|
|
| PREPARING AND SUBMITTING A HUMAN SUBJECTS PROTOCOL APPLICATION |
|
- Does my project need to be reviewed?
- Is the terminology "human research participants" the same as "human subjects"?
- Who do I talk to if I'm not sure whether or not my project needs to be reviewed?
- Why do I need to submit a protocol for a project that in my own judgement meets the exemption criteria?
- What are the types of IRB review?
- How do I know whether my project would be considered exempt from further review or non-exempt?
- How do I know which application form to use?
- My research project spans more than one year. Do I have to submit a protocol each year?
- How do I submit my protocol application?
- Where do I send my completed protocol application?
- What if I need to include materials not in electronic format, such as a previously published questionnaire that I plan to use?
- Does a hardcopy with signatures of the researcher(s) and faculty sponsor also have to be submitted?
- I have been asked to collaborate with a colleague at another institution who has already received IRB approval for this project from their institution. Do I have to submit this same protocol application to the College's IRB?
- The application form asks about how research records will be secured/stored. What do you recommend?
- Is an English consent document acceptable when enrolling non-English-speaking subjects?
- How do you obtain consent from someone who speaks and understands English but cannot read?
- Does my project need to be reviewed?
The Human Subjects IRB is charged with reviewing research that involves humans as research participants. You project needs to be reviewed if it meets the following criteria:
(a) The research is a systematic investigation designed to discover or contribute to a body of generalizable knowledge, regardless of whether or not the results will be publicly disseminated.
(b) It involves human participants. Human participants include those who are actively involved in the research process (i.e., being interviewed, filling out surveys, etc.). They could also include those who may not be in the presence of the researcher. The IRB reviews research that involves living individuals (1) about whom "an investigator conducting research obtains data through intervention or interaction with the individual" or (2) which obtains "identifiable private information" (Title 45 CFR, Part 46.102(f)). Secondary data analysis of existing datasets where participants are individually identifiable should be reviewed by the IRB.
BACK TO QUESTIONS
- Is the terminology "human research participants" the same as "human subjects"?
The phrases "human subjects" and "human research participants" can be used interchangeably. "Participant" is the preferred term.
BACK TO QUESTIONS
- Who do I talk to if I'm not sure whether or not my project needs to be reviewed?
Please contact the IRB Chair (Dr. Meghan Griffith, 704-894-24o3) or Vice Chair (Ms. Sharon Byrd, 704-894-2158).
BACK TO QUESTIONS
- Why do I need to submit a protocol for a project that in my own judgment meets the exemption criteria?
The College takes its human subjects research obligations seriously and has entrusted the IRB with responsibility for assuring that all projects comply with all the rules. Sometimes a project may appear at first glance to meet all exemption criteria when in fact a closer reading by experienced and uninvolved outsiders reveals that it does not.
BACK TO QUESTIONS
- What are the types of IRB review?
There are three types of IRB review: Exempt, Expedited and Full Board. The level of review depends on the risk to the human participants. The IRB makes the determination of the level of review.
(a) Exempt - Studies that meet explicit criteria set forth in the Code of Federal Regulations. Examples of studies in this category are anonymous questionnaires or surveys that do not involve sensitive topics, research being conducted in educational settings involving normal curriculum, and research on archival data.
(b) Expedited - Studies that involve minimal risk and meet explicit criteria set forth in the Code of Federal Regulations. Examples include studies using questionnaires, surveys and interviews that are not anonymous and that involve only minimal risk to the participant.
(c) Full Board Review - Studies that do not meet the criteria for Exempt or Expedited Review and are usually greater than minimal risk are reviewed by the Full Board. Examples are studies that could potentially put a person at risk of physical, legal, or social harm, even if the probability of that risk is small.
BACK TO QUESTIONS
- How do I know whether my project would be considered exempt from further review or non-exempt?
Use the Exempt Status Decision Tree as a tool to guide you as you decide the status of review for which you need to apply.
BACK TO QUESTIONS
- How do I know which application form to use?
If applying for exemption, you must use the Davidson HSIRB Application for Exempt Research. If your project is non-exempt, you must use the Davidson HSIRB Standard Application for Non-Exempt Research.
BACK TO QUESTIONS
- My research project spans more than one year. Do I have to submit a protocol each year?
Federal regulations require that IRB approved protocols be reviewed and approved no less than once every twelve months. If your protocol was initially approved as exempt and has not been modified, then it is exempt from continuing/annual review.
BACK TO QUESTIONS
- How do I submit my protocol application?
Download and complete the application form that best fits your research (Davidson IRB Application for Exempt Research or Davidson Standard IRB Application for Non-Exempt Research). The application form and any other documents requested on the application form (e.g., consent form, questionnaire, survey, etc.) must be submitted electronically to the IRB as attachments from your on-campus e-mail address. If you are a Student Principal Investigator, additionally, you must have your faculty sponsor complete a Faculty Sponsor Assurance Form and submit it to the IRB (hsirb@davidson.edu) as an attachment from their on-campus faculty e-mail address.
BACK TO QUESTIONS
- Where do I send my completed protocol application?
All protocol application documentation (including consent form, questionnaires, surveys, etc.) must be sent as attachments to the IRB via e-mail (hsirb@davidson.edu).
BACK TO QUESTIONS
- What if I need to include materials not in electronic format, such as a previously published questionnaire that I plan to use?
Materials not in electronic form should be scanned as a PDF file and submitted along with the protocol application as a separate attachment.
BACK TO QUESTIONS
- Does a hardcopy with signatures of the researcher(s) and faculty sponsor also have to be submitted?
No. As of January, 2010, a hardcopy is no longer required IF the researcher types their name and date on the signature line of the protocol application form and sends it to the IRB (hsirb@davidson.edu) from their Davidson College e-mail address. In the instance of a student researcher, their faculty sponsor should complete a Faculty Sponsor Assurance form after they have reviewed the student protocol, by typing their name and date on the signature line, and sending it the IRB from their College faculty e-mail address.
BACK TO QUESTIONS
- I have been asked to collaborate with a colleague at another institution who has already received IRB approval for this project from their institution. Do I have to submit this same protocol application to the College's IRB?
If the other institution is willing to allow Davidson College to rely on their federal-wide assurance for the research project, it is not necessary for you to submit the protocol application to the Davidson IRB. However, you must inform Davidson's IRB of your intent to collaborate with someone at another institution. Davidson's IRB will then contact the IRB of the collaborating institution, and execute an IRB Authorization Agreement for Collaborating Institutions and add the collaborating institution's IRB to Davidson's federal-wide assurance (FWA).
BACK TO QUESTIONS
- The application form asks about how research records will be secured/stored. What do you recommend?
You should always be careful to store data so that others cannot accidentally see what participants said or did, especially if the data could reveal their identities. Locked desk drawers or locked rooms (if you live alone) would be appropriate choices. If you have a list that connects code numbers on data sheets to actual names of participants, it should be stored separately from the data sheets. All electronic data should be secured at all times on a password-protected computer. Don't forget that some forms of data might be identifiable even if participants' names are not on them. For example, the combination of several demographic variables in a questionnaire (age, sex, eating house or fraternity, ethnicity, religion, athletic team, etc.) could easily identify an individual at Davidson College. You need not destroy your data after your project is completed, but if you plan to do so, please specify how it will be done. If your research will be published, you might wish to store your original data securely for some time after publication. Consent forms must be kept for a minimum of 3 years in a secure location. They may be destroyed after that time, although they can be kept longer. We usually recommend that students ask their faculty mentor to store the forms and destroy them when appropriate.
BACK TO QUESTIONS
- Is an English consent document acceptable when enrolling non-English-speaking subjects?
Study participants must be given a copy of the consent to be used as a reference document and to reinforce their understanding of the study. Regulations require that the consent document must be in language understandable to the participant. When the prospective participant is fluent in English, the consent document should be in English. However, when the participant is non-English-speaking, the PI should submit a translated consent form for IRB review along with a certification from the translator that the English and non-English versions are the same. While a translator may be used to facilitate conversation with the participant, routine ad hoc translation of the consent document may not be substituted for a written translation.
BACK TO QUESTIONS
- How do you obtain consent from someone who speaks and understands English but cannot read?
Illiterate persons may have the consent form read to them and "make their mark." In this instance, regulations additionally require a signature of a witness to the consent process and signature of the person conducting the consent interview. Investigators should not enroll participants who may not truly understand what they have agreed to do.
|
|
