Frequently Asked Questions

• What is the Human Subjects Review Board (HSRB)?

  The HSRB is a group of scientific and non-scientific individuals who conduct the initial and ongoing review of research studies in order to ensure the protection of the rights, safety, and well-being of human subjects participating in those studies. The federal code of regulations governs the composition and conduct of the HSRB (Title 45)

• Does my Project need to be reviewed?

The HSRB is only charged with reviewing research that involves people as research participants. Your project needs to be reviewed if it meets the following criteria:

• The research is a systematic investigation (including the development, testing, and evaluation) designed to discover or contribute to a body of generalizable knowledge.
  
• It involves human participants. Human participants include those who are actively involved in the research process (being interviewed, filling out surveys, etc.). They also include those who may not be in front of us: those who provide medical samples, left records of their activities through applying for marriage licenses, etc. The HSRB 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 contains "identifiable private information" (Title 45 CRF, Part 46.102.f) Secondary data analysis of existing datasets where participants are individually indentifiable should be reviewed by the HSRB.
  
• You are applying for external funding from a governmental agency such as NSF or NIA.
  
  
• Can I begin my research before I recieve HSRB approval?

No. Research must be approved by the HSRB before research can be conducted.

• Who do I talk to if I'm not sure if my project needs to be reviewed?

Please contact Mary Inman, Ph.D, HSRB chair at inman@hope.edu or 616-395-7148.

• Where do I send my completed proposal?

  Please send it to the HSRB chair, Mary Inman, Ph.D at inman@hope.edu, or fax at 616-395-7121.

• Where do I get training in the ethical treatment of human research participants?

  CITI online training

• What are the levels of review?

  The levels of HSRB review include exempt, expediated, and full. The level of review depends on the risk to the human partcipants. The HSRB makes the determination of level. All levels of review complete the same form and have the same review process.

  • Exempt: Studies that involve no or low risk
  • Expedited: Studies that involve minimal risk
  • Full: Studies that involve a greater than minimal risk, deal with questions of a sensitive nature, or involve minors or other vulnerable participants will require a full institutional board member review

• What is exempt review?

  Research projects that involve human participants and are exempt review involve no risks to the participants. Examples of studies that are exempt review are ones involving anonymous questionnaires or surveys that do not involve a sensitive topic or utilize minors, research being conducted in educational settings involving normal curriculum, and research on archival data. The following exempt conditions have been developed and decribed within the Federal Common Rule (45 CFR 46)

  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special educational instructional strategies, or (ii) 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 observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside of the research could reasonably place the subject at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
     
  3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observations of public behavior that is not exempt under category (b) of this section; if: (i) the human participants are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
     
  4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or indirectly through identifiers linked to subjects. (NOTE: According to the Office of Human Rights Protection [OHRP], "to qualify for this exemption, the data, documents, records, or specimens must be in existence before the project begins. The principle behind this policy is that the rights of the individuals should be respected; subjects must consent to participation in research.")
     
  5. Research and demonstration projects that are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
     
  6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed, or (ii) if a food is consumed that contains a food ingredient at or below the level found to be safe by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection of the U.S. Department of Agriculture.

  Exemptions do not apply to research involving:

  • Pregnant Women
  • Fetuses
  • Prisoners
  • Minors/Children (<18 years)
  • Persons with cognitive disabilities

• What is expedited review?

  Expedited review protocols are usually the studies that pose no more than minimal risks to the participants and do not utilize minors or other vulnerable participants.Examples include studies using questionnaires, surveys, and interviews that are not anonymous but do not involve sensitive topics or minors. These protocols are reviewed by the HSRB Expedited Review Team. Applications may be submitted at any time. The review and approval process takes approximately two weeks.

• What is full board review?

  Full Review protocols involve more than just minimal risks, minors, vulnerable participants or questionnaires/surveys on a sensitive topic. These protocols are reviewed by the full HSRB at the monthly board meetings (the first Wednesday of each month). Applications should be submitted at least 10 days prior to the meeting.

• What is the average turn-around time for a protocol to be reviewed?

  The HSRB Committee reviews proposals as they are submitted. The HSRB Expedited Review Team reviews protocols that are minimal risk or below with an average turn-around time of two weeks. Please note that turn-around time is dependent on the completeness of the application packet and the PI's responsiveness to the review requirements and requests.

• If I submit a grant proposal, do I have to propose and submit a protocol?

Yes, you can submit a HSRB protocol at that time. Depending on the sponsor, you may also wait until you know if you will recieve the award. Please note that the Office of Sponsored Programs will not release the funding until there is an approved protocol.

• Do Students' academic research projects require HSRB approval?

  If human subjects are involved, yes. Student research that involves human subjects, whether of a biomedical or social-scientific nature, requires approval or granting of exemption by the HSRB prior to initiation. Please note: student researchers are required to obtain a faculty sponsor for each project.

• Why do you talk about "Human Research Participants" Is this the same as "human subjects"?

  The phrases "human subjects" and "human research participants" can be used interchangeable. The disadvantage of using the term "human subjects" is that it objectifies the people who have volunteered to take part in the research.

• Who can sign the consent form of behalf of a minor or other subject incapable of giving consent?

  A minor human subject or a human subject considered mentally incapable of consenting on their own behalf requires consent by a court appointed guardian. The use of minors as subjects requires consent by a parent or legal guardian as well as an assent by the minor.

• Is an English consent document OK when enrolling non-English-speaking subjects?

  Study subjects are given a copy of the consent to be used as a referenence document to reinforce their understanding of the study. In order to meet the regulations, the consent document must be in a language understandable to the subject. When the prospective subject is fluent in English, the consent document should be in English. However, when the subjects, are non-English-speaking people, the PI should submit a translated consent form for HSRB review along with a certification from the translator that the English and non-Engish versions are the same. While a translator may be used to facilitate conversation with the subject, routine ad hoc translation of the consent document may not be substituted for a written translation.

• 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." There are regulations that require a signature of a witness to the consent process and signature of the person conducting the consent interview must be followed. Investigators should not enroll subjects who may not truely understand what they have agreed to do.

• If I make any changes in my protocol does the HSRB have to review and approve it again?

Yes. Any changes to your protocol must be reviewed and approved by the HSRB prior to the implementation of those changes. In most cases, however, this can be done quickly through an expedited review. Hightlight the changes on the application and send the application to the HSRB chair's office at armstrong@hope.edu, DeVos Fieldhouse Room 2C17 or fax at 616-395-7175

• Does the HSRB continue to review projects once they have been approved?

Yes. The HSRB is required to conduct continuing review of research that is required by federal regulations at intervals appropriate to the degree of risk, but no less than once each year.

• Do I need HSRB approval if my work will be conducted outside of the campus? Do I need HSRB approval if my study is already approved by another HSRB?

Yes. To ensure that investigators comply with federal and College regulations, it is important that the College, through the HSRB, be aware if where and by whome such research is being done, even if it is done in a foreign country. Formal approval still much come from a human subjects review panel in the host institution or country. If none is available, Hope College will be the HSRB of record. This approval must then be recieved and approved by Hope College's HSRB

• What happens if I conduct human research without HSRB approval?

  You will be out of compliance with federal requirements for human subject research. This can result in federal or Hope College actions that will prevent you from conducting human subject research and will jeopardize the Hope College human research certification