IRB decisions on submitted research protocols fall into four categories:
1. Exempt from IRB oversight
2. Approved with expeditied review
3. Approved with review of the full committee
4. Disapporved with review of the full committee
Eight categories of research are deemed to involve so low a risk to subjects as not to require IRB oversight. Risk is reduced through anonymity of responses, non-invasive procedures that will not harm subjects, or use of existing or publicly available data whose collection has been undertaken using approved procedures.
A streamlined process has been developed to apply for exempt status. The researcher must complete the one-page Application for Exempt Status, submit it to the IRB, and receive a letter agreeing that the research has exempt status. The research may not proceed without having received a formal designation as exempt.
As the research is conducted, it will be up to the research team to continue to incorporate all ethical principles of conducting rsearch with humans, minimizing risk, maximizing benefit, and ensuring privacy. All rights and protections afforded to human subjects in research also remain applicable and are required.
The eight categories are as follows:
1. Research involving normal educational practices conducted in commonly accepted educational settings, so long as the research is not likely to adversely impact student learning or the status of the instructor.
2. Research involving educational tests, survey procedures, interview procedures, or obseration of public behavior not influenced by the investigator, as long as either a. the identity of the subject cannot readily be ascertained; b. disclosure of the subject's responses would not be reasonably put the subject at risk. No interventions other than data collection are allowed.
3. Research involving benign "behavioral" intervents from adult subjects though verbal or written responses or recording if the subject agrees in advance and the responses would not put the subjects at risk. "Benign" means brief, harmless, painless, not physically invasive, not likely to have adverse lasting impact, and not anticipated to be offensive or embarassing. Procedures may not involve deception of the subject unless the subject has authorized deception in advance.
4. Secondary research involving identifiable private information or biospecimens for which consent is not required. This would be the case for publicly available data sets or private data for which the identity of the subjects cannot be readily ascertained by the secondary researcher.
5. Research conducted by a Federal department or agency designed to study, evaluate, improve, or otherwise examine the public benefit of its programs.
6. Evaluation of quality of taste or food and consumer acceptance studies, as long as wholesome additive-free foods are consumed and all ingredients are found to be safe by the Food and Drug Administration.
7. Storage or maintenance of private information or identifiable biospecimens for potential secondary research for which broad consent is required (see informed consent below).
8. Secondary research for which broad consent is rquired, involving the use of identifable private information or identifiable biospecimens.
The IRB is required to conduct a further “limited review” of research in categories 2, 7, and 8 to verify that adequate provisions are in place to protect the privacy of subjects and the confidentiality of data (for 2) and that broad consent has been obtained and appropriately documented (for 7 and 8).
Certain categories of non-exempt research involve low risk to the subjects or collection of samples and data in a manner that is not anonymous. Protocols for research in some of these categories may nevertheless qualify for expedited review, in which a single member of the Human Subjects Committee (usually the Chair) determines whether the protocol is approved. Since the full committee need not be convened, approval usually takes less time than otherwise.
Protocols approved by the expedited process may commence once word of approval has been received. The approval remains in effect for the duration of the project, subject to periodic reporting to the Committee of any changes in the procedures, requests for changes in the number of subjects to be used, and unanticipated adverse outcomes. As of January 21, 2019 it is no longer required to obtain continuing approval annually for projects originally approved by the expedited process. Once the project is concluded, the Holy Cross Human Subjects Committee asks that a Termination Form be submitted so that we can close the file on that protocol.
Categories ordinarily qualifying for expedited review include the following:
1. Clinical studies of drugs and medical devices, as long as either an investigational new drug application or investigational device exemption application is not required or the medical device is approved for marketing and is being used in accordance with labeling.
2. Collection of blood samples by finger, heel, or ear stick or venipuncture, subject to limitations as to the age, weight, health, and pregnancy status of the subjects and the frequency and volume of sample collected.
3. Noninvasive collection of biological specimens for future research.
4. Noninvasive collection of data routinely employed in clinical practice, not involving sedation or general anesthesia, nor x-rays or microwaves.
5. Materials originally collected for non-research purposes, e.g. medical treatment or diagnosis.
6. Collection of data from voice, video, digital or image recordings made for research purposes.
7. Research on individual or group characteristics or behavior, such as research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior. Research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. Note: This applies only to those studies not deemed exempt.
8. Continuing review of research previously approved by the full committee, as long as no new subjects are to be enrolled, all research interventions have been complete, and only long-term follow-up activities are being undertaken.
9. Continuing review of research in categories 2-8 for which the IRB has found that the research involves no greater than minimal risk and no additional risks have been identified.
Most protocols submitted by Holy Cross researchers qualify for expedited review under category 7. If the designated reviewer cannot approve the protocol as presented, two courses are possible. The researcher can negotiate changes in the protocol to bring it into agreement with the review criteria; or the protocol can be reviewed by the full Committee. Disapproval can only be handed down by majority vote of the full Committee (see below).
Full Committee Review
Protocols in this category include research involving more than minimal risk (with potential offsetting benefit), invasive procedures, issues protecting subject privacy or data confidentiality, or other issues that require a full discussion by the convened Committee on Human Subjects. Up to a month may be needed to complete such a review, since the Committee must have the opportunity to review to protocol, find a time to meet and discuss, and occasionally seek answers to questions that arise from the researcher before coming to a decision. Approvals require a majority vote of the Committee.
Approvals can be for periods of up to one year. If the research will continue beyond that point, the researcher must file a continuation application in enough time that, if deemed necessary, the full Committee can meet to act upon it without the need for interrupting the progress of the research. If conditions 8 or 9 above hold, the continuation review can be carried out by the expedited process. During the year researchers with approved protocols must inform the Committee of any changes in procedure, unexpected adverse responses of subjects, or changes in the numbers of subjects to be used.
Protocols that are not supported by a majority of the Committee are disapproved. The Committee is prepared to work with the researcher to help modify the protocol to bring it into approval status, but that process also takes time.