The Institutional Review Board is charged with ensuring that all human and animal subjects who participate in research are appropriately informed and/or protected from any adverse consequences of that research.

KSC IRB Policies and Procedures
Sample Informed Consent Document
Office for Human Research Protections (OHRP)
Animal Welfare Policy

FAQ's

• What is the IRB?
• Who has to apply for human subjects review through the IRB?
• What is research?
• I'm not applying for funding for my research, do I still have to go through the IRB?
• What's the worst that can happen if I don't get IRB approval?
• How do I submit a proposal for IRB review?
• How long will it take for my proposal to be reviewed?
• What if IRB approval is denied?
• Will I be asked to attend an IRB meeting?
• I'm not the only investigator on this project. How should I submit my project for IRB review?
• What are the different levels of IRB review?
• Are there forms of data collection that do not require IRB review?
• What about blanket approvals for class-wide projects?
• How often does the IRB meet?
• What does the IRB look for in a proposal?
• How do I know the IRB will understand my proposed research?
• How do I know when my protocol's been approved?
• I'm conducting my research at a non-KSC site with its own IRB. Should I apply for project approval through that site's IRB and the KSC IRB?
• I'm conducting my research at a non-KSC site that doesn't have an IRB. I know I need KSC IRB approval, but how do I document approval from the non-KSC site?
• My protocol was approved, but now I want to modify it. How do I do that?
• I still have questions, who can help?
• How were the KSC human subjects guidelines established?

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What is the IRB?
The IRB is the institutional review board. An IRB committee is required in all institutions that conduct research. The role of the IRB is to assure the protection of human and non-human animal subjects.

Who has to apply for human subjects review through the IRB?
Anyone who intends to conduct research that involves people must apply for and receive unconditional IRB approval (approval without contingency) before beginning the research. This applies to ALL research involving people, not just clinical research. Social science, behavioral, historic, linguistic and marketing research projects must be reviewed and approved by the IRB, also (this is a representation of likely projects, and not an exhaustive list). Check with the IRB chairperson, Anthony Scioli (603-358-2541), if you're in doubt about the need for IRB review or would like to consult with members of the IRB about a particular project.

What is research?
Research is broadly defined as a systematic investigation designed to develop or contribute to generalizable knowledge, or an investigation designed to test a hypothesis.

I'm not applying for funding for my research, do I still have to go through the IRB?
Yes. Any research protocol involving human subjects must be submitted to the IRB, regardless of funding source. Research protocol review for protection of human subjects is made without regard for funding source.

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What's the worst that can happen if I don't get IRB approval?
Aside from potential ethical implications for the subject and for the investigator, bypassing IRB review brings other risks:

Students

Funding may be withheld: IRB approval is required for research projects funded through the undergraduate research grant program. Funds will not be released without IRB approval.

Credit may be withheld: The University may, at its discretion, refuse to grant students course credit for research conducted without IRB approval.

Honors or M.A. projects will not be accepted: Honors and graduate students must present to their departments evidence of IRB approval for their projects involving human subjects. Honors or graduate projects will not be accepted without it. Degrees will not be awarded for work based on non-IRB-reviewed projects.

Articles may not be published: Most professional journals require evidence of IRB approval when considering articles for publication.

Faculty and Staff

Funding may be withheld: Federal sponsors, and virtually all private sponsors, require IRB approval as a condition of funding. Sponsors may postpone review of proposals for which review is not complete/pending at the time of proposal submission. Some sponsors will not release funds to the College for the investigator's use without IRB approval.

Articles may not be published: Many professional journals require evidence of IRB approval when considering articles for publication.

The College will not support unapproved research: Liability issues arising from unapproved research become the responsibility of the investigator. Persons conducting unapproved research are deemed to be acting outside the scope of authority granted them by the College. The College will not, therefore, provide an investigator of an unapproved project the resources to answer a liability complaint.

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How do I submit a proposal for IRB review?
Submit all proposals to the IRB chairperson (Anthony Scioli, MS3400):

For research involving human subjects submit the following:

1. A brief cover letter
2. A brief summary of the project, including a clear description of the subjects and procedures to be used. It is particularly important that you describe who your subjects will be, including age, gender, source (e.g. KSC students or random consumers at a mall), and any inclusionary or exclusionary criteria you hope to apply in selecting subjects.
3. A copy of your informed consent form (See sample consent form at the end of this document). A good consent form will be free of jargon and technical terms, and will include the following information:
1. A statement that the study involves research
2. A statement regarding the purpose of the research
3. The nature and duration of the subject's participation (what will be required)
4. A statement regarding potential risks (if any), and potential benefits,
5. A statement regarding steps that will be taken to protect confidentially
6. A statement informing subjects of their right to discontinue without incurring any penalty
7. The name and phone number of a contact person to address any questions or concerns
8. A signature page. For adult subjects the signature of the subject and the experimenter is required. When the subject is a child, signature of the parent or guardian, and the assent of the child is required, along with the signature of the experimenter
9. A copy of the signed consent form should be retained by the investigator. A copy should also be given to the participants to retain.
4. A copy of the protocol with all measures (e.g., surveys, questionnaires, tasks or task descriptions).

For research involving non-human animals submit the following:

1. Invertebrate Research: Research involving invertebrate animals does not require IRB review.
2. Vertebrate Research: Research involving vertebrate animals is reviewed by the full IRB. committee. Because there is no vertebrate research currently being conducted at KSC, this is not an issue at this time. However the requirements for IRB review are presented here for the review of interested faculty and students, and in the event that vertebrate animal research is considered at some later point.
1. Cover letter
2. Brief summary of the project, including the experimental design
3. Description of the animals to be used
4. Description of the care and maintenance of the animals
5. Steps taken to minimize pain, and criteria used to assess pain levels.
6. Description of surgical and non-surgical procedures, and any restraints to be used
7. Techniques for euthanasia and/or disposition of animals at end of project
8. Description of the background and training of all personnel who will handle the animals.
9. Summary of any biohazards or controlled substances in use
10. Consideration of alternatives to animal use, and justification for using an animal model

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How long will it take for my proposal to be reviewed?
Note: You should not begin your research until the IRB has given your research protocol full approval.

Review of exempt or expedited protocols takes can usually be completed within a few days. The review process for protocols submitted for full board review can take up to a month or longer to complete.

You should include sufficient time in your research plan as allowance for any IRB-required changes to the research protocol. Minor revisions may be reviewed by the chair alone, or by a subcommittee of the full IRB. Substantive revisions usually return to the full board for review at a regularly scheduled meeting.

What if IRB approval is denied?
You may contact the IRB chairperson and ask to discuss your proposal with the full IRB committee at the next scheduled meeting. It may also be possible to revise your proposal and thereby get approval.

Will I be asked to attend an IRB meeting?
You may be asked to attend an IRB meeting to clarify questions that are raised by your proposal.

I'm not the only investigator on this project. How should I submit my project for IRB review?
The IRB will want to know name and background information for each person on the project, but only one person need be listed on the proposal as principal investigator. If necessary, submit co-investigator or affiliated staff information on an additional sheet of paper.

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What are the different levels of IRB review?
There are three levels of IRB review:

1. Exempt

   "Exempt" means a protocol does not require extensive initial regulatory review. It does not mean the protocol is exempt from IRB review. To qualify as exempt, research must fall into any of six (6) regulated exemption categories. The categories represent a low potential for risk to subjects. Risk is reduced through anonymity of responses, use of existing or publicly available data, or through the use of non-invasive paradigms that will not harm subjects.

   Exempt reviews are conducted by designees of the full IRB. Some common examples of Exempt research:

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as 1) research on regular and special educational instructional strategies, 2) research on the effectiveness of, or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) survey procedures, interview procedures or the observation of public behavior, unless:
1. information is recorded in such a manner that human subjects can be identified
2. any disclosure of the human subjects responses outside the research could place subjects at risk of criminal or civil liability, or be damaging to the subject's financial standing, employability, or reputation.
3. Research involving the collection of existing data, if these sources are publicly available, or if the data is collected in such a way that the subjects cannot be identified.

   Important: The likelihood that a proposal of this kind will be found exempt does not relieve you of the responsibility to submit your proposal to the IRB chair and have him or her decide if the proposal is in fact exempt.

2. Expedited

   To qualify for expedited review, research must fall into any of ten (10) regulated expedited categories. "Expedited" categories involve collection of samples and data in a manner that is not anonymous and that involves more than minimal risk to subjects.

   Expedited reviews are conducted by a subcommittee of the full IRB. Some common examples of expedited research:

• studies including blood samples taken from healthy volunteers
• studies including moderate exercise by healthy volunteers
• analyses of voice recordings (such as those taken in the investigation of speech defects)
• studies of existing data or pathological specimens that include patient identifiers
3. Full Board

   Proposed human subject research that does not qualify for exemption or expedited review must be reviewed by the full IRB. Protocols sent to the full board represent more than minimal risk to subjects, and are, therefore, reviewed rigorously for compliance with all applicable federal, state, local and university regulations. Some common examples of research requiring full IRB review:

• Research on Substance Abuse
• Research on Sexual and Physical Abuse
• Research on Depression and Suicide
• All Research Involving Children and Adolescents
• Research on Sexuality and Gender
• All research involving subjects with diminished capacity
• All institutionalized subjects (e.g., prisoners, state hospital patients)

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Are there forms of data collection that do not require IRB review?
Routine and anonymous institutional surveys that are conducted to gather faculty, staff, or student opinions will not generally require IRB approval (e.g., Freshmen and Senior Surveys, Add-drop or reading day surveys). (An exception might be found where the survey asks personal or sensitive questions, or where there is not a reasonable expectation of privacy.)

What about blanket approvals for class-wide projects?
Faculty in some classes encourage or require students to conduct small scale studies, interview members of the campus or local community, etc. If the procedure is standardized, a blanket approval may be obtained from the IRB. All the information described above should be included (see under, "how do I submit a proposal for IRB review?"). In addition, a sample letter of instructions to the student, from you (the faculty member) outlining to the student what they will need to do (obtaining consent from subject, obtain consent from program directors where applicable, etc.).

How often does the IRB meet?
The IRB typically meets two to three times a semester. Additional meetings may be scheduled if there is greater demand.

What does the IRB look for in a proposal?
The IRB seeks:

• Research design that's sound, given the proposed use of human subjects in the project
• Equitable selection of subjects
• Balanced risks and benefits
• A thoughtful and comprehensive informed consent process

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How do I know the IRB will understand my proposed research?
The IRB is a standing committee of at least five individuals, including faculty, researchers and members of the community at large. Individual experiences and interests cross diverse areas.

When the IRB receives protocols that require expertise beyond that available on the Board, it seeks assistance from qualified persons outside its membership. While outside experts may inform the IRB's decisions, they do not vote on KSC research protocols presented for review.

How do I know when my protocol's been approved?
You will receive written notification of the status of your protocol following IRB review. The IRB will also identify any required revisions at that time.

I'm conducting my research at a non-KSC site with its own IRB. Should I apply for project approval through that site's IRB and the KSC IRB?
Yes. Many hospitals, universities and other institutions have their own IRBs. If the site of your research has an IRB, the site IRB and the KSC IRB must approve your project before you begin your project.

You may submit your protocol for review to KSC at the same time you submit your protocol to the other institution's IRB for review, or you may submit the protocol after the other institution's review is completed.

Remember that review and approval requirements may vary among institutions, so you should familiarize yourself with each IRB's policies. You should also plan your research timeline accordingly.

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I'm conducting my research at a non-KSC site that doesn't have an IRB. I know I need KSC IRB approval, but how do I document approval from the non-KSC site?
Elementary schools and high schools, and community centers often serve as non-KSC research sites, and rarely have IRBs.

You should ask appropriate personnel (e.g., school principal, director of nursing home, community center director) at the research site to provide a letter indicating that you, the investigator, have permission to conduct your research at their facilities. Alternatively, appropriate personnel may co-sign, with you, an invitation-to-participate letter to indicate institutional permission for you to conduct your research on-site.

The KSC requires evidence of site permission for its review and approval of your project.

My protocol was approved, but now I want to modify it. How do I do that?
Changes to a research protocol must be reviewed and approved by the IRB prior to their implementation. To submit proposed changes for IRB review, send a cover letter (be sure to include the IRB protocol number from your approval letter) with a summary of modifications you wish to make. Attach new or revised instruments, measures, consent documents, etc., as appropriate.

I still have questions, who can help?
You may e-mail or call the IRB chair, Anthony Scioli at 603-358-2541

How were the KSC human subjects guidelines established?
IRB principles are based largely on The Belmont Report (The chair has copies for those interested). The Belmont Report charges each researcher with responsibility to demonstrate the following while conducting research:

1. Respect for Persons: recognition of the personal dignity and autonomy of individuals and special protection for persons who lack sufficient capacity or those with diminished autonomy;
2. Beneficence: obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm; and
3. Justice: fairness in the distribution of research benefits and costs.

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