Section 8: Procedures for Research with Vulnerable Populations

8.0 Inclusion of Pregnant Women, Human Fetuses, and Neonates in Research
8.1 Inclusion of Prisoners in Research
8.2 Inclusion of Children in Research
8.3 Requirements for Assent / Consent / Authorization by Children
8.4 Inclusion of Adults who Lack Decision-Making Capacity in Research
8.5 Inclusion of University of Texas at Austin Students and Staff in Research
8.6 Subject Pools
8.7 Student Class Projects

8.0 INCLUSION OF PREGNANT WOMEN, HUMAN FETUSES, AND NEONATES IN RESEARCH

In addition to the responsibilities prescribed for the IRB, the Board shall follow special procedures with respect to vulnerable populations. In this case the procedures provide additional safeguards in research activities involving, pregnant women, human fetuses, and neonates. This section is intended to follow the guidelines set forth in Subpart B of 45 CFR 46. Investigators should include in the research proposal the rationale and details for the inclusion of pregnant women, fetuses, or neonates in research activities. Researchers should ensure that the informed consent process adequately addresses the risk to the fetus or neonate and pregnant women. The IRB reviews all guidelines as set forth in Subpart B of 45 CFR 46 by utilizing the primary and secondary reviewer form. The IRB approves only those studies the IRB has determined to fulfill all necessary regulatory requirements. The IRB when reviewing research ensures that there is adequate scientific and scholarly expertise to review the research. The University of Texas at Austin IRB reserves the right to request expert consultation as necessary for adequate review.

Definitions:

"Pregnancy" encompasses the period of time from implantation until delivery¹⁹. A woman shall be assumed to be pregnant if she exhibits any of the presumptive signs of pregnancy, such as missed menses, until the results of pregnancy testing are negative or until delivery.
"Fetus" means the product of conception from implantation until delivery.
“Neonate” means a newborn.

Pregnant women or fetuses may be involved in research if all of the following conditions are met (45 CFR 46.204):

Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on nonpregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses;
The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means;
Any risk is the least possible for achieving the objectives of the research;
If the research holds out
1. the prospect of direct benefit to the pregnant woman,
2. the prospect of a direct benefit both to the pregnant woman and the fetus, or
3. no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means, the woman’s consent is obtained;
If the research holds out the prospect of direct benefit solely to the fetus, then the consent of the pregnant woman and the father is obtained, except that the father’s consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest;
Each individual providing consent under (4) or (5) above is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate;
For children who are pregnant, assent and permission are obtained in accord with Subpart D for studies involving children;
No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy;
Individuals engaged in the research will have no part in determining the viability of a neonate, and
A data safety monitoring plan has been established to monitor participants.

Neonates of uncertain viability and nonviable neonates may be involved in research if all of the following conditions are met (45 CFR 46.205a):

Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for assessing potential risks to neonates;
Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the neonate;
Individuals engaged in the research will have no part in determining the viability of a neonate; AND if the neonate is of uncertain viability (45 CFR 46.205(b), until it has been ascertained whether or not a neonate is viable, the following additional conditions are met:

a. The IRB determines that the research holds out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective, or the purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means and there will be no added risk to the neonate resulting from the research; and
b. The legally effective informed consent of either parent of the neonate or, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent of either parent’s legally authorized representative is obtained in accord with Subpart A, except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.

OR

According to 45 CFR 46.205(c) if the neonate is nonviable after delivery, all of the following additional conditions are met:

a. Vital functions of the neonate will not be artificially maintained;
b. The research will not terminate the heartbeat or respiration of the neonate;
c. There will be no added risk to the neonate resulting from the research;
d. The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means; and
e. The legally effective informed consent of both parents of the neonate is obtained, except that the waiver and alteration provisions of Subpart A do not apply. However, if either parent is unable to consent because of unavailability incompetence, or temporary incapacity, the informed consent of one parent of a nonviable neonate will suffice to meet the requirements of this paragraph, except that the consent of the father need not be obtained if the pregnancy resulted from rape or incest. The consent of a legally authorized representative of either or both of the parents of a nonviable neonate will not suffice to meet the requirement of this paragraph.

According to 45 CFR 46.207(b) research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates will be sent to the Secretary of DHHS for review. The Secretary will determine the approvability of the research based on the conditions stated in 45 CFR 46.207 (b).

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8.1 INCLUSION OF PRISONERS IN RESERACH

Special procedures are in place in the Federal Regulations that provide additional safeguards for the protection of prisoners involved in research activities. Investigators using prisoners as participants should provide specific detail and rationale in the research proposal. Investigators are also required to take extra measures to ensure appropriate informed consent. Since prisoners may be influenced by their incarceration to participate in research, and, in order to assure that their decision to participate is not coerced, the IRB will adhere to Subpart C of 45 CFR 46. Prior to IRB approval, investigators are required to obtain and submit written confirmation from the prison that the parole boards will not take into account a prisoner’s participation in the research when making decisions regarding parole. In the review of research involving prisoners the University of Texas at Austin IRB will apply the prisoner specific definition of minimal risk as stated in 45 CFR 46.303(d). In reviewing prisoner research the University of Texas at Austin IRB will follow the requirements for IRB membership outlined in 45 CFR 46.107. Reviewers will document their findings in the primary and secondary reviewer checklist and the University of Texas at Austin IRB will document all committee findings in the minutes. If at some point while participating in a research project a participant becomes incarcerated, it is the responsibility of the PI to notify ORS. The protocol will then be re-reviewed according to Subpart C or the participant-prisoner withdrawn from research. Subpart C of 45 CFR 46 provides four research categories that IRB may approve for prisoner research. Using the primary and secondary reviewer checklist the IRB will review the proposed research to ensure one of the following four categories is applicable:

Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects (45 CFR 46.306(a)(1)(A)).
Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects (45 CFR 46.306(a)(1)(B)).
Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults) provided that the study may proceed only after the Secretary has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of his intent to approve such research (45 CFR 46.306(a)(1)(C)).
Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject. In cases in which those studies require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit from the research, the study may proceed only after the Secretary has consulted with appropriate experts, including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of the intent to approve such research (45 CFR 46.306(a)(1)(D)).

The IRB will then proceed to confirm that the following items are applicable 45 CFR 46.305(a):

Any possible advantages accruing to the prisoner through his/her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his/her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired;
The risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers;
Procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides to the Board justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project;
The information is presented in language which is understandable to the subject population;
Adequate assurance exists that parole boards will not take into account a prisoner’s participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have not effect on his or her parole;
Where the Board finds there may be a need for follow-up examinations or care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners’ sentences, and for informing participants of this fact, and
A data-safety monitoring plan has been established to monitor participants.

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8.2 INCLUSION OF CHILDREN; IN RESEARCH

Special procedures are in place in the Federal Regulations that provide additional safeguards for the protection of children involved in research activities. The IRB will adhere to 45 CFR Part 46, Subpart D or 21 CFR Part 50, Subpart D. The exemptions listed in 45 CFR 46.101(b)(1) through b(6) are applicable for research involving children except for 45 CFR 46.101(b)(2) for research involving surveys, interview procedures, or interventions with children. Studies involving children require parental, guardian, or LAR consent and participant assent. However if there is any person other than the biological or adoptive parent who claims to be the child’s guardian (grandparents, foster parents, etc.) the PI must contact the ORS and IRB legal counsel will be consulted to determine whether the individual has the legal authority to make health care decisions on behalf of the child and therefore is the guardian as defined in federal regulations. Reviewers document findings in the primary and secondary reviewer checklist and the IRB formally documents findings in the appropriate minutes.

Definitions:

"Children" are persons who have not attained the legal age for consent to treatments or procedures involved in research or clinical investigations, under the applicable law of the jurisdiction in which the research or clinical investigations will occur. In Texas, a child can petition to be "emancipated", but must do so by filing a petition and meeting the statutory requirements. Only if a child were "emancipated" as described above; or was adjudicated to be an adult for the purpose of criminal prosecution under the Juvenile Justice Code would the state of Texas consider the child an “adult.”
"Assent" means the child's affirmative agreement to participate in research or clinical investigation. Mere failure to object may not, absent affirmative agreement, be construed as assent.
"Permission" means the agreement of parent(s) or guardian to the participation of the child in the research or clinical investigation.
"Parent" means a child's biological or adoptive parent.
Guardian" Pursuant to Section 601 of the Texas Probate Code, a “guardian" means a person who is appointed guardian of the person and/or the estate of an incapacitated person under a court order issued pursuant to Section 693 of the Texas Probate Code.

If research takes place outside the state of Texas, the IRB will consult with legal counsel; Legal counsel provides guidance and interpretation to the IRB.

For studies involving children where the risk is greater than minimal, the IRB may approve only the categories of research listed below provided all applicable criteria are met:

Research not involving greater than minimal risk (45 CFR 46.404), if the IRB finds that no greater than minimal risk to children is presented, approval may be given only if adequate provisions are made for soliciting the assent of the children and the permission of at least one (1) parent/guardian. Minimal risk means that the probability and magnitude of the harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological exams or tests.
Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects (45 CFR 46.405), if the IRB finds that more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject’s well-being, approval may be given only if the IRB finds that:
1. the risk is justified by the anticipated benefit to the subjects, and
2. the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches, and
3. adequate provisions are made for soliciting the assent of the children and permission of at least one (1) parent/guardian, and
4. a data safety monitoring plan has been established to monitor participants.
Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition (45 CFR 46.406), if the IRB finds that more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject, approval may be given only if IRB finds that:
1. the risk represents a minor increase over minimal risk, and
2. the intervention/procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations, and
3. the intervention/procedure is likely to yield generalizable knowledge about the subject’s disorder or condition which is of vital importance for the understanding or amelioration of the subject’s disorder or condition, and
4. adequate provisions are made for soliciting assent of the child and permission of both parents/guardians, and
5. a data safety monitoring plan has been established to monitor participants.
Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children (45 CFR 46.407), if the IRB does not believe the research meets the requirement of 404, 405, or 406, approval may be given only if:
1. The IRB 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, and
2. The Secretary of DHHS, after consultation with a panel of experts in pertinent disciplines and following opportunity for public review and comment has determined either (1) that the research in fact satisfies the conditions of 404, 405, or 406, or (2) the research presents a reasonable opportunity to further the understanding, prevention or alleviation of a serious problem affecting the health or welfare of children and the research will be conducted in accordance with sound ethical principles and adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, and
3. data safety monitoring plan has been established to monitor participants.

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8.3 REQUIREMENTS FOR CONSENT AND ASSENT INVOLVING CHILDREN

In accordance with 45 CFR 46.408(a) the University of Texas at Austin IRB must determine that adequate provisions have been made for soliciting the assent of children, when in the judgment of the University of Texas at Austin IRB the children are capable of providing assent. The assent to participate in a research protocol should be obtained in accordance with instructions found with the sample consent form found at http://www.utexas.edu/research/rsc/humansubjects/forms.html. The University of Texas at Austin IRB recommends that assent be sought for children ages seven and older, but may be appropriate for younger children depending on their aptitude. The University of Texas at Austin IRB may determine that assent is not a necessary condition for proceeding with the research if:

The aptitude of some or all of the children is so limited that they cannot reasonably be assented (determinations of capacity to assent will be assessed by age, maturity, and psychological state; and may be made for one, some, or all children in the research as the University of Texas at Austin IRB deems appropriate).
The intervention or procedure involved holds out a prospect of direct benefit that is important to the health or well being of the children and is available only in the context of research; or
The research meets the required criteria for waiver of consent stated in 45 CFR 46.116(d).

When assent is required, the PI and the child will sign the assent form to document that the participant has been given an explanation of the proposed research, in language appropriate to the children’s age and intellectual capacity.

In addition to the children’s assent, the PI is required to solicit consent of each child’s parents or adoptive parents. However if there is any other person who claims to be the child’s guardian (grandparents, foster parents, etc.) the PI must contact the ORS and IRB legal counsel will be consulted to determine whether the individual has the legal authority to make health care decisions on behalf of the child and therefore is the guardian as defined in federal regulations. Parents must be consented following criteria in 45 CFR 46.116(a)(1-8) and any additional elements the University of Texas at Austin IRB deems necessary. One parents signature is sufficient for research that is minimal risk or greater than minimal risk with the prospect of direct benefit to the participant (45 CFR 46.404 through 46.405). For research conducted under 45 CFR 56.406 (21 CFR 50.53) and 45 CFR 46.407 (21 CFR 50.54) consent is required from both parents unless: 1) one parent is decease, unknown, incompetent, or not reasonably available; or 2) when only one parent has legal responsibility for the care and custody of the child. Parental consent must be documented according to 45 CFR 46.117.

The University of Texas at Austin IRB may waive the requirement for obtaining consent from a parent or legal guardian if the research meets the provisions for waiver set forth in 45 CFR 46.116(d)(1-4), if the University of Texas at Austin IRB determines that the research is designed for conditions or a population for which parental, guardian, or LAR is not a reasonable requirement to protect the participants (examples: homeless, neglected, abused children), the waiver is consistent with Federal, State, or local law, and the research is not subject to FDA regulations. The criteria for approving such a waiver are that the research is designed for: conditions for which parental, guardian, or LAR permission is not a reasonable requirement to protect the participants, or a participant population for which parental, guardian, or LAR permission is not a reasonable requirement to protect the participants. However, in such cases the University of Texas at Austin IRB will substitute an appropriate mechanism for protecting the children who will participate. The determination for an appropriate mechanism would depend upon the nature and purpose of the research, risks, benefits, age, maturity, and psychological condition of the participants.

Children who are wards of the State or any other agency, institution, or entity can be included in research approved under 45 CFR 46.406 and 45 CFR 46.407 only if such research is: 1) related to their status as wards; or 2) conducted in school, camps, hospitals, institutions, or similar setting in which the majority of children involved as participants are not ward. If the research meets the criteria above, the University of Texas at Austin IRB requires the appointment of a participant advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or LAR. One individual may serve as an advocate for more than one child. The advocate must have necessary expertise experience, and agree, to act in the best interest of the child. The University of Texas at Austin IRB requires the advocate to disclose any conflicts of interest. Only those advocates without any conflicts of interest can be appointed as advocates.

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8.4 INCLUSION OF ADULTS WHO LACK DECISION-MAKING CAPACITY IN RESEARCH

Special procedures for IRB review and approval apply to research activities involving potential research subjects who, for a wide variety of reasons, are incapacitated to the extent that their decision-making capabilities are diminished or absent. Impaired capacity is not limited to individuals with neurologic, psychiatric, or substance abuse problems. Conversely, individuals with these problems should not be presumed to be cognitively impaired.

Generally, cognitively impaired potential or actual research subjects may not understand the difference between research and treatment or the dual role of the researcher. Therefore, when appropriate, it is essential that the consent / assent process clearly indicate the differences between individualized treatment (e.g., special education in classroom settings) and research. PI should also consider implementing DSMP to review the consent / assent process. PIs may want to consider using an independent expert to assess the participant’s capacity to consent or assent. PIs need to specify in the research proposal consent, assent, and LAR procedures. Participants unable to consent must have consent of their LAR. The IRB will evaluate whether participants unable to consent should be required to assent to participation. In some circumstances consent may need at appropriate intervals to be reviewed with participants. The University of Texas at Austin IRB will only approve research involving adults that cannot consent provided the following criteria are met

The research question cannot be answered by using adults able to consent;
The research is of minimal risk or more than minimal risk with the prospect of direct benefit to each individual participant;
The assent of the adult will be a requirement for participation unless the adult is incapable of providing assent;
When assent is obtained, the PI will document the assent by noting on the consent or assent form that the participant assented to participate in research

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8.5 INCLUSION OF THE UNIVERSITY OF TEXAS AT AUSTIN STUDENTS AND STAFF IN RESARCH

In addition to pregnant women, children, incapacitated adults, and incarcerated individuals, University of Texas at Austin’s IRB considers students and staff a vulnerable population. Therefore, the IRB follows special procedures designed to safeguard these subjects. Students and staff at University of Texas at Austin have the same rights as any other potential subject to participate in a research project, irrespective of the degree of risk, provided all of the following conditions exist:

The research must not bestow upon participating University of Texas at Austin subjects any competitive academic or occupational advantage over other University of Texas at Austin students or staff who do not volunteer, and the researchers must not impose any academic or occupational penalty on those University of Texas at Austin students or staff who do not volunteer.
University of Texas at Austin students and staff must not be systematically treated differently from non- University of Texas at Austin subjects as part of the project.
Due to the potential for perceived or real coercion to participate, University of Texas at Austin students and staff who desire to participate in the research must not be under the direct supervision of the principal investigator or listed research collaborators except as necessitated by scientific merit or overwhelming benefit to subject(s).

In accordance with 45 CFR 46 and 21 CFR 50 and 56, the University of Texas at Austin IRB will review all studies (exempt, expedited, and full board) requesting the use of University of Texas at Austin students or staff. The IRB may waive any and or all of the above conditions provided the study demonstrates either of the following:

Overwhelming benefit to the subject;
Reasonable scientific merit.

The IRB encourages the investigator to submit documentation supporting the waiver request.

Definitions:

"Student" is any individual who is enrolled at University of Texas at Austin.
"Staff" is all other employees of University of Texas at Austin, including faculty.

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8.6 SUBJECT POOLS

Subject pools are undergraduate students enrolled in particular departmental courses requiring participation in one or more research projects. The Institutional Review Board provides guidance and oversight of departmental subject pools, and reviews all research requesting subject pool participation. All student participation in subject pool research must be completely voluntary. Departments provide students with incentives (usually extra credit) to participate in the subject pool. Reimbursement for participation must not jeopardize the subject confidentiality or anonymity. Any subject pools offering extra credit to participating students must provide alternative opportunities to earn extra credit to students declining to participate in research. Subject pools including subjects under 18 years-of age are required to obtain parental consent prior to their involvement in research unless those individuals are emancipated. It is up to the student to decide whether to participate in any study; instructors cannot mandate or require student participation. In accordance with our recruitment policy (Section 3.11) instructors are strongly discouraged from recruiting subjects they directly supervise or selecting subjects on such basis. Subject pool requirements and procedures vary by department so it is best to consult with your individual departments for specific guidelines and additional requirements.

Department of Communication Studies. In the department of Communication Studies, any class for which extra credit may be given can provide volunteers for the participant pool. Such a class is often but not always a large lecture section such as CMS 306M, Professional Communication Skills. A course such as 306M, for instance, will provide extra points (a maximum of 4pts) for their students to do a maximum of 2 projects (outside research, or other cultural activity such as viewing a performance or listening to a speaker). Students are notified of this opportunity in the syllabus. Students can look on-line (http://www.utexas.edu/coc/cms/306M/extra/) to see if opportunities are available. Then, they sign up for these opportunities on the participant pool board located on the 7th floor of CMA outside the main office. The researchers will provide an alphabetized list of the participants in their study to the Instructors of the course such as 306M. Students interested in earning extra credit will regularly check this account for opportunities to sign up for. These opportunities will occur throughout the semester, and are not guaranteed at any specific time. They are first come, first serve. The students AI will receive a written notice from the researcher telling him/her that the student participated. Finally, CMS researchers and instructors post alternative studies to participation at the same Web address provided above.
Department of Psychology. At University of Texas at Austin, the Department of Psychology requires each student enrolled in PSY 301 to gain some familiarity with, and appreciation of, the aims, methods, problems, and results of psychological research. There are two options the student has for completing this requirement: the research paper option, and the experiment option. The two research requirement options are discussed during one of the first meetings of the Psychology 301 class. If you feel that you cannot complete the requirement in either of the ways outlined on this page, you should see the teaching assistant to discuss the possibility of alternatives.
Department of Educational Psychology. Some of the undergraduate courses in the Department of Educational Psychology have a subject pool requirement. By virtue of being registered in EDP 310 (Individual Learning Skills), EDP 363 (Human Sexuality), or EDP 371 (Introduction to Statistics), you become part of the Subject Pool. The subject pool requirement applies to all students enrolled including those taking these courses on a credit/no-credit basis. If you would prefer not to, or are unable to participate in the research, you may complete an alternate assignment. This assignment, given at semester's end, will be a written review of related research. The time needed to complete the assignment will be approximately the same as that for the research study participation. If you have additional questions about the Subject Pool requirement or have trouble registering through this website, please contact Alison Wilkinson, Subject Pool TA, at awilkins@mail.utexas.edu or at 453-7794 (before 10pm).
Department of Advertising. The Department of Advertising permits students to earn extra credit by participating in a departmental subject pool. The pool is open to advertising courses: 305, 319, 334, and 344. The subject pool enhances student experiences by providing an experiential method of learning about current issues in brand communications. This pool is completely voluntary and no student is required to participate. Alternatives to participating in the subject pool are discussed by each participating class instructor. For more information visit the advertising subject pool’s home page or download their informational brochure.

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8.7 Student Class Projects:

The class project form is for student class projects only. This excludes all faculty research and any graduate research relating to thesis or dissertation. A study is considered a “student class project,” if it is a systematic investigation students conduct as assignments designed to teach human research methods, where the results and data are not being disseminated outside of the classroom. Please note this form is only applicable for UT Austin students. Class projects cannot involve the following participants: institutionalized persons, persons unable to consent, children (children may be used in class projects for observational research), or members of a subject pool. Data collected for class projects are the student’s data and should not be utilized by faculty or instructors without the student’s express written permission. Faculty and instructors are not permitted to intentionally use class projects as a means of collecting data for their use.

The ORS HRPP associates or coordinator will evaluate class project forms to ensure the research does not require exempt, expedited, or full board review, that the participants do not include members of vulnerable populations, that there is a supervising faculty member, and the activity is appropriate to be conducted at the class project level. The ORS will contact faculty sponsors and students submitting class projects identified by the ORS as requiring exempt, expedited, or full board review and request appropriate resubmission. Upon approval class projects will be listed as “approved” in IRBaccess. Class project forms are available at: http://www.utexas.edu/research/
rsc/humansubjects/forms/student_class_project_form.pdf.

Instructions for Class Project Review Forms:

Training Requirements: Supervising Faculty or instructors must complete the 5-part HRPP training http://www.utexas.edu/research/rsc/humansubjects/
training/index.html. The IRB strongly encourages that students also complete this training. Supervising faculty/instructors are responsible for the ethical conduct of class project research.
Log onto IRBaccess;
Complete Application: be sure to indicate “class project” under student research type.
Answer all required questions be sure to list your faculty sponsor
Upload protocol and consent form (optional)
Click collect signature
IRBaccess sends the application to the faculty sponsor for approval
Once approved application is forwarded to ORS for review.
ORS will update IRBaccess and indicate “approved” when the class project has been approved.
Once the “class project” status is “approved” students may begin research.

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NOTES:

19) Delivery means complete separation of the fetus from the woman by expulsion, or extraction, or any other means.