SOP #12 APPROVAL OF RESEARCH

Criteria For IRB Approval Of Research and Checklist


Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 12
Effective Date: 10/8/2022

1. Policy

It is the policy of the CSS IRB to follow the criteria for IRB approval of research (45 CFR 46.111 and 21 CFR 56.111) requirements prior to approval of CSS research.

All research proposals that intend to enroll human subjects must meet certain criteria before study related procedures can be initiated. Three core principles: respect for persons, beneficence and justice, as discussed in the Belmont Report are the basis of the criteria for IRB approval. All regulatory criteria must be met, and any applicable state or local laws apply. In addition, certain other criteria that are unique to The College of St. Scholastica may apply and must be met as well. In order to assure that all regulatory criteria and any other applicable requirements are met, the IRB uses a checklist system.

If project activities occur or continue after the expiration date, the investigator is out of compliance with both federal regulations and CSS policy. The IRB cannot grant retroactive approval for work done after the expiration date. Even if the continuing review application has been submitted to the IRB, all activities must stop until approval is granted.

The application for continuing review will ask for details about any lapses and will also ask for a corrective action plan to ensure such lapses do not occur in the future. (See, CSS IRB SOP #30 Non-compliance With Human Subjects Research Policies/Guide and Report Form).

2. Purpose

The CSS IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy (CFR 46.109 (a)), including exempt research activities under §46.104 for which limited IRB review is a condition of exemption (under §46.104(d)(2)(iii) – identifiable recorded educational test information, (d)(3)(i)(C) – identifiable recorded benign adult behavioral information, and (d)(7) – storage or maintenance for secondary identifiable research for which broad consent is required and (8) – secondary identifiable research for which broad consent is required.

3. IRB Creep

The CSS IRB is mindful of IRB Creep in keeping with those requirements and not straying beyond those requirements. IRB Creep is often defined as applying the Common Rule requirements to research that is not federally funded. Another instance of defining IRB Creep is that the human subject regulations were written for biomedical research and the creep is that these same regulations are being applied to social science research. The CSS IRB practices strong ethical standards in maintaining optimum protection of human subjects and regulatory compliance, this includes the decision to follow the Common Rule regulations in non-federally funded research.

It is up to the Institutional Official and others at the institution responsible for the oversight of research to impose sanctions and conditions that go beyond the IRB's authority.

4. Assessing Scientific Validity

Some points to consider when the CSS IRB conducts an assessment of scientific validity.

  1. Knowledge of the field, background information, and preliminary results – Has the researcher displayed knowledge of the field, provided adequate background with an appropriate number of references, and has developed this protocol in regard to the state of knowledge? Is there preliminary data to support the research question?
  2. Hypotheses or Research Questions – Are the hypotheses or research questions clearly stated and appear sound and reasonable?
  3. Methodology – Is the methodology well thought out and sound and consistent with methods used in the field? Is the proposed subject population appropriate?
  4. Sample Size and Statistical Analysis – Are statistical considerations, including sample size and justification, estimated accrual and duration, and statistical analysis clearly described and adequate to meet the study objectives?
  5. Significance, Benefit and Risk – Has the investigator adequately articulated the significance of the research, and whether the benefits (either to the participants or science/society) clearly outweigh the risks to human subjects?
  6. Qualifications of the investigator and Research Team – Does the investigator and research team have the skills, capacity, and experience to carry out this project? A procedure may be great and appropriate, but if the investigator is not qualified to perform the procedure, the results may be dubious.
  7. Resources – Will the investigator be provided with, or obtain (e.g. grant), adequate resources to conduct the project and protect human subjects before the project commences? And finally,
  8. What is the importance of the knowledge expected to result from the research?”

 

5. Criteria for Approval

The criteria for approval and other applicable requirements are included in the board member checklist (attached). Assigned IRB reviewers must complete the IRB Review Checklist to ensure that the criteria for approval and other applicable requirements are met.

  1. Risks to subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
  2. 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. 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). 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.
  3. Selection of subjects is equitable. In making this assessment the IRB should consider the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
  4. Recruitment of Subjects The investigator will provide the IRB with a plan for recruitment of all potential subjects. All recruiting materials will be submitted to the IRB, including advertisements, flyers, scripts, information sheets and brochures. The IRB should ensure that the recruitment plan and materials appropriately protect the rights and welfare of the prospective subjects (e.g., do not present undue influence).
  5. Informed consent will be sought from each prospective subject or the subject's legally authorized representative. (See, Informed Consent SOP #16 Informed Consent w/Checklist and Templates.)
  6. Informed consent will be appropriately documented or appropriately waived in accordance with the general requirements for Informed Consent (§46.117). (See, Informed Consent SOP #16 and IRB Informed Consent Checklist.)
  7. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
  8. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

6. Limits of the IRB Authority

The CSS IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities. In addition, the CSS IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements (See, CSS IRB SOP #31 Suspension or Termination of IRB Approval and Report Form) or that has been associated with unexpected serious harm to subjects (See, CSS IRB SOP #24 Reporting an Unanticipated Problem Involving Risks to Subjects or Others/Adverse Event and Report Form).

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

References

45 CFR 46.111

21 CFR 56.111

IRB EasyEd™ - Volume 1 Number 6 and Volume 3 Number 1. Copyright © 2015 Apex Ethical

Allina Health HRPP/IRB SOPs - https://www.allinahealth.org/-/media/allina-health/files/for-medical-professionals/research/allina-r esearch-administration-home/hrpp-irb-sop-manual.pdf

 

This is a new policy per the 2018 Common Rule Requirements.

IRB REVIEW CHECKLIST

(Courtesy of USC Guidelines)

1. PROJECT DESCRIPTION AND METHODOLOGY
Yes / No / N/A

a. Are the aims and underlying hypotheses of the research stated clearly?

 

b. Does the research use procedures consistent with sound research design?

 

c. Does the research design allow the proposed research question to address the proposed study objectives and result in scientifically and statistically valid results?

 

d. Does the research contribute to generalizable knowledge?

 

e. Is there an adequate justification for involving human subjects?

 

f. Is there an adequate explanation of the research issues?

 

g. Is there an adequate description of the activities involving human subjects?

 

h. Is there a detailed description of the data collection and methods of recording?

 

i. Have the questionnaires and interview tools been provided?

 

j. Is there an adequate justification for the sample size?

 

 

2. RISK AND BENEFIT CONSIDERATIONS
Yes / No / N/A

a. Are the risks (physical, psychological, legal, economic, and social) to subjects minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk?

 

b. Are the risks minimized, whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes?

 

c. Are the risks to subjects reasonable in relation to anticipated benefits, if any, to subjects and to the importance of the knowledge that may reasonably be expected to result?

 

d. Are the risks to subjects reasonable in relation to the importance of the knowledge that may reasonably be expected to result?

 

e. Are both risks and anticipated benefits accurately identified, evaluated, and described?

 

f. Have the risks and benefits of the research interventions been evaluated separately from those of the therapeutic interventions?

  

 

3. SELECTION OF SUBJECTS
Yes / No / N/A

a. Is the subject selection equitable?

 

b. Are the criteria for inclusion/exclusion equitable?

 

c. Will the recruitment process alter equitable selection?

 

d. Does the nature of the research justify using the proposed subject population?

 

e. Are there adequate procedures for identifying those who might be more susceptible to the risks and who therefore ought to be excluded?

 

f. Has there been appropriate consideration of any special physiological, psychological, or social characteristics of the subject group that would pose special risks?

 

g. Are some or all the subjects likely to be vulnerable to coercion or undue influence, such as children prisoners, pregnant women, mentally disabled persons or economically disadvantaged persons?

 

h. If yes to question 3.g, have additional safeguards been included in the study to protect the rights and welfare of these subjects?

 

i. If there is a special population (children, prisoners, pregnant women and fetuses), has the appropriate justification been provided?

 

j. Is the exclusion of study subjects justified and appropriate?

 
 
4. PRIVACY AND CONFIDENTIALITY
Yes /  No   /  N/A

a. Are there adequate provisions to protect the privacy interests of participants?

 

b. Are there adequate provisions for protecting the confidentiality of the data through coding, destruction of identifying information, limiting access to the data, or whatever methods that may be appropriate to the study?

 

c. If the information obtained about subjects might interest law enforcement or other government agencies, has a certificate of confidentiality been obtained?

 

d. Are the investigator's disclosures to subjects about confidentiality adequate?

 

 

5. MONITORING
Yes /  No   /  N/A

a. Does the research plan make adequate provision for monitoring the data collected to ensure the safety of subjects?

 

b. Is there documentation indicating appropriate reporting to the IRB if unexpected results are discovered or there are adverse events?

 

c. If appropriate has a data safety monitoring committee been established?

 

d. If the study is a multi-center study and CSS is the coordinating center, is the plan for the management of information that is relevant to the protection of participants, such as reporting of unexpected problems, protocol modifications, and interim results adequate?

 

e. If the PI is conducting research at an external site, is there an adequate management and communication plan among the IRBs involved?

 
 
6. INCENTIVES FOR PARTICIPATION
Yes /  No   /  N/A

a. Are the incentives offered reasonable, based upon the complexities and inconveniences of the study and the subject population?

 

b. Is the compensation or reimbursement appropriately prorated?

  

 

7. CONFLICT OF INTEREST
Yes /  No   /  N/A

a. Is there a conflict of interest that requires management?

  

 

8. INFORMED CONSENT PROCESS AND CONTENT
Yes /  No   /  N/A

a. Do the proposed explanations of the research provide an accurate assessment of its risks and anticipated benefits? Is the possibility (or improbability) of direct benefit to the subjects fairly and clearly described?

 

b. Is the language and presentation of the information to be conveyed appropriate to the subject population? Language written at the 8th grade level?

 

c. Is the timing of and setting for the explanation of the research and obtaining informed consent conducive to good decision making?

 

d. Is it clear who is authorized to obtain informed consent for the study?

 

e. Have the informed consent issues for secondary study subjects been addressed?

  

f. Will the investigator obtain legally effective informed consent of the participant or the participant’s legally authorized representative?

  

g. Will the circumstances of the consent process provide the prospective participant or the representative sufficient opportunity to consider whether to participate?

  

h. Will the circumstances of the consent process minimize the possibility of coercion or undue influence?

  

i. Will the individuals communicating information to the participant or the representative during the consent process provide the information in language understandable to the participant or the representative (individuals talking to the participants and answering questions will be able to communicate in a manner that is understandable to the participant)?

  

j. Did the PI report that they plan to enroll non-English speaking subjects?

  

k. Will the information being communicated to the participant or the representative during the consent process not include exculpatory language through which the participant or the representative is made to waive or appear to waive any of the participant’s legal rights?

  

l. Will the information being communicated to the participant or the representative during the consent process not include exculpatory language through which the participant or the representative releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence?

  

m. Are subjects informed to take as much time necessary to read the consent form?

  

n. Are subjects informed that they will receive a copy of the consent form?

  

o. The consent from contains contact information for a person independent of the research team for the following:

  • To obtain answers to questions about the research
  • In the event the research staff could not be reached
  • In the event they wished to talk to someone other than the research staff?
  

 

9. BASIC ELEMENTS OF INFORMED CONSENT (REQUIRED)
Yes / No / N/A

a. A statement that the study involves research

  

b. An explanation of the purposes of the research

 

c. The expected duration of the subject's participation

 

d. A description of the procedures to be followed

 

e. Identification of any procedures which are experimental

 

f. A description of any reasonably foreseeable risks or discomforts to the subject

 

g. A description of any benefits to the subject or to others which may reasonably be expected from the research

 

h. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject

 

i. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained

 

j. 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 further information may be obtained

 

k. An explanation of whom to contact for answers to questions about the research

 

l. An explanation of whom to contact for answers to questions about injury

 

m. An explanation of whom to contact concerning rights as a research subject.

 

n. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits and the subject may withdraw without penalty.

 
 

 

ADDITIONAL ELEMENTS OF INFORMED CONSENT
Yes / No / N/A

o. A statement that the treatment or procedure may involve risks to the subject or to the embryo or fetus, if the subject is or may become pregnant which are currently unforeseeable.

  

p. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.

  

q. Any additional costs to the subject that may result from participation in the research.

  

r. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.

  

s. A statement that significant new findings developed during the research which may relate to the subject's willingness to continue participation will be provided to the subject.

  

t. The approximate number of subjects involved in the study.

 

u. The storage and use of research specimens disclosed.

 

v. Agreement and spaces for signatures/dates for subject, and/or representative (if applicable) and person obtaining consent.

 

w. Is a witness signature required?

 

x. If FDA Regulated, a statement that the FDA may inspect the records. (Include if the research is subject to FDA regulations)

 

y. Are subjects informed to take as much time necessary to read the consent form?

 

z. Are subjects informed that they will receive a copy of the consent form?

 

aa. The consent from contains contact information for a person independent of the research team for the following:

  • To obtain answers to questions about the research
  • In the event the research staff could not be reached
  • In the event they wished to talk to someone other than the research staff?

 

 

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