Standard Operating Procedures of the Institutional Review Board

III. Procedures for Conducting Initial Review of Research

A. The Process of Informed Consent


Conceptualizing the process of informed consent is one of the most important parts of planning a research study. Participants must be able to exercise their right of free will in making the decision to participate. It is equally important that participants be given the correct information, comprehend what is being said and read and have the time to make their own decision about participation. The following elements constitute the consent process:

  • Recruitment materials;
  • Verbal instructions;
  • Written materials;
  • Questions/answer sessions; and
  • Agreement by documented signature.

Prospective participants may elect to not sign the consent form at the initial time of the consent discussion. It is their option to take the consent form home and discuss it with family and friends. However, prospective participants may not participate in the study until they have signed the consent form or, in the instances in which written informed consent has been waived, otherwise indicated their willingness to participate.

Participants must be informed that it is their right to withdraw from a study at any time without penalty. The consent form must be read to any participants who cannot read. Likewise, for participants who do not read English, the consent form must prepared in the preferred language or be read and signed by an interpreter in a language the subject comprehends. Children and other vulnerable participants may need information presented as simply and straightforwardly as possible. In cases where the potential subject cannot read the consent form, it must be read to the individual and a witness signature is required on the form. This signature indicates that a witness was present during the reading/interpreting of the consent form and that it was presented in a manner that was comprehendible to the subject.  

1.    Recruitment Materials

Copies of advertisements, videos, or any other materials used for the recruitment of participants must be submitted with the IRB protocol for approval. The IRB reviews the methods that investigators use to recruit participants because advertising for study participants starts the informed consent and subject selection process. Advertising for participants is considered to be a reasonable recruitment practice as long as the advertisement has been reviewed and approved by the IRB. Examples include materials such as ads in the newspaper and on the radio; posters, flyers, and bulletin board “tear sheets;” e-mail solicitations, and Internet communications designed to reach potential participants. UNF faculty should contact the Public Affairs office for guidance. Researchers are strongly encouraged to include the following information in recruitment materials as appropriate:

    • The name and address of the investigator or research facility;
    • The condition under study and/or the purpose of the research;
    • In summary form, the criteria that will be used to determine eligibility for the study;
    • A brief list of participation benefits, if any (e.g., a no-cost health examination);
    • The time or other commitments required of the participants; and
    • The research location and the person or office to contact for further information

Finder’s fees (cash or non-monetary payment) for the referral of participants to investigators are considered, in most situations, unethical. This practice has the potential to violate the subject’s trust in the referring entity, the investigator, and in the process of research. In instances where it is deemed appropriate the investigator should submit a written justification for offering a finder’s fee with the protocol submission. The Board will closely examine studies which include a finder’s fee, and decisions for approval will be made on a case-by-case basis.

2.    Assessing Capacity to Consent

Individual’s capacities, impairments, and needsmust be taken into account, in order to develop ethical approaches in allowing participation. Even for minimal risk studies, prospective participants must demonstrate that they can make a choice for themselves and understand information relevant to the study. For studies involving greater than minimal risk, the participants should also be able to demonstrate that they understand how this relevant information applies to their own situation and be able to manipulate this information rationally. If the subject is unable to do any of the above, a legally authorized decision maker must give surrogate consent before the study may begin.

3.    Required Elements of Informed Consent

The following elements must be included in an informed consent document:

    • Statement that the study involves research, explanation of the purposes of the research, description of the procedures to be followed, and identification of any procedures which are experimental. It is essential that the consent process (including consent documents) clearly indicate differences between individualized “treatment” and “research.”
    • Description of any reasonable foreseeable risks or discomforts to the participant.
    • Description of any benefits to the participant or to others.
    • Disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant.
    • Statement describing the extent to which confidentiality of records identifying the participant will be maintained.
    • For research involving more than minimal risk, an explanation as to whether any compensation is available if injury occurs, whether any medical treatments are available if injury occurs, and, if so, what they consist of or where further information can be obtained.
    • Explanation of whom to contact for answers to pertinent questions about the research, the rights of research participants, and whom to contact in the event of a research-related injury.
    • Statement that participation is voluntary, that refusal to participate involves no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled [45 CFR 46.1169(a)].

4.    Other Elements of Informed Consent

The following elements may be included in an informed consent document as appropriate to the research:

    • A statement that the particular treatment or procedure may involve risks to the participant that were unforeseeable at the time the study was initiated.
    • Circumstances under which the subject’s participation may be terminated by the PI without regard to the subject’s consent.
    • Any additional costs to the participant that may result from participation in the research.
    • Consequence of a participant’s decision to withdraw from the research and procedures for termination of participation.
    • Statement that significant new findings developed during the course of the research which may relate to the participant’s willingness to continue will be provided to the participant.
    • Approximate number of participants in the study.
    • Study treatment(s) and the probability of random assignment to placebo or to each treatment.
    • Other information that is required by the IRB because it would meaningfully add to the protection of the rights and welfare of participants. [45 CFR 46.116(b)].

5.    Exceptions to Informed Consent 

The IRB may approve a consent procedure that does not include or that alters some or all of the elements of informed consent or waives the requirement to obtain informed consent provided that the IRB finds and documents one of the following two conditions.

    • The research is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine public benefit or service programs as described in 45 CFR 46.116(c) and the research could not be carried out without the waiver or alteration.
    • The research meets the following conditions as described in 45 CFR 46.116(d):
    • The research involves no more than minimal risk to participants;
    • The waiver or alteration will not adversely affect the rights and welfare of the participants;
    • The research could not practicably be carried out without the waiver or alteration; and
    • Whenever appropriate, the participants will be provided with additional pertinent information after participation.

The IRB may waive the requirement for the investigator to obtain a signed consent form if it finds that one of the following two conditions apply:

    • The only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. In these instances, participants should be asked whether they want documentation that links them with the research. Each participant’s wish should govern the process.
    • The research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide participants with a written statement regarding the research [45 CFR 46.117(c)].



B. Determining the Type of Evaluation


A research study will undergo one of three levels of IRB evaluation depending on the level of risk to human participants. These three levels are:

  • Exempt from further IRB review;
  • Expedited IRB review; and
  • Full IRB Board review. 

Special Note: The level of evaluation can only be determined by the IRB, in accordance with federal guidelines. Even if an investigator believes a study is exempt, no research should begin until the IRB reviews the protocol and makes the final determination. Many research studies require expedited or full Board review and approval.

1.  Exempt from Board Review 

1.1.      Type of Research Which May Qualify for Exemption

 

The Code of Federal Regulations, Title 45 CFR Part 46, identifies several different categories of minimal risk research as being exempt from Federal Policy for the Protection of Human Research Subjects. The criteria are briefly described below. UNF is required to adhere to the language of 45 CFR Part 46, and investigators are encouraged to consult with UNF IRB staff with any questions about specific exemption criteria. 

 

    1. Research conducted in established or commonly accepted educational settings and involving normal educational practices. This includes items such as curriculum design, instructional strategies, and classroom management methods in regular and special education.
    2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior unless the information is recorded so that human subjects can be identified directly or indirectly and “any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation
    3. Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior if the subjects are elected or appointed public officials or candidates for public office.
    4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available, or if the information is recorded by the investigator in a manner that subjects cannot be identified directly or through identifiers linked to the subject.
    5. Research and demonstration projects related to public benefit or service programs which are conducted by or subject to the approval of federal department or agency heads or any other officer or employee of any department or agency to whom authority has been delegated.
    6. Taste and food quality evaluation and consumer acceptance studies conducted under the conditions specified in 45 CFR 46.101(b)(6).

1.2.      Research that is not exempt: 

  • Research that involves greater than minimal risk. As defined in the federal regulations, minimal risk means “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.”
  • Research with vulnerable populations. The following do not qualify for exempt status: (a) research that involves the survey procedures or interviews with children; (b) observation of the public behavior of children when investigators interact with the children; and (3) research involving prisoners.

Applications that do not meet the criteria for exempt review will be recommended for either expedited review or full board review.

The IRB does not actually approve an exempt study but instead makes a determination that the project meets at least one of the federal exempt categories criteria. Therefore, annual continuing review is not required and no expiration date will be listed on the declaration of exempt status letter.  

1.3.      Documentation Required for Exemption

 

Investigators must provide sufficient information about proposed research to determine whether it is exempt. Electronic copy of the following forms must be submitted: 

  • North Florida – IRB Protocol
  • Instruments/Surveys/Questionnaires or other data gathering materials
  • Attachment B
  • CITI Completion reports for all personnel
  • Documentation regarding internal and external funding applied for or received 

1.4.      Criteria Used for Evaluation of Exemptions

 

The IRB Chair or Chair’s designee makes the decision as to whether the study qualifies for exemption from review. If determined to be Exempt, a written notice confirming this status will be sent to the principal investigator and/or sponsoring faculty member. Each notice includes:

 

  • The investigator’s name;
  • The UNF IRB number;
  • The study title;
  • The method of evaluation (e.g., a statement that the study was evaluated by the IRB to be exempt from review);
  • Exemption status under which the study qualifies.
  • Information about changes that will affect the status of the Exempt project (see also 1.4 below)
  • Information about the ongoing protection of human subjects. It will be stated in the notice that once data collection under the exempt status begins, the PI agrees to abide by these requirements:
    • All investigators and co-investigators, or those who obtain informed consent, collect data, or have access to identifiable data are trained in the ethical principles and federal, state, and institutional policies governing human subjects research.
    • An informed consent process will be used, when necessary, to ensure that participants voluntarily consent to participate in the research and are provided with pertinent information such as identification of the activity as research; a description of the procedures, right to withdraw at any time, risks, and benefits; and contact information for the PI and IRB chair.
    • Human subjects will be selected equitably so that the risks and benefits of research are justly distributed.
    • The IRB will be informed as soon as practicable but no later than 3 business days from receipt of any complaints from participants regarding risks and benefits of the research.
    • The IRB will be informed as soon as practicable but no later than 3 business days from receipt of the complaint of any information and unexpected or adverse events that would increase the risk to the participants and cause the level of review to change. Please refer to section V. B. of the UNF IRB Standard Operating Procedures for details about the reporting requirements.
    • The confidentiality and privacy of the participants and the research data will be maintained appropriately.

Once the declaration of exempt status letter is received, the project may begin.

 

If the study does not qualify for an exemption, the principal investigator will be notified of the reasons the research does not meet the criteria for exempt review and that the protocol must be submitted for either expedited or full board review. Additional information will be requested from the PI in order to facilitate this level of review. 

 

1.5       Revisions of Exempt Research

While the exempt status is effective for the life of the study, if it is modified, all substantive changes must be submitted to the IRB for prospective review. In some circumstances, changes to the protocol may disqualify the project from exempt status. Revisions in procedures that would change the review level from exempt to expedited or full board review include, but are not limited to, the following:

 

  • New knowledge that increases the risk level;
  • Use of methods that do not meet the exempt criteria;
  • Surveying or interview children or participating in the activities being observed;
  • Change in the way identifiers are recorded so that participants can be identified;
  • Addition of an instrument, survey questions, or other change in instrumentation that could pose more than minimal risk;
  • Addition of prisoners as research participants;
  • Addition of other vulnerable populations;
  • Under certain circumstances, addition of a funding source.

 

Investigators who plan to make any of the above changes should contact the IRB staff so that the review level can be changed as necessary. If investigators are unsure of whether a revision needs to be submitted, they should contact the IRB staff for clarification. 

1.6       Audit of Exempt Research Projects

The IRB maintains the authority to audit research determined to be exempt. If the audit reveals that the research activities differ from the application to the IRB for exempt status or if the principal investigators are not fulfilling the agreed-upon assurances for participant protection, the research will be considered in noncompliance and investigators may be required to halt the study pending further IRB review.

1.7       Closing Exempt Research Projects

 

Principal investigators must notify the IRB when an exempt research project is closed by completing a closing report. This will remove the project from the group of projects subject to an audit. An investigator must close a project when the research no longer meets the definition of human subject research (e.g., the data are de-identified and the researcher does not have the ability to match data to participants) or data collection and analysis are complete. After 3 years, if the research is still active or if the IRB has not received notification that the research has been completed, the IRB will send correspondence to the Principal Investigator to request a status update. If no response is received from the Principal Investigator within 90 days, then the IRB will close the research file. 

 

2.  Expedited Review

2.1.      Type of Research Which May Qualify for Expedited Review

In research studies qualifying for expedited review, human participants incur no more than minimal risk. Research activities that may qualify for expedited review are the following:

    • Certain kinds of research on drugs and devices, though this category is rarely applicable.
    • Collecting blood by stick or venipuncture with limits for age, health, and pregnancy status.
    • The prospective collection of specimens for research purposes by noninvasive means.
    • Data collected through noninvasive means (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding x-rays and microwaves.
    • Materials (e.g., data, documents, records, or specimens) that have been collected solely for non-research purposes such as medical treatment or diagnosis unless the information is considered sensitive and any breach of confidentiality would not be damaging to the subject.
    • Collection of data from voice, video, digital, or image recording made for research purposes.
    • Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program or human services evaluation, and quality assurance methodologies.

2.2.      Documentation Required for Expedited Review

Electronic copy of the following forms should be submitted:

    • “Application for IRB Protocol Review”;
    • Informed consent form, parental permission form, and child assent form (if applicable);
    • Copy of any materials (e.g., e-mail, flyer, telephone contact script) use to recruit participants for the study; and
    • Copy of survey instruments, questionnaires, interview questions, tests, or other data gathering source.
    • Documentation regarding internal and external funding applied for or received.

2.3.      Criteria Used for Review of Expedited Studies

Applications for expedited review will be reviewed by the IRB chair or by one or more experienced IRB Board members designated by the chair. The assigned reviewers may exercise all of the authorities of the IRB, except that they may not disapprove the research. Only the full Board may disapprove a study.

The following criteria are used in the review of expedited studies:

    • Risks to subjects are minimized.
    • Risks to subjects are reasonable in relation to the anticipated benefits;
    • Selection of subjects is equitable.
    • Documented, informed consent is obtained from each prospective subject or the subject’s legal guardian or healthcare decision-maker.
    • Informed consent will be sought from each prospective subject or the subject’s legally authorized representative to the extent required by 45 CFR 46.116.
    • Informed consent is appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117.
    • When appropriate provisions are made for the protection of the privacy of subjects and confidentiality of data is maintained.
    • Provisions are made for monitoring the data collected to ensure the safety of subjects.
    • Safeguards are included to protect members of vulnerable population groups (45 CFR 46.111).

2.4.      Outcomes of Expedited Review

The review of studies by the full Board will result in one of the following actions:

    • Approval without changes;
    • Approval with modifications;
    • Approval contingent upon specific conditions; or
    • Not approved.

If the study qualifies for expedited review and is approved, a notice confirming approval for the study will be sent to the principal investigator. Each approval notice includes the following stamped and dated documents:

    • An approval memorandum containing the investigator’s name; the UNF IRB number; the study title; the method of review (i.e., expedited review) and the category/categories under which the study qualifies; the date the study may begin; the period for which the study is approved; and the date the first progress report is due.
    • All study documents approved such as the research protocol, consent and assent forms, instruments, investigator brochure, recruitment flyers and scripts.

Once the notice is received, the project may begin. The minutes of the Board meeting will reflect the approval of the study through the expedited process. If the study does not qualify for expedited review or if the research does not receive approval by the reviewer(s), a letter requesting additional information/clarification will be sent to the PI or the study will be prepared for full board review at the next scheduled IRB meeting. Additional information may or may not be requested from the PI in order to facilitate this next level of review.

 

Unless otherwise specified, the approval period for research approved is one year from the date of the approval letter sent by the IRB. In specific cases, the IRB may specify a shorter approval period. Such instances might include complex studies, studies that include vulnerable participants, and studies conducted at multiple sites. The IRB may also consider the qualifications of the principal investigator and other members of the research team and the specific experiences of the PI and other members of the research team in determining the approval period.

Any proposed amendments to the protocol or informed consent forms must be approved by the IRB prior to implementation. See Part V. Additional Administrative Actions Requiring IRB Review/Approval, Part A Review of Amendments/Revisions.

Any unexpected or adverse events must be reported to the IRB. See Part V. Additional Administrative Actions Requiring IRB Review and Approval, Part B Reporting Unexpected (Adverse) Events.

3.  Full Board Review

3.1.      Types of Research Which May Require Full Board Review

Research studies that involve greater than minimal risk for human participants require full Board review. Research that requires full Board review includes:

    • Some research involving children or other vulnerable populations
    • Research that involves experimental drugs or devices.
    • Research that involves invasive procedures.
    • Some research that involves deception.
    • Some survey research or interviews that involve sensitive questions, information about HIV, or result in distress for human participants.

3.2.      Documentation Required for Full Board Review

The IRB administrators screen all applications before they are assigned to reviewers. Protocols are placed on the Board Agenda in the order they are received. The sooner a study is submitted in the cycle, the more likely it will be reviewed at the next Board meeting. Incomplete applications are returned to the principal investigator. Documentation required for full Board review includes electronic copy of the following forms:

    • “Application for IRB Protocol Review”;
    • Copy of any materials (e.g., e-mail, flyer, telephone contact script) used to recruit participants for the study;
    • Informed consent form, parental permission form, and child assent form (if applicable); and
    • Copy of survey instruments, questionnaires, interview questions, tests or other data gathering source.
    • Documentation regarding internal and external funding applied for or received.

3.3.      Criteria Used for Review of Full Board Studies

The following criteria are used in the full Board review:

    • Risks to subjects are minimized.
    • Risks to subjects are reasonable in relation to the anticipated benefits.
    • Selection of subjects is equitable.
    • Documented, informed consent is obtained from each prospective subject or the subject’s legal guardian or healthcare decision-maker.
    • Informed consent will be sought from each prospective subject or the subject’s legally authorized representative to the extent required by 45 CFR 46.116.
    • Informed consent is appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117.
    • When appropriate provisions are made for the protection of the privacy of subjects and confidentiality of data is maintained.
    • Provisions are made for monitoring the data collected to ensure the safety of subjects.
    • Safeguards are included to protect members of vulnerable population groups (45 CFR 46.111). 

3.4.      Outcomes of Full Board Review

 The review of studies by the full Board will result in one of the following actions:

    • Approval without changes;
    • Approval with modifications;
    • Not approved.

After a study is approved, a notice is sent to the principal investigator informing the PI of the approval of the study by the IRB. Each approval notice includes the following stamped and dated documents:

    • An approval memorandum containing the investigator’s name; the UNF IRB number; the study title; the method of review (i.e., review by the convened IRB Board); the date the study may begin; the period for which the study is approved; and the date the first progress report is due.
    • All study documents approved such as the research protocol, consent and assent forms, instruments, investigator brochure, recruitment flyers and scripts.

Institutional notice regarding approved protocols will be given through minutes documenting the decisions of the IRB.

If the Board granted “approval with modifications,” a letter specifically identifying changes to be made to appropriate study documents is sent to the principal investigator. In reply, the investigator should submit two (2) copies of the document(s) requiring modification, with the changes highlighted on one of the copies. Note: The study is not approved and may not begin until the investigator receives a letter stating that the IRB Chair approves the modification(s).

 

Unless otherwise specified, the approval period for research approved is one year from the date of the approval letter sent by the IRB. In specific cases, the IRB may specify a shorter approval period. Such instances might include complex studies, studies that include vulnerable participants, studies with high risk to participants, and studies conducted at multiple sites. The IRB may also consider the qualifications of the principal investigator and other members of the research team and the specific experiences of the PI and other members of the research team in determining approval period.

 

When the convened IRB disapproves or requires modifications to proposed research, PIs may appeal the IRB decision in writing to the IRB. All appeals of full board decisions will be reviewed by the full board. Only the IRB may change or overturn a decision not to approve a study. The Board is willing to meet with the investigator and discuss alternatives that might allow eventual approval of a rejected study. Written notification is also promptly provided to the institution when a study is not approved by the IRB. Investigators may have the opportunity to resubmit their study and appear before the Board to answer questions or discuss any concerns the Board has with the study.

 

Any proposed amendments to the protocol or informed consent forms must be approved by the IRB prior to implementation. See Part V. Additional Administrative Actions Requiring IRB Review/Approval, Part A Review of Amendments/Revisions. 

 

Any unexpected or adverse events must be reported to the IRB. See Part V. Additional Administrative Actions Requiring IRB Review and Approval, Part B Reporting Unexpected (Adverse) Events.



C. Special Considerations for Vulnerable Populations


1.  Definition of Vulnerable Populations

 

Federal regulations define vulnerable populations as the following:

  • Children, including newborns and minors (anyone under 18 years of age), because of their vulnerability, diminished autonomy and incomplete comprehension;
  • Pregnant women without regard to stage of pregnancy and viable fetuses, both in utero and ex utero;
  • Cognitively impaired persons with conditions that affect their decision-making abilities;
  • Incarcerated persons;
  • Participants whose economic or educational conditions predispose them to certain incentives.

The IRB may identify potential participants as vulnerable if one or more of the following conditions apply:

  • Cognitive or communicative vulnerability. Potential participants may be insufficiently able to comprehend information, deliberate, or express decisions.
  • Institutional vulnerability. Individuals, including students, may be subject to the formal authority of others.
  • Deferential vulnerability. Potential participants may be informally subordinate to another person.
  • Medical vulnerability. Potential participants with serious health conditions for which there is no satisfactory standard treatment may not be able to adequately weigh risks and benefits or may mistake research for treatment.
  • Economic vulnerability. Individuals may lack access to adequate income, housing, or health care and, if such benefits are available through research participation, may be unduly influenced.
  • Social vulnerability. Stereotyping and otherwise disvaluing participant groups may result in a risk/benefit ratio that would not be acceptable to the general population (see Bankert & Amdur, 2006).

 2.  Studies Involving Children

Special considerations must be made when performing research with children (less than 18 years of age)

2.1.      2011 Parental/Guardian Permission and Child Assent

Parental/Guardian Permission Form – For research studies that have greater than minimal risk to children as participants, provide two signature lines for parents/guardians. A reasonable effort must be made to obtain the signatures of both custodial parents. However, one parent’s signature is acceptable if the study is of minimum risk or of more than minimal risk but includes the prospect of direct benefit to participants and in cases where one parent is deceased, unknown, incompetent, or not reasonably available, or where one parent has legal responsibility for the care and custody of the child. The IRB may waive parental or guardian permission when such permission is not a reasonable requirement to protect the participants (for example, neglected or abused children) provided an appropriate mechanism for protecting child participants is substituted [see 45 CFR 46.408(c)].

 

Assent of the Child – for research studies that involve children ages 8 through 17. It is assumed that children ages 0 through 7 are not capable of giving formal assent but informal assent may be appropriate. The giving of formal and informal assent depends upon the subject’s level of maturity and judgment and should be made on a case-by-case basis.

2.2.      Conditions for IRB Approval of Research Involving Children

The IRB can approve research involving children only if it meets the criteria for approval of research as outlined in 45 CFR 46.111 and it falls into one of the following four categories as described in 45 CFR 46.404-407.

    • The research involves no more than minimal risk.
    • The research involves more than minimal risk but has the potential of direct benefit to the individual participants.
    • The research involves more than minimal risk and no prospect of direct benefit to individual participants but is likely to yield generalizable knowledge about the participant’s disorder or condition.
    • Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

3.  Studies Involving Pregnant Women

3.1.      Pregnant Women, Fetuses, and Human in Vitro Fertilization

Federal regulations require that IRBs treat pregnant women as a vulnerable population because of the need to avoid unnecessary risk to the mother and fetus. IRBs have additional duties in connection with activities involving fetuses, pregnant women, or human in vitro fertilization. Additional protections for these populations may include the use of witnesses for the consenting process, requiring consultants or patient advocates to monitor the consent process, and limiting the scope of research activities. In addition, principal investigators must give scientific justification for the exclusion of pregnant or potentially pregnant females in research studies [45 CFR 46.201(a,b)].

3.2.      Conditions for IRB approval of research involving pregnant women and fetuses

Research involving pregnant women may be exempt if it meets the criteria outlined in 45 CFR 46.101(b)(1) through (6).

Research involving pregnant women or fetuses that is not exempt may be approved only if all of the conditions outlined in the Code of Federal Regulations are met (see 45 CFR 46.204).

Pregnant women may also be enrolled in minimal risk studies when the enrollment of pregnant women is entirely coincidental and bears no relationships to the research.

4.  Studies Involving Prisoners 

4.1.      Definition

A prisoner is defined in federal regulations as “any individual involuntarily confined or detained in a penal institution” [45 CFR 46.303(c)].

4.2       Membership of the IRB if the IRB reviews research involving prisoners

    • At least one member of the Board shall be a person with appropriate background and experience to serve as a prisoner representative.
    • If the Board does not include such a member, then an individual with appropriate background or experience will be used as a consultant in the deliberation about the proposed research [45 CFR 46.107(f)].

4.3       Conditions for IRB approval of research involving prisoners.

Research involving prisoners may be approved if the conditions outlined in the Code of Federal Regulations are met (45 CFR 46.305). Special considerations apply to biomedical or behavioral research on prisoners that is conducted or supported by the Department of Health and Human Services (45 CFR 46.306).



D. Submission Timeline - New Proposals


New protocols can be submitted at any time and will be processed in the order received during regular business hours. New protocols that require full board review are considered by the Board at the next scheduled meeting of the IRB provided they are received (2) weeks prior to the meeting. This gives the IRB members sufficient time to review proposed projects prior to discussion at the full board meeting. New protocols that are reviewed for exempt status and those that are reviewed as expedited will be processed expeditiously and in the order received.