Frequently Asked Questions

There are two conditions under which research is federally required to be submitted for IRB approval: (1) the research is federally funded or (2) a sponsoring agency for the research requires federal-level institutional review. Only research falling into one of these two categories has a federal requirement to obtain IRB approval.

Aside from research in these two categories, the FSU IRB also routinely reviews research that is voluntarily submitted by an applicant for a federal-level institutional review. See below for reasons why researchers may voluntarily submit when they are not required to do so.

In some cases, IRB approval of research may be a requirement for a class. This type of requirement is different from the federal requirement and is considered voluntary submission under the guidelines of the FSU IRB.

IRB approval ensures that your research meets the highest ethical standards with regard to the treatment of human subjects and so submitting research for approval is a way to make sure your subjects’ rights and well-being are best protected.

Some publishing outlets may require confirmation that the research has been approved by the IRB. Since IRB approval cannot be made after the start of a study and since decisions on where to publish often come at the end of a study, this is a major reason why researchers should consider obtaining IRB approval.

Submitting to the IRB is also an especially useful academic exercise for students to gain experience in crafting research proposals and working with an IRB.

If a research project is not required to obtain IRB approval, and the researcher chooses not to voluntarily apply, it is still expected that the FSU community member conducting the research does so in accordance with the highest ethical and moral standards and accepted practices within their discipline.

There are three levels of IRB review: exempt, expedited, and full review. These levels correspond to the level of risk posed to human subjects, with exempt status involving the least amount of risk and full review status involving the most. We outline the criteria for each level of review below.

Exempt Review [see Uniform Federal Policy for the Protection of Human Subjects §46.101 (b)]:
If the application conforms to criteria outlined below, the FSU IRB may confirm the review category as Exempt. Specifically, research activities in which the involvement of human subjects is limited to one or more of the following categories (and which are not otherwise required to be reviewed by the FSU IRB by a federal funding or other sponsoring agency) are classified as Exempt:

“Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
1. research on regular and special education instructional strategies, or
2. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods;
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
1. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects, and
2. 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;
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under item 2 of this section, if:
1. the human subjects are elected or appointed public officials or candidates for public office, or
2. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter;
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 such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects;
Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
1. Public benefit or service programs,
2. Procedures for obtaining benefits or services under those programs,
3. Possible changes in or alternatives to those programs or procedures, or
4. Possible changes in methods or levels of payment for benefits or services under those programs;
Taste and food quality evaluation and consumer acceptance studies,
1. If wholesome foods without additives are consumed or
2. If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and
  1. Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.”

Expedited Review [see Uniform Federal Policy for the Protection of Human Subjects §46.110]:

This applies to research that involves no more than minimal risk to subjects. A risk is minimal “where the probability and magnitude of harm or discomfort anticipated in the proposed 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.”

Full Review:
Research in this category involves more than minimal risk to subjects and will receive a full review by the entire FSU IRB.

It is not. While “exempt” might seem to suggest a study does not need to go through any IRB review, it actually means “exempt” from continuing review. In order to be designated as such, a researcher must submit an application and the application must be reviewed by the IRB. “Exempt status” is a determination made by the IRB for studies falling into one of six (6) categories defined by federal regulations. Exempt studies present the lowest levels of risk to human subjects through, for example, the use of anonymous data collection techniques or non-invasive procedures. For a list of the categories for exempt review and for more information on the different levels of IRB review, see the FAQ above, What are the different levels of IRB review and what do they mean for me?

Federal regulations [§46.109 (e)] from the Department of Health and Human Services (DHHS) require that non-exempt studies (i.e. research approved under expedited or full review) be continually reviewed by the IRB at intervals appropriate for the level of risk to human subjects - and at least annually. For this reason, IRB approval for expedited- and full-review-level studies runs for a maximum of a calendar year. PIs wishing to extend approval beyond this period should apply for an extension

Per the DHHS’ Office of Human Research Protection (OHRP), PIs should provide the IRB with information on the status of the research, including for example (1) the number of subjects in the study; (2) the number of subjects who have withdrawn; (3) any adverse events or unanticipated problems; (4) any complaints received about the research; (5) relevant findings; and (6) the current informed consent document. To facilitate this process, the FSU IRB provides a status report template available here. PIs seeking extensions to ongoing research should fill out the report and submit along with their request for extension.

If your research (1) is federally funded, or (2) is sponsored by an agency which requires federal-level institutional review, then you would need to seek IRB approval even if it does not involve human subjects (for more information on the types of research which require IRB approval, see the FAQ above, I’m planning a research project. Do I need to go through the IRB?).

Research that does not involve human subjects would fall into the “exempt” category of review (for more information on the different levels of IRB review, see the FAQ above, What are the different levels of IRB review and what do they mean for me?).

The IRB would evaluate a research design only to the degree that it may impact the rights and well-being of human subjects. The IRB’s role is to ensure that the treatment of human subjects complies with the highest federal standards. It is plausible that poorly designed research could still meet the requirements for the ethical treatment of human subjects, so researchers should not consider IRB approval as confirmation of the overall quality of their study design. Such questions are best addressed by review of the design by qualified individuals within your particular field.

The IRB would evaluate writing style only in cases where there may be a lack of clarity with regard to the treatment and well-being of human subjects. Researchers should neither expect that the IRB will improve one’s writing, nor that approval by the IRB constitutes an affirmation of writing quality. If you have concerns about your writing style, there are several resources available to you. Student researchers are encouraged to take advantage of the writing resources provided by the Center for Academic Success and Achievement (CASA), which include professional writing tutoring. Faculty researchers are encouraged to take advantage of the CELTSS writing retreat. CELTSS also supports writing groups initiated by faculty. Faculty can contact the CELTSS Director for details.

Yes. Informed consent is a requirement for any study involving human subjects and must be obtained from all human subject participants. Informed consent is one of the most important aspects of human subjects research. In order to make a truly informed consent, prospective study participants (1) must be able to legally provide consent; (2) must be provided with an explanation of the benefits and risks of a research project; and (3) must be informed of their rights as study participants, which include the right to withdraw from a study at any time or the right to refuse to answer any question or participate in any aspect of research. To review the required elements of an informed consent form, see the FAQ below, What should I include in an informed consent form? For an overview of “vulnerable subjects,” such as those who may be unable to legally provide consent, see the FAQ below, What are “vulnerable subjects” and what if my study includes them? For a history of the evolution of informed consent, click here.

Under federal regulations [45 CFR 46.116 (c)], informed consent may be waived by the IRB if the research meets one of the following two conditions:

Condition 1:

The research or demonstration project 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: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; AND
The research could not practicably be carried out without the waiver or alteration.

Condition 2:

The research involves no more than minimal risk to the subjects;
The waiver or alteration will not adversely affect the rights and welfare of the subjects;
The research could not reasonably be carried out without the waiver or alteration; and
Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

The consent form should include the following information:

A statement that the study involves research (including an explanation of the purposes of the research, the duration of the subject’s participation, the procedures to be followed, and any experimental procedures).
A statement of whether the results may be published or otherwise presented publicly.
A statement of the foreseeable risks or discomforts to the subject.
A statement of the benefits to the subjects and/or society that may be reasonably expected from the research.
A statement of the extent, if any, to which anonymity or confidentiality of records will be maintained.
A statement that participation is voluntary and refusal to participate, or the decision to withdraw from the study, at any time will incur no penalty or loss of benefits to which the subject would otherwise be entitled.
Information about whom to contact for answers to questions about subjects’ rights and whom to contact in the event of a research-related injury to the subject. This should include the PI, faculty advisor (where appropriate), and the IRB administrator.

Click here for a sample informed consent form which may be used as a template.

Vulnerable subjects, sometimes referred to as “special populations,” are research populations that are considered at heightened risk or which are more susceptible to coercion. Examples of vulnerable subjects include pregnant women, human fetuses and neonates; prisoners; children; those who are economically or socially disadvantaged; those with cognitive impairments; the terminally ill; and HIV/AIDS patients.

If a researcher wishes to study these groups, additional consideration and protection are required. For some of these populations, federal guidelines outline specific procedures:

A common issue that arises with research involving vulnerable populations involves the ability to give informed consent. Some groups, such as children or the cognitively impaired, may be unable to legally give consent. In these cases, the researcher may obtain consent from a parent or guardian and assent from the subject. Other groups, such as prisoners or the economically or socially disadvantaged, may feel undue pressure to participate because of their disadvantaged status and so be unable to give a truly voluntary consent to participation. In such cases, researchers must take additional measures to ensure that subjects’ participation in the research is not coerced.

If you intend to study members of vulnerable groups and are unsure how best to proceed, you can always contact the FSU IRB chair with questions, or even request to attend an IRB meeting to discuss your study. Part of the IRB’s role is to work together with researchers to meet the shared goal of treating all subjects humanely, ethically, and fairly.

Each subject must:

sign a consent form (see sample here) explicitly indicating that they have been informed about the nature of the research and agree to participate in the research, or
be read a disclosure statement. A disclosure statement may be used only when subjects will remain totally anonymous and there are no risks to the subjects. This statement is not sufficient if subjects’ responses are to be tape recorded. The disclosure statement should contain the same information as that found in an informed consent form. The statement may be read or given to the subject, but does not require the subject’s signature.

When a consent form is used, a copy of the signed form must be offered to the subject to keep for their records. The PI must securely maintain the original copy of the signed form in locked storage for a minimum of three (3) years after completion of the research project. In research involving Protected Health Information (PHI) – such as studies for which the researcher has obtained HIPAA authorizations or HIPAA waivers – consent forms must be maintained for a minimum of six (6) years.

For any subjects under 18 years of age, or any subjects not legally competent to give informed consent, assent should be obtained from those subjects, while consent must be obtained from the parent(s) or legal guardian(s).

“Anonymous” means that no one, not even the researcher, can connect respondents’ data to any particular individual. Anonymous studies do not collect any personally-identifying information.

“Confidential” means that respondents’ data can be connected back to particular individuals. To prevent the release of confidential data, researchers must take care to ensure that their data are secured.

Not necessarily. If you plan to use an online survey system such as SurveyMonkey or even Blackboard, by default these platforms collect user information, sometimes just in the form of an IP address, which can be used to identify individual respondents. Just because many people wouldn’t be able to determine identities from IP addresses doesn’t mean that the data are anonymous. Several platforms have options to make a survey truly anonymous, in which no identifying information is captured. You should consult the documentation for a particular program to determine whether it will collect personally-identifying information.

When thinking about securing data, the goal is to eliminate or minimize the chances that non-study personnel could access study data, which could put subjects at risk, especially for data containing sensitive and/or personally-identifying information. For example, if a cell phone contained study documents or even participants’ contact information, the IRB would want to ensure that steps have been taken to prevent someone else from accidentally or intentionally accessing the information.

In general, methods of securing data depend on whether the data collected will be in hard copy (i.e., physical data) or in soft copy (i.e., digital data). For physical data, the researcher should identify a secure physical location, such as a lockbox, locking file cabinet, or closet, to which only the researcher or designated study personnel will have access. For digital data, the researcher should use password-protection on any devices on which data will be stored (e.g., cell phones, tablets, laptops, or desktop computers). Researchers may wish, instead or in addition, to password-protect individual files or folders containing study data and stored on electronic devices.

In cases of student research, if data will be stored on university-owned equipment, plans should be made for securing data after the student graduates.

Researchers seeking IRB approval should submit a complete application (click here for application instructions and here for the submission form) for review. Once a complete application is received, the IRB chair reviews and determines whether the proposal qualifies for exempt, expedited, or full review. The proposal is then sent to the appropriate IRB reviewers. Reviewers will review the application to ensure that ethical standards in the treatment of human subjects are met. Reviewers can decide among four options: (1) approve without changes; (2) consider approval with changes; (3) refer for full IRB review; or (4) request outside consultant review. Once the IRB makes an initial determination, the researcher is notified by email.

Researchers are entitled to a timely review of applications. The FSU IRB will normally complete its initial review within seven (7) business days of the submission of a complete and properly formatted application. Please note that initial FSU IRB responses cannot, under any circumstances, be expected in less than seven (7) business days from FSU IRB receipt of a completed application. Should the FSU IRB determine that modifications need to be made to the application, the FSU IRB will respond within seven (7) business days of the revised application.

In the event that the workload of the FSU IRB precludes review of applications within seven (7) business days, Principal Investigators will be notified immediately. Upon request, the FSU IRB will prioritize proposals by urgency of start date of proposed research or submission deadlines of sponsoring agencies.

According to federal guidelines, non-exempt level approval (i.e. expedited or full-review) for a research project can be for a maximum of one year. If a study approved under expedited or full review extends beyond one year, the researcher must apply for an extension of the approval prior to the end of the approval period. Please note that data collection must not continue until continuing approval is granted.

Yes. However, any modifications to a previously-approved protocol need to be reviewed by the IRB to ensure that modifications continue to meet the requirements of the originally approved proposal. The researcher must apply for approval of any modifications. Click here for instructions on submitting a request to modify a previously-approved proposal and click here for the modification request form.

Congratulations! Once your study is complete, the PI should complete the Final Study Report form and submit a copy to Patricia Bossange, IRB Administrator, Office of Grants & Sponsored Programs (pbossange@framingham.edu | 508-626-4996). Please ensure that all study-related records are retained for a minimum of three (3) years. [For studies involving Protected Health Information (PHI), such as those with HIPAA authorizations or those receiving HIPAA waivers, federal guidelines require records be retained for six (6) years post research.]