerable Populations Under 45 CFR 46

When some or all of the participants in a protocol are likely to be vulnerable to coercion or undue influence, the IRB will include additional safeguards to protect the rights and welfare of these participants. Some of the vulnerable populations that might be involved in research include children, pregnant women, fetuses, neonates, prisoners, adults who lack the ability to consent, students, employees, unhoused persons, and other groups deemed vulnerable by the IRB.

If the IRB reviews research that involves categories of participants vulnerable to coercion or undue influence, the review process will include one or more individuals who are knowledgeable about or experienced in working with these participants. For example, the IRB will include one or more individuals who are knowledgeable about or experienced in working with children, prisoners, or adults with limited decision-making capacity, when reviewing research that involves individuals from these populations.

The Department of Health and Human Services (HHS), Code of Federal Regulation, Title 45 Public Welfare, Part 46 Protection of Human Subjects, contains additional safeguards designed to provide extra protections for vulnerable populations. These provisions provide for additional requirements for IRBs. Relevant subparts include:

• • Subpart B - Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
• • Subpart C - Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects’
• • Subpart D - Additional Protections for Children Involved as Subjects’ in Research

Research that involves any of these populations must comply with the requirements of the relevant subparts. In addition, although research funded by other federal agencies may or may not be covered by the subparts, these additional agencies may impose additional requirements for the protection of human subjects in research.

Children

Federal regulations mandate when and how children may be involved in human subjects research (45 CFR 46 Subpart D). Children are defined in the Common Rule as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted” (45 CFR 46.402a). All child subjects are to be given a clear and complete picture of the research in which they are asked to participate, together with its attendant risks and benefits, as their developmental status and competence will allow them to understand. Emancipated minors (16 years or older) and married minors are not considered children under this policy as per the State of Montana’s statutory definitions.

Minor Assent

The Common Rule requires that a child whose age, maturity, and psychological state make it possible for him or her to make an independent decision to participate in a study must have the chance to give assent. Assent should be an ongoing dialogue between the researcher and the child.

All children from 10 to 17 years of age are required to give written assent. Children under 10 years old only need to give verbal assent if appropriate for their age. The IRB proposal must clearly describe acceptable procedures for informing the child subjects of the nature of the research and of its risks and benefits, as well as how the level of competence to understand and assent will be ascertained. This assessment must consider the child’s age, maturity, psychological, and emotional state.

Waivers of Documentation of Child Assent

In some cases, the IRB may consider a researcher’s request for a waiver of documentation of minor assent. This means that assent is still being collected, but there is no signed document involved. This may be appropriate in cases where the child is too young to sign an informed consent form, and in cases when there is risk involved with having a participant’s name linked to a study via a signature (e.g., illegal drug/alcohol use, child abuse, etc.).

Full Waivers of Child Assent

The UM IRB may consider a full waiver of a child’s assent to participate in research if: the child is incapable of providing or communicating assent and the study offers clear promise of benefit through a treatment that is not available outside the research setting; or the research is no more than minimal risk, the waiver would not adversely impact the rights or welfare of the participants, the research would be impracticable without the waiver, and appropriate information about the study will be provided to the child.

Parental Consent

Federal regulations mandate when and how parental consent must be collected when children are involved in research (45 CFR 46.408). Parental consent is required for children ages birth through 17 years to participate in a research study. Often children, particularly young children, are unable to understand the full scope of the decision put before them. Therefore, it is important that a parent/legally authorized representative be the primary person to give consent in order to act in the child’s best interests.

For studies involving minimal risk, or more than minimal risk with the prospect of direct benefit to the child, the IRB may find that the permission of one parent is sufficient for enrollment in the research project. Otherwise, the permission of both parents is required unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. Parental permission is required for all survey research, including online surveys, unless the investigator can make a compelling argument to the contrary.

Active vs. Passive Parental Consent

Active (opt-in) consent is typically required before conducting research with human participants. In most cases, parents or legal guardians must affirmatively communicate their approval before their child may participate in research.

In limited cases, the IRB may allow an opt-out consent process (passive consent), where a parent or guardian’s consent is assumed unless they communicate otherwise. This is limited to cases where all of the following are true:(1) the study poses minimal risk; (2) the research cannot practicably be carried out otherwise; and (3) the IRB agrees that opt-out consent is appropriate under the circumstances. If research is conducted in a school setting, the school must agree that an opt-out model is consistent with their internal policies. Additional considerations include:

1. Justify waiver of active consent: Since active consent is expected, you must justify your use of opt-out consent as necessary and ethically appropriate. The IRB will want to know: if the research is part of regular classroom activities; the expected duration of the children’s participation; whether the research could pose any risk, such as sensitive questions that may upset or embarrass; and whether identifying information will be collected.
2. Document school approval: For research in schools, include in your IRB application a letter of support for using opt-out consent, signed by the principal or another senior administrator.
3. Develop a robust plan for informing parents: Inform parents/guardians about the study and give them an opportunity to state that they do not want their child to participate. Ensuring that information is actually received can be a challenge - a flyer sent home may never make it there. Therefore, use more than one method to contact parents/guardians, if possible.
4. Make it easy to opt out: Similarly, the IRB recommends providing multiple ways for a parent/guardian to inform the researcher that they do not want their child to participate.
5. Build in sufficient time: Make sure to give sufficient time for parents/guardians to review the information and act (at least a week), and include a due date for responses.
6. Set the right tone: Be helpful and respectful in your communications. Describe the study activities clearly and in detail.
7. Have a plan to address concerns: If a parent/guardian expresses a concern you should address it immediately, beginning by informing the IRB office.
8. Consider non-English speakers: In situations where the researcher expects that a substantial number of parents/guardians are illiterate or do not read English, offer an appropriate alternative method of communicating information about the study.

Waivers of Documentation of Parental Consent

A waiver of documentation of parental consent means that the researcher does not have to have a physical, signed copy of parent permission. Federal regulations allow the IRB to waive documentation of parental consent when the following is true: (1) the research is minimal risk; (2) no procedures are involved for which written consent is normally required; and (3) the only record lining the subject to the research is the consent form. The Common Rule also allows the IRB to waive documentation of parental consent when the subjects are members of a distinct cultural group in which signing forms is not the norm.

Full Waivers of Parental Consent

Although rare, there may be circumstances under which the IRB may consider a full waiver of parental consent. The investigator must make a compelling and persuasive argument to the IRB for why a full waiver is necessary for the conduct of the research. Waivers of parental consent are usually granted in circumstances when parent permission is not a reasonable requirement to protect the child, such as in cases of abuse or neglect. Requests for waivers of parental consent must demonstrate that the waiver will not adversely affect the rights or welfare of the child and that the research would be impracticable without the waiver. The waiver must also not be inconsistent with federal or state law. Sometimes the IRB may require that parental consent is substituted with something else, such as permission from a legal guardian or an advocate. When research takes place within a school district, school officials must agree to the waiver of parental permission.

Wards of the State

Research with wards is regulated by the Common Rule (45 CFR 46.409). Children who are wards of the state or any other agency, institution, or entity can be included in research only when (1) the research is related to their status as wards, or (2) the research is conducted in a setting where most children involved as subjects are not wards (e.g., school, camp, hospital). When wards are specifically enrolled in research, the IRB requires that an advocate is appointed for the child in addition to any other individual who acts on behalf of the child as a guardian. Advocates must have the background and experience to act in the best interest of the child and may not be associated with the research, the investigator(s), or the guardian organization in any way.

Pregnant People, Fetuses, and Neonates

The 91´ÎÔª IRB requires adherence to DHHS regulations regarding additional protections required for research involving pregnant individuals, fetuses, and neonates. In addition to the other responsibilities assigned to the IRBs under 45 CFR Part 46 Subpart A, the 91´ÎÔª requires the IRB to review research involving these participants by applying the protections of 45 CFR 46 Subpart B for HHS supported research. The IRB will provide for equivalent protections when the research is not supported by HHS. Montana law may place additional restrictions on research on the fetus. The IRB will consult with UM Legal Council on a case-by-case basis for research protocols involving this class of participant.

Prisoners

If an investigator indicates that incarcerated persons will participate in the research, or that participants may reasonably be expected to be incarcerated at some time point during the study, the IRB will adhere to the requirements found at 45 CFR 46, Subpart C. A majority of the IRB (exclusive of incarcerated person members) will have no association with the prison involved apart from membership on the IRB. At least one IRB member who is an incarcerated person or incarcerated person representative with appropriate background and experience to serve in that capacity will be present at the meeting.

When Participants Become Prisoners During a Research Protocol

This policy applies whenever any human participant in a research protocol becomes an incarcerated person at any time during the protocol, e.g., after the research has commenced. This is necessary because it is unlikely that review of the research and the consent document contemplated the constraints imposed by the possible future incarceration of the participant. If a participant becomes an incarcerated person after enrollment in research, the Principal Investigator is responsible for reporting in writing this situation to the IRB immediately. Each incarcerated person will be informed in advance that participation in the research will have no effect on his/her/their parole.

At the earliest opportunity after receiving the Principal Investigator’s notice or otherwise becoming aware of the incarcerated person status of a participant the IRB will review the protocol again with an incarcerated person representative as a member of the IRB. 

The IRB will take special consideration of the conditions of being an incarcerated person. Upon this review, the IRB can either (a) approve the involvement of the incarcerated person-participants in the research in accordance with this policy and all applicable regulations; or (b) determine that this participant must be withdrawn from the research.

Additionally, the IRB should confirm that, when appropriate, the informed consent process includes information regarding when subsequent incarceration may result in termination of the participant’s participation by the investigator without regard to the participant’s consent.

3. Other Vulnerable Populations

Federal regulations require that the IRB consider additional protections for other vulnerable populations such as but not limited to persons lacking decision-making capacity and economically or educationally disadvantaged individuals. The IRB will consider these additional protections as part of the criteria for approval.

Although the federal regulations do not list all vulnerable groups, the IRB considers vulnerable groups to also include students, employees, and those within potentially compromised autonomy. The IRB will determine special protections for these groups on a case-by-case basis taking into account the risks and benefits and other protections afforded by institutional policies and state and federal law.

Adults with Impaired Decision-Making Capacity

Cognitively impaired adults are individuals who have a diminished capacity for judgment and reasoning due to a psychiatric, organic, developmental, or other disorder that affects cognitive or emotional functions. Other individuals may be considered decisionally-impaired or have limited decision-making ability because they are under the influence of or dependent on drugs or alcohol, suffering from degenerative diseases affecting the brain, are terminally ill, or have severely disabling physical handicaps.

There are no federal regulations specific to research involving adults with impaired decision-making capacity. The IRB takes special care to consider issues such as the selection of participants, privacy and confidentiality, undue influence, and risk-benefit analysis. Decisions should be made with the utmost deference to the ethical principles underlying human research as set forth in the Belmont Report.

The National Bioethics Advisory Commission (NBAC) has issued 21 recommendations for IRBs, the research community, and Federal regulators to consider regarding the decision-making capacity of particularly vulnerable participants.

The following criteria may be taken into consideration for adult participants with impaired decision-making capacity involved in a research protocol:

• The objectives of the research cannot be met by conducting the research in a population that does not have the disorder that may affect decision making capacity.
• The research is designed for a disease or condition relevant to the vulnerable population under study.
• The research is either minimal risk, more than minimal risk with a prospect of direct benefit, or more than minimal risk without a prospect of direct benefit, but of vital importance to the vulnerable population.
• Adequate provisions are made for obtaining consent from the participant’s legally authorized representative. The use of a legally authorized representative will be consistent with applicable state law(s).
• Adequate provisions are made for obtaining assent from the participant, unless the IRB determines that assent is not appropriate as a condition of participation or that some or all participants are not capable of providing assent.
• The protocol must describe when and how the participants will be assessed for capacity for formal consent or assent and understanding of the proposed research, and the process for a second confirming assessment. Competency should be evaluated on an individual basis to avoid incorrect assumptions as to an individual’s ability to make decisions. Criteria for determining competence might vary according to the degree of risk or discomfort presented by the research procedures and the extent to which therapeutic gain can be anticipated. Mentally disabled or cognitively impaired participants for additional considerations the IRB may make surrounding informed consent.

The IRB may also consider additional safeguards to protect participants. These include:

• Requiring the involvement of participant advocates
• Requiring independent monitoring
• Requiring waiting periods
• Appointing a monitor to supervise the informed consent process

Such decisions may be based on the amount of risk involved in the research and the likelihood that participants will derive health benefits from their participation.

Students

If an investigator will be conducting research with students as research participants, the IRB application should provide the following basic information where prompted:

• A rationale for recruiting students as research participants that demonstrates that students are the logical choice for answering the research questions (e.g., the research is related to student issues, academics, curriculum, instructional strategies, instructional techniques, classroom management methods, or program evaluation). If a study topic does not necessitate the recruitment of students specifically, then researchers should recruit from the general population. Students may be included as part of the general population, but they should not be singled out for recruitment.
• Whether the PI is a university faculty member, a teacher in a primary school setting (perhaps the PI is a student working on a degree program at UM), an administrator, or other service provider in the education setting and:
  • Information about the PI’s specific role(s) at the school or institution, whether or not the PI intends to recruit students who are enrolled in their courses/classes or students to whom they provide direct services. If PIs want to recruit students whom they teach or directly serve, the IRB application must provide a strong justification for pursuing an approach where there is an interpersonal conflict of interest. A clear explanation about why the research questions cannot be answered any other way needs to be provided. In addition, the PI must provide a strategy for mitigating an interpersonal conflict of interest.

Strategies for Minimizing Interpersonal Conflict of Interest

If PIs plan on recruiting students whom they teach or directly serve, the application may not state that there is no interpersonal conflict of interest. When the subject pool is the researcher’s own class or client roster, participants are often recruited out of convenience, and there may be more benefit to the researcher than to the participants. Past history and a continuing relationship with students can also bias a researcher and affect whether or not free informed consent and assent can truly be achieved.

The protocol application must address the PI’s dual role and the resulting power imbalance. A description of the tangible measures that will be used to mitigate the conflict of interest needs to be provided where prompted. A tangible strategy is not merely stating that participation is voluntary and will not affect course grades or other services to which students are entitled.

The following options are available to mitigate interpersonal conflicts of interest:

• Ensure that data collection is anonymous and that the PI would not be able to trace individual responses. This option is not feasible if the class or client roster is small and if the responses provide enough contextual information that could result in the identification of students. As well, this option is not feasible if PIs wish to access FERPA-protected data for which written consent is required. See the heading Secondary Data below for more information about FERPA requirements.
• Ask a neutral third party not involved in the research to recruit students and collect consent and assent forms (if applicable) on the PI’s behalf. The third party may also need to collect the data if doing so could result in the identification of participants (e.g., interviews); the data would then either be de-identified by the third party, if possible, or provided to the PI after a grade in the course has been assigned or after the students are no longer under the PI’s supervision if de-identification is not possible.
• Conduct the study in another course not taught by the PI.
• Conduct recruitment, consent, and data collection after grades have been assigned.

Addressing Inequitable Subject Selection and Stigmatization

Every effort should be made to recruit students who would most benefit from participation in the study. This must be balanced by an equal effort to avoid singling out students from their classmates, especially in primary and secondary education settings where students may not have a choice about which classes they are enrolled in. The following three examples outline some problematic subject selection strategies that have been presented in IRB protocols in the past as well as some alternative strategies that can be employed.

• Research targeting specific groups of students in a specific class. Concerns are raised when investigators target a specific sub group of students in a class in a way that could cause stigmatization (e.g., low performing students, minority students). You can’t isolate students within a class based on their race, ethnicity, gender, or academic performance. 
  
  Alternative: invite all students to participate (after obtaining parental consent if students are minors) and design data instruments with screening criteria built in, so that your target group is evaluated in the analysis stage and not during the recruitment stage.
  
  Alternative: Keep the decision to participate private by handing out materials to all students - some of which may include the research instruments, some of which may include alternative activities.
  
  
• Cherry picking a representative sample from a group of eligible participants to be subjects of the research. This practice lends itself to researcher bias and does not yield generalizable results. If the research questions are broad, but the sample size is too small, conclusions can only be made about those particular subjects.
  
  Alternative: invite all students to participate and allow for a control group, if feasible, to support conclusions and eliminate alternate explanations for results.
  
  
• Research that withholds educational benefits to students who do not participate. You cannot apply an intervention to a small group of students who agree to participate in the research if the intervention could benefit all students.
  
  Alternative: either apply the intervention to all students who stand to benefit or ensure that the intervention will be applied to the rest of the group after the research is concluded.

What Does Research Participation Mean in a Classroom Setting?

When conducting research in a class setting, the IRB protocol needs to make a distinction between required classroom work and research. Data cannot be used for research without consent, even if students are required to complete the class assignments and curriculum.

From the beginning, the research methods described in the protocol should clearly delineate between school-driven versus investigator-driven research and between normal educational practices and special, research-specific interventions. The protocol should explain whether the planned activities were designed by the school or department and would occur regardless of whether the research takes place or whether the planned activities are designed by the study team to be done exclusively as part of the research.

Normal educational practices

If PIs plan on investigating the effectiveness of normal educational practices such as instructional strategies, instructional techniques, curricula, or classroom management methods, the research summary in the IRB application needs to explain the difference between choosing and not choosing to participate in the research. This information should also be communicated in the consent and assent documents and procedures. For example, if the research entails analyzing class assignments that students are required to complete, the consent/assent language should indicate that all students are required to do the work but that the research team will only analyze the work from those students from whom consent/assent has been obtained.

The burden of demonstrating whether an activity is part of normal educational practices is on the researcher. If a proposed research project appears to place participants at risk or has no precedent in previous, published research, the IRB will likely question the “normalcy” of the activity. For this reason, the PI should be prepared with a brief literature review that provides enough background information for the IRB to determine whether the proposed work falls within what is typical in the context of a specific classroom setting. What is considered to be normal in one classroom may not be in another. For example, curriculum and interventions for special education students in the primary or secondary school setting are tailored to each student, so normal classroom activities in a special education environment are student-specific in a way that they would not be in a general education environment. Be prepared to provide the contextual information about the school environment in which you intend to conduct the research in the IRB protocol – do not assume that IRB members will automatically know this.

Special, research-specific interventions

If the PI plans on conducting a special investigation or intervention that goes beyond assessing normal classroom practices, the consent and assent language must explain what those who choose not to participate will be doing in the meantime. An alternate assignment or activity may need to be designed, and non- participating students cannot be singled out by either their peers or their teacher (see above sections on interpersonal conflict of interest and stigmatization). The research must be designed so that neither the participating group nor the non-participating group forego any educational benefits because of their choices. That is, participating students should not be made to devote time to the research at the expense of their learning or in a way that is disruptive to the classroom environment, and non-participating students should not be excluded from the potential educational benefits that might be provided by an intervention. In the former instance, the PI should consider setting aside non-classroom time for participating students to complete research tasks, or come up with a research design that keeps information about who is and who is not participating private. In the latter case, when students might stand to benefit from the intervention but may not want to participate in the research, the PI can offer to apply the intervention to all students after the research is concluded. 

Secondary Data

The IRB has oversight over the use of secondary data that contain identifying information. In most cases, consent and assent are also required for the use of individually identifying educational records in research, even if a school has given permission to access and use the information for other purposes. If a PI have access to educational records as part of their job function, this does not automatically mean that they may use the records for research purposes.

Educational records are protected under the Family Educational Rights and Privacy Act (FERPA), and there is no statute of limitations on the privacy of uniquely identifying educational records. FERPA still applies to students’ records even if they have graduated or are no longer enrolled at the school. FERPA may also apply to counseling and medical records. Teachers and administrators cannot be asked to share information about specific students without the student’s and (for minors) a parent’s consent.

School permission alone is only acceptable if it confirms that the research team will not access educational records or the school will provide the PI with information from which all of the identifying information has already been removed.

In the protocol materials, please also avoid false claims about anonymity. If a researcher has access to individual student information and if he/she knows who participated in the research and who did not participate, the subjects are not anonymous. Efforts should be made to maintain confidentiality – such as through the use of pseudonyms – but anonymity cannot be guaranteed. Do not use the word “anonymous” in the protocol submission if it does not apply.

Observations in the Classroom

If the classroom environment will be observed, the IRB application must provide details about what information the research team wishes to gather from the observations and how the observations will help to answer the research questions. The IRB often receives educational research submissions that contain vague language about classroom observations. A rationale, justification, and details must be provided in order for proposed observations to be approved. In addition to explaining the nature of the observations, the IRB application must also explain who will conduct observations, when they will occur and how frequently they will occur, whether or not any information that could identify individual students will be recorded, and what data elements will be recorded. The PI may wish to create an observation intake sheet to record specific data elements to be gathered from observations.

Audio and Video Recording in the Classroom

If the classroom environment will be recorded, an explanation should be provided in both the IRB application and on the consent form about why the recordings are needed to carry out the research. A video-recording may be able to catch more than what a teacher could observe. In a primary or secondary school setting, the teacher/researcher role can become conflated when recordings capture behavior that may require disciplinary action on the part of the teacher but that may not be relevant to the research. The teacher’s role may interfere with the researcher’s promise that participation will not negatively impact the student. The protocol should explain how such situations will be handled. As with individually-identifying secondary data, video recordings by default are not anonymous. The protocol should explain how recordings will be handled in a classroom where some students may have provided consent/assent for participation in the research and some have not. If the purpose of the recording is to focus on the teacher and not the students, this needs to be outlined in detail, including the procedures for ensuring that students will not be video recorded. The protocol application should also explain who will have access to recordings, whether or not they will be disseminated, how long the recordings will be kept, where they will be stored, and when and how they will be destroyed.

Extra Credit as an Incentive for Participation in Research

The decision about whether or not to participate in research should not affect a student’s grade in a course. For this reason, extra credit may only be offered as an incentive for participation in research if an alternative, equivalent form of extra credit is offered for those students who want to obtain extra credit but who do not want to participate in research. In a college setting many institutions, including UM, use Sona Systems for advertising studies and credit management for college student subject pools. At UM, the department of Psychology uses Sona Systems; this tool is not available to all researchers. Where there is no system in place, researchers must describe the alternative extra credit in their IRB application. In addition, all researchers offering extra credit must specify the amount. For example, Sona allows assignment of credit hours in 15-minute increments. Researchers should not offer extra credit from differing instructors unless they can guarantee all students will receive the same amount and that an alternative is available. Extra credit may not be a feasible option if you are trying to maintain anonymity of subjects. Researchers using Sona cannot and should not guarantee anonymity for their participants since names must be known in order to assign credit to the correct student.

Validity of Data Instruments

The data instruments selected should be age and developmentally appropriate if they will be distributed to students in primary or secondary education settings and should be relevant to the research questions posed in the IRB application. While the selection of data instruments pertains to research design, if the instruments are too complex or cannot possibly answer the research questions posed, the IRB may request that they be revised or replaced. Inappropriate data instruments can contribute to additional risks for participants; at best the research can be a waste of the subjects’ time and, at worst, the research may lead to false conclusions that affect student learning. It is important that the instruments are not only reliable and well-established, but that they are designed to address the issue that is being studied and that they are used as they are designed for the specific research context.

Student Athletes

When specifically recruiting student athletes at the 91´ÎÔª or any of its affiliate campuses, investigators must first obtain permission from the appropriate campus’s Athletic Director.

Employees

91´ÎÔª employees may enroll in research protocols approved by the IRB. However, additional considerations and safeguards should be considered.

Employees, including 91´ÎÔª and affiliate employees (e.g., full-time, part-time, temporary, visiting, student employee appointments, etc.) may be recruited for research participation; however, an employee may not be required to participate in research as a condition of employment. Employees (individuals or groups) should not be selected solely on the basis of convenience when they would not otherwise be appropriate for inclusion.

Recruitment of potential participants who are employees must be designed to minimize the possibility of coercion or undue influence. In general, potential participants should be solicited from a “broad base” of individuals meeting the conditions for study, rather than from individuals who report directly to the investigator(s). Strategies to minimize the potential influence of an investigator when recruiting his/her own employees include recruitment through a third party unassociated in a supervisory relationship with the employee, postings or sign-up sheets, or other methods that require an employee interested in participation to initiate contact with the investigator(s).

Investigators and IRBs must consider strategies to ensure voluntary participation when the subjects of research include employees who are directly supervised by the investigator(s). An employee’s decision about research participation may not affect (favorably or unfavorably) performance evaluations, career advancement, or other employment-related decisions made by peers or supervisors. Investigators may act as participants in their own studies if they meet the inclusion/exclusion criteria and all procedures including consent are completed by a Co-Investigator or Coordinator.

Except in unusual circumstances, investigators should not enroll employees under their direct supervision into research studies that involve greater than minimal risk without the prospect of direct benefit. Such studies should proceed only where the IRB determines that adequate provisions have been made to minimize the possibility of coercion, and the research is of significant importance and cannot be conducted without the enrollment of these employees.

Additional safeguards may be needed to protect the privacy interests of employees who are also research participants. Workplace conditions may make it difficult for investigators to keep an individual’s participation confidential, which could pose risks to participants, e.g., when stigma is associated with the condition or question under study or when peer pressure is a component of the research. In such situations, research should be conducted off-site and/or outside of regular work hours when possible to minimize potential risks.

Protecting the confidentiality of research participants’ personal information when the participants are employees may also present additional challenges. The extent to which medical information and/or research data may be accessible to supervisors or others not directly involved in the research must be considered and disclosed to potential participants in the informed consent process.

In cases where regular workplace activities are also the topic of research, investigators must clarify for potential research participants those activities that are optional and distinct from any mandatory workplace activities that would take place even without the research. When access to individuals or the facilities of the site is needed for recruitment and/or research activities, a letter of support from someone authorized to speak on behalf of the employees/site may be required.

Self-Experimentation

Researchers can be subjects in their own studies. However, UM policy regards this type of research (investigator self-experimentation) as research with human participants, and generally requires the same review and approval as research that recruits other people as subjects.

Though investigator self-experimentation may not raise the conventional ethical concerns outlined in the Belmont Report, all human research projects should undergo ethical review to assure the safety of people involved and the integrity of the research at the university. While researchers may be aware of the risks of self-experimentation, they may also be more willing to accept risks that are ill-advised. Application for review with the IRB office allows a neutral third party to raise concerns and/or propose measures to promote the welfare of researchers.

The Common Rule and FDA regulations also require that informed consent be obtained from all research participants unless certain conditions are met. The IRB recommends researchers provide a consent document based on the template provided on the UM IRB website, with their IRB application, which will serve as the basis for documentation of informed consent for participation in human subjects research when the experimentation involves the researcher.

Other Vulnerable Populations

The context of the research is an important consideration for the IRB when reviewing research that involves potentially vulnerable participants. Members of the following groups may be considered potentially vulnerable. The IRB will consider the context of the research and determine whether additional protections may be needed if members of the following groups are a targeted study population:

• Members of disenfranchised racial or ethnic communities
• Members of disenfranchised groups, such as the LGBTQ+ community
• Members of the Armed Forces and veterans
• Refugees, undocumented immigrants, etc.
• Educationally disadvantaged persons
• Economically disadvantaged persons
• People experiencing homelessness
• Institutionalized individuals
• Individuals with mental illness and/or substance use disorders

4. Reporting Suspected Abuse or Neglect of Children, Elderly Individuals, and Dependent Adults

An investigator who knows of or reasonably suspects neglect or abuse of a child, elder, or dependent adult while engaged in university-approved research may need to report the abuse. An investigator who is classified as a mandated reporter under Montana law (e.g., teacher or medical practitioner) must report such abuse or neglect to appropriate authorities unless otherwise directed by the Associate Vice President (AVP) for Research and Creative Scholarship. An investigator who is not otherwise classified as a mandated reporter under Montana law and who knows or reasonably suspects that a child, elder, dependent adult has been abused or neglected, should seek guidance from the AVP who will consult with University Legal Counsel to determine an appropriate course of action. Investigators also must report such incidents of abuse or neglect to the IRB.

Examples of abuse and neglect that researchers may be legally and/or ethically required to report to authorities include, but are not be limited to:

• Physical neglect - a parent or caregiver is not caring for a dependent’s physical needs, such as the need for food, water, or shelter. Signs of physical neglect may include frequent complains of hunger/thirst; signs of malnourishment, such as low body weight; hygiene issues, such as unwashed skin, hair, or clothing; and untreated wounds, dental issues, or medical conditions.
• Physical abuse – a parent or caregiver uses physical violence against a dependent, including hitting, kicking, burning, pinching, or corporal punishment. Signs of physical abuse may include visible injuries such as bruises, especially if they are at different stages of healing, cigarette burns, cuts, or lash marks; jumpiness or fearful behavior; and emotional outbursts.
• Emotional abuse – a parent or caregiver insults, intentionally humiliates, manipulates, gaslights, isolates, threatens, or coercively controls a dependent. Signs of emotional abuse may be hard to distinguish and researchers should be aware of this when working with vulnerable participants. Signs of emotional abuse may include but are not limited to lack of eye contact, expressions of fear or anxiety, withdrawal, and talk of death or dying.
• Sexual abuse – sexual abuse is any inappropriate touching, contact, or exposure of sexual content or nature by a parent or caregiver to a dependent. This includes but is not limited to rape, incest, sexual coercion, sex trafficking, or exposing children to sexual content. Signs of sexual abuse may be hard to distinguish and researchers should be aware of this when working with vulnerable participants.
• Financial abuse – a caregiver is stealing a dependent’s money, seizing control of it, or preventing them from having their own. There are many signs of financial abuse but some may include, but are not limited to, preventing someone access to their bank account; preventing someone from working and/or interfering with job performance in some way; forcing someone to account for all money spent by, for example, looking at receipts; and forcing someone to turn over their paychecks.

IRB Responsibility

The IRB is required to determine whether the risks to subjects are sufficiently minimized, informed consent is appropriate, vulnerable research subjects are adequately protected, and that privacy and confidentiality protections are adequate. If the IRB believes that a reportable observation or revelation of suspected harm to a child or other vulnerable person, such as a dependent adult or elder, might occur during the research, it may require that the informed consent statement include a warning of the limits to research confidentiality and advise subjects of the investigator’s duty to report known or suspected incidents of abuse or neglect to appropriate authorities, including law enforcement.

Investigator Responsibility

Each proposal for research that includes procedures which might lead to the disclosure of known or suspected child, dependent adult or elder abuse, OR will be conducted in subjects' homes (where signs of abuse may be observed), should include the following in the application for IRB review:

1. An investigator should explain to the IRB whether he/she is a "mandated reporter" as defined by Montana law governing child or elder and dependent adult abuse and neglect.
2. An investigator who is not a mandated reporter should clarify whether he/she intends to report information about alleged, probable, or known sexual or physical abuse of a child, dependent adult or elder which may be disclosed during the research.
3. The investigator should delineate in the IRB application any conditions under which confidential information might be disclosed, should specify what information will be reported to the authorities, and describe the procedures which will be followed. (i.e., who will make the report, to whom the report will be made, etc.)
4. The investigator should create and submit for IRB review an informed consent document that accurately reflects the conditions under which confidential information might be disclosed, including any voluntary disclosure by the researcher about alleged, probable, or known abuse or neglect of a child, dependent adult or elder.

The informed consent and assent form confidentiality section should include a description and examples of the types of information which the research team may report to authorities.

Consent form requirements for investigators who ARE in mandated reporter classifications:

Consent form: Under Montana law, the researcher(s) will not maintain as confidential, information about known or reasonably suspected incidents of abuse or neglect of a child, dependent adult or elder, including, but not limited to, physical, sexual, emotional, and financial abuse or neglect. If any researcher has or is given such information, he or she may be required to report it to the authorities… [provide description and examples of types of information which would be reported ...]

Assent Form: We will not tell anyone what you tell us without your permission unless there is something that could be dangerous to you or someone else. If you tell us that someone is or has been hurting you, we may have to tell that to people who are responsible for protecting children so they can make sure you are safe.

Consent form requirements for investigators who are NOT in mandated reporter classifications:

Consent form: The researcher(s) may not be able to maintain as confidential, information about known or reasonably suspected incidents of abuse or neglect of a child, dependent adult or elder, including, but not limited to, physical, sexual, emotional, and financial abuse or neglect. If the researcher is given such information, he or she may report it to the authorities [provide description and examples of types of information which would be reported ...]

Assent Form: We will not tell anyone what you tell us without your permission unless there is something that could be dangerous to you or someone else. If you tell us that someone is or has been hurting you, we may have to tell that to people who are responsible for protecting children so they can make sure you are safe.

5. Certificates of Confidentiality

Certificates of Confidentiality are an important tool to protect the privacy of research subjects. Certificates are issued by the National Institutes of Health (NIH) and other HHS agencies (such as the Centers for Disease Control and Prevention, and the Food and Drug Administration) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research subjects in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.

Certificates of Confidentiality may be granted for studies collecting information that if disclosed could damage their financial standing, employability, insurability, or reputation or have other adverse consequences for the subjects. By protecting researchers and institutions from being compelled to disclose information that would identify research subjects, Certificates of Confidentiality help achieve the research objectives and promote participation in studies by assuring confidentiality and privacy to subjects.

The certificate goes beyond the consent form in ensuring confidentiality and anonymity. Without the certificate, researchers can be required by a court-ordered subpoena to disclose research results (usually as part of a criminal investigation of the subjects). Certificates of Confidentiality protect subjects from compelled disclosure of identifying information but do not prevent the voluntary disclosure of identifying characteristics of research subjects.

Any investigator engaged in research in which sensitive information is gathered from human subjects (or any person who intends to engage in such research) may apply for a Certificate of Confidentiality. Research can be considered "sensitive" if it involves the collection of:

• information about sexual attitudes, preferences, practices;
• information about personal use of alcohol, drugs, or other addictive products;
• information about illegal conduct;
• information that could damage an individual's financial standing, employability, or reputation within the community;
• information in a subjects’ medical record that could lead to social stigmatization or discrimination;
• genetic information;
• tissue samples; or
• information about a subjects’ psychological well-being or mental health.

This list is not exhaustive. Researchers contemplating research on a topic that might qualify as sensitive should contact the IRB office for help in applying for a certificate.

Certificates are granted sparingly. The study's funding source, if any, is not relevant to the decision. The IRB may require investigators to apply for a Certificate of Confidentiality.

Statutory Basis for Protection

Protection against compelled disclosure of identifying information about subjects of biomedical, behavioral, clinical, and other research is provided by the Public Health Service Act §301(d), 42 U.S.C. §241(d): "The Secretary may authorize persons engaged in biomedical, behavioral, clinical, or other research (including research on mental health, including research on the use and effect of alcohol and other psychoactive drugs) to protect the privacy of individuals who are the subject of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals. Persons so authorized to protect the privacy of such individuals may not be compelled in any Federal, State or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals."

Limitations

The protection offered by a Certificate of Confidentiality is not absolute. A Certificate protects research subjects only from legally compelled disclosure of their identity. It does not restrict voluntary disclosures.

For example, a Certificate does not prevent researchers from voluntarily disclosing to appropriate authorities such matters as child abuse or a subject’s threatened violence to self or others, or from reporting a communicable disease. However, if researchers intend to make such disclosures, this should be clearly stated in the informed consent form that research subjects are asked to sign.

In addition, a Certificate of Confidentiality does not authorize the person to whom it is issued to refuse to reveal the name or other identifying characteristics of a research subject if:

• the subject (or, if he or she is legally incompetent, his or her legal guardian) consents, in writing, to the disclosure of such information;
• authorized personnel of the Department of Health and Human Services (HHS) request such information for audit or program evaluation, or for investigation of HHS grantees or contractors and their employees; or
• release of such information is required by the Federal Food, Drug, and Cosmetic Act or regulations implementing that Act.

Mandatory Reporting

While any person may make a report if they have reasonable cause to believe that a child or elder was abused or neglected, Montana law mandates that certain persons who suspect child or elder abuse or neglect report this to the appropriate authorities.

6. International Research

Research with international subjects requires sensitivity, as different cultural contexts may indicate certain classes of people are more vulnerable to being coerced or influenced to participate in human subjects research. There may also be increased risks to breaches of confidentiality or the consequences of such a breach. Therefore it is recommended that the IRB seek the expertise of someone familiar with the culture of the country where the investigator is proposing to conduct research.

Additional considerations when conducting international research include ensuring that all consent documentation are translated into the native language of the target population. The monitoring plan needs to include someone in-country for subjects to contact with their questions and concerns.

Finally, the investigator needs to be aware of local laws which may limit contact with subjects or indicate different privacy regulations than what are expected in the United States. For example, people residing in the European Union Economic Area (EEA) have rights in the General Data Protection Regulations (GDPR) which determine what is considered private information and how a researcher can collect, transport, analyze, and share personal data. 

7. Research with Test Articles (FDA)

Certain categories of research involve either methodologies that might require additional considerations or for which there are federally mandated determinations that IRBs are required to make and document. These categories of research include, but are not limited to:

• Clinical investigations involving drugs or biologics
• Clinical investigations involving medical devices
• Gene therapy research
• Prospective research in emergency settings
• Expanded access of an investigational drugs or devices, including single patient treatment use and compassionate use requests
• Emergency use of an investigational article or product
• Humanitarian use devices

Research Involving Drugs or Biologics

All research involving use of FDA regulated drugs or biologics require submission of an Investigational New Drug Application to the FDA unless the research meets the criteria for exemption from the requirements as outlined below or the research involves the use of a drug other than the use of a marketed drug in the course of medical practice.

For sponsored research, applications for research on the use of a drug, unless that research is exempt from the IND regulations, must be accompanied by documentation from the FDA that includes a valid IND number. The IND number must either match the number on the sponsor protocol with the same title as the proposed research or be listed on communication from the sponsor specific to the proposed research, or on communication with the FDA. The research must not begin until a valid IND is in effect. This includes recruiting, obtaining consent, and screening participants for a specific study that is subject to an IND.

A study may qualify for IND exemption if it meets one of the FDA exemptions from the requirement to have an IND:

• Exemption 1: A clinical investigation of a drug product that is lawfully marketed in the United States if all the following apply:
  • The investigation is not intended to be reported to the FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug;
  • If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation is not intended to support a significant change in the advertising for the product;
  • The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product;
  • The investigation is conducted in compliance with the requirements of 21 CFR 312.7.

• Exemption 2: A clinical investigation involving an in vitro diagnostic biological product if all the following apply:

  • The diagnostic involves one or more of the following: blood grouping serum, reagent blood cells, and anti-human globulin;

  • The diagnostic test is intended to be used in a diagnostic procedure that confirms the diagnosis made by another, medically established, diagnostic product or procedure; and

  • The diagnostic test is shipped in compliance with 21 CFR 312.160.

• Exemption 3: A drug intended solely for test in vitro or in laboratory research animals if shipped in accordance with 21 CFR 312.160.

• Exemption 4: A clinical investigation involving use of a placebo if the investigation does not otherwise require submission of an IND

When an exemption determination is needed, this assessment will be based on the information provided by the investigator and/or the sponsor. If information provided by the investigator and/or the sponsor is unclear or incomplete, the IRB staff may request submission of the THIS IS MISSING FROM PDF...CHECK LATER

It is the responsibility of the investigator and/or sponsor to provide accurate information. Exemption determinations may be made by the IRB or may be determined by the FDA.

Research Involving Medical Devices

Research with medical devices falls into four categories:

• • Investigations of significant risk devices
• Investigations of non-significant risk devices
• Investigations exempted from the IDE regulations
• Research involving medical devices for the collection of data but where the medical device is not under investigation to evaluate the safety and effectiveness of the device

When a device risk determination is needed, the convened IRB will determine whether the study presents a significant risk or a non-significant risk of harm to study participants. This assessment will be based on the information provided by the investigator and/or the sponsor. It is the responsibility of the investigator and/or sponsor to provide accurate information.

The IRB’s risk determination will be documented in the IRB meeting minutes. If an investigator submits a Non-Significant Risk research protocol that is determined by the IRB to be a Significant Risk study, the investigator and the Sponsor, if necessary, will be notified in writing. No further action will be taken by the IRB on the research until the sponsor or investigator has met the requirements for a SR study described in 21 CFR 812.

Significant Risk Device Investigations

Applications for research on the use of a significant risk medical device must be accompanied by documentation from the FDA that includes a valid IDE number.

The IDE number must either match the number on the sponsor protocol with the same title as the proposed research or be listed on communication from the sponsor specific to the proposed research, or on communication with the FDA.

Non-significant Risk Device Investigations

When research involves use of a medical device and the investigators/sponsor indicates that the device may qualify as non-significant risk, the IRB either confirms (1) that appropriate documentation is provided from the FDA to classify the device as non-significant risk or (2) the device does not qualify as a significant risk device, according to the following regulatory criteria outlined below. A significant risk device is an investigational device that presents a potential for serious risk to the health, safety, or welfare of a participant AND:

1. Is intended as an implant; or
2. Is purported or represented to be for a use in supporting or sustaining human life; or
3. Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health; or
4. Otherwise presents a potential for serious risk to the health, safety, or welfare of a participant.

If the above criteria above are not met, the device may be designated as non-significant risk. No application is required to be submitted to the FDA. If the IRB cannot determine the risk of the device, the IRB may defer the determination to the FDA.

When research is conducted to determine the safety or effectiveness of the non-significant risk device the following abbreviated IDE requirements must be ensured by the designated Sponsor (or the Principal Investigator, if there is no sponsor):

• The device is not a banned device. 
• The sponsor labels the device in accordance with 21 CFR 812.5.
• The sponsor obtains approval of the investigation after presenting the reviewing IRB with a brief explanation of why the device is not a significant risk device and maintains such approval.
• The sponsor ensures that each investigator participating in an investigation of the device obtains from each participant enter investigator’s care, consent under 21 CFR 50 and document it, unless documentation is waived.
• The sponsor complies with the requirements of 21 CFR 812.46 with respect to monitoring investigations;
• The sponsor maintains the records required under 21 CFR 812.150 (b) (1) through (3) and (5) through (10);
• The sponsor ensures that participating investigators maintain the records required by 21 CFR 812.140 (a) (3) (i) and make the reports required under 812.150 (a) (1), (2), (5), and (7); and
• The sponsor complies with the prohibitions in 21 CFR 812.7 against promotion and other practices.

Investigations Exempted from IDE regulations

Clinical investigations that are exempt from IDE regulations still require IRB review and approval. An investigation of a medical device in human subjects research that is exempt from the IDE regulations must fall into one of the following categories and will be determined along with the review and approval of a submission:

• A device legally marketed in the US that is used or investigated in accordance with the indications in the FDA-approved labeling.
• A device, other than a transitional device, in commercial distribution immediately before May 28, 1976, when used or investigated in accordance with the indications in labeling in effect at that time.
• A device, other than a transitional device, introduced into commercial distribution on or after May 28, 1976, that FDA has determined to be substantially equivalent to a device in commercial distribution immediately before May 28, 1976, and that is used or investigated in accordance with the indications in the labeling FDA reviewed under subpart E of part 807 in determining substantial equivalence.
• A diagnostic device (that is, an in vitro diagnostic device) if the testing:
  • Is noninvasive
  • Does not require an invasive sampling procedure that presents significant risk,
  • Does not by design or intention introduce energy into a participant, and 
  • Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure.
• A device undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution, if the testing is not for the purpose of determining safety or effectiveness and does not put participants at risk.
• A custom device as defined in 21 CFR 812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution.

When an exemption determination is needed, this assessment will be based on the information provided by the investigator and/or the sponsor. It is the responsibility of the investigator and/or sponsor to provide accurate information. Exemption determinations may be made by the IRB or may be determined by the FDA.

Research Involving Medical Devices for the Collection of Data

Expedited review category 4 allows for the “collection of data through noninvasive procedures” and specifically notes: “Where medical devices are employed, they must be cleared/approved for marketing.” Studies intended to evaluate the safety and effectiveness of the medical device do not qualify under this category of review. The use of marketed medical devices for the collection of data on research studies may be part of a research protocol undergoing expedited or convened review. This type of use is generally considered not to be FDA regulated as it does not meet the definition of a clinical investigation intended to evaluate the safety and effectiveness of the medical device. In essence, the device is not the participant of the investigation.

Gene Therapy Research

Gene therapy research may require special considerations. If the project involves gene transfer (administration of recombinant vectors) to human participants for other than clinical purpose review by the NIH Recombinant DNA Advisory Committee (RAC) may be required. The FDA must review any such study prior to final IRB approval. In addition, the protocol will require review by the 91´ÎÔª Institutional Biosafety Committee.