FAQs for Research Investigators
- What type of projects require IRB review?
- What are the steps to obtaining IRB approval for my project?
- What is the purpose of IRB review?
- Most common delays in obtaining project approval
- What happens if a human subjects research project is conducted without IRB approval?
- I believe my project would be 'exempt'; why would I have to submit a protocol to the IRB?
- Do all surveys require IRB approval?
- My research survey will be totally anonymous; is IRB approval required?
- My research will only involve previously collected data (or records, documents, or specimens); is IRB approval required?
- What is the difference between 'anonymous' and 'confidential' data?
NDSU IRB review (or certification of exempt status) is required when faculty, staff, students, or other representatives of NDSU become engaged in research that will involve human subjects/participants. This also includes clinical investigations of drugs, medical devices, biologics, food additives, or other articles regulated by the FDA. The review requirement applies regardless of funding source, and also includes collaborative projects when an agent or employee of NDSU will be involved (e.g., receiving funding, project planning/design, participant recruitment, obtaining informed consent, data collection, or handling of identifiable human data). In addition, it is important to note that IRB review would also be required if a project or activity conducted for other purposes (e.g., program evaluation, quality improvement, education), will also involve a research component. IRB approval must be obtained prior to initiating any research involving human subjects.
Human subjects research projects are not limited to the medical, social, or behavioral science fields, but may be conducted in many different disciplines. It is important to consider the definition of 3 terms in order to classify a project or activity as human subjects research that requires review by NDSU IRB: 'research', 'human subject/participant' and 'engagement'.
The federal policy (45 CFR 46) adopted by NDSU defines research:
45 CFR 46.102 (d) Definitions. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
The Office of Human Research Protections (OHRP) has cautioned that 'research' should be defined conservatively; the IRB provides guidance to investigators, and retains the final authority in the classification of projects as 'research', or 'not research'. In general, a contribution to generalizable knowledge could include a journal publication, conference presentation, or dissertation, although this is not the sole factor in making the determination. Further definition and examples can be found in the Standard Operating Procedures:
The question of what constitutes research may be especially relevant in relation to activities designed to gather data to evaluate a specific program. If there is also an intent to contribute to “generalizable knowledge” , the activity would also be considered research, and require IRB review. In general, OHRP gives guidance that if the activity will be used to draw conclusions related to a larger entity then the activity is considered 'research'. Therefore, the following considerations should be made:
QA/QI, program evaluation, surveillance, etc. activities would be considered 'research' if any of the following are true:
- there is also an intent to use the data to contribute to generalizable knowledge
- experimental or non-standard interventions will be involved
- there is a random assignment of participants to compare outcomes
- the activities are not normally done as part of standard operating procedures
- results will be used to apply knowledge to other programs
- project is subject to peer review (designed to be used outside of the institution).
Course assignment projects that collect information about individuals are not normally considered to be 'research' and would not normally require IRB review. In these instances, the project should be clearly represented to individuals as a course assignment, and not as an NDSU research project, to avoid confusion about the need for IRB review. Class instructors are responsible for the conduct of these course assignments.
Sometimes, a student will also want to utilize this data as a part of their thesis/dissertation, or for a publication. This would then constitute a contribution to generalizable knowledge, therefore 'research'. In these cases, IRB review must be sought prior to contacting or collecting any data from participants; the IRB is prohibited from granting retroactive approval.
The federal policy defines a human subject as "...a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information." NDSU policy expands this definition to include some use of de-identified existing data, records or specimens from human subjects. A human subject is also someone on whom, or with whose specimen or medical record, a clnical investigation is conducted to determine the safety and effectiveness of a drug, medical device, or other test article regulated by the FDA.
Some examples (not an all-inclusive list):
- Surveys, interviews, focus groups (even if information will be recorded anonymously)
- Educational tests (ie. cognitive, aptitude, achievement, etc)
- Observation of public behavior
- Gathering data (academic records, or other data) from students to evaluate educational or other programs
- Obtaining data from individuals to evaluate computer software programs
- Collection of (or use of pre-existing) human blood, tissues, specimens, etc.
- Use of existing medical, educational or other records or data that is not publicly available
- Collection of data through non-invasive procedures (ie, X-ray, EEG, eye exam, etc.)
- Exercise, strength testing
- Collection of data from human voice, video, or image recordings
- Taste and food quality evaluations
- Gathering data from individuals to evaluate electrical, electronic, or other devices or instruments
- Clinical studies of drugs or medical devices
* NOTE: Some types of projects may also require prior approval from the Food and Drug Administration. It should be noted that the definition for 'medical device' used by the FDA includes anything that will be used for diagnosis, cure, treatment, prevention of disease or other conditions, as well as anything that will affect the structure/function of the body of man or other animals.
Collaborative projects require NDSU IRB review when NDSU employees or agents will become 'engaged in research involving human subjects':
- receive a direct award for human subjects research
- interact or intervene with individuals for research purposes
- receive identifiable information for research purposes, or
- direct or oversee other individuals performing these activities
When a collaborating institution's IRB also has jurisdiction, joint review arrangements may be possible. Review by a collaborator's IRB may be accepted in lieu of NDSU's review, provided that:
- the IRB is registered with OHRP
- the protocol application is at least as comprehensive as NDSU requires
- a signed agreement is in place (expedited and full reviews)
If a joint review arrangement is not possible, submit the NDSU protocol form and any attachments for NDSU IRB review.
Refer to the CITI training modules (Student Research, and Human Subjects Research-SBR) for a more comprehensive discussion of these terms and specific examples (see link under the 'Training' menu).
IRB approval must be obtained prior to initiating any procedures with potential participants. The process of obtaining IRB approval starts with describing the project on a protocol form (available on the 'Forms' page of this site), and submitting the signed protocol and relevant attachments to the IRB Office (Research 1) for review. You will need to draft the participant information sheet, cover letter, or oral script (otherwise known as the consent) that will present the required elements of information about the project to potential participants. Additional documents may be needed, depending on the type of research. Forms and templates for consent documents are available on the Forms page as protected Word documents. Contact the IRB Administrator if you have questions as you prepare your submission.
Once your submission is received, it will be screened in the IRB office in the order in which it was received. IRB staff ensure that it is complete and all personnel listed on the protocol have completed a course in the ethical conduct of human subjects research within the last three years. Additional information or materials may be requested as needed. The submission will then be processed according to the following categories:
Exempt Certification: The IRB will verify that all requests for exempt status meet the qualifications for exemption, (45 CFR 46.101(b)) and that the rights and welfare of the participants are protected in accordance with NDSU policies and procedures. Additional information and/or revisions may be requested as needed. The project may begin only after receiving written notice from the IRB that the project qualifies for exempt status. As long as the protocol submission is complete, this process usually requires 5–7 business days.
Expedited Review: Research activities involving no more than minimal risk and qualifying in one of the listed categories are eligible for expedited review. The IRB office assigns the 1 or 2 members to review the protocol, in accordance with federal regulations and NDSU policy. The members ensure that the protocol meets the review criteria. The reviewers may approve the protocol as submitted, or require modifications to the protocol, consent form, or request additional information. Once all requirements are met, researchers are notified in writing of final IRB approval, and may begin the study. This process generally requires 10 business days.
Full Board Review: Research projects that do not qualify for exemption or expedited review must be reviewed by the full IRB at a convened meeting. The board meets once/month, and protocol submissions must be received by the posted deadline.
The board reviews the protocol in accordance with federal regulations, state and local laws, and institutional policies, using a review criteria that describes the required findings the IRB must make in order to approve the project. (Projects involving prisoners, minors, or other vulnerable groups require additional protections; these are outlined in the Standard Operating Procedures.)
Investigators are encouraged to attend the IRB meeting, if possible, to present their project and respond to any reviewers' questions and concerns in person, thereby saving time in the review process. At the conclusion of the meeting, the board may approve the protocol as submitted, require minor changes in the protocol as a condition for approval, defer due to insufficient information, or disapprove the project. Researchers are notified of the IRB's decision in writing. If revisions are required for final approval, these must be submitted within 30 days of the review. The research may begin only after receiving written notification of the board's final approval.
In fulfillment of the terms of NDSU's assurance (FederalWide Assurance) with the DHHS Office of Human Research Protections, the IRB must propspectively review human research to ensure that the rights, safety and welfare of participants will be protected. Specifically, participants should have the right to:
- be told everything they need to know about the research before being asked to participate
- freely choose whether or not to participate in a research project
- be aware of any available alternatives
- be free to quit participating at any time
- to have their privacy and confidentiality of their information respected
- know that their safety and welfare come first
- keep all the legal rights they already have
- ask questions or voice concerns to the investigator or the IRB
These rights are extended to participants of all NDSU human research projects, including those projects that may involve little or no risk, or eligible under one of the exempt categories. Through the protocol review process, the IRB obtains the necessary information to verify that the project will be conducted so that participants are afforded these rights.
Projects involving a vulnerable population, and/or some level of risk (e.g., physical, psychological, social, legal, privacy, employability, etc) require a higher level of review and federal regulations have more stringent requirements; it is important the IRB be able to provide documented evidence of all findings.
By reviewing all materials that will be shown to subjects (recruitment messages, invitations, consent forms), the IRB is able to verify that participants will be fully informed of the nature of the research, what is being asked of them, as well as any potential risks, harms and benefits.
- Training documentation is not current
- Information on the protocol form is incomplete or inconsistent
- Recruitment and/or consent process appears problematic (e.g. use of dual relationships and/or circumstances which may be perceived as undue influence).
- Plan for protecting privacy and maintaining confidentiality is inadequate
- Consent document lacks required elements
- Consent form not printed on department letterhead or equivalent
- Protocol lacks some or all required signatures
Because the IRB is responsible for assuring that participant's rights and welfare will be protected, the prior review process is intended to identify and correct any deficiencies in these protections prior to a researcher recruiting, obtaining informed consent, or starting interventions or data collection from participants.
If an NDSU research project involving human participants has been initiated prior to receiving IRB approval, participants could be exposed to unnecessary risks, and their rights to sufficient information, fair recruitment, and a voluntary choice may be limited. In addition, failure to obtain this approval could pose liabilities for the researcher, as well as the institution. Federal regulations and IRB policy require that serious or continuing instances of noncompliance be reported to institutional officials, the Office of Human Research Protections, as well as funding or other applicable agencies. Conducting a human research project (that would not qualify under an exemption category) without IRB approval is considered to be serious noncompliance.
In those instances where the IRB has determined that noncompliance has occured, the seriousness, as well as the specific circumstances of the events, and welfare of participants are considered. Suitable corrective actions are proposed, and a determination made as to whether or not the data collected may be utilized.
All research projects that will involve human subjects, even if they would qualify under one of the 6 exempt categories, require some type of IRB approval to ensure that the rights and welfare of participants will be protected. The terms of NDSU's FederalWide Assurance require the IRB to certify all claims for 'exemption'; this determination cannot be made solely by the investigator.
The federal eligibility criteria for exemptions are very complex and confusing. There may be situations where a project does not qualify for exemption, as an investigator had anticipated. In those situations, the IRB may require additional information, forms, or consent documents, and will assign the protocol for expedited or full review in order to ensure adequate protection of subjects and compliance with federal regulations.
Only those surveys that fit the definition of 'human subjects research' (see definition above) require IRB approval. A survey that is not being done for research purposes (does not intend to contribute to generalizable knowledge) would be outside the purview of the IRB. For example, if the survey is being conducted solely for internal, quality improvement purposes, it would not be considered 'research' and would not require IRB approval.
Or, if the survey will not gather any information about living individuals—e.g., their feelings, thoughts, opinions, behaviors, characteristics, actions, etc., the definition of 'human subjects' would not apply, and IRB approval would not be required. An example may be a survey sent to various businesses asking about their supply purchases, level of inventory, and shipping policies.
IRB approval is required if the survey fits the definition of 'human subjects research', which often includes anonymous surveys. This is true even when the data could not possibly be traced back to an individual person, or used to deduce their identity, directly or indirectly with other information or search engines.
9. My research will only involve previously collected data (or records, documents, or specimens); is IRB approval required?
In almost all situations, a protocol is required to the IRB for use of individual-level data, documents or records, or human specimens from living individuals. In some situations, however, the IRB may determine that their use does not constitute 'human subjects'.
If information to be used is available to the general public, without restriction or limitation, no protocol is required. This would include public newspapers, journal articles, public web sites. Researchers should be aware, however, that some web sites or online communities have limitations to use of their information and postings; use of this type of information would require IRB approval.
Also, some human specimens are available through commercial sources, and/or have been obtained from deceased individuals; these may not require a protocol to the IRB; however, if and FDA regulated device or drug is being tested, and IRB protocol is required.
If researchers are collecting data where no one, not even the researcher will be able to tell where or from whom the data came from, then the data is considered to be 'anonymous.' However, data which may be linked to an individual through use of codes, video/audio recording, or other identifiers woudl be considered to be 'identfiable data.' If a researcher promises to keep identities of participants private and not to disclose these identifiers to anyone other than the researcher, the data is considered to be 'confidential.'
Last updated: December 7, 2011