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Guidelines & Procedures
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|4.||Special/ Vulnerable Subject Populations|
|The IRB follows special procedures with respect to special/ vulnerable subject populations. The procedures provide additional safeguards in research activities involving: children; children assent and consent; children within Milwaukee Public Schools; mentally disabled; mentally disabled assent and consent; pregnant women and fetuses; and prisoners.|
When research subjects are children, federal regulations impose additional requirements on the researcher. Two such limitations include (1) some research which would fall in the exempt category if the subjects were all competent adults is not exempt, and (2) some research involving more than minimal risk to the subjects is prohibited. The informed consent process also requires some additional steps.
1. Categories of exempt research when the subjects are children
2. Special considerations in research when subjects are children
45 CFR 46.404 - Research not involving greater than minimal risk to the children.
To approve this category of research, the IRB must make the following determinations:
45 CFR 46.405 - Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual child subjects involved in the research.
To approve research in this category, the IRB must make the following determinations:
45 CFR 46.406 - Research involving greater than minimal risk and no prospect of direct benefit to the individual child subjects involved in the research, but likely to yield generalizable knowledge about the subject's disorder or condition.
In order to approve research in this category, the IRB must make the following determinations:
A fourth category of research requires a special level of HHS review beyond that provided by the IRB.
45 CFR 46.407 - Research that the IRB believes does not meet the conditions of 45 CFR 46.404, 46.405, or 46.406, but finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children.
If the IRB believes that the research does not meet the requirements of 45 CFR 46.404, 46.405, or 46.406, but finds that it presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children, it may refer the protocol to HHS for review. The research may proceed only if the Secretary, HHS, or his or her designee, after consulting with a panel of experts in pertinent disciplines (e.g., science, medicine, education, ethics, law) and following an opportunity for public review and comment, determines either: (1) that the research in fact satisfies the conditions of 45 CFR 46.404, 46.405, or 46.406, or (2) the following:
|4.2||Children: Assent & Consent|
|See 3.4.5 Assent for Children|
|4.3||Children: Milwaukee Public Schools (MPS) Policy on Research|
|Investigators should be aware that if their research involves MPS students, they may be subject to MPS policies on research. Click here to view Milwaukee Public Schools policy on research.|
The IRB has adopted special rules that apply when research subjects are mentally disabled. Most of the general requirements for approving research with human subjects apply, but with some exceptions and additions. The major exceptions are that (1) some research which would fall in the exempt category if the subjects were all competent adults is not exempt, and (2) some research involving more than minimal risk to the subjects is prohibited. Additional requirements pertain to informed consent. For the purpose of these requirements, a "mentally disabled" person is a person who, because of mental illness, mental retardation, emotional disturbance, or senility, is incapable of giving informed consent.
Of course, some persons who have these conditions are also able to give informed consent, but the IRB cannot determine the capacity of persons with these conditions on the basis of labels alone. Therefore, whenever proposed research involves subjects who have been diagnosed with one of these conditions or who may have such a condition, the researcher should explicitly tell the IRB whether the subjects are able to give informed consent because of the condition. If the subjects are able to give informed consent, the special rules in this section do not apply, and only the general requirements for research with human subjects must be satisfied.
Categories of exempt research when the subjects are mentally disabled.
Special considerations in research when subjects are mentally disabled.
2. Research that poses more than minimal risk but which promises to benefit the individual subject directly will be permitted if:
3. In addition, if the mentally disabled subjects are wards of the state or any other agency, institution, or entity, they may be the subjects of research that poses more than minimal risk only if the research is: (1) related to their status as wards, or (2) conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of the subjects involved are not wards. Furthermore, if the research poses more than minimal risk, an advocate must be appointed for each mentally disabled person who is a ward. The advocate must be a person who has the background and experience to act in, and agrees to act in, the best interests of the mentally disabled person for the duration of the person's participation in the research. The advocate cannot be associated in any way with the research, the investigator(s) or the guardian organization. A person can be the advocate for more than one person. The requirement for an advocate is in addition to any other person acting on behalf of the mentally disabled person as guardian.
4. Research that poses more than minimal risk and does not promise to benefit the individual subject directly will be permitted if:
|4.5||Mentally Disabled: Assent & Consent|
Assent of the subjects.
Consent (permission) from competent adults acting on behalf of the subjects.
The parent of a mentally disabled person below the age of 18 is presumed to be the person's guardian. If the mentally disabled person is older than 18, the parent is not automatically the guardian. If the subjects are mentally disabled adults who have not formally had legal guardians appointed for them, the researcher should propose a procedure for securing permission from a competent adult acting solely in the interests of the mentally disabled person. This procedure must be consistent with federal, state, and local law.
Information that must be provided in requests for assent and consent (permission ) & documentation of informed consent. Mentally disabled subjects and the competent adults acting on their behalf must be given the same information that is generally required when informed consent for participation in research is sought, and their permission and assent must be documented in writing. The assent form for the mentally disabled subjects should, of course, be written in language appropriate to their level of understanding.
Waiving assent and consent:
|4.6||Pregnant Women & Fetuses|
Pregnant Women & Fetuses - 45 CFR 46, Subpart B
Pregnancy encompasses the period of time from confirmation of implantation (as evidenced by missed menses or a medically acceptable test) until expulsion or extraction of the fetus. Fetus means the product of conception, from the time of implantation until a determination is made, following expulsion or extraction, that it is viable.
Activities Directed Toward Pregnant Women
Additional Consent Requirements
Prisoners - 45 CFR 46, Subpart C
Prisoner means any individual involuntarily confined or detained in a penal institution. The term applies to those sentenced to such an institution, those detained in other facilities as alternatives to prosecution, and those detained pending arraignment, trial, or sentencing.
Prisoners may be under constraints because of their incarceration that affect their ability to make a truly voluntary decision whether or not to participate as subjects in research. Additional safeguards are required, therefore, when prisoners are proposed as subjects.
IRB Membership Regarding Research with Prisoners
Types of Research Permitted
In all cases, the research is to present no more than minimal risk and inconvenience to subjects. For research in the latter two categories above, consultation may be necessary to determine possible need for approval by experts in penology, medicine and ethics.
It is the obligation of researchers to conduct activities in a manner and at such locations as will assure the proximity of adequate medical attention if warranted, and to provide appropriate referrals to subjects for adequate facilities and professional attention should subjects suffer physical, psychological or other injury.
The seriousness of a risk to subjects is a function of the magnitude of the harm and the probability of the harm. A risk may be serious or significant because it has a probability (even a low probability) of great harm (e.g., a low probability of death), or because it has a high probability of slight harm (e.g., a near certainty of physical discomfort or psychological distress).
The risks of participation in research may be part of the research design or may be a consequence of the research procedures, or both (e.g., the risks of an adverse reaction to an investigational drug are part of the research design, while the risk of hematoma from blood drawn in the research is not part of the design but a consequence of the research procedures). Risks may be a consequence of the methods of recording, maintaining, or reporting data, and they may be a consequence of methods of obtaining informed consent.
|Physical risks include physical discomfort, pain, injury, illness or disease brought about by the methods and procedures of the research. A physical risk may result from the involvement of physical stimuli such as noise, electric shock, heat, cold, electric, magnetic or gravitational fields, etc. Engaging a subject in a social situation which could involve violence may also create a physical risk.|
|Psychological risks include the production of negative affective states such as anxiety, depression, guilt, shock and loss of self-esteem and altered behavior. Sensory deprivation, sleep deprivation, use of hypnosis, deception or mental stresses are examples of psychological risks.|
|Social risks include alterations in relationships with others that are to the disadvantage of the subject, including embarrassment, loss of respect of others, labeling a subject in a way that will have negative consequences, or in some way diminishing those opportunities and powers a person has by virtue of relationships with others. Economic risks include payment by subjects for procedures not otherwise required, loss of wages or other income and any other financial costs, such as damage to a subject's employability, as a consequence of participation in the research.|
|5.5||Deception/ Non Disclosure|
Occasionally, some degree of deception is involved in a research study. Minor deception, such as failing to tell the subject what the specific points of interest are, in an attempt to prevent biasing the results, can be acceptable provided the subject is fully debriefed after participating. Risks stemming from major deceptions, such as leading a subject to believe that s/he has committed a crime or has a disease, must be clearly counterbalanced by the benefits of the research. Withholding information cannot be used as a means to secure the participation of subjects in research.
The use of deception imposes special responsibilities on the investigator. One of these responsibilities is to provide appropriate debriefing to the subjects. In each case, the UWM IRB will require information sufficient to understand why deception is needed, how the potential benefits justify its use, and how debriefing will be done.
If information was temporarily withheld from the subject during the study, or if deception was employed, a separate debriefing statement should be presented at the end of the procedure. This statement should clearly indicate why information was withheld during the study, and/or the purpose of the deception.
|5.6||Loss of Confidentiality|
In all research involving human subjects, confidentiality of identifiable information is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. Subjects have the right to be protected against injury or illegal invasions of their privacy and to preservation of their personal dignity. The more sensitive the research material, the greater the care that must be exercised in obtaining, handling, and storing data.
Investigators should be cognizant of the following guidelines to ensure confidentiality:
Voluntariness begins with recruitment. Potential subjects must not feel that they have been coerced into participating, nor must they fear the loss of some benefit to which they are otherwise entitled if they choose not to participate (such as on-going support by a social agency).
Special care must be taken if the person doing the recruiting is a person who is in a position of authority (such as a teacher recruiting his or her own students) or makes decisions about the provision of services (such as a director of a training clinic). It is the researcher's responsibility to ensure that a person's decision to participate or not participate, will have no other effect on an existing relationship.
|6.1||Recruiting UWM Students|
Students in UWM classes are occasionally asked to participate in research. In such cases, the researcher should ask the instructor to give her/his permission to use class time to conduct a study. Because students in classrooms comprise a captive audience, care should be taken to respect their rights as subjects and as students. If participation as a subject is part of the academic work of a student, it must not be a coercive requirement, and informed consent, if appropriate, must be obtained. Alternate means of receiving credit if a student chooses not to participate or chooses to withdraw during the course of the study should be provided.
To assure that students feel free to refuse to participate without concern that the evaluation of their classroom performance will be affected, the instructor should not be present during any research activities. Furthermore, the instructor should not be informed nor be aware of who participates. When researchers wish to audiotape or videotape university classes, students have the right to refuse participation. At the same time, students should not be penalized by losing significant classroom instruction, in the event they decide not to be taped. The following procedures should be used:
Because research involves time that would otherwise be used for instructional activities, departments may wish to promulgate policies with regard to classroom research. The IRB recognizes that participating in research and receiving information about the research may be instructionally relevant.
|6.2||Recruiting Clients of Social Service Agencies, Schools, and Other Institutions|
The researcher shall not ask institutions to directly identify potential subjects for a research study. Rather, the investigator shall ask an intermediary (doctor, case worker, school administrator) to first approach potential subjects (or their guardians, as appropriate) and inform them about the research. If a potential subject agrees to participate, the intermediary should provide her/him with the information necessary to contact the researcher, in such a way that the institution is unaware whether the subject chooses to participate in the research. The intermediary should not obtain consent from potential subjects.
The researcher shall not ask institutions to release records or anecdotal information either for the purposes of identifying subjects, or for examination by the investigator, unless this information is public. An investigator wishing to examine records must first obtain permission of the subject via an intermediary. If a potential subject agrees to release his or her records, the intermediary should provide the information necessary to contact the researcher. This provision does not apply to records with all identifiers removed (see exemption 4).
If advertising for subjects, investigators must follow these guidelines:
|7.||Payments to Research Subjects|
|Access the Business and Financial Services' Administrative Financial Manual on Payments to Research Subjects.
If you plan to pay research subjects using prizes, raffles, or awards, please review the guidance from UWM's Legal Affairs Office.
|8.||Off-Site Research (Collaborative Research)|
A Federalwide Assurance (FWA) is an agreement between the institution (UWM) and OHRP where the institution agrees to conduct research involving human subjects by certain standards. UWM has its own FWA (FWA00006171) for research conducted at UWM. Under the FWA, the IRB is also charged with the responsibility for assuring that all human subject research conducted under the auspices of UWM (e.g., investigators and facilities) is conducted in compliance with federal law.
All institutions "engaged" in human subjects research that is not exempt from the regulations, and is conducted or supported by any HHS agency must be covered by an OHRP assurance of compliance (FWA).
Off-Site Cooperative Research (research outside of UWM):
|Step 1.||Determine if the non-UWM institution is “engaged” in the human subject research as defined by OHRP. An institution becomes “engaged” in human subjects research when its employees or agents (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes. Click here for examples.|
|Step 2.||Determine if the research study is supported by HHS.|
|Step 3.||Based on responses to Step 1 and 2, determine the appropriate action that is required for the study.|
|Action 1.||Engaged = Yes, HHS Supported = Yes|
|Action 2.||Engaged = Yes, HHS Supported = No|
|Engaged = No, HHS Supported = Yes|
|Engaged = No, HHS Supported = No|
Additional Guidance for Online Research Activities on what is considered private v. public websites and consent options.
The IRB recommends researchers utilizing the Internet as a research tool to address the following in their protocol procedures and informed consent:
Research in foreign countries also presents special concerns regarding the rights and welfare of human subjects. In general, the IRB accepts the standards of the location in which the research is taking place, unless those standards grossly violate the basic ethical principles of human subject research. In addition, the following issues apply to international human subject research:
Student research conducted purely for instructional purposes is generally not reviewed by the IRB. If, however, there is a possibility that the data will be published or maintained for later use, the project should be approved by the IRB prior to human subjects involvement. The Board is unable to give post facto approval.
Even though classroom initiated research is not reviewed for risk by the IRB at this time, it is important that instructors and students discuss the guidelines and ethics for protection of research subjects and incorporate these into their methodology.
Particular emphasis should be place on:
|12.||Audio/ Video/ Photograph Recordings|
Audio/Video/Photographic Recording of Human Subjects requires unique handling and storage, particularly if the content may be considered sensitive. As with all research procedures, the dignity of human subjects should be respected. Therefore, adequate justification for its necessity is required. Research subjects must be informed prospectively that such recording will occur (e.g., information letter, verbal script, informed consent form, etc.) and be provided with information about the storage, confidentiality, and future use of the resulting tape.
The following should be addressed in the protocol:
If the recording is not required as part of the research procedures, then the consent document must include a specific statement indicating that participation in the research study is not contingent upon agreeing to be recorded. A separate consent signature for permission to record will be necessary.
|13.||Modifications/ Amendments to an IRB Approved Study|
Regardless of how minor it is, approval from the IRB is required for any modifications or amendments to a previously approved protocol or consent form. Changes to the study can be reviewed either by a Full Board or through Expedited status.
Expedited Review: Minor changes to previously approved protocols may be reviewed in an expedited manner by the IRB Administrator and designated IRB board member. Minor changes include those that pose no greater than minimal risk to the participant and do not negatively impact the risk-benefit ratio of the research. Examples of amendments that consist of simple changes include:
Full Committee Review: When proposed changes in a research study do not meet the requirements for expedited review, the IRB must review changes at a convened meeting of the full IRB Committee before they can be implemented. The only exception is the rare circumstance in which a change is necessary to eliminate apparent immediate hazards to the research participants. In this case, the IRB should be promptly informed of the change following its implementation.
|14.||Continuing Review to an IRB Approved Study|
Federal regulations require protocols receive continuing review not less than once per year. 45 CFR 46.109(e). UWM does not annually review Exempt protocols. Study original reviewed and approved as either Full Board or Expedited are reviewed at least annually. Two (2) months before the 1 year approval period on a protocol expires, the IRB office will send the principal investigator a notification letter reminding them of continuing review.
If the study is considered active by the investigator (i.e., still enrolling, performing research procedures, recording/analyzing data, etc.) and submission for continuing review has not been filed and reviewed by the IRB before the date of IRB expiration, the study will automatically be "Terminated". Federal regulations make no allowances for grace periods.