- What does "exempt" mean?
- What regulations and policies govern exempt research?
- What kinds of research are eligible for exemption?
- What kinds of research are not eligible for exemption at SMC?
- Who makes the decision about whether research is exempt?
- Can research with children be considered for exemption?
- How do I apply for an exemption?
- How long does it take to secure an exemption?
- I am asking sensitive questions, but I will not record names of my subjects. Can I get an exemption?
- Can written consent be waived in educational research using one's own students as subjects?
Q1. What does “exempt” mean?
A. Exempt research is research with human subjects, but once approved, it is “exempt” from ongoing review, unless the research is amended in such a way that it no longer meets the eligibility requirements. Also, while exempt research does requires an informed consent process, it is not subject to the same exacting consent requirements as is research reviewed through the expedited and full processes. Please note that “exempt” does not mean "exempt from review."
Q2. What regulations or policies govern exempt research?
A. Exempt research is subject to the ethical principles outlined in the Belmont Report, a statement of principles adopted by the College. Thus, for example, the principle of respect for persons requires a consent process that includes full disclosure in a manner understandable to subjects and voluntary participation.
Q3. What kinds of research are eligible for exemption?
There are six categories of activity, defined in the federal regulations that are often risk free and eligible for exemption. The use of exemptions is limited by SMC Policy and subject population. These are spelled out on the “Request for Screening for an Exemption” IRB application form. Common examples of exempt research are also provided in A-C below:
- With the exception of studies listed below in response to Q4, any research that is conducted by SMC Faculty, Staff, or Graduate Students in established or commonly accepted educational settings, involving normal educational practices such as
- research on regular or special education instructional strategies
- research on the comparison among instructional techniques, curricula, or classroom management techniques
- Except for the exceptions listed below, any research that is conducted by SMC Faculty, Staff, and Graduate Students involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
- information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; 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.
- the human subjects are elected or appointed public officials or candidates for public office
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available and if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to subjects. Please note that for studies involving these types of existing data, a researcher should complete and submit the form “Request for Protocol Approval Secondary Analysis of Data.”
- Research that does not fit in one of the eligible categories of exempt research activity
- Research involving deception
- Research using experimental manipulations of subjects and/or their environments
- Research involving people whose decision-making capacity is impaired
Common examples of non-exempt research at SMC includes research that:
- involves children as participants, with the exception of
- research involving normal educational practices in commonly accepted educational settings
- educational testing
- observation in public settings
- gathers information about illegal activities, such as underage drinking, which place the data at risk of subpoena
- collects information about socially stigmatized behaviors or attitudes
- places the participants at risk due to emotionally-charged subject matter
- involves a sensitive population such as pregnant women, prisoners, etc.
- involves students in the Psychology Participant Pool
Q5. Who makes the decision about whether research is exempt?
A. In accordance with SMC Policy, the determination that research is eligibility for exemption must always be made by the administrative staff of the IRB, rather than by the investigator. This determination must be made regardless of the source of funding and when the research is unfunded.
Q6. How long does it take to get an exemption approved?
A. It depends. It can take only a week or so if the application is complete. It may take longer if there are issues to resolve, for example, the staff may need consultation about assessing risk in a foreign country. Also, we anticipate that 50% of reviews will be screenings for exemption, and at times, there may be a backup. It is always advisable not to wait until the last minute.
1) research involving normal educational practices in commonly accepted educational institutions,
2) educational testing, and
3) observation in public settings. Research involving interviews, surveys, and participant observation will be considered on a case-by-case basis
Q8. How do I apply for an exemption?
A. Submit the form called “Request for Screening for an Exemption”, unless your research is limited to the analysis of secondary data. In that case, submit the form called “Request for Protocol Approval for Secondary Analysis of Existing Data.” Questions in the forms may not apply to your research. Just respond to the ones that do.
A. Probably not. While anonymity will prevent the inadvertent disclosure of the subjects’ responses, asking sensitive questions may pose other kinds of risks, such as emotional distress in research about trauma. When the subjects will be exposed to risk, the IRB needs to assess the risk management strategy
A. Rarely, but this can occur for a project:
1. With minimal/no risk.
2. When the potential educational benefit outweighs any risk.
3. When the design necessitates the use of intact groups or other features that make written consent unwieldy.
4. There is no audio or video taping.
5. No identifiers are collected or data will be held in strict confidence.