Pre-Review Supplemental Worksheet:VULNERABLE POPULATIONS
Study IDStudy Title
Principal Investigator
Submission Type
Pre-Reviewer / Date of Review
VULNERABLE POPULATIONS
The study involves which of the following populations defined as vulnerable under the Subparts of the Common Rule:
☐ Pregnant women, fetuses, and/or neonates
☐Prisoners
☐ Children
Reviewer(s) with knowledge and experienceworking with this population[1]:
Feedback from Consultant:
The study involves which of the following additional populations:
☐ Subjects with cognitive impairment
☐Employees
☐ Students
☐ Non-English speakers(Unless completing international research section of Special Elements supplement)
Reviewer(s) with knowledge and experience working with this population[2]:
Feedback from Consultant:
Complete only the relevant sections below.
1. PREGNANT WOMEN, FETUSES, OR NEONATES / YES / NO / N/A / COMMENTSa)Does the study pose any risks specific to pregnant women, fetuses, or neonates as subjects?
If “no”, skip to next section. / ☐ / ☐ / SKIP THIS SECTION IF STUDY MEETS FLEX CRITERIA
b)If “yes”, are the following elements adequately addressed? / ☐ / ☐ / ☐
- Where scientifically appropriate, preclinical studies and data are available;
- 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 research objectives;
- Only the woman’s consent needs to be obtained.
c)Is the research directed at fetuses after delivery (neonates)?
If “yes”, viable neonates are considered children and Subpart D applies. Complete above section regarding children. / ☐ / ☐ / ☐
d)Is the research directed at neonates of uncertain viability? / ☐ / ☐
e)If “yes”, the answer to each of the following must also be “yes” before the research may proceed:
- The research holds out the prospect of enhancing the probability of survival of the PARTICULAR fetus to the point of viability;
- Any risk is the least possible; or the purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means and there is no added risk to the neonate from the research;
- Either parent may consent and LAR may provide consent.
f)Is the research directed at nonviable neonates? / ☐ / ☐
g)If “yes”, the answer to each of the following must also be “yes” before the research may proceed:
- Vital functions will not be artificially maintained;
- The research will not terminate the heartbeat or respiration of the fetus;
- The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means and there is no added risk to the neonate from the research;
- Both parents consent to the research. LAR consent is NOT permitted.
For research not otherwise approvable under this section: / ☐ / ☐ / ☐
a)Has the IRB determined that the research has the reasonable probability of providing important biomedical knowledge? AND / ☐ / ☐ / ☐
b)If federally funded, will the IRB determination be forwarded to the Secretary of HHS who will consult with experts and determine whether the research should go forward? / ☐ / ☐ / ☐
2. PRISONERS / YES / NO / N/A / COMMENTS
a)Has the researcher submitted an IRB application to the Oregon Department of Corrections and provided documentation of either approval or feasibility? / ☐ / ☐
b)The answer to each of the following must be “yes” before the research may proceed:
- Advantages to participation are not coercive; AND
- Risks are commensurate with what would be acceptable to non-prisoners; AND
- The selection procedures are fair; AND
- The information is presented in an understandable language; AND
- There is no effect on decisions related to parole; AND
- Provisions for follow-up are adequate.
c)Does the consent form include the required disclosure regarding mandatory reporting requirements? / ☐ / ☐
d)Does the consent form include the required disclosure regarding reporting of rule infractions as dictated by the correctional facility? / ☐ / ☐ / ☐
e)Which of the following determinations (46.306) describes the research?
☐ / Research on 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; OR
☐ / Research on 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; OR
☐ / Research on conditions particularly affecting prisoners as a class, provided that the study may proceed only after the Secretary of DHHS has consulted with appropriate experts (in penology, medicine, and ethics) and published notice in the Federal Register of the intent to approve such research; OR
☐ / Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subjects; OR
☐ / If the research includes the assignment of prisoners to control groups that might not benefit from the research, it may proceed only after the Secretary of HHS has consulted with appropriate experts and published a note in the Federal Register of the intent to approve the research.
3. CHILDREN
Which conditions apply:
☐ / §46.404 No greater than minimal risk, and assent of child and permission of parents are obtained. The permission of one parent is sufficient.
☐ / §46.405 Greater than minimal risk, but presents the prospect of direct benefit to individual subjects. Note: the IRB must find that (a) the risk is justified by the anticipated benefit to the subjects; (b) 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 (c) adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians. The permission of one parent is sufficient.
☐ / §46.406 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. Note: the IRB must find that (a) the risk represents a minor increase over minimal risk; (b) the intervention or procedure represents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; (c) the research is likely to yield knowledge of vital importance; and (d) adequate provisions are made for soliciting the assent of the children and permission of both parents or guardians.
☐ / §46.407 Not otherwise approvable, but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. Note: after the IRB makes this finding, the Secretary of the Department of Health and Human Servicesmay allow the research to proceed after consultation with a panel of experts in pertinent disciplines (for example, science, medicine, education, ethics, law) and following opportunity for public review and comment.
☐ / §46.408(c) In addition to the provisions for waiver contained in §46.116 of subpart A, if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in Subpart A provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with federal, state, or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.See Obtaining Parental Permission decision tree.
☐ / §46.409 Wards
(a) Children who are wards of the state or any other agency, institution, or entity can be included in research approved under §46.406 or §46.407 only if such 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 children involved as subjects are not wards.
Note: If the research is approved under paragraph (a) of this section, the IRB shall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.
☐ / FLEX Waiver of Parental Permission
Permits waiver of the requirement for parental permission if adequately justified by the Principal Investigator and consistent with any relevant requirements from the research site if minors are being recruited from or studied in a school, camp, or other similar setting. When appropriate, parental notification with a reasonable opt-out period should be utilized. A waiver can only be permitted if it is also consistent with the requirements under FERPA and PPRA.
3a. ASSENT / YES / NO / N/A / COMMENTS
Is assent required of all children? / ☐ / ☐
Are the procedures for documenting assent appropriate for the age and ability of the children (generally verbal assent up to 7 years and written for 8 years and older)? / ☐ / ☐ / ☐
If assent is not a requirement for some or all children, check applicable reason(s):
☐ / The children are not capable of providing assent based on the age, maturity, or psychological state.
☐ / The capability of the children is so limited that they could not reasonably be consulted.
☐ / The research 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 the research.
☐ / The assent can be waived using the criteria for waiver of informed consent.
4. SUBJECTS WITH COGNITIVE IMPAIRMENT / YES / NO / N/A / COMMENTS
c)Is the use of cognitively impaired subjects justified? / ☐ / ☐
d)Are the risks no more than minimal or, if they are more than minimal, is there direct benefit to the subjects? / ☐ / ☐
e)Is adequate consent or surrogate consent being obtained? / ☐ / ☐ / ☐
f)Are adequate procedures in place to determine the capacity of subjects to give consent? / ☐ / ☐ / ☐
g)Is assent from subjects being obtained and documented? / ☐ / ☐ / ☐
5. EMPLOYEES / YES / NO / N/A / COMMENTS
Is targeting this population scientifically justified? / ☐ / ☐ / ☐
If use of OSU employee data is planned, has Human Resources approved the use of this data? / ☐ / ☐ / ☐
Does the recruitment plan comply with the OSU IRB policy in that it emphasizes voluntariness, confidentiality, and permits self-identification of study interest? / ☐ / ☐ / ☐
6. STUDENTS / YES / NO / N/A / COMMENTS
a)Is targeting this population scientifically justified? / ☐ / ☐
b)Does the recruitment plan comply with the OSU IRB policy in that it emphasizes voluntariness, confidentiality, and permits self-identification of study interest? / ☐ / ☐ / ☐
c)If students are being recruited to participate by investigators who are also the class instructor(s), should an exception be granted to permit direct recruitment? Note: Exceptions may be granted if the purpose of the research is directly connected to students in a particular class. / ☐ / ☐ / ☐
d)Do the investigators ensure that students know they may choose not to participate in the research and that their decision will not affect their grade, class standing, or relationship with any instructor? / ☐ / ☐ / ☐
e)Is extra credit offered as compensation to students? / ☐ / ☐ / ☐
f)If yes, is an alternative means of earning equivalent extra credit for an equivalent commitment of time and effort made available for those who cannot or choose not to participate in the research? / ☐ / ☐ / ☐
g)Does the research use class time? / ☐ / ☐ / ☐
h)If yes, does the investigator explain how participation in the research would be a learning experience to the students, AND how the research is relevant to the course? / ☐ / ☐ / ☐
i)Is an alternative activity provided for students who choose not to participate? / ☐ / ☐ / ☐
j)Are investigators using education records in research, such as class assignments, grades, student evaluations, etc.? / ☐ / ☐
i)If yes and at OSU, Registrar approval is required. Is there an approved internal data request form for this study? / ☐ / ☐ / ☐
ii)Is it clear who will be providing the records (i.e. Registrar’s Office, Class instructor, other)? / ☐ / ☐ / ☐
iii)Is written consent being sought from participants? Such consent may be written or obtained electronically within an authenticated environment, such as MyOSU.
See the FERPA decision tree
/ ☐ / ☐ / ☐
Relevant Regulation: FERPA 34 CFR 99.30
In addition to the usual elements consent information must include:
- Signature and Date*
- Specify the records that may be disclosed;
- State the purpose of the disclosure; and
- Identify the party or class of parties to whom the disclosure may be made (i.e. researchers, external collaborators, etc.)
(1) Identifies and authenticates a particular person as the source of the electronic consent; and
(2) Indicates such person's approval of the information contained in the electronic consent.
k)If K-12, does the project involve survey, analysis, or evaluation involving a PPRA topic?
See the PPRA decision tree
If yes, PPRA consent requirements apply. / ☐ / ☐ / ☐
Relevant Regulation: PPRA 34 CFR 98
If PPRA is applicable:
- Prior written consent of the parent or guardian or adult/ emancipated student must be obtained (34 CFR 98.4 (b)(2))
- Materials must be available for inspection by the parents or guardians of the children (34 CFR 98.3 (a))
7. NON-ENGLISH SPEAKERS / YES / NO / N/A / COMMENTS
h)Is the investigators language proficiency in the subjects’ native language described? / ☐ / ☐
i)If the investigator is not proficient in this language, will a translator/interpreter be used? / ☐ / ☐ / ☐
j)Have the qualifications of the translator/interpreter been described? / ☐ / ☐ / ☐
k)Are issues of confidentiality related to the use of a translator/interpreter described? For example, is the selected translator in a position of authority? Is it appropriate for the selected translator to handle the information that will be shared? / ☐ / ☐ / ☐
l)Are instructions to translators regarding privacy and confidentiality adequately described? / ☐ / ☐ / ☐
m)Is consent being obtained from the subject in a language that is understandable to them? / ☐ / ☐ / ☐
n)Are adequate procedures in place to assess the subjects understanding of the consent information? / ☐ / ☐ / ☐
o)If a translator is utilized during the consent process, is their signature being obtained on the consent form? / ☐ / ☐ / ☐
p)Are translated documents being provided to subjects? / ☐ / ☐ / ☐
q)If yes, does the translator have graduate degree in languages, or are they a native speaker, or professional translator? / ☐ / ☐ / ☐
r)If no, has a back translation been provided for each of the translated documents? / ☐ / ☐ / ☐
1HRPP Form | v. date July 2016
[1]Reviewer must be a board member if target population includes prisoners. Otherwise, the individual can be an HRPP staff member or consultant with experience working with these subjects (§46.107).
[2]If additional expertise is needed. Otherwise, enter N/A.