Institutional Review Board Policy

Ross Woods, 2020

Contents

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Preface

Ref.: 46.101

This policy applies as follows:

1. This policy applies to all research done under the auspices of the university involving human subjects, even it is done outside the US.
2. Research done outside the US could also also be subject to other laws within that jurisdiction.
3. The university does not auspice research that is subject to the regulation of a Federal Department or agency.
     For legal purposes, Part 46 does not actually apply to research that is not subject to US federal regulation. 
   
4. The university does not auspice any research in which biospecimens are collected and/or stored.
5. The university does not auspice any research on the health or welfare of pregnant women, fetuses, or neonates or that that uses prisoners as subjects. Ref.: Subparts C & D
6. If any part of this policy is inconsistent with Part 46, and Part 46 is shown to be mandatory, then Part 46 shall apply.

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Definitions

Ref.: 46.102

Broad consent refers to consent to store and maintain identifiable private information and do secondary research on it. §46.116(a)(1)-(4), (a)(6), and (d).

Consent to store or maintain private information means consent to store or maintain identifiable private information for potential secondary research use if an IRB conducts a limited IRB review and makes the determination.

Certification means the official notification by the institution to the supporting Federal department or agency component, according to the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB according to an approved assurance.

Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

Department or agency head means the head of any Federal department or agency and any officer or employee to whom it has delegated authority.

Federal department or agency refers to a federal department or agency (the department or agency itself rather than its bureaus, offices or divisions).

Human subject means a living individual about whom a researcher conducts research:

1. Obtains information through intervention or interaction with the individual, and uses, studies, or analyzes the information; or
2. Obtains, uses, studies, analyzes, or generates identifiable private information.

Identifiable biospecimen is a biospecimen that the researcher could readily identify or associate with its subject.

Identifiable private information is private information that the researcher could readily identify or associate with its subject.

Interaction includes communication or interpersonal contact between researcher and subject.

Intervention includes both physical procedures by which information are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.

IRB means the Institutional Review Board.

IRB approval means the determination of the IRB that the research has been reviewed and may be conducted under the auspices of the institution within the constraints set forth by the IRB and by other institutional and mandatory requirements.

Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, legally authorized representative means an individual recognized by institutional policy as acceptable for giving consent in the nonresearch context on behalf of the prospective subject to the subject's research participation.

Limited IRB review means an IRB review that makes the following determinations:

1. Broad consent for storage, maintenance, and secondary research use of identifiable private information and (d);
2. Broad consent is appropriately documented or waiver of documentation is appropriate, and
3. If there is a change made for research purposes in the way the identifiable private information are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
   Ref. §46.111(8))

Minimal risk means that the probability and magnitude of 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 examinations or tests.

Private information includes:

1. information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and
2. information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public.

Public health authority means a governmental authority that is responsible for public health matters as part of its official mandate.

Recipient means, in the context of informed consent, the subject or the sunject's legally authorized representative.

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge, whether or not they are considered research for other purposes.

Researcher means anybody (whether professional or student) conducting research under the auspices of the university.

Vulnerable subjects means research subjects who are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.

Written, or in writing, refers to writing on paper or in an electronic format.

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Categories of research auspiced by the university

Ref.: 46.104

The university auspices only the following kinds of research:

1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
2. Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
3. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
   1. The information obtained is recorded by the researcher in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
   2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
   3. The information obtained is recorded by the researcher in such a way that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination.
4. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
   1. The information obtained is recorded by the researcher in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
   2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
   3. The information obtained is recorded by the researcher in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination).
5. Benign behavioral interventions that are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the researcher has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
6. Research in which the researcher does not deceive subjects about the nature or purposes of the research.
7. Research in which subjects authorize deception about the nature or purposes of the research through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
8. Secondary research for which consent is not required using identifiable private information, if at least one of the following criteria is met:
   1. The identifiable private information are publicly available;
   2. Information is recorded by the researcher in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the researcher does not contact the subjects, and the researcher will not re-identify subjects;
   3. The research involves only information collection and analysis involving the researcher's use of identifiable health information when that use is regulated under 45 CFR (q.v.)

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IRB membership

Ref.: 46.107

1. The IRB shall have at least five qualified persons representing diverse backgrounds of race, gender, and cultural backgrounds, and the fields of studies in which it oversees research. One member must be external to the university.
2. The IRB may invite extra advisors if needed.
3. Conflicts of interest are not permitted.
4. If the IRB regularly reviews research among vulnerable subjects, it shall include a knowledgeable and experienced person in that category of vulnerable subjects.
5. If the IRB must be registered with the US government, it shall have at least one member whose primary concerns is in scientific areas and at least one member whose primary concerns is in nonscientific areas.

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IRB functions and operations

Ref.: 46.108

1. The IRB shall have access to meeting space and sufficient staff to support the IRB's review and recordkeeping duties;
2. The IRB shall prepare and maintain a current list of the IRB members identified by:
   1. Name
   2. Earned degrees
   3. Representative capacity
   4. Indications of experience such as board certifications or licenses sufficient to describe each member's chief anticipated contributions to IRB deliberations and
   5. Any employment or other relationship between each member and the institution, for example, full-time employee, part-time employee, member of governing panel or board, paid or unpaid consultant;
3. The IRB shall establish and follow written procedures for:
   1. Conducting its initial and continuing review of research and
   2. reporting its findings and actions to the researcher and the institution;
   3. Determining which projects require review more often than annually and which projects need verification from sources other than the researchers that no material changes have occurred since previous IRB review; and
   4. Ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that researchers will conduct the research activity according to the terms of the IRB approval until any proposed changes have been reviewed and approved by the IRB, except when necessary to eliminate apparent immediate hazards to the subject.
4. The IRB shall establish and follow written procedures for ensuring prompt reporting to the IRB, and if mandatory, to the appropriate Federal department or agency:
   1. Any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and
   2. Any suspension or termination of IRB approval.
5. Except when doing an expedited review, an IRB must review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.

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IRB review of research

Ref.: 46.109

1. The IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities.
2. The IRB shall require that information given to subjects (or legally authorized representatives, when appropriate) as part of informed consent is according to (Ref. Sect. 46.116). The IRB may require that information, in addition to that specifically mentioned in (Ref. Sect. 46.116), be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.
3. The IRB shall require documentation of informed consent or may waive documentation (See with (Ref. Sect. 46.117).
4. The IRB shall notify researchers and the University in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the researcher an opportunity to respond in person or in writing.
5. The IRB shall conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, not less than once per year.
6. Unless the IRB determines otherwise, continuing review of research is not required in the following circumstances:
1. The research is eligible for expedited review.
2. Research is eligible for limited IRB review.
3. Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
   1. Data analysis, including analysis of identifiable private information, or
   2. Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
   3. The IRB shall have authority to observe or have a third party observe the consent process and the research.

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Expedited reviews

Ref.: 46.110

1. This procedure applies to research involving no more than minimal risk, and to minor changes in approved research.
2. An IRB may use the expedited review procedure to review the following:
   1. Some or all of the research appearing on the list described in (See with (paragraph (a) of this section), unless the reviewer determines that the study involves more than minimal risk;
   2. Minor changes in previously approved research during the period for which approval is authorized; or
   3. Research for which limited IRB review is a condition of exemption.
3. An expedited review may be done by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among the IRB members.
4. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review according to the nonexpedited procedure.
5. The person conducting and expidited review shall keep all IRB members advised of research proposals that have been approved under the procedure.

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Criteria for IRB approval

Ref.: 46.111

1. The IRB shall determine that all the following requirements are satisfied.
2. Risks to subjects are minimized:
   1. Procedures are consistent with sound research design and do not unnecessarily expose subjects to risk, and
   2. Whenever appropriate, procedures are already being performed on the subjects for diagnostic or treatment purposes.
3. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
   1. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research).
   2. The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
4. Selection of subjects is equitable.
   1. The IRB should consider the purposes of the research and the setting in which the research will be conducted.
   2. The IRB should consider any special problems relating to vulnerable subjects.
5. The researcher will seek informed consent from each prospective subject (or the subject's legally authorized representative) according to the General requirements for informed consent. (See below.)
6. Informed consent will be appropriately documented or appropriately waived according to the Documentation of informed consent. (See below.)
7. When appropriate, the research plan provides for:
   1. monitoring of the data collected to ensure the safety of subjects.
   2. protection of subjects' privacy and the confidentiality of data.
8. In limited IRB reviews, the IRB shall make the following determinations:
   1. Broad consent for storage, maintenance, and secondary research use of identifiable private information and (d);
   2. Broad consent is appropriately documented or waiver of documentation is appropriate, and
   3. If there is a change made for research purposes in the way the identifiable private information are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

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Review by institution

Ref.: 46.112

Research that has been approved by the IRB may be subject to further appropriate review and approval or disapproval by senior university officials.. However, those officials may not approve the research if it has not been approved by an IRB.

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Suspension or termination of IRB approval

Ref.: 46.113

The IRB may suspend or terminate approval of research that is not being conducted according to the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the researcherr, appropriate institutional officials, and the department or agency head.

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Cooperative research

Ref.: 46.114

1. Cooperative research projects are those projects that involve more than one institution.
2. Broad consent is appropriately documented or waiver of documentation is appropriate.
3. In cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy.
4. Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research. The following research is not subject to this provision:
   1. Cooperative research for which more than a single IRB review is required by law, or
   2. Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.
   3. Othewise, when the University participates in a cooperative project, it may enter into a joint review arrangement, rely on the review of another IRB, or make similar arrangements for avoiding duplication of effort.

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IRB records

Ref.: 46.115

1. The IRB shall prepare and maintain, as a minimum, the following records of its activities:
   1. Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent forms, progress reports submitted by researchers, and reports of injuries to subjects.
   2. Minutes of IRB meetings, with sufficient detail to show:
      1. attendance at the meetings
      2. actions taken by the IRB
      3. the vote on these actions including the number of members voting for, against, and abstaining
      4. the basis for requiring changes in or disapproving research and
      5. a written summary of the discussion of controverted issues and their resolution.
   3. Records of continuing review activities, including the rationale for conducting continuing review of research that otherwise would not require continuing review.
   4. Copies of all correspondence between the IRB and the researchers.
   5. A list of IRB members in the same detail as described in above.
   6. Detailed written procedures for the IRB.
   7. Statements of significant new findings provided to subjects).
   8. The rationale for an expedited reviewer's determination when research poses more than minimal risk.
   9. Documentation specifying the responsibilities of the University and the IRB to ensure compliance with the requirements of Part 46 Protection of Human Subjects.
2. The IRB shall retain these for at least 3 years, and shall retain records relating to research for at least 3 years after completion of the research.
3. The IRB may maintain the records in either printed or electronic form.

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Consent to store or maintain private information

Ref.: 46.104, 46.116(d). "Broad consent"

1. Consent to store or maintain private information means consent to store or maintain identifiable private information for potential secondary research use if an IRB conducts a limited IRB review and makes the determination.
2. This kind of consent is an alternative to informed consent.
3. The criteria to obtain this kind of consent are as follows:
   1. Before involving a human subject in research, a researcher shall obtain the legally effective informed consent of the recipient (subject or the subject's legally authorized representative).
   2. Documentation of informed consent or waiver of documentation of consent was obtained according to "Requirements for informed consent"(Ref. Sect. 46.117);
   3. An IRB conducts a limited IRB review and determines that the proposed research meets the criteria below.
   4. The researcher does not include returning individual research results to subjects as part of the study plan. This provision does not prevent a researcher from abiding by any legal requirements to return individual research results.
   5. The recipient has had sufficient opportunity to discuss and consider whether or not to participate.
   6. The researcher has minimized the possibility of coercion or undue influence.
   7. Information must be given to the recipient.
      1. Information shall be in language understandable to the recipient.
      2. The information must be such that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.
   8. No informed consent may include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
   9. Information must include:
      1. A description of any reasonably foreseeable risks or discomforts to the subject;.
      2. A description of any benefits to the subject or to others that may reasonably be expected from the research;
      3. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
      4. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled
   10. Ref.: §46.116 (b)(2), (b)(3), (b)(5), and (b)(8). Cf. above. "2. Basic elements of informed consent."
   11. And, if appropriate, the following information:
       1. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject;
       2. One of the following statements about any research that involves the collection of identifiable private information:
          • A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
          • A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
       3. Ref.: §46.116 (c)(7) and (9). Cf. above. "2. Basic elements of informed consent."
   12. A general description of the types of research that may be conducted with the identifiable private information. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted;
   13. A description of the identifiable private information that might be used in research, whether sharing of identifiable private information might occur, and the types of institutions or researchers that might conduct research with the identifiable private information;
   14. A description of the period of time that the identifiable private information may be stored and maintained (which period of time could be indefinite), and a description of the period of time that the identifiable private information may be used for research purposes (which period of time could be indefinite);
   15. Unless the recipient will be given details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the subject's identifiable private information, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies;
   16. Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject; and
   17. An explanation of whom to contact for answers to questions about the subject's rights and about storage and use of the subject's identifiable private information, and whom to contact in the event of a research-related harm.
       Ref. (Sect. 46.116(a)(1) through (4), (a)(6), and (d));

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Requirements for informed consent

Ref.: 46.116

1. Introduction

Ref.: 46.116(a)

1. Before involving a human subject in research, a researcher shall obtain the legally effective informed consent of the recipient (subject or the subject's legally authorized representative).
2. A researcher shall seek informed consent only under circumstances that:
   1. Give the recipient sufficient opportunity to discuss and consider whether or not to participate and
   2. Minimize the possibility of coercion or undue influence.
3. Information must be given to the recipient.
4. Information shall be in language understandable to the recipient.
5. The information must be such that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.
6. Except for broad consent obtained according to paragraph (d) of this section:
   1. Informed consent must begin with a concise and focused presentation of the key information that is most likely to help the recipient to understand the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
   2. Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the rcipient's reasons why one might or might not want to participate.
7. No informed consent may include any language through which the recipient is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the researcher, the sponsor, the University, or its agents from liability for negligence.

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2. Basic elements of informed consent

Ref.: 46.116(b)

Except as provided in elsewhere in this section, the basic elements of informed consent to be provided are as follows:

1. A statement that:
   1. the study involves research,
   2. an explanation of the purposes of the research
   3. the expected duration of the subject's participation
   4. a description of the procedures to be followed, and
   5. identification of any procedures that are experimental;
2. A description of any reasonably foreseeable risks or discomforts to the subject;
3. A description of any benefits to the subject or to others that may reasonably be expected from the research;
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where the recipient can get further information;
7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject;
8. A statement that participation is voluntary
9. A statement that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled
10. A statement that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled, and
11. One of the following statements about any research that involves the collection of identifiable private information:
    1. A statement that identifiers might be removed from the identifiable private information and that, after such removal, the information could be used for future research studies or distributed to another researcher for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
    2. A statement that the subject's information collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

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3. Additional elements of informed consent

Ref.: 46.116(c)

Except as provided elswhere in this section, one or more of the following elements of information, when appropriate, shall also be provided to each recipient:

1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable;
2. Anticipated circumstances under which the subject's participation may be terminated by the researcher without regard to the subject's or the legally authorized representative's consent;
3. Any additional costs to the subject that may result from participation in the research;
4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
5. A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject;
6. The approximate number of subjects involved in the study;
7. A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions

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4. Waiver or alteration of consent

Ref.: 46.116(f), 46.116(g) or (e)?

Researchers may apply to the IRB for a waiver or alteration of consent under the terms of Para. 46.116. The university shall prescribe a separate fee for the extra review.

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5. Screening, recruiting, or determining eligibility

Ref.: 46.116(g)

1. The IRB may approve a research proposal in which a researcher will obtain information or biospecimens in order to screen, recruit, or determine the eligibility of prospective subjects without the informed consent of the recipient, if:
   1. the researcher will obtain information through oral or written communication with the recipient, or
   2. the researcher will obtain identifiable private information by accessing records or stored identifiable biospecimens.

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6. Preemption

Ref.: 46.116(i)

These informed consent requirements do not preempt any applicable laws that require additional information to be disclosed for informed consent.

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7. Emergency medical care

Ref.: §46.116(j)

Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under law.

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Documentation of informed consent

Ref.: §46.117

Applicants must meet ONE of the following sets of requirements.

1. The signed informed consent form is required. §46.117(a), §46.117(b)(1)
   1. The IRB must approve the written informed consent form. §46.117(a)
   2. The subject will sign a written informed consent form, which may be electronic. §46.117(a)
   3. The subject will be given a written copy of the form. §46.117(a)
   4. The informed consent form meets the requirements of Checklist: Information for prospective subjects (above) §46.116, §46.117(b)(1)
   5. The researcher shall either give the subject adequate opportunity to read the informed consent form before signing or read the form to the subject. §46.117(b)(1)
2. The signed informed consent form is required. §46.117(a), §46.117(b)(2)
   1. The IRB must approve the written informed consent form. §46.117(a)
   2. The subject will sign a written informed consent form, which may be electronic. §46.117(a)
   3. The subject will be given a written copy of the form. §46.117(a)
   4. A short form stating that the elements in “Information items for prospective subjects” above. §46.116
   5. The short form has been presented orally to the subject.
   6. Before other information (if any), was provided to prospective subjects, they are given a concise and focused presentation of the key information that is most likely to help them to understand the reasons why one might or might not want to participate in the research, organized and presented in a way that facilitates comprehension. §46.116(a)(5)(i)
   7. There will be a witness to the oral presentation. The subject signs only the short form. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary.
   8. A copy of both the summary and the short form shall be given to the subject.
3. The signed informed consent form is waived. §46.117(c)(1)(i)
   1. The only record linking the subject and the research would be the informed consent form.
   2. The principal risk would be harm resulting from a breach of confidentiality.
   3. Each subject will be asked whether he/she wants documentation linking them with the research, and his/her wishes will govern.
   4. The IRB may require the researcher to provide subjects with a written statement regarding the research. §46.117(c)(2)
4. The signed informed consent form is waived. §46.117(c)(1)(ii)
   1. The research presents no more than minimal risk of harm to subjects.
   2. The research involves no procedures for which written consent is normally required outside the research context.
   3. The IRB may require the researcher to provide subjects or legally authorized representatives with a written statement regarding the research. §46.117(c)(2)
5. The signed informed consent form is waived. §46.117(c)(1)(iii)
   1. The subjects are members of a distinct cultural group or community in which signing forms is not the norm.
   2. The research presents no more than minimal risk of harm to subjects.
   3. The research plan has an appropriate alternative way of documenting informed consent.
   4. The IRB may require the researcher to provide subjects with a written statement regarding the research. §46.117(c)(2)

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Applications and proposals lacking definite plans for involvement of human subjects

Ref.: 46.118

Certain types of applications for grants, cooperative agreements, or contracts are submitted to Federal departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal.

These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds.

Except for research waived under (Ref. Sect. 46.101(i)) or exempted under (Ref. Sect. 46.104), no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the Federal department or agency component supporting the research.

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Research done without the intention of involving human subjects

Ref.: 46.119

When the IRB has already approved a research project and the the researcher subsequently wants to add a component to the project using human subjects, the researcher shall sumbit new proposal to the IRB for approval. The university shall prescribe a separate fee for the extra review.

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Registration of the Institutional Review Board

Ref.: Subpart E: 46.501

1. The university shall register its IRB with the US government if it wishes to commence research activities that fall under Part 46 Protection of Human Subjects.
2. The IRB must be registered if:
   1. it is designated by the university under an assurance of compliance approved for federalwide use by the Office for Human Research Protections (OHRP) under (Ref. Sect. 46.103(a)) and
   2. it reviews research involving human subjects conducted or supported by the Department of Health and Human Services (HHS), in which case it must be registered with HHS.
3. An individual authorized to act on behalf of the university or organization operating the IRB must submit the registration information.