Institutional Review Board

All Offices & Services

Federal Regulations

The Ursinus College IRB was created within the guidelines of the Common Rule.  The procedures for review described below adhere to the regulations of the Department of Health and Human Services (45 CFR 46, as amended and published in the Federal Register on June 18, 1991), and to the Federal Wide Assurances filed with the HHS by the College.

 In addition, the IRB has consulted Protecting Human Subjects: Institutional Review Guidebook (Office for Protection from Research Risks of the National Institutes of Health, 1993), Institutional Review Board: Management and Function (Andur & Bankert, 2002), and has adopted sections from the policies of Bryn Mawr College.

§46.111 Criteria for IRB approval of research
Exempt: Part A (all items must apply)
Exempt: Part B (at least one item should apply)
Expedited Review: Part A (all items must apply)
Expedited Review: Part B (at least one item should apply)
Full Committee Review 

§46.111 Criteria for IRB Approval of Research

(1) Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disable persons, or economically or educationally disadvantaged persons.

(4) Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by §46.116. 

(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.

(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

Exempt: Part A (all items must apply)

  1. The research does not involve as subjects prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults. 
     
  2. The research does not involve the collection or recording of behavior which, if known outside the research, could reasonably place subjects at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation. 
     
  3. The research does not involve the collection of information regarding sensitive aspects of subjects’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior). 
     
  4. The research does not involve subjects under the age of 18 (except as they are participating in projects that fall under categories 1, 3, 4, and/or 5 in Part B). Category B 2 studies that include minors should be submitted for expedited review. 
     
  5. The research does not involve deception. 
     
  6. The procedures of this research are generally free of foreseeable risk to the subject. 
     
  7. The research does not require a waiver from informed consent procedures.

Exempt: Part B (at least one item should apply)

  1. Research conducted in established or commonly accepted educational settings and involving normal educational practices (e.g., research on regular and special education instructional strategies, research on 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, where information is recorded anonymously (i.e., so that the human subject cannot be identified, directly or indirectly through identifiers linked to the subject). [NB: All survey/interview/observational research in which elected or appointed public officials or candidates for public office serve as subjects is exempt, whether or not data collection is anonymous.] 
  3. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens. These sources must be either publicly available or the information must be recorded anonymously (i.e., in such a manner that subjects cannot be identified, directly or through identifiers linked to the subject). 
  4. Research (including demonstration projects) conducted by or subject to the approval of federal department or agency heads, and designed to study, evaluate, or otherwise examine (i) public benefit or service programs (e.g., social security, welfare, etc.); (ii) procedures for obtaining benefits or services 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. 
  5. Research involving taste or food quality evaluations or consumer acceptance studies, where the tested products are wholesome foods without additives, or foods which contain additives at or below levels found to be safe by the FDA or approved by the EPA of the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Expedited Review: Part A (all items must apply)

  1. The research does not involve as subjects prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults. 
  2. The research does not involve the collection or recording of behavior which, if known outside the research, could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation. 
  3. The research does not involve the collection of information regarding sensitive aspects of the subjects’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).

The procedures of this research present no more than minimal risk to the subject. (“Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.)

Expedited Review: Part B (at least one item should apply)

 

  1. Collection of data from voice, video, or image recordings made for research purposes where identification of the subjects and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

  2. Research on individual or group characteristics or behavior (including but not limited to research involving perception, cognition, surveys, interviews, and focus groups) as follows:

    • Involving adults, where (i) the research does not involve stress to subjects, and (ii) identification of the subjects and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation;

    • Involving children, where (i) the research involves neither stress to subjects nor sensitive information about themselves, or their family; (ii) no alteration or waiver of regulatory requirements for parental permission has been proposed; and (iii) identification of the subjects and/or their responses would not reasonably place them or their family members at risk of criminal or civil liability or be damaging to the financial standing, employability, or reputation of themselves or their family members.

  3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior. [NB: Although confidentiality will be strictly maintained, information will not be recorded anonymously (e.g., use will be made of audio-or videotapes, names will be recorded, even if they are not directly associated with the data).]

  4. Research that involves deception. [NB: Deception must be scientifically justified and de-briefing procedures must be outlined in detail.]

  5. Prospective collection for research purposes of biological specimens; research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required; collection of blood samples by finger stick or venipuncture.

  6. Research previously approved by the convened IRB as follows: 

    • where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or 

    • where the research remains active only for the purposes of data analysis; or 

    • where the IRB has determined that the research involves no greater than minimal risk and no additional risks have been identified; 

    • where no subjects have been enrolled and no additional risks have been identified.

Full Committee Review
If ANY of these apply:

  1. The research involves prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults as subjects.

  2. The research involves the collection or recording of behavior which, if known 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.

  3. The research involves the collection of information regarding sensitive aspects of the subjects’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).

  4. The procedures of the research involve more than minimal risk to the subject (where “more than minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the proposed research is greater than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests).

  5. Any research which does not fall into any of the categories explicitly identified as qualifying for exempt or expedited status.