Human Studies Guidelines

The IRB (Institutional Review Board) serves as an objective third party, an oversight committee, goverened by Federal Regulations (45CFR46, 20CFR50, 21CFR56) with the pupose of protecting and managing risk to human participants involved in research. Although these regulations specifically apply only to federally funded research, the policy of the University of Hawaii is that all research conducted under its banner should meet the same standard. Following is a short list of specific aims of the IRB:

  • To promote the safety and wellbeing of human participants
  • To ensure adherence to the ethical values and principles underlying research
  • To ensure that only ethical and scientifically valid research is implemented
  • To allay concerns by the general public about the responsible conduct of research

Do you need to obtain approval from the UH Committee on Human Studies?

When research involves data collected from human participants, the University of Hawai‘i requires compliance with federal guidelines concerning safety, anonymity, privacy, and equitable treatment. Sometimes, this means submitting your research proposal for consideration by the UH Committee on Human Studies (CHS).

There are five possible answers to the question of whether or not you need to contact the CHS for approval of your research:

  1. No. You do not need to do anything. ( e.g., the research is for a class assignment and will, without doubt, not be pursued further.)
  2. Yes. You need to obtain approval for exemption from “45 CFR 46″ (federal rules)
  3. Yes. You need to undergo an expedited review.
  4. Yes. You need to undergo a full review.
  5. Yes. You need to undergo an expedited or full continuing research review.

This guide is intended to help you choose among the five courses of action listed above. The guidelines intend only to save time by identifying clear-cut cases involving typical SLS research (e.g., class assignments, scholarly papers, theses, dissertations, and faculty projects). The basic assumption should be that you will need to get approval. If you are in any doubt whatsoever, contact the DSLS Human Studies Coordinator, or visit the comprehensive CHS website. Furthermore, always follow the policies of the institution in which you are collecting data (e.g., ELI or HELP or LLL). For example, it is very important always obtain informed consent from your study participants.

Quick Guidelines

All cases below assume that the anonymity of the human participants is guaranteed.

Case Where You Do Nothing

  • If your research is a class project or term paper and will not be published in any form at any time, you should not contact CHS. There are no other stipulations, since class work technically is not considered research. Note: if you think you may eventually wish to publish your work, you must seek exemption or approval from CHS before collecting the data.

Case Where You Apply for an Exemption

  • If the study participants are over the age of 18 AND are not appointed or elected public officials, AND if your research is on instruction; involves educational testing; uses survey or interview procedures; or utilizes existing, publicly available data, you need only apply for an exemption from review.

Cases Where You May be Eligible for an Expedited Review

  • If your research involves minimal risk BUT does not qualify under any of the above-described exempt categories, you may qualify for an expedited review. For example, this includes the collection of voice, video, digital, or image recordings; OR investigations of individual or group characteristics; OR using surveys or evaluation instruments, as well as other categories.

Cases Where You Submit to a Full Review

  • If your research does not fit any of the above categories OR involves more than minimal risk (physical, psychological, social or economic), you may need to submit to a full review by the CHS.

Case Where You Apply for Renewal

  • If your research is a continuation of research that has already been approved (except exempt) you need to apply for a continuing research review.
  • If you are now certain which case applies to your research, you may go to the last section which explains how to begin the relevant procedures. If you are still uncertain, please read on.

Detailed Guidelines

Research that DOES NOT require CHS Review:

Class-project research does not normally, but occasionally does require CHS review. These are the essential questions that determine if class-project research requires review:

Will this research be published?

  • If yes, the research is required to be reviewed prior to implementation (“published” includes SPs, masters theses, doctoral dissertations, and faculty publications).

What will be done with the data/information?

  • If the information is identifiable to an individual or may be used or published in the future, the research may require review.

Research that normally Qualifies for EXEMPTION:

The following types of non-class-project research are exempt from 45 CFR 46 federal rules, and all you have to do is apply for approval of the exemption:

  • The study of or comparison among instructional techniques, curricula, or classroom management methods.
  • The use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless this involves any one under the age of 18.
  • The collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or the information is collected in a way that cannot be linked either directly or through identifiers to an individual.

Research that May be Eligible for an EXPEDITED approval:

Projects that involve minimal risk and that do not qualify for exemption may have an expedited review. Age or other population category is not a limiting factor. Examples of projects that qualify for an expedited review include but are not limited to:

  • Collection of data from voice, video, digital, or image recordings made for research purposes.
  • Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior); OR research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

If you are still uncertain of what to do, you may require full review and should contact the DSLS Human Studies Coordinator, and visit the CHS website.

Procedures

Applications for exemption approval and for all types of review are submitted to:

UH Committee on Human Studies
2540 Maile Way, Rm. 252B
University of Hawaii
Honolulu, HI 96822

Campus address (for delivery/pickup of applications): Spalding 252B

Exemption Approval

Currently takeing 3 weeks.

Criteria for approval: More or less automatic if research fits one of the three exempt categories above.

  1. Obtain and complete the Declaration of Exemption Form.
  2. Prepare a brief description of proposed research, highlighting the use of human subjects/participants and an explanation as to why you believe the research is exempt, a list of questions or survey instruments (if applicable), and consent / assent forms (if applicable).
  3. Submit one copy of the form and two copies of any instruments.

Expedited Review

Currently taking 4 weeks.

Criteria for approval: minimal risk, appropriate risk/benefit ratio, equitable selection of subjects, informed consent, safety, privacy, and anonymity.

  1. Obtain and complete the Application Form.
  2. Submit signed application form plus a copy and two copies of any instruments.

Full CHS Review

Can take up to two months. (The Committee meets during the third week of the month, if an application is in by the first week it will be on that month’s agenda. If not, it will be on the next month’s agenda)

Criteria for approval: Please consult the CHS guidelines.

  1. Obtain and complete the Application Form
  2. Note that you must submit 13 copies.

Continuing Research Review

  1. Obtain and complete a Status Report Form
  2. Submit the Status Report Form plus a copy of the current approved consent/assent forms (if applicable). Submit one original and 13 copies of all documents (unless the continuing research qualifies for expedited review).
 

Comments are closed.